Forum: Crucell » draadje Malaria » Pagina: 5

[verwijderd] 21 augustus 2006 09:00

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In afwachting van een update......
Factsheet
Malaria

Developing a Malaria Vaccine

Currently there is no effective vaccine to protect against infection with the Plasmodium falciparum parasite, which
causes a great number of cases of malaria. Various treatments are available but due to the worsening problems of
drug resistance in many parts of the world, adequate treatment of malaria is becoming increasingly difficult. In
addition, many insecticides are no longer useful against mosquitoes transmitting the disease.

To develop an effective and safe malaria vaccine, Crucell has formed two collaborative development programs
involving three leading malaria research organizations: New York University (NYU), GlaxoSmithKline Biologicals (GSK),
and Walter Reed Army Institute of Research (WRAIR). Further, in March 2004, the National Institutes of Allergy and
Infectious Diseases (NIAID) agreed to support the development of Crucell's candidate malaria vaccine, in effect
covering full preclinical costs.

Crucell's collaboration with NYU has yielded favorable results demonstrating that Crucell’s candidate malaria vaccine
protected mice against infection with a mouse parasite equivalent to that of the human parasite causing malaria.

The second collaboration is with WRAIR and GSK. The two parties, together with Crucell, have entered into a
Cooperative Research and Development Agreement (CRADA) to evaluate Crucell's candidate malaria vaccine directed
against the human malaria parasite, Plasmodium falciparum. Crucell's candidate vaccine will be tested as a standalone
vaccine or in combination with GSK’s malaria vaccine candidate, called RTS,S.

The GSK candidate malaria vaccine, RTS,S, has been shown to confer partial protection to human volunteers in both a
laboratory challenge model conducted at WRAIR and under natural challenge conditions in a field study conducted in
Gambia. In a study published in the Lancet in October 2004, results from a Phase 2b pediatric trial in Mozambique
showed that the RTS,S vaccine protected a significant percentage of children against uncomplicated malaria infection
and even severe forms of the disease for at least six months. The tests conducted under the CRADA are designed to
assess whether a combination of GSK’s candidate vaccine with Crucell's candidate vaccine can lead to improved
results.

Malaria Vaccine Production Process

Crucell’s candidate malaria vaccine is based on Crucell’s AdVac® technology. It is made by inserting selected parts of
the malaria parasite into an adenoviral vector, which acts as a ‘vehicle’ for vaccination delivery. AdVac® technology
uses adenoviral vectors that do not regularly occur in the human population. In this case, the vector is based on
adenovirus serotype 35 (Ad35).

The AdVac® vector carrying the malaria gene cannot “replicate independently” – it is replication incompetent.
Replication of the vector can only occur in PER.C6® cells. Once the vector carrying the malaria gene is introduced to
PER.C6® cells, large quantities of the vector are produced, making commercial-scale manufacturing of the vaccine
possible. The resulting product then undergoes extensive purification before use as a vaccine.

This vaccination method provides a very important safety advantage, while ensuring that a strong immune response is
elicited against the malaria parasite. The steps used in producing such a vaccine are outlined in a simplified form in the
following diagram.

Figure 1. Malaria Vaccine Production Process

About PER.C6® Technology

Crucell's PER.C6® human cell line technology is ideally suited for the development and large-scale manufacturing of a
wide range of biopharmaceuticals including vaccines, antibodies, therapeutic proteins and gene therapy products.
Many of today's vaccines are produced on animal-derived substrates, including fertilized chicken eggs and mouse
brains. To overcome limitations in production capacity, processing time, and potential safety risks associated with the
use of animal-derived substrates, Crucell's PER.C6® technology is an attractive alternative production technology for
the manufacturing of inactivated whole virus, live-attenuated, live-vector and subunit vaccines. PER.C6® technology
supports the growth of a wide variety of human disease-causing viruses that can subsequently be processed into
vaccines suitable for administration to humans. Many viruses have been demonstrated to efficiently replicate on
PER.C6® cells. In addition, Crucell's PER.C6® technology allows for efficient production of recombinant vaccines.

About AdVac®

AdVac® technology supports the practice of inserting genetic material from a disease-causing virus or parasite into a
‘vehicle’ called a vector, which then delivers the immunogenic material directly to the immune system. Currently, the
most commonly used recombinant vaccine vector is based on adenovirus serotype 5 (Ad5), a virus that causes the
common cold. However, antibodies to Ad5 are widespread among people of all ages and are known to lower the
immune response to recombinant Ad5-based vaccines, thereby impairing the efficacy of these vaccines. The AdVac®
technology is specifically designed to manage the problem of pre-existing immunity in humans against Ad5, without
compromising large-scale production capabilities or the immunogenic properties of Ad5. AdVac® technology is based
on adenovirus vectors that do not regularly occur in the human population, such as adenovirus serotypes 11 and 35. In
view of the prevalent pre-existing immunity to Ad5 in humans, AdVac® vectors may potentially be more effective
vaccine vectors. All of Crucell’s vaccine candidates based on AdVac® are produced using Crucell’s PER.C6® production
technology.

[verwijderd] 21 augustus 2006 09:01

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Crucell is developing a recombinant malaria vaccine based on Crucell's AdVac® technology and produced on Crucell's PER.C6® production technology. The vaccine is made by inserting the gene for the circumsporozoite protein (CSP) from the malaria parasite, Plasmodium falciparum, into an adenoviral vector, which acts as a 'vehicle' for vaccination delivery. AdVac® technology uses adenoviral vectors that do not regularly occur in the human population. In this case, the vector is based on adenovirus serotype 35 (Ad35).

