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

RTS,S Epidemiology EPI-MAL-002 Study Group, Prince Darko Agyapong, Elaine Jacqueline Akite, Nana Akosua Ansah, Patrick Odum Ansah, Kwaku Poku Asante, Denis Azabra Awuni, Daniel K Azongo, Owusu Boahen, Marie-Cecile Bozonnat, Nathanial K Copeland, Yolanda Guerra Mendoza, Valerie Haine, Samuel Bernard Ekow Harrison, Seyram Kaali, Michael Bandasua Kaburise, Abraham Oduro, Esther Oguk, Lucas Otieno, Walter Otieno, Seth Owusu-Agyei, Janet Oyieko, Jean-Yves Pirçon, Nicolas Praet, François Roman, Lode Schuerman, Valentine Sing'oei, Mathilda Tivura, RTS,S Epidemiology EPI-MAL-002 Study Group, Prince Darko Agyapong, Elaine Jacqueline Akite, Nana Akosua Ansah, Patrick Odum Ansah, Kwaku Poku Asante, Denis Azabra Awuni, Daniel K Azongo, Owusu Boahen, Marie-Cecile Bozonnat, Nathanial K Copeland, Yolanda Guerra Mendoza, Valerie Haine, Samuel Bernard Ekow Harrison, Seyram Kaali, Michael Bandasua Kaburise, Abraham Oduro, Esther Oguk, Lucas Otieno, Walter Otieno, Seth Owusu-Agyei, Janet Oyieko, Jean-Yves Pirçon, Nicolas Praet, François Roman, Lode Schuerman, Valentine Sing'oei, Mathilda Tivura

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
Fig. 1
CONSORT diagram. KE, Kenya; GH, Ghana; ATP, According to protocol; M, Months; W, Weeks
Fig. 2
Fig. 2
Plain Language Summary

References

    1. WHO. World malaria report 2019. Geneva, World Health Organization, 2019. . Accessed 20 Jan 2020.
    1. WHO. Global Technical Strategy for Malaria 2016–2030. Geneva, World Health Organization, 2015. . Accessed 19 March 2020
    1. European Medicines Agency. Mosquirix H-W-2300. European Public Assessment Report. Accessed 19 March 2020.
    1. Malaria vaccine: WHO position paper-January 2016. Wkly Epidemiol Rec. 2016;91:33–51.
    1. WHO. Q&A on the malaria vaccine implementation programme (MVIP). Geneva, World Health Organization. Accesssed 22 January 2020.
    1. Guerra Mendoza Y, Garric E, Leach A, Lievens M, Ofori-Anyinam O, Pircon JY, et al. Safety profile of the RTS, S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa. Hum Vaccin Immunother. 2019;15:2386–2398. doi: 10.1080/21645515.2019.1586040.
    1. Guignard A, Praet N, Jusot V, Bakker M, Baril L. Introducing new vaccines in low- and middle-income countries: challenges and approaches. Expert Rev Vaccines. 2019;18:119–131. doi: 10.1080/14760584.2019.1574224.
    1. RTS,S Clinical Trials Partnership 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 trial. Lancet. 2015;386:31–45. doi: 10.1016/S0140-6736(15)60721-8.
    1. INDEPTH Network. INDEPTH Standardized Verbal Autopsy questionnaire. . Accessed 26 Feb 2019.
    1. Streatfield PK, Khan WA, Bhuiya A, Hanifi SM, Alam N, Ouattara M, et al. Cause-specific childhood mortality in Africa and Asia: evidence from INDEPTH health and demographic surveillance system sites. Glob Health Action. 2014;7:25363. doi: 10.3402/gha.v7.25363.
    1. Diallo AO, Soeters HM, Yameogo I, Sawadogo G, Ake F, Lingani C, et al. Bacterial meningitis epidemiology and return of Neisseria meningitidis serogroup a cases in burkina faso in the five years following MenAfriVac mass vaccination campaign. PLoS ONE. 2017;12:e0187466. doi: 10.1371/journal.pone.0187466.
    1. "RTS,S Epidemiology EPI-MAL-005 Study Group Estimating annual fluctuations in malaria transmission intensity and in the use of malaria control interventions in five Sub-Saharan African countries. Am J Trop Med Hyg. 2020;103:1883–1892. doi: 10.4269/ajtmh.19-0795.
    1. Jiang J, Jiang B, Parashar U, Nguyen T, Bines J, Patel MM. Childhood intussusception: a literature review. PLoS ONE. 2013;8:e68482. doi: 10.1371/journal.pone.0068482.
    1. Burton DC, Bigogo GM, Audi AO, Williamson J, Munge K, Wafula J, et al. Risk of injection-site abscess among infants receiving a preservative-free, two-dose vial formulation of pneumococcal conjugate vaccine in Kenya. PLoS ONE. 2015;10:e0141896. doi: 10.1371/journal.pone.0141896.
    1. Gouda HN, Charlson F, Sorsdahl K, Ahmadzada S, Ferrari AJ, Erskine H, et al. Burden of non-communicable diseases in sub-Saharan Africa, 1990–2017: results from the Global Burden of Disease Study 2017. Lancet Glob Health. 2019;7:e1375–e1387. doi: 10.1016/S2214-109X(19)30374-2.
    1. World Health Organization Regional Office for Africa. The health of the people: what works–the African regional health report 2014. Accessed 19 March 2020.

Source: PubMed

3
Předplatit