RTS vaccines: 20 years of false hopes
RTS: ein Impfstoff ohne Hoffnung
The first results of the RTS,S vaccine already appeared in 1998 in a scientific paper. The conclusion was: Immune responses did not correlate with protection. Further optimization in vaccine composition will be required to induce longer-lasting protective immunity. Stoute JA, Kester KE, Ballou Wr. Long-term efficacy and immune responses following immunization with the RTS,S malaria vaccine. J Infect Dis. 1998 178(4), 1139-44 Another randomised trial of the efficacy of RTS,S against natural P. falciparum infection in semi-immune adult men was run in The Gambia in 2001. Vaccine efficacy, adjusted for confounders, was 34%. Protection seemed to wane: estimated efficacy during the first 9 weeks of follow-up was 71% (46-85), but decreased to 0% (-52 to 34) in the last 6 weeks. Bojang KA, Milligan PJ, RTS, S Malaria Vaccine Trial Team Efficacy of RTS,S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: a randomised trial. Lancet. 2001 Dec 8;358(9297):1927-34 In a trial of 2008, the rate of efficacy against the more clinically relevant end point of clinical malaria in children 1 to 4 years of age was 30% Philip Bejon, John Lusingu, Ally Olotu., Efficacy of RTS,S/AS01E Vaccine against Malaria in Children 5 to 17 Months of Age. NEJM 2008, 359, 2521-39 In 2009 vaccine efficacy over the 45-month surveillance period against a first or only episode of clinical malaria disease was 30.5% and the VE against all episodes was 25.6% Sacarlal J, Alonso PL. Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children. J Infect Dis. 2009 Aug 1;200(3):329-36. doi: 10.1086/600119. In 2013 6,537 infants aged 6–12 wk and 8,923 children aged 5–17 mo were randomized to receive three doses of RTS,S/AS01. Vaccine efficiency against clinical malaria in infants was 27%, with no significant protection against severe malaria, malaria hospitalization, or all-cause hospitalization Sanjeev Krishna, Academic Editor. Efficacy 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 Jul; 11(7): e1001685. To continuously raise false hopes by massive press releases is immoral. Who pays for all these guinea pigs: Bill Gates or GSK Wavre?