Malaria, together with HIV/AIDS and tuberculosis, is one of the major public health challenges undermining development in the poorest countries in the world. In fact, malaria currently represents one of the most prevalent infections in tropical and subtropical areas causing severe illness in up to 500 million individuals worldwide, and causing up to three million deaths each year.
Malaria is caused by a one-cell parasite called Plasmodium. The Plasmodium falciparum parasite accounts for the majority of infections and is the most lethal type. The parasite is transmitted from person to person through the bite of female Anopheles mosquitoes. Infected mosquitoes inject the malaria parasites into the bloodstream, where they remain for a few minutes before invading the liver cells. Once in the liver, the parasites replicate and develop for about one week until released into the bloodstream. The parasites then invade red blood cells, where they undergo several stages of replication and development before invading new red blood cells. When susceptible mosquitoes ingest infected blood, the parasite completes its maturation inside the insect's gut, finally migrating to the mosquitoes salivary glands. The malaria life cycle is perpetuated when the infected mosquito bites a new human host.
Malaria symptoms appear about 9 to 14 days after the infectious mosquito bite, although this varies with different Plasmodium species. Typically, the symptoms of infection are flu-like including chills, fever and sweating, accompanied by headache, nausea and vomiting. Life-threatening illnesses, such as severe anemia or cerebral malaria, may occur in some infected individuals.

Despite earlier promising results in the 1960’s with prototype vaccines, there is no effective vaccine against malaria available today.
Various treatments are available but due to the worsening problems of drug resistance in many parts of the world, adequate treatment of malaria is becoming increasingly difficult. In addition, many insecticides are no longer useful against mosquitoes transmitting the disease.

Crucell’s candidate malaria vaccine is currently in preclinical development. To develop a safe and effective malaria vaccine, Crucell has formed two collaborative development programs involving three leading malaria research organizations: New York University (NYU), GlaxoSmithKline Biologicals (GSK) and Walter Reed Army Institute of Research (WRAIR). Further, in March 2004, the National Institute of Allergy and Infectious Diseases (NIAID) agreed to support the development of Crucell's candidate malaria vaccine, in effect covering full preclinical costs.
Crucell's collaboration with NYU has yielded favorable results demonstrating that Crucell's candidate malaria vaccine protected mice against infection with a mouse parasite equivalent to that of the human parasite causing malaria.
The second collaboration is with the WRAIR and GSK. The two parties, together with Crucell, have entered into a CRADA to evaluate Crucell's vaccine candidate directed against the human malaria parasite Plasmodium falciparum. Crucell's vaccine candidate is undergoing testing as a stand-alone vaccine or in combination with GSK's malaria vaccine candidate, called RTS,S.
The GSK malaria vaccine candidate RTS,S has been shown to confer partial protection to human volunteers in both a laboratory challenge model conducted at WRAIR and under natural challenge conditions in a field study conducted in the Gambia. The tests conducted under the CRADA are designed to assess whether a combination of the GSK vaccine candidate with Crucell's vaccine candidate can lead to improved results. The first results from the studies with WRAIR and GSK resulted in highly effective immune responses for Crucell's AdVac®-based malaria vaccine.

Crucell's malaria vaccine is expected to enter Phase I trials in the second quarter of 2006.

***************
En de linkjes uit de posting van ivet:

www.bernabiotech.com/news/archive/new...

www.bernabiotech.com/news/archive/new...

www.pevion.com/downloads/pevion/doc/P...

www.iex.nl/forum/topic.asp?forum=228&...

[verwijderd] 21 augustus 2006 19:00

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Vaccine. 2006 Aug 1; [Epub ahead of print] Links
Viral vectors for malaria vaccine development.Li S, Locke E, Bruder J, Clarke D, Doolan DL, Havenga MJ, Hill AV, Liljestrom P, Monath TP, Naim HY, Ockenhouse C, Tang DC, Van Kampen KR, Viret JF, Zavala F, Dubovsky F.
PATH Malaria Vaccine Initiative, Bethesda, MD, USA.

A workshop on viral vectors for malaria vaccine development, organized by the PATH Malaria Vaccine Initiative, was held in Bethesda, MD on October 20, 2005. Recent advancements in viral-vectored malaria vaccine development and emerging vector technologies were presented and discussed. Classic viral vectors such as poxvirus, adenovirus and alphavirus vectors have been successfully used to deliver malaria antigens. Some of the vaccine candidates have demonstrated their potential in inducing malaria-specific immunity in animal models and human trials. In addition, emerging viral-vector technologies, such as measles virus (MV), vesicular stomatitis virus (VSV) and yellow fever (YF) virus, may also be useful for malaria vaccine development. Studies in animal models suggest that each viral vector is unique in its ability to induce humoral and/or cellular immune responses. Those studies have also revealed that optimization of Plasmodium genes for mammalian expression is an important aspect of vaccine design. Codon-optimization, surface-trafficking, de-glycosylation and removal of toxic domains can lead to improved immunogenicity. Understanding the vector's ability to induce an immune response and the expression of malaria antigens in mammalian cells will be critical in designing the next generation of viral-vectored malaria vaccines.

PMID: 16914237 [PubMed - as supplied by publisher]
www.ncbi.nlm.nih.gov/entrez/query.fcg...

[verwijderd] 30 augustus 2006 13:12

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www.iex.nl/forum/topic.asp?forum=228&...

