Final results from a pivotal phase 3 malaria vaccine trial

Abstract

In The Lancet, the RTS,S Clinical Trials Partnership 1 RTS,S Clinical Trials PartnershipEfficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial. Lancet. 2015; (published online April 24.)http://dx.doi.org/10.1016/S0140-6736(15)60721-8 Google Scholar report the most recent results from the pivotal phase 3 trial of RTS,S/AS01 malaria vaccine, the fourth major publication from this randomised controlled trial. 2 RTS,S Clinical Trials PartnershipFirst results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children. N Engl J Med. 2011; 365: 1863-1875 Crossref PubMed Scopus (653) Google Scholar , 3 RTS,S Clinical Trials PartnershipA phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. N Engl J Med. 2012; 367: 2284-2295 Crossref PubMed Scopus (541) Google Scholar , 4 RTS,S Clinical Trials PartnershipEfficacy and safety of the RTS,S/AS01 malaria vaccine during 18 months after vaccination: a phase 3 randomized, controlled trial in children and young infants at 11 African sites. PLoS Med. 2014; 11: e1001685 Crossref PubMed Scopus (322) Google Scholar The trial enrolled 15 459 infants and young children at 11 centres in seven sub-Saharan African countries: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and Tanzania. Two age groups were included: 6–12 weeks and 5–17 months at first dose. The schedule involved a primary series of three monthly doses, with a booster dose given 18 months later in one of the three trial groups. The partnership responsible for undertaking this trial, consisting of GlaxoSmithKline and PATH, are to be congratulated on the quality of the study. Industry involvement in malaria vaccine development has been crucial to the promising next-generation malaria vaccine work that is underway. The generous funding from the Bill & Melinda Gates Foundation to PATH for clinical trials of RTS,S/AS01 has been very important, as has the continued commitment of a large pharmaceutical company to this project despite the absence of a market for this product in high-income settings. GlaxoSmithKline and PATH worked with many of the leading scientists in sub-Saharan Africa in a clinical trial partnership model, through a committee in which many of the decisions were taken together with and by local investigators. The strengthening of clinical trial capacity in sub-Saharan Africa to support the trial has already left a strong legacy. Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trialRTS,S/AS01 prevented a substantial number of cases of clinical malaria over a 3–4 year period in young infants and children when administered with or without a booster dose. Efficacy was enhanced by the administration of a booster dose in both age categories. Thus, the vaccine has the potential to make a substantial contribution to malaria control when used in combination with other effective control measures, especially in areas of high transmission. Full-Text PDF From work with men and boys to changes of social norms and reduction of inequities in gender relations: a conceptual shift in prevention of violence against women and girlsViolence perpetrated by and against men and boys is a major public health problem. Although individual men's use of violence differs, engagement of all men and boys in action to prevent violence against women and girls is essential. We discuss why this engagement approach is theoretically important and how prevention interventions have developed from treating men simply as perpetrators of violence against women and girls or as allies of women in its prevention, to approaches that seek to transform the relations, social norms, and systems that sustain gender inequality and violence. Full-Text PDF Pedro L Alonso: mapping out the future of malaria controlPedro L Alonso has pioneered many innovations in public health during his 30-year long career in malaria research and global health. Known as someone who thrives on a challenge, some think he faces one of his biggest challenges yet in his role as the Director of the WHO Global Malaria Programme , which he took up in October, 2014. Alonso and his team in Geneva coordinate WHO's work to control and eliminate malaria. Full-Text PDF