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Estimation of primary, secondary and composite effects of the RTSS/AS01 vaccine
Proposal
11347
Title of Proposed Research
Estimation of primary, secondary and composite effects of the RTSS/AS01 vaccine
Lead Researcher
Paul Milligan
Affiliation
London School of Hygiene&Tropical Medicine
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
14 July 2020
Lay Summary
An effective malaria vaccine affects the risk of malaria directly, through the vaccine-induced immune response (which we refer to as the primary effect), and indirectly, as a consequence of reduced exposure to malaria infection and disease, leading to slower acquisition of natural immunity (which we call the secondary effect). An important research question is the extent the beneficial primary effect of a malaria vaccine may be offset by a negative secondary effect, resulting in a smaller or nil composite effect (the net or total effect). The aim of this project is to develop improved statistical methods for estimating primary, secondary and composite effects of malaria vaccines from trial data.
Study Data Provided
[{ "PostingID": 1998, "Title": "GSK-257049/026", "Description": "A study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals’ candidate malaria vaccine RTS,S/AS02A, administered intramuscularly according to a 0, 1 and 2 month vaccination schedule in toddlers and children aged 1 to 4 years in a malaria-endemic region of Mozambique." },{ "PostingID": 1999, "Title": "GSK-104297", "Description": "An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose." },{ "PostingID": 4651, "Title": "GSK-110021", "Description": "Efficacy of GSK Biologicals’ candidate malaria vaccine (257049) against malaria disease caused by P. falciparum infection in infants and children in Africa" },{ "PostingID": 20045, "Title": "GSK-200599", "Description": "Extension to study MALARIA-055 PRI (NCT00866619) for evaluation of long-term efficacy, safety and immunogenicity of GSK Biologicals’ candidate malaria vaccine (SB257049) in infants and children in Africa" }]
Statistical Analysis Plan
Publication Citation
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