Japies - 30 aug 06, 13:05 | Reageer | Quote | Zoek | Aanbevolen: 0

yinx schreef:

- Crucell indicated that it intends to arrange funding from several foundations for its malaria vaccine. We believe that a likely foundation to fund this programme would be the Gates Foundation, which has been highly active in the field of malaria. Furthermore, Crucell stated it is confident that it can move this programme forward on its own, which should create more value for Crucell.

YinX

Likely???? the Bill gates Foundation??
Mag ik even wijzen op het feit dat Ronald Brus tijdens het bedrijfsbezoek waar ik bij was, de Bill Gates Foundation heeft genoemd als zijnde geldverstrekker voor het malaria onderzoek!
Zie mijn verslag:
iex.nl/forum/topic.asp?forum=228&topi...

Japies schreef:

* Malaria wordt grotendeels betaald door amerikaanse leger en Bill Gates Foundation (via GSK?). Crucell stelt zich hard op richting GSK momenteel, immers via Berna kan Crucell nu ook zelf produceren en verkopen.

Dit is geen toeval meer, nu dit ook bij Kempen erin staat! Laat mij maar verbanden leggen, ik vind het heerlijk! De conference call wordt steeds mooier :)!!!

Japie

[verwijderd] 30 augustus 2006 13:26

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quote:
Japies schreef:
Dit is geen toeval meer, nu dit ook bij Kempen erin staat! Laat mij maar verbanden leggen, ik vind het heerlijk! De conference call wordt steeds mooier :)!!!
Japie

Lekker blijven breien Japie, chapeau!

[verwijderd] 2 september 2006 20:52

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Uit Cicero (LUMC), 1 september 2006 | nummer 10

De voorbereidingsstrategie van de malariaparasiet

Klaargelegd voor later

Alles willen ze weten van de boosdoener, maar vooral hoe hij zich voortplant. Wat er aan de
bevruchting voorafgaat, welke voorbereidingen voor de geboorte er worden getroffen en hoe
het in de kraamkamer toegaat. Andy Waters en collega-onderzoekers zijn al jaren bezig met
het doorgronden van de parasiet die malaria veroorzaakt. De nieuwste ontdekking betreft een
eiwit dat klaargelegd wordt voor na de bevruchting. door WILLY VAN STRIEN

Wie veel mensen te eten krijgt, zal de gerechten van tevoren
zoveel mogelijk klaarmaken zodat alles met etenstijd snel
op tafel staat. Iets dergelijks doet de malariaparasiet. Voorlopers van vrouwelijke geslachtscellen in de bloedcellen van de gastheer (bijvoorbeeld een besmet persoon) bereiden de productie voor
van eiwitten die later in de maag van de mug nodig zijn. Dat blijkt uit
een artikel van de groep van prof. dr. Andy Waters en dr. Chris Janse
(Parasitologie) in Science van 4 augustus.

Voorbereidingsstrategie

Waters en Janse zijn erop uit de biologie van Plasmodium tot in de fi nesses te doorgronden, in de hoop aanknopingspunten te vinden voor bestrijding. Hogere dieren, wisten ze, passen een voorbereidingsstrategie
(translational repression) toe op genen die na bevruchting nodig zijn
voor de ontwikkeling van het jonge embryo. Rijpende eicellen schrijven
het betrokken dna alvast over tot boodschapper-rna, maar ze vertalen
dat vervolgens niet meteen tot eiwitten. In plaats daarvan bewaren ze
het boodschapper-rna voor later, na bevruchting, in speciale eiwitcomplexen. Waters kreeg het vermoeden dat de malariaparasiet, Plasmodium, dit ook doet en stapsgewijs heeft hij dat laten zien. “De nieuwste
publicatie maakt de puzzel af”, zegt hij.
Zijn groep had al ontdekt dat negen genen in de voorlopers van vrouwelijke geslachtscellen wel worden overgeschreven tot boodschapperrna, maar niet tot eiwitten vertaald. Vervolgens hadden de onderzoekers in vrouwelijke cellen een eiwit gevonden, dozi, dat boodschapperrna kan binden. Het vermoeden werd een waarschijnlijkheid.

Snel afgebroken

Nu heeft de groep, met name dr. Gunnar Mair, de voorbereidings-strategie bewezen. De onderzoekers lieten zien dat acht van de negen
boodschapper-rna’s inderdaad aan dozi gebonden zijn in vrouwelijke
voorloper-geslachtscellen. Ze schakelden dozi uit om te kijken wat er
dan gebeurt. Manlijke geslachtscellen, die overigens geen dozi maken,
bleven gewoon functioneren. Maar vrouwelijke geslachtscellen weigerden na bevruchting tot ontwikkeling te komen. En wat gebeurt er met
het boodschapper-rna als er geen dozi is? Waters: “Dat wordt dan niet
bewaard en ook niet tot eiwit vertaald, maar snel afgebroken.”
Conclusie: dozi zorgt ervoor dat de productie van bepaalde eiwitten
wordt opgeschort door het boodschapper-rna te bewaren. De groep
van Waters en Janse ontdekte tenslotte dat de productie van veel meer
dan negen eiwitten wordt voorbereid, maar opgeschort.

