BACKGROUND: The lack of background disease incidence rates in sub-Saharan countries where the RTS,S/AS01E malaria vaccine is being implemented may hamper the assessment of vaccine safety and effectiveness. This study aimed to document baseline incidence rates of meningitis, malaria, mortality, and other health outcomes prior to vaccine introduction through the Malaria Vaccine Implementation Programme. METHODS: An ongoing disease surveillance study is combining prospective cohort event monitoring and hospital-based disease surveillance in three study sites in Ghana and Kenya. An interim analysis was performed on the prospective cohort in which children were enrolled in two age-groups (the 5 to 17 months or 6 to 12 weeks age-group), capturing data in the framework of routine medical practice before the introduction of the malaria vaccine. Incidence and mortality rates were computed with 95% confidential intervals (CI) using an exact method for a Poisson variable. RESULTS: This analysis includes 14,329 children; 7248 (50.6%) in the 6 to 12 weeks age-group and 7081 (49.4%) in the 5 to 17 months age-group. In the 5 to 17 months age-group (where the malaria vaccine was planned to be subsequently rolled out) the meningitis, malaria, severe malaria and cerebral malaria incidences were 92 (95% CI 25-236), 47,824 (95% CI 45,411-50,333), 1919 (95% CI 1461-2476) and 33 (95% CI 1-181) per 100,000 person-years, respectively. The all-cause mortality was 969 (95% CI 699-1310) per 100,000 person-years. CONCLUSION: Incidence estimates of multiple health outcomes are being generated to allow before-after vaccine introduction comparisons that will further characterize the benefit-risk profile of the RTS,S/AS01E vaccine. TRIAL REGISTRATION: clinicaltrials.gov NCT02374450.
BACKGROUND: The lack of background disease incidence rates in sub-Saharan countries where the RTS,S/AS01E malaria vaccine is being implemented may hamper the assessment of vaccine safety and effectiveness. This study aimed to document baseline incidence rates of meningitis, malaria, mortality, and other health outcomes prior to vaccine introduction through the Malaria Vaccine Implementation Programme. METHODS: An ongoing disease surveillance study is combining prospective cohort event monitoring and hospital-based disease surveillance in three study sites in Ghana and Kenya. An interim analysis was performed on the prospective cohort in which children were enrolled in two age-groups (the 5 to 17 months or 6 to 12 weeks age-group), capturing data in the framework of routine medical practice before the introduction of the malaria vaccine. Incidence and mortality rates were computed with 95% confidential intervals (CI) using an exact method for a Poisson variable. RESULTS: This analysis includes 14,329 children; 7248 (50.6%) in the 6 to 12 weeks age-group and 7081 (49.4%) in the 5 to 17 months age-group. In the 5 to 17 months age-group (where the malaria vaccine was planned to be subsequently rolled out) the meningitis, malaria, severe malaria and cerebral malaria incidences were 92 (95% CI 25-236), 47,824 (95% CI 45,411-50,333), 1919 (95% CI 1461-2476) and 33 (95% CI 1-181) per 100,000 person-years, respectively. The all-cause mortality was 969 (95% CI 699-1310) per 100,000 person-years. CONCLUSION: Incidence estimates of multiple health outcomes are being generated to allow before-after vaccine introduction comparisons that will further characterize the benefit-risk profile of the RTS,S/AS01E vaccine. TRIAL REGISTRATION: clinicaltrials.gov NCT02374450.
Authors: Likeng Liang; Jifa Hu; Gang Sun; Na Hong; Ge Wu; Yuejun He; Yong Li; Tianyong Hao; Li Liu; Mengchun Gong Journal: Drug Saf Date: 2022-05-17 Impact factor: 5.228
Authors: Aaron M Samuels; Daniel Ansong; Simon K Kariuki; Samuel Adjei; Anne Bollaerts; Christian Ockenhouse; Nelli Westercamp; Cynthia K Lee; Lode Schuerman; Dennis K Bii; Lawrence Osei-Tutu; Martina Oneko; Marc Lievens; Maame Anima Attobrah Sarfo; Cecilia Atieno; Danielle Morelle; Ashura Bakari; Tony Sang; Erik Jongert; Maame Fremah Kotoh-Mortty; Kephas Otieno; François Roman; Patrick Boakye Yiadom Buabeng; Yaw Ntiamoah; Opokua Ofori-Anyinam; Tsiri Agbenyega Journal: Lancet Infect Dis Date: 2022-06-23 Impact factor: 71.421