Baseline incidence of meningitis, malaria, mortality and other health outcomes in infants and young sub-Saharan African children prior to the introduction of the RTS,S/AS01E malaria vaccine

Abstract

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.

Keywords: Adverse event; Malaria; Meningitis; Mortality; Plasmodium falciparum.

Conflict of interest statement

EJA and VH are employed by the GSK group of companies. YGM, J-YP, FR and LS are employed by the GSK group of companies and hold shares in the GSK group of companies. NP was employed by the GSK group of companies at the time of the work and hold shares in the GSK group of companies. NP is now employed by Janssen Pharmaceutica NV, Beerse, Belgium. M-CB is employed by 4Clinics on behalf of the GSK group of companies. DAA, DKA, PDA, NAA, POA, KPA, OB, NKC, SBEH, SK, MBK, AO, EO, LO, WO, SO-A, JO, VS, MT, via their institutions, received grants from the GSK group of companies for the conduct of this study/work and for the conduct of studies outside the submitted work.

Figures

Fig. 1

CONSORT diagram. KE, Kenya; GH, Ghana; ATP, According to protocol; M, Months; W, Weeks

Fig. 2

Plain Language Summary