Van gist tot mens

De vondst is vooral wetenschappelijk interessant. dozi lijkt op het eiwit dat boodschapper-rna bindt van andere soorten, van gist tot mens.
De voorbereidings-strategie moet dus al vroeg in de evolutie zijn ontstaan. Net als andere soorten kan Plasmodium zich dankzij dozi na
bevruchting ontwikkelen. De afkorting staat voor development of zygote
inhibited, oftewel: ontwikkeling van bevruchte eicel geremd (namelijk
in afwezigheid van dozi). Maar voor de parasiet heeft de strategie nog
een voordeel. De voorlopers van de geslachtscellen zitten in de bloedcellen van de gastheer (besmette persoon). Pas als ze door een mug
zijn opgezogen, rijpen ze in diens maag en vindt bevruchting plaats.
De vele door dozi gespaarde boodschapper-rna’s coderen ook voor eiwitten die betrokken zijn bij de overgang naar het nieuwe milieu en de
rijping. De geproduceerde eiwitten zouden in de gastheer een afweerreactie oproepen, dus het is slim om de aanmaak uit te stellen.

Afweerreactie

Toepassing is nog ver weg. Maar wellicht is het in de toekomst mogelijk de vorming van eiwitcomplexen waarin boodschapper-rna wordt
bewaard tegen te gaan zodat de eiwitten al in de gastheer verschijnen;
tegen die voortijdig geproduceerde eiwitten kan dan een afweerreactie
worden opgewekt via een vaccin. Of het is misschien mogelijk het uiteenvallen van de rna-bevattende eiwitcomplexen in de mug te verhinderen, zodat seksuele voortplanting van de parasiet geblokkeerd
wordt.

www.lumc.nl/1080/uitgaven/pdf/2006nr1...
Pagina 23.

[verwijderd] 3 september 2006 10:52

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Public release date: 1-Sep-2006
Contact: Katarina Sternudd

New findings could lead to vaccine for severe malaria

The most severe form of malaria hits pregnant women and children the hardest. A joint study between Karolinska Institutet in Sweden and Makerere University in Uganda has now produced some important findings on how the malaria parasite conceals itself in the placenta.
Plasmodium falciparium is the name of by far the most virulent of the four malaria parasites that infect man. It is particularly dangerous in that it also infects the placenta of pregnant women, with fatal consequences for both her and the foetus. This, combined with the often feeble medical resources of malaria-stricken countries, can lead to such serous complications that the mother dies during delivery.
"For some reason, women in their first pregnancy lose the semi-immunity that is normally found in adults," explains Niloofar Rasti, a KI graduate student who has been working with the study. "The placenta seems to be an anatomically favourable environment for a subpopulation of the parasites."
The research group from Karolinska Institutet, under the leadership of Professor Mats Wahlgren, has been working with colleagues from KI's partner university in Uganda to study in detail how the parasite infects the placenta. Their results, which are published in the American scientific journal PNAS, can enable the development of vaccines and therapies to combat severe malarial infections.
During one particular phase of its lifecycle, the parasite enters human red blood cells, where it produces proteins that attach themselves to receptors in the wall of the blood vessels. This causes the red blood cells to accumulate in organ capillaries, and gives rise to life-threatening symptoms. Adults who have been infected several times can become partly immune as their defence system gradually starts to recognise the parasite's proteins. When the placenta is formed, however, a new environment is introduced with a different set of receptors. This means that a new growth niche is made available to a subpopulation of the parasites.
Earlier studies have suggested that each protein from the parasite attaches to only one specific protein, a receptor, in the placenta. Ms Rasti and her colleagues suspected, however, that the natural mechanisms are more complex than laboratory studies have shown. They therefore collected and analysed placentas on site in Uganda.
"Most of the parasites we studied could bind to three different receptors in the placenta," she says. "This would mean that a future vaccine cannot be based on the principle of one protein-one receptor, as was previously believed."
Now that scientists know that several placental receptors are involved in the binding mechanism, attention will be shifted to the parasite itself, and whether it produces many different surface proteins or if one and the same protein is able to bind to many host receptors.
www.eurekalert.org

[verwijderd] 8 september 2006 20:18

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Locally Acquired Mosquito-Transmitted Malaria: A Guide for Investigations in the United States

Summary
Recent outbreaks of locally acquired mosquito-transmitted malaria in the United States demonstrate the continued risk for reintroduction of the disease. Since 1957, when CDC's Malaria Branch started conducting malaria surveillance, 63 outbreaks have occurred, constituting 156 cases (annual range: 1--32) that were a result of locally acquired mosquitoborne transmission. This report describes the steps that should be taken to 1) investigate a case that might have been acquired locally, 2) prevent a small focus of malaria cases from becoming a source of sustained transmission, and 3) inform clinicians regarding the process of an investigation so they can effectively address concerns and questions from patients.
Although these locally acquired mosquito-transmitted outbreaks frequently involve only a limited number of infected persons, they frequently raise concerns in the community and require substantial public health resources. For example, as a result of the most recent local outbreak of eight malaria cases in Florida in 2003, reverse 911 telephone calls (a community notification system) were made to approximately 300,000 residents; insect repellent, postcards, flyers, and posters in multiple languages were distributed; public announcements were made through the media and to schools and homeless shelters; and notifications were sent to local hospitals and physicians to inform residents of that community.
When a local health department investigates a potential locally acquired mosquito-transmitted case, the systematic inquiry should include epidemiologic, environmental, and laboratory components. Local and state health departments inquiring about the proper approach to investigate and control a potential locally acquired case frequently request urgent assistance and tools from CDC. This report provides a starting point for such investigations to local and state health departments by providing them with the tools necessary to initiate an investigation.
www.cdc.gov/mmwr/preview/mmwrhtml/rr5...

