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Reviews of "Baseline Malaria Infection Status and RTS,S/AS01E Malaria Vaccine Efficacy"

Reviewers: M Laurens (University of Maryland) | 📗📗📗📗◻️

Published onJun 01, 2024
Reviews of "Baseline Malaria Infection Status and RTS,S/AS01E Malaria Vaccine Efficacy"
key-enterThis Pub is a Review of
Baseline malaria infection status and RTS,S/AS01E malaria vaccine efficacy
Baseline malaria infection status and RTS,S/AS01E malaria vaccine efficacy
Description

Abstract Background The only licensed malaria vaccine, RTS,S/AS01E, confers moderate protection against symptomatic disease. Because many malaria infections are asymptomatic, we conducted a large-scale longitudinal parasite genotyping study of samples from a clinical trial exploring how vaccine dosing regimen affects vaccine efficacy (VE).Methods 1,500 children aged 5–17 months were randomized to receive four different RTS,S/AS01E regimens or a rabies control vaccine in a phase 2b clinical trial in Ghana and Kenya. We evaluated the time to the first new genotypically detected infection and the total number of new infections during two follow-up periods in over 36K participant specimens. We performed a post hoc analysis of VE based on malaria infection status at first vaccination and force of infection.Results We observed significant and comparable VE (25–43%, 95% CI union 9–53%) against first new infection for all four RTS,S/AS01E regimens across both follow-up periods (12 and 20 months). Each RTS,S/AS01E regimen significantly reduced the number of new infections in the 20-month follow-up period (control mean 4.1 vs. RTS,S/AS01E mean 2.6–3.0). VE against first new infection was significantly higher in participants who were malaria-infected (68%; 95% CI, 50 to 80%) versus uninfected (37%; 95% CI, 23 to 48%) at the first vaccination (P=0.0053) and in participants experiencing greater force of infection between dose 1 and 3 (P=0.059).Conclusions All tested dosing regimens blocked some infections to a similar degree. Improved VE in participants infected during vaccination could suggest new strategies for highly efficacious malaria vaccine development and implementation. (ClinicalTrials.gov number, NCT03276962)

To read the original manuscript, click the link above.

Summary of Reviews: The study analyzed data from 1500 children in Ghana and Kenya to assess the efficacy of the RTS,S/AS01E malaria vaccine, finding that RTS,S reduces new infections and the risk of highly polyclonal first infections. Notably, children who were parasite-positive at the beginning of vaccination demonstrated higher vaccine efficacy compared to those who were parasite-negative. Reviewers highlighted that the study challenges previous findings by suggesting pre-existing malaria infection enhances immune response, contradicting studies indicating immunosuppressive effects of malaria on vaccine efficacy. However, concerns were raised about the study’s small sample size, wide confidence intervals, and post-hoc nature. The lack of differences between dosing regimens and the need for further explanation of certain results were also noted.

Reviewer 1 (Matthew L…) | 📗📗📗📗◻️

RR:C19 Strength of Evidence Scale Key

📕 ◻️◻️◻️◻️ = Misleading

📙📙 ◻️◻️◻️ = Not Informative

📒📒📒 ◻️◻️ = Potentially Informative

📗📗📗📗◻️ = Reliable

📘📘📘📘📘 = Strong

To read the reviews, click the links below. 

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