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Following the release of new Phase III trial data on the malaria vaccine candidate RTS,S, Dr Seth Berkley, CEO of the GAVI Alliance, said:
“Every year, malaria kills hundreds of thousands of children so a vaccine offering good protection has the potential to bring enormous public health benefits.
“Today’s RTS,S trial results show encouraging signs in terms of initial protection. It will be important to understand the duration of protection and impact of booster shots when further data is released in 2014.
“A licensed vaccine could join insecticide-treated bed nets and anti-malarial drugs as important tools to protect the most vulnerable from malaria. How and where this vaccine would be used will depend on consultation and recommendations from the World Health Organization and its Strategic Advisory Group of Experts.
“Malaria is one of the disease areas currently under consideration for future vaccine support by the GAVI Alliance and these results are a useful contribution to our analyses.”
Background on RTS,S
The RTS,S malaria vaccine candidate has been under development since the 1980s with partners from the public and private sectors. The collaboration involves researchers in many GAVI-eligible countries in Africa, including Burkina Faso, Gambia, Ghana, Kenya, Malawi, Mozambique, and Tanzania, and in the United States and Europe. In January 2001, GlaxoSmithKline Vaccines and the PATH Malaria Vaccine Initiative entered into a public-private partnership specifically to develop the vaccine for infants and young children living in malaria-endemic regions in sub-Saharan Africa.
A large-scale Phase III safety and efficacy trial began in May 2009. The study is being conducted in eleven sites across sub-Saharan Africa. The study has enrolled 15,460 infants and children in two age groups, 5-17 months and 6-12 weeks of age at the time of the first vaccination. First results on children aged 5-17 months were reported in October 2011 in the New England Journal of Medicine. Those results indicated that three doses of the RTS,S vaccine candidate reduced the number of malaria episodes over the first year of follow-up by an estimated 55%. Data for children vaccinated aged 6-14 weeks of age, in co-administration with other vaccines, were released in November 2012. Estimated overall efficacy in this age group over 12 months of follow-up was 33% for all malaria episodes. Today, the third set of results reports efficacy in both the 6-14 week and 5-17 month age groups over 18 months of follow-up. In the younger age group efficacy against clinical malaria was 27% after 18 months. In the 5-17 month age group efficacy after 18 months was 46% (CI: 42%-50%), ranging between 40%-77% in different study sites.
Children in this study were also provided insecticide treated bed nets, other interventions according to national policies, and ready access to malaria treatment. Insecticide-treated bed nets were used by approximately 80% of children.
Data on the efficacy of a booster dose is forthcoming in 2014. A WHO recommendation on the use of RTS,S is anticipated in 2015.
Study centres / trial sites participating in the Phase III efficacy trial
- Burkina Faso – Nanoro, Institut de Recherche en Science de la Santé (IRSS) / Centre Muraz
- Gabon – Lambaréné Albert Schweitzer Hospital, Medical Research Unit
- Ghana – Agogo/Kumasi: School of Medical Sciences, Kwame Nkrumah University of Science and Technology; Kumasi Centre for Collaborative Research, Agogo Presbyterian Hospital
- Ghana – Kintampo: Kintampo Health Research Centre, Ghana Health Service
- Kenya – Kilifi, KEMRI-Wellcome Trust Research Program
- Kenya – Kombewa (Kisumu), KEMRI-Walter Reed Project Kenya Medical Research Institute
- Kenya – Siaya (Kisumu), KEMRI-CDC Research and Public Health Collaboration
- Malawi – Lilongwe, University of North Carolina Project at the Tidziwe Centre
- Mozambique – Manhica, Centro de Investigação em Saúde de Manhiça
- Tanzania – Bagamoyo, Ifakara Health Institute
- Tanzania – Korogwe, National Institute for Medical Research
- Tanzania, Kilimanjaro Christian Medical Centre
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Following the release of new Phase III trial data on the malaria vaccine candidate RTS,S, Dr Seth Berkley, CEO of the GAVI Alliance, said:
“Every year, malaria kills hundreds of thousands of children so a vaccine offering good protection has the potential to bring enormous public health benefits.
“Today’s RTS,S trial results show encouraging signs in terms of initial protection. It will be important to understand the duration of protection and impact of booster shots when further data is released in 2014.
“A licensed vaccine could join insecticide-treated bed nets and anti-malarial drugs as important tools to protect the most vulnerable from malaria. How and where this vaccine would be used will depend on consultation and recommendations from the World Health Organization and its Strategic Advisory Group of Experts.
“Malaria is one of the disease areas currently under consideration for future vaccine support by the GAVI Alliance and these results are a useful contribution to our analyses.”
Background on RTS,S
The RTS,S malaria vaccine candidate has been under development since the 1980s with partners from the public and private sectors. The collaboration involves researchers in many GAVI-eligible countries in Africa, including Burkina Faso, Gambia, Ghana, Kenya, Malawi, Mozambique, and Tanzania, and in the United States and Europe. In January 2001, GlaxoSmithKline Vaccines and the PATH Malaria Vaccine Initiative entered into a public-private partnership specifically to develop the vaccine for infants and young children living in malaria-endemic regions in sub-Saharan Africa.
A large-scale Phase III safety and efficacy trial began in May 2009. The study is being conducted in eleven sites across sub-Saharan Africa. The study has enrolled 15,460 infants and children in two age groups, 5-17 months and 6-12 weeks of age at the time of the first vaccination. First results on children aged 5-17 months were reported in October 2011 in the New England Journal of Medicine. Those results indicated that three doses of the RTS,S vaccine candidate reduced the number of malaria episodes over the first year of follow-up by an estimated 55%. Data for children vaccinated aged 6-14 weeks of age, in co-administration with other vaccines, were released in November 2012. Estimated overall efficacy in this age group over 12 months of follow-up was 33% for all malaria episodes. Today, the third set of results reports efficacy in both the 6-14 week and 5-17 month age groups over 18 months of follow-up. In the younger age group efficacy against clinical malaria was 27% after 18 months. In the 5-17 month age group efficacy after 18 months was 46% (CI: 42%-50%), ranging between 40%-77% in different study sites.
Children in this study were also provided insecticide treated bed nets, other interventions according to national policies, and ready access to malaria treatment. Insecticide-treated bed nets were used by approximately 80% of children.
Data on the efficacy of a booster dose is forthcoming in 2014. A WHO recommendation on the use of RTS,S is anticipated in 2015.
Study centres / trial sites participating in the Phase III efficacy trial
- Burkina Faso – Nanoro, Institut de Recherche en Science de la Santé (IRSS) / Centre Muraz
- Gabon – Lambaréné Albert Schweitzer Hospital, Medical Research Unit
- Ghana – Agogo/Kumasi: School of Medical Sciences, Kwame Nkrumah University of Science and Technology; Kumasi Centre for Collaborative Research, Agogo Presbyterian Hospital
- Ghana – Kintampo: Kintampo Health Research Centre, Ghana Health Service
- Kenya – Kilifi, KEMRI-Wellcome Trust Research Program
- Kenya – Kombewa (Kisumu), KEMRI-Walter Reed Project Kenya Medical Research Institute
- Kenya – Siaya (Kisumu), KEMRI-CDC Research and Public Health Collaboration
- Malawi – Lilongwe, University of North Carolina Project at the Tidziwe Centre
- Mozambique – Manhica, Centro de Investigação em Saúde de Manhiça
- Tanzania – Bagamoyo, Ifakara Health Institute
- Tanzania – Korogwe, National Institute for Medical Research
- Tanzania, Kilimanjaro Christian Medical Centre