[verwijderd] 16 september 2006 19:02

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WHO backs DDT for malaria control

The World Health Organization (WHO) has reversed a 30-year policy by endorsing the use of DDT for malaria control.

The chemical is sprayed inside houses to kill malaria-carrying mosquitoes.

DDT has been banned globally for every use except fighting disease because of its environmental impacts and fears for human health.
WHO says there is no health risk, and DDT should rank with bednets and drugs as a tool for combating malaria, which kills more than one million each year.
"The scientific and programmatic evidence clearly supports this reassessment," said Dr Anarfi Asamoa-Baah, WHO assistant director-general for HIV/AIDS, TB and Malaria.
"Indoor residual spraying is useful to quickly reduce the number of infections caused by malaria-carrying mosquitoes; it has proven to be just as cost effective as other malaria prevention measures, and DDT presents no health risk when used properly."
Teams of sprayers typically visit endemic areas once a year, spraying the chemical on the inside walls of houses; mosquitoes landing there absorb it and die.

Global ban
A potent insecticide, DDT fell into disrepute with the publication of Rachel Carson's Silent Spring just over 40 years ago.
The book showed that widespread, indiscriminate use of DDT and related compounds was killing wildlife over vast tracts of North America and western Europe.

A number of countries banned it, and in 2004 the global treaty on Persistent Organic Pollutants (POPs) made the prohibition global - except for a clause allowing its manufacture and use in disease control.
Some African countries have continued to use it, though most have either switched to other kinds of insecticide or pursued a strategy of issuing insecticide-impregnated bednets. Some aid agencies have policies of not funding programmes involving DDT.
South Africa was one country that switched, but it had to return to DDT at the beginning of the decade after mosquitoes developed resistance to the substitute compounds.
"Of the dozen insecticides WHO has approved as safe for house spraying, the most effective is DDT," said Arata Kochi, director of the WHO's Global Malaria Programme.
Richard Tren of the pressure group Africa Fighting Malaria has been campaigning for DDT's rehabilitation.
"All development agencies and endemic countries need to act in accordance with WHO's position on the use of DDT for indoor residual spraying," he said.
news.bbc.co.uk/1/hi/sci/tech/5350068.stm

[verwijderd] 17 september 2006 18:54

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Adenovirus Vaccine for Malaria
This study is not yet open for patient recruitment.
Verified by National Institute of Allergy and Infectious Diseases (NIAID) August 2006

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00371189 FPRIVATE "TYPE=PICT;ALT=" Purpose
The study’s purpose is to find out if a new malaria vaccine is effective, safe, and tolerated in healthy adults 18 to 45 years of age. The vaccine is expected to be tolerated in humans and boost immunity to malaria. At least 96 healthy male and female volunteers will participate in this study at Vanderbilt University Medical Center in Nashville, TN. Volunteers will receive 3 doses of either the new malaria vaccine being or a placebo (contains no vaccine) by injection into the shoulder muscle at 0, 1 and 6 months. Investigators will look at the safety and effectiveness of increasing dosage strengths of the vaccine. Increasing the dosage will proceed only after a review of the 2-week safety data of the 2 initial doses of the prior dosage level. Participants will have 13 study visits and complete a Memory Aid (study diary) at home. Blood will be drawn 7 times from each volunteer during participation in the study. Each participant will be followed for about 1 year.

Condition Intervention Phase
Malaria
Vaccine: Ad35, CS
Phase I

MedlinePlus related topics: Malaria
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title: A Phase I Randomized, Controlled, Dosage-Escalation Trial to Evaluate the Immunogenicity, Safety, and Reactogenicity of an Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Healthy Adults 18 to 45 Years of Age
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Expected Total Enrollment: 96
The purpose of this phase I, randomized, controlled, dosage-escalation trial is to evaluate the immunogenicity, safety, and tolerability of an Adenovirus Type 35 Based Circumsporozoite Malaria vaccine in healthy adults 18 to 45 years of age. At least 96 healthy male and female subjects aged 18 to 64 years will be recruited in Nashville, Tennessee for this study conducted at Vanderbilt University Medical Center. Subjects will be randomized in a 5:1 ratio to receive 3 doses of the Adenovirus Type 35 Circumsporozoite (Ad35.CS) Malaria Vaccine or vaccine formulation buffer control by the intramuscular route at 0, 1 and 6 months. The safety and immunogenicity of ascending dosages of the vaccine will be assessed. Fifteen subjects will receive vaccine at each of the following dosage levels: 10 [to the 8th power] vp/ml and 10 [to the 9th power] vp/ml with three subjects receiving control at each of these dosage levels. Twenty-five subjects will receive vaccine at each of the next dosage levels of 10 [to the 10th power] vp/ml and 10 [to the 11th power] vp/ml with five subjects receiving control at each of these dosage levels. Dosage escalation will proceed only after review of the 2-week safety data of the 2 initial doses of the prior dosage level. The primary objective is to assess the safety and reactogenicity of ascending dosages of Adenovirus Type 35 based circumsporozoite malaria vaccine among healthy subjects given in 3 intramuscular doses at 0, 1 and 6 months. The secondary objective is to evaluate the immunogenicity of the Adenovirus Type 35 based circumsporozoite malaria vaccine through performance of Humoral Immune Assays (ELISA [enzyme-linked immunosorbent assay] for antibodies to circumsporozoite antigen and Adenovirus Neutralization Assay for neutralizing antibodies to Adenovirus type 35) and Cellular Immune Assays (Elispot and Flow Cytometry) for CS-specific CD4+ and CD8+ T cell responses. The primary outcome measure will be frequency and severity of local, systemic, and safety laboratory adverse events. The secondary outcome measures will be: 1) antibody titers against the malaria circumsporozoite antigen via ELISA, 2) neutralizing antibody titers against Adenovirus type 35 by Adenovirus Neutralization Assay, and 3) T cell responses against the malaria circumsporozoite antigen by Elispot and Flow Cytometry.

www.clinicaltrials.gov/ct/show/NCT003...

