Malvac-Pmc

July 24, 2022 | Ongoing Projects | Reading time: 6 min

Investigators
Dr. Kwaku Poku Asante,Daniel Chandramohan & Brian Greenwood

Background
An individually randomized, double blind, placebo controlled trial that seeks to evaluate the impact of a combination of RTS, S/ASO1E malaria vaccine and perennial malaria chemoprevention (PMC) with either Sulphadoxine-pyrimethamine ( SP) or SP plus Amodiaquine (SPAQ) is being implemented in Ghanaian children. Two thousand, three hundred and ten (2310) infants living in the Atebubu-Amantin Municipality of the Bono East Region of Ghana will be recruited at 14 to 18 weeks of age and are being randomized 1:1:1 to receive RTS,S/AS01E + PMC-SP-placebo AQ, RTS,S/AS01E + PMC-SPAQ, or RTS,S/AS01E + PMC-placebo SPAQ. The study duration is 36 months and each participant will remain in the study for approximately 22 months (from 3 months – 24 months inclusive). Recruitment started in October 2023 and it is anticipated that this will be completed by December 2024. Ancillary studies include a social science study that will assess the acceptability and the feasibility of the delivery of the combined intervention among health care staff and parents of study children and an immunological study that will assess the impact of combining the two interventions on the immune response to the vaccine and to malaria more generally.

Impact
This Trial explores a new approach in malaria prevention by combining the RTS,S/ASO1E malaria vaccine and PMC-SP or PMC-SPAQ. This novel combination has the potential to significantly reduce malaria incidence, hospital admissions and deaths attributable to malaria in children. The study utilizes a double blind, placebo-controlled design to ensure unbiased and high quality results. Advanced data collection and adverse events monitoring methods are being employed to thoroughly assess the efficacy and safety of the combination. Positive outcomes from this study could lead to the inclusion of this multimodal approach in both local and international health policies, including recommendations by the WHO. If the study shows benefits of adding PMC with malaria vaccines, it will be integrated within Ghana’s Essential immunization program.

External Collaborators

1. London School of Hygiene and Tropical Medicine (LSHTM)
2. Program for Appropriate Technology in Health (PATH)
3. PMI Insights
4. PMI (USAID and the US Centers for Disease Control and Prevention)
5. Ghana Health Service (GHS)
6. National Malarial Elimination Program (NMEP)

Funding
This study is funded by the US President’s Malaria Initiative (PMI), GiveWell, and the Gates Foundation through the PMI Insights project ( https://www.insightsmalaria.org/).