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Dear friends of the PATH Malaria Vaccine Initiative,
This World Malaria Day allows us to recognize the unique impact of our collaborative work. In addition to unprecedented progress toward a first-generation malaria vaccine, we have expanded our partnerships to advance a new generation of malaria vaccine approaches that support the global push to eradicate malaria.
Already this year, our collaboration with GlaxoSmithKline Biologicals (GSK) and African researchers has achieved an important milestone. At the end of January, the large-scale Phase 3 efficacy trial of RTS,S reached its target enrollment of more than 15,000 infants and young children in seven African countries.
In addition to approaches meant to protect young children in Africa against clinical disease, our projects now include transmission-blocking vaccine approaches that seek to disrupt the life cycle of the malaria parasite and interrupt transmission of the parasite from mosquitoes to humans. The idea of a transmission-blocking vaccine is attracting heightened interest, as such a vaccine could have the potential to be used with more traditional vaccines and with other malaria interventions to make elimination and eventually eradication of the disease a reality.
Pursuing this multi-pronged research and development strategy also means diversifying our collaborations, as demonstrated by our work with partners such as India's Gennova Biopharmaceuticals Ltd., the Johns Hopkins Bloomberg School of Public Health, Merck, New York University (NYU), and the Sabin Vaccine Institute.
We look forward to continued productive collaborations throughout the remainder of 2011. In addition to the release of the first RTS,S Phase 3 data, we expect to begin a clinical trial of at least one prime-boost approach and to bring into our portfolio more projects focused on blocking transmission of the parasite from mosquitoes to humans. We expect to release at least two reports, one on perceptions of malaria and vaccines in several African communities, and the other on recent trends in funding for malaria research and development.
Finally, MVI has joined other PATH programs based in this metropolitan area in new quarters in Washington, DC. You can find us at:
455 Massachusetts Avenue, NW
Suite 1000
Washington, DC 20001
Phone: 202.822.0033
We wish you success on this World Malaria Day and look forward to new ventures and adventures throughout the year.
Sincerely,
Christian Loucq, MD
Director
PATH Malaria Vaccine Initiative
mvi_info@path.org
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What’s in, what’s out in the MVI pipeline?
 What’s new?
- Expanded focus on TBVs: Tulane University/Gennova Biopharmaceuticals, Johns Hopkins University (JHU)/Sabin (and more will be added in 2011).
- Fewer blood-stage projects: in 2009, there were six projects; now we have three.
- New focus on Plasmodium vivax: a collaboration with the Walter Reed Army Institute of Research (WRAIR) and GSK and another with the International Centre for Genetic Engineering & Biotechnology (ICGEB).
- New feasibility studies with NYU/Merck, Emory University, JHU/Oncovir/Infectious Disease Research Institute (IDRI), University of Pennsylvania/Inovio, Liquidia, and others.
What’s out?
- Collaborative projects with Sanaria, GenVec, Lipoxen, Juvaris, and Rockefeller Foundation/National Institutes of Health.
What’s still going strong?
- RTS,S vaccine candidate and Crucell Ad35.CS/Ad26.CS prime-boost translational project.
See the current MVI portfolio here.
Full enrollment achieved in large-scale Phase 3 malaria vaccine candidate trial
The large-scale Phase 3 efficacy trial for the RTS,S malaria vaccine candidate successfully reached its target enrollment on January 31, 2011. Total enrollment for the study is 15,460 young children (6,537 infants aged 6–12 weeks and 8,923 children aged 5–17 months). Vaccination of the children participating in the study will continue until the end of 2012, with additional follow-up through the end of 2013. If all goes well in Phase 3 testing, the World Health Organization (WHO) has indicated that a policy recommendation for RTS,S is possible as early as 2015, paving the way for decisions to be made by African nations regarding implementation of the vaccine through their national immunization programs.
This Phase 3 trial began in May 2009, with the first child vaccinated in Bagamoyo, Tanzania, at one of 11 trial sites in seven sub-Saharan African countries participating in the study. Initial results from the study are expected in late 2011 for the 5–17 month age group and late 2012 for the 6–12 week group. The final analysis is expected in late 2014.
RTS,S is the most clinically advanced malaria vaccine candidate in the world. In clinical trials, it was the first to demonstrate that it can provide substantial, although not complete, protection for young children and infants in malaria-endemic areas against infection and clinical disease caused by P. falciparum, the most deadly species of the malaria parasite.
In January 2001, GSK and MVI—with grant monies from the Bill & Melinda Gates Foundation to MVI—entered into a public-private partnership to develop the vaccine for use in infants and young children in sub-Saharan Africa. Beginning in 2001, Phase 2 trials were conducted in partnership with African health research institutions. Today, RTS,S is the first malaria vaccine candidate to ever reach large-scale Phase 3 clinical testing, one of the final stages of development before regulatory file submission.
Transmission-blocking vaccine workshop
MVI held a well-received transmission-blocking vaccine (TBV) workshop last June in Bethesda, Maryland. Organized by MVI’s Elimination and Eradication team, the discussion focused on (a) whether the development of a vaccine that targets only P. falciparum and/or P. vivax sexual, sporogonic, and/or mosquito antigens is biologically and technically feasible, and (b) whether such a vaccine could have a policy and regulatory pathway defined for licensure and use in conjunction with other malaria interventions. Participants included senior research professionals from government, academia, and industry; regulatory experts from the US Food and Drug Administration (FDA) and WHO; and leading African public health professionals. Outcomes included:
- A statement by an FDA representative that licensing a TBV is possible, but a regulatory decision on each vaccine approach would be made in the context of a specific application.
- The identification of seven priority areas for follow-up and a proposal that working groups be formed around each area: (1) regulatory and policy pathways; (2) assays and correlates of protection; (3) clinical development plans; (4) baseline data required for field efficacy testing and measures of transmission; (5) product design; (6) scenarios for vaccine implementation; and (7) ethics and communication. Most of these groups have formed and have begun their work.
MVI and Sanaria conclude clinical development activities
MVI has concluded its clinical development activities with the Maryland-based company Sanaria Inc. MVI had been collaborating with Sanaria to accelerate development of a novel malaria vaccine approach. The collaboration focused on the development and manufacture of Sanaria’s PfSPZ malaria vaccine—one that uses a weakened form of the whole malaria parasite (at its sporozoite stage) harvested from irradiated mosquitoes.
While Sanaria will continue to advance the development of their approach, MVI’s role in these efforts concludes with the Phase1/2a clinical trial.
Malaria vaccine development at RBM board meeting
 Responding to a request from the Roll Back Malaria (RBM) Partnership
, MVI director Christian Loucq led a briefing on the status of malaria vaccine development at the December RBM Partnership board meeting. He was joined by Dr. Roma Chilengi, former head of clinical trials for the KEMRI-Wellcome Trust Collaborative Research Programme
and former principal investigator for the RTS,S Phase 3 clinical trial at Kilifi, Kenya, who focused on the history and development of RTS,S. Drs. Loucq and Chilengi made a total of six presentations as board members and others moved through a “marketplace” held on the first day of the three-day meeting at the Mulungushi International Conference Center in Lusaka, Zambia. Also on hand to help answer questions was Jon Pender, vice president of government affairs, intellectual property & access, GlaxoSmithKline.
Other news
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