MVI Update: News from the PATH Malaria Vaccine Initiative

This issue: December 2011

Greetings from the director, Dr. Christian Loucq

Dear friends of the PATH Malaria Vaccine Initiative,

It has been an eventful few months at MVI, from the publication of the first RTS,S results in the New England Journal of Medicine to the announcement of Director Christian Loucq’s departure from MVI. Through it all, we continued on the march toward a first-generation malaria vaccine, while expanding our partnerships to advance new malaria vaccine approaches that support the global push to eradicate malaria.

We were encouraged by the first results from the Phase 3 RTS,S efficacy trial: the data show that this malaria vaccine candidate, under development with GlaxoSmithKline Biologicals (GSK), provides young African children with significant protection against clinical and severe malaria. These results are also evidence of the power of partnerships, and we tip our hats to our colleagues at GSK, the African research centers where the trial is being conducted, and to their Northern partners. We especially want to acknowledge the contribution and commitment of the trial participants’ parents and their communities in making this study possible.

We continued to work apace on other vaccine approaches and on diversifying our partnerships. Just this month, we announced a collaboration with the US National Institutes of Health and the Johns Hopkins Bloomberg School of Public Health to conduct a clinical trial of a transmission-blocking vaccine (TBV), the first TBV trial MVI has supported. TBV approaches aim to disrupt the lifecycle of the malaria parasite and interrupt transmission of the parasite from humans to mosquitoes. We also began a clinical trial of MVI’s second prime-boost approach—Ad35.CS/Ad26.CS—with Crucell and Seattle Biomedical Research Institute.

Finally, we said goodbye to our director, Christian Loucq, in November. Christian has moved to Seoul, South Korea, to take up his new position as Director General at the International Vaccine Institute. Christian led MVI for nearly five years; his many accomplishments include taking MVI through the launch of the Phase 3 trial of RTS,S and through a major rethinking of our research and development strategy. All of us wish him the best in his new role and look forward to our paths continuing to cross in the months and years ahead.

As we approach 2012, we look forward to charting new territory with our next director, for whom a global search is already well underway, to the forging of new partnerships, and to the success of ongoing collaborations.

To our partners, friends, and supporters, we wish you a very happy new year!

Sincerely,

The PATH Malaria Vaccine Initiative team
mvi_info@path.org

 

First results from Phase 3 trial of RTS,S

On October 18, the first results from the large-scale Phase 3 trial of RTS,S, the world’s most clinically advanced malaria vaccine candidate, were published in the New England Journal of Medicine and announced at the Malaria Forum hosted by the Bill & Melinda Gates Foundation in Seattle, Washington. The results showed that RTS,S reduced the risk of children 5 to 17 months of age experiencing clinical malaria and severe malaria by 56 percent and 47 percent, respectively, over a 12-month follow-up period. The vaccine candidate also demonstrated an acceptable safety and tolerability profile. Efficacy results for clinical and severe disease in infants 6 to 12 weeks of age are anticipated by the end of 2012, with longer-term results, which will also report on the effects of a booster dose, expected in 2014.

RTS,S is under development through a collaboration between GlaxoSmithKline Biologicals and MVI, together with prominent African research centers and their Northern partners, and with the support of the Bill & Melinda Gates Foundation to MVI.

“This trial represents a powerful example of the high-quality science that is moving us toward controlling and someday potentially eliminating malaria,” said PATH CEO Chris Elias at the time of publication.

Read more »

Malaria Vaccine Decision-Making Framework in Gabon

On December 5 and 6, MVI facilitated a meeting on RTS,S and the Malaria Vaccine Decision-Making Framework, organized by the Medical Research Unit of Lambaréné Albert Schweitzer Hospital in collaboration with the Ministry of Health and Social Affairs of Gabon. Dr. Maxime Agnandji, the RTS,S study Principal Investigator in Gabon, presented the RTS,S results to the assembly, which then discussed the implications of the results for public health and malaria within the context of Gabon.