***********************************
A malaria vaccine is also expected to enter a Phase I trial in the third quarter of 2006 at Vanderbilt University in the US. This randomized, double-blind, placebo-controlled study in 76 healthy volunteers will include dose-escalation studies and multiple vaccination regimens. Studies in large animal models have shown that Crucell's recombinant Ad35 vaccine provides a demonstrated higher level of protection than the existing RTS,S vaccines.

[verwijderd] 18 september 2006 00:04

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Our malaria vaccine is expected to enter a Phase I trial in the third quarter of 2006.

[verwijderd] 18 september 2006 03:06

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Zie onder ... op clinicaltrials.gov is afgelopen vrijdag dit document "processed". Is malaria dan in officieel in Phase 1 ? of begint dat bij patient recruitment ?

Please refer to this study by ClinicalTrials.gov identifier NCT00371189

Tennessee
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States

More Information

Study ID Numbers: 05-0050
Last Updated: September 14, 2006
Record first received: August 31, 2006
ClinicalTrials.gov Identifier: NCT00371189
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-09-15

[verwijderd] 18 september 2006 07:29

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quote:
Crusader schreef:
Our malaria vaccine is expected to enter a Phase I trial in the third quarter of 2006.
[/quote]

[quote=patrick_5]
Zie onder ... op clinicaltrials.gov is afgelopen vrijdag dit document "processed". Is malaria dan in officieel in Phase 1 ? of begint dat bij patient recruitment ?

****************************************

Zie pagina 9 in deze draad.

Adenovirus Vaccine for Malaria

This study is NOT YET OPEN for patient recruitment.
Verified by National Institute of Allergy and Infectious Diseases (NIAID) August 2006

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00371189
The study’s purpose is to find out if a new malaria vaccine is effective, safe, and tolerated in healthy adults 18 to 45 years of age. The vaccine is expected to be tolerated in humans and boost immunity to malaria. At least 96 healthy male and female volunteers will participate in this study at Vanderbilt University Medical Center in Nashville, TN. Volunteers will receive 3 doses of either the new malaria vaccine being or a placebo (contains no vaccine) by injection into the shoulder muscle at 0, 1 and 6 months. Investigators will look at the safety and effectiveness of increasing dosage strengths of the vaccine. Increasing the dosage will proceed only after a review of the 2-week safety data of the 2 initial doses of the prior dosage level. Participants will have 13 study visits and complete a Memory Aid (study diary) at home. Blood will be drawn 7 times from each volunteer during participation in the study. Each participant will be followed for about 1 year.

www.clinicaltrials.gov/ct/show/NCT003...

diederique 18 september 2006 19:46

goed bericht voor de betrokkenen !
-----------------

WHO gives indoor use of DDT a clean bill of health for controlling malaria

WHO promotes indoor spraying with insecticides as one of three main interventions to fight malaria

15 SEPTEMBER 2006 | WASHINGTON, D.C. -- Nearly thirty years after phasing out the widespread use of indoor spraying with DDT and other insecticides to control malaria, the World Health Organization (WHO) today announced that this intervention will once again play a major role in its efforts to fight the disease. WHO is now recommending the use of indoor residual spraying (IRS) not only in epidemic areas but also in areas with constant and high malaria transmission, including throughout Africa.

Related links

:: Malaria health topic

“The scientific and programmatic evidence clearly supports this reassessment,” said Dr Anarfi Asamoa-Baah, WHO Assistant Director-General for HIV/AIDS, TB and Malaria. "Indoor residual spraying is useful to quickly reduce the number of infections caused by malaria-carrying mosquitoes. IRS has proven to be just as cost effective as other malaria prevention measures, and DDT presents no health risk when used properly.”

WHO actively promoted indoor residual spraying for malaria control until the early 1980s when increased health and environmental concerns surrounding DDT caused the organization to stop promoting its use and to focus instead on other means of prevention. Extensive research and testing has since demonstrated that well-managed indoor residual spraying programmes using DDT pose no harm to wildlife or to humans.

"We must take a position based on the science and the data," said Dr Arata Kochi, Director of WHO’s Global Malaria Programme. “One of the best tools we have against malaria is indoor residual house spraying. Of the dozen insecticides WHO has approved as safe for house spraying, the most effective is DDT.”

Indoor residual spraying is the application of long-acting insecticides on the walls and roofs of houses and domestic animal shelters in order to kill malaria-carrying mosquitoes that land on these surfaces.

“Indoor spraying is like providing a huge mosquito net over an entire household for around-the-clock protection,” said U.S. Senator Tom Coburn, a leading advocate for global malaria control efforts. “Finally, with WHO’s unambiguous leadership on the issue, we can put to rest the junk science and myths that have provided aid and comfort to the real enemy – mosquitoes – which threaten the lives of more than 300 million children each year.”

Views about the use of insecticides for indoor protection from malaria have been changing in recent years. Environmental Defense, which launched the anti-DDT campaign in the 1960s, now endorses the indoor use of DDT for malaria control, as does the Sierra Club and the Endangered Wildlife Trust. The recently-launched President’s Malaria Initiative (PMI) announced last year that it would also fund DDT spraying on the inside walls of households to prevent the disease.

“I anticipate that all 15 of the country programs of President Bush’s $1.2 billion commitment to cut malaria deaths in half will include substantial indoor residual spraying activities, including many that will use DDT,” said Admiral R. Timothy Ziemer, Coordinator of the President’s Malaria Initiative. “Because it is relatively inexpensive and very effective, USAID supports the spraying of homes with insecticides as a part of a balanced, comprehensive malaria prevention and treatment program. “

Programmatic evidence shows that correct and timely use of indoor residual spraying can reduce malaria transmission by up to 90 percent. In the past, India was able to use DDT effectively in indoor residual spraying to cut dramatically the number of malaria cases and fatalities. South Africa has again re-introduced DDT for indoor residual spraying to keep malaria case and fatality numbers at all-time low levels and move towards malaria elimination. Today, 14 countries in Sub-Saharan Africa are using IRS and 10 of those are using DDT.

At today’s news conference, the World Health Organization also called on all malaria control programmes around the world to develop and issue a clear statement outlining their position on indoor spraying with long-lasting insecticides such as DDT, specifying where and how spraying will be implemented in accordance with WHO guidelines, and how they will provide all possible support to accelerate and manage this intervention effectively.

“All development agencies and endemic countries need to act in accordance with WHO’s position on the use of DDT for indoor residual spraying,” said Richard Tren, Director of Africa Fighting Malaria. “Donors in particular need to help WHO provide technical and programmatic support to ensure these interventions are used properly.”

Indoor residual spraying is one of the main interventions WHO is now promoting to control and eliminate malaria globally. A second is the widespread use of insecticide-treated mosquito nets. While the use of bed nets has long been encouraged by WHO, the recent development of “long-lasting insecticidal nets” (LLINs) has dramatically improved their usefulness. Unlike their predecessors, the long-lasting nets need not be re-dipped in buckets of insecticide every six months as they remain effective for up to five years without retreatment.

Finally, for those who do ultimately become sick with malaria, more effective medicines are increasingly becoming available. Unlike previous antimalarials that have been rendered useless in many regions due to drug resistance, Artemisinin Combination Therapies (ACTs) are now recommended. These lifesaving medications are becoming more widely available throughout the world. In January of this year, WHO took stringent measures to help prevent future resistance to antimalarial medicines by banning the use of malaria monotherapy. An example of the negative consequences of drug resistance is apparent in the threat it poses to intermittent preventive treatment in pregnancy (IPTp), a crucial strategic intervention to protect pregnant women from the consequences of malaria.

Potential funding to scale up the availability of all three of these strategic interventions has dramatically increased over the past few years through the inception of the Global Fund to Fight AIDS, TB and Malaria, World Bank plans to significantly increase its funding for malaria, and the launch of the President’s Malaria Initiative.

“With serious money finally becoming available to fight malaria, it is more imperative than ever that WHO provides sound technical guidance and programme assistance to ensure timely and effective use of these resources,” said Dr Kochi.

Each year, more than 500 million people suffer from acute malaria, resulting in more than 1 million deaths. At least 86 percent of these deaths are in sub-Saharan Africa. Globally an estimated 3,000 children and infants die from malaria every day and 10,000 pregnant women die from malaria in Africa every year. Malaria disproportionately affects poor people, with almost 60 percent of malaria cases occurring among the poorest 20 percent of the world’s population.

[verwijderd] 1 oktober 2006 01:28

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Of het nu vaccin is of spray,er is wel een veilig ,goed,productie platform nodig,en op de human-cellbased PERc6 is al een hoop vertrouwen gemeld,kortom,Crucell zal hier een major rol in spelen,en is al ver met haar eigen onderzoeken,waar we de komende weken nog wat van gaan horen!!!!

RB

[verwijderd] 1 oktober 2006 10:26

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Onrust over middel tegen malaria in Oeganda 27 - 09 - 2006
Bron: IPS/OneWorld
Bewoners van het zuidwesten van Oeganda klagen over bijwerkingen van een bestrijdingsmiddel tegen malaria. Het middel wordt vanaf juni door de organisatie USAID verspreid.

Hoofdpijn, duizeligheid, tijdelijk gehoorverlies en jeukende ogen, oren en neus. Dat zijn volgens het Oegandese ministerie van Landbouw de klachten van de mensen die het middel gebruikten.

Het programma van de Amerikaanse organisatie USAID werkt met het insectenbestrijdingsmiddel lambda-cyhalothrin (Icon), een product van de Amerikaanse chemiereus Monsanto.

Tussen 1 juni en 22 augustus van dit jaar werden ruim 100.000 huizen in het Oegandese Kabale behandeld met Icon. Het middel wordt binnenshuis gebruikt: de binnenmuren en de binnenkant van het dak worden ermee besproeid.

'Niet schadelijk op lange termijn'

Projectcoördinator Patrick Buyinza van USAID stelt dat Icon op lange termijn geen schadelijke gevolgen voor milieu en gezondheid veroorzaakt. In een interview zei hij dat muggen in het door malaria geteisterde Kabale doodvielen zodra ze in aanraking kwamen met Icon. 'Icon bestrijdt niet alleen malariamuggen, maar ook kakkerlakken, vliegen en luizen, allemaal schadelijke bacillendragers.'