Attendees also revisited the generic document for the Gabon Malaria Vaccine Decision-Making Framework that was developed in 2008 and suggested changes, resulting in an updated national version and a recommendation to establish a group to work on implementation of the framework for decisions on RTS,S. In order to form the group, the Expanded Program on Immunization Director will suggest relevant staff to the Director General of Health Programmes. The group will be officially appointed as the national technical advisory group on the RTS,S decision-making framework by the first quarter of 2012.

Meeting attendees included health authorities at the central and provincial levels, scientists from national research institutions and the University of Libreville, Gabon Food and Drug Administration representatives, the president of the national ethics committee, partners, and representatives from the World Health Organization country office.

MVI collaborates with two organizations in a clinical trial of a transmission-blocking vaccine

MVI has partnered with the National Institute of Allergy and Infectious Diseases at the US National Institutes of Health and the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research to evaluate a potential transmission-blocking vaccine (TBV) candidate—Pfs25—in a Phase 1 clinical trial in adults.

Pfs25 is a leading target for development of a TBV. TBVs aim to block transmission of the parasite from humans to mosquitoes by inducing antibodies in humans that prevent the parasite from developing in the mosquito. While they would not directly protect an individual from developing malaria, effective implementation across a community is expected to result in a steady decline in the number of infected mosquitoes, thereby reducing the number of human infections.

This is the first clinical trial using a transmission-blocking approach to be supported by MVI. Eradication of malaria may be decades away, but a successful TBV, used alongside safe and effective drugs, insecticides, bednets—and possibly a malaria vaccine that protects the individual against infection and disease—would be essential to achieving that goal.

Read more »

Phase 1/2a challenge trial of GSK/Crucell prime-boost vaccine approach begins

MVI is collaborating with GlaxoSmithKline Biologicals (GSK) and Dutch biopharmaceutical company Crucell, N.V. (a wholly owned subsidiary of the Johnson & Johnson pharmaceuticals group) to develop a next-generation vaccine against malaria. The Phase 1/2a challenge trial of this approach, which primes with Crucell’s adenovirus-based Ad35.CS.01 and boosts using GSK’s first-generation vaccine candidate, RTS,S/AS01, is ongoing at the Walter Reed Army Institute of Research.

Read more »

MVI on the road and other news

This month, several MVI staff—as well as MVI partners and PATH staff—attended the American Society of Tropical Medicine and Hygiene annual meeting in Philadelphia, Pennsylvania, participating in various sessions, symposia, and other events. Topics included immunology, antimalarial drug safety, malaria elimination, transmission, vaccines, and more. MVI-supported projects were the focus of sessions throughout the week. Mary Hamel of the US Centers for Disease Control and Prevention and Daniel Ansong, Principal Investigator (PI) for the Kumasi/Agogo trial site, presented initial results from the Phase 3 trial of RTS,S in a session on malaria vaccines, while Seth Owusu-Agyei, PI at Kintampo, presented a poster on the results.

In September, MVI co-sponsored the London launch of the Roll Back Malaria Decade Report.

October was a very busy month for MVI. Team members participated in two panels at the Malaria Forum, held October 17–19 in Seattle, Washington: one focused on the first RTS,S trial results and the other on next-generation vaccine projects in MVI’s portfolio. The RTS,S panel was webcast to colleagues in Africa and followed by a press briefing in Nairobi, Kenya, later that same week, where MVI was also represented. MVI also presented at the World Vaccine Congress in Lyon, France, and at the annual meeting of the Infectious Diseases Society of America in Boston, Massachusetts.

In November, MVI participated in the Seventh Annual Meeting of the African Sciences Academies in Kampala, Uganda, presenting “Building national capacity for and translating research into policies and programs: MVI experience in malaria vaccine research.”

Lastly, in December, TIME magazine named the RTS,S malaria vaccine candidate the second biggest medical breakthrough of 2011.

Keep in touch!

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