Ook Patrick Tusiime, directeur van de lokale gezondheidsdienst, doet de klachten over het bestrijdingsmiddel Icon af als tijdelijk. Hij benadrukt het belang van de malariabestrijding. De ziekte maakt volgens hem dagelijks 320 doden in Oeganda.

Het Oegandese ministerie van gezondheid is bezig met een onderzoek naar mogelijk schadelijke gevolgen van het middel.

Het sproeien met Icon werd eind augustus stilgelegd. Volgens Buyinza heeft dat niets te maken met de klachten. De pauze zou ingelast zijn om het project te evalueren voordat het in januari volgend jaar een vervolg krijgt.

Internationaal programma

Ook in Angola en Tanzania heeft USAID een Icon-programma lopen, in samenwerking met de International Union for Conservation of Nature (IUCN). Afhankelijk van de effectiviteit van het project in Kabale, wil de Oegandese regering het middel ook inzetten in de rest van het land.

De klachten over Icon komen vlak na een hernieuwde interesse in het middel DDT, dat ook binnenshuis gebruikt wordt om malariamuggen te bestrijden. DDT heeft decennialang op de zwarte lijst gestaan, maar vorige week drong de WHO erop aan DDT opnieuw als bestrijdingsmiddel in te zetten.

www.oneworld.nl/index.php?page=_conte...

Word tijd voor iets nieuws ;-)

[verwijderd] 1 oktober 2006 10:34

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A Malaria Vaccine That Elicits in Humans Antibodies Able to Kill Plasmodium falciparum

He wat staat daar nou Berna?

Methods
Clinical Trial
The conditions for production of the MSP3 LSP under Good Manufacturing Practices, quality assurance, quality control, pharmacotoxicity, enrolment of the 36 volunteers, and clinical and laboratory investigations, have been described in detail elsewhere [15]. Briefly, 36 volunteers with no previous history of malaria were recruited for the study and were randomly allocated to six treatment groups, with no major imbalance in sex and age distributions. The study was approved by the Institutional Review Board. Immunisations were performed subcutaneously at months 0, 1, and 4. Samples for immunological studies were taken 1 mo after each immunisation, i.e., at months 1, 2, and 5. The MSP3 LSP polypeptide was adjuvated either by Montanide ISA720 (SEPPIC, Paris, France) or adsorbed onto aluminium hydroxide (alum; Berna Biotech, Bern, Switzerland). The dose-escalating trial design included four dosages with Montanide of 10 μg, 20 μg, 30 μg, or 100 μg of polypeptide, and two groups with alum with either 30 μg or 100 μg of polypeptide. In view of the very strong immunogenicity of the molecule, and of local DTH reactions mostly with Montanide (in four of the five cases recorded), the original protocol of immunisation was amended by the clinicians [15] so that the final regimens received by the six different treatment groups were as follows: for Montanide (each polypeptide dose given in micrograms), 10–10–10, 30–30–10, 100–10–10, and 20–20–20, and for alum, 30–30–30 and 100–10–10. Thirty volunteers underwent the full immunisation schedule. The corresponding 90 sera collected at months 0, 5, and 12 were used in the present study.

Conclusion
This is the first malaria vaccine clinical trial to clearly demonstrate antiparasitic activity by vaccine-induced antibodies by both in vitro and in vivo methods. The results, showing the induction of long-lasting antibodies directed to a fully conserved polypeptide, also challenge current concepts about malaria vaccines, such as unavoidable polymorphism, low antigenicity, and poor induction of immune memory.

medicine.plosjournals.org/perlserv/?r...

gogogoo 1 oktober 2006 10:45

www.bernabiotech.com/news/archive/new...

[verwijderd] 2 oktober 2006 14:26

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quote:
flosz schreef:
Adenovirus Vaccine for Malaria
This study is not yet open for patient recruitment.
Verified by National Institute of Allergy and Infectious Diseases (NIAID) August 2006
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
www.clinicaltrials.gov/ct/show/NCT003...

***********************************
Studies in large animal models have shown that Crucell's recombinant Ad35 vaccine provides a demonstrated higher level of protection than the existing RTS,S vaccines.

Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.

This study is not yet open for patient recruitment.
Verified by GlaxoSmithKline September 2006

Sponsors and Collaborators: GlaxoSmithKline
(JMP) Korogwe, Tanzania
Kenya KEMRI)
Wellcome Collaborative Research Programme Kilifi, Kenya
(MVI) at Program for Appropriate Technology in Health (PATH)
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00380393 Purpose
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Bio’s Candidate Vaccine RTS,S/AS01, Administered According to a 0,1,2-Mths Schedule in Children Aged 5 to 17 Mths Living in Tanzania & Kenya
Further study details as provided by GlaxoSmithKline:
Primary Outcomes: Time to 1st case of malaria (P. fal infection >2500 parasites/mcL & fever >=37.5 C) over a period starting 14 days post-Dose 3 & extending for 4 mths; safety
Expected Total Enrollment: 890
Study start: September 2006
Study ID Numbers: 106464
Last Updated: September 26, 2006
Record first received: September 25, 2006
ClinicalTrials.gov Identifier: NCT00380393
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-09-29
clinicaltrials.gov/ct/show/NCT0038039...

[verwijderd] 3 oktober 2006 08:13

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Uit de posting van Robert( draadje Weinig nieuws uit Hoorn 02/10):

De malariadeal had eigenlijk al erdoor moeten zijn maar nu toch binnen enkele weken moet komen i.s.m. Walter Reed(wrair) en GSK.
www.iex.nl/forum/topic.asp?forum=228&...

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