Structured PREreview of Safety and efficacy of the blood-stage malaria vaccine RH5.1/Matrix-M in Burkina Faso: interim results of a double-blind, randomised, controlled phase 2b trial in children

Does the introduction explain the objective of the research presented in the preprint?

Yes

The introduction clearly states the objective of assessing the safety and efficacy of the RH5.1/Matrix-M blood-stage malaria vaccine candidate in children aged 5-17 months in Burkina Faso. It provides context on existing pre-erythrocytic vaccines and explains the potential benefits of a blood-stage vaccine.

Are the methods well-suited for this research?

Highly appropriate

The study uses a double-blind, randomized, controlled design, which is the gold standard for vaccine efficacy trials. The methods include appropriate control groups, blinding procedures, and statistical analyses. The trial design, including the use of two different dosing regimens, allows for comprehensive evaluation of the vaccine's safety and efficacy.

Are the conclusions supported by the data?

Somewhat supported

The conclusions are largely supported by the data presented. The authors accurately report the efficacy results and safety profile. However, some conclusions about the potential for combining this vaccine with pre-erythrocytic vaccines are somewhat speculative and would require further study to confirm these claims. Additionally, longer-term follow-up studies are necessary to confirm the durability and efficacy of the vaccine.

Are the data presentations, including visualizations, well-suited to represent the data?

Somewhat appropriate and clear

The current figures and tables effectively communicate the key results, but additional visualizations could further enhance clarity and interpretation. Specifically, adding forest plots for efficacy comparisons between dosing regimens and subgroups would provide a more detailed view of the effect sizes and confidence intervals. Furthermore, the Kaplan-Meier curves for efficacy could benefit from additional annotations or breakpoints, highlighting when and where differences in efficacy become evident between groups. These enhancements would make it easier for readers to grasp the nuances of vaccine performance across different conditions and over time.

How clearly do the authors discuss, explain, and interpret their findings and potential next steps for the research?

Somewhat clearly

The authors mention ongoing trials but could improve the discussion by specifying how these studies will address the limitations of the current trial, such as testing in areas with varying malaria transmission intensities. Highlighting potential combination strategies with pre-erythrocytic vaccines in future work could also provide a roadmap for their next experiments.

Is the preprint likely to advance academic knowledge?

Highly likely

This study represents the first demonstration of significant efficacy for a blood-stage malaria vaccine in young children. It provides important proof-of-concept data that could lead to new approaches in malaria vaccine development and potentially improve overall vaccine efficacy when combined with existing strategies.

Would it benefit from language editing?

No

The preprint is well-written and clear. Any minor language issues do not significantly impact the understanding of the research, however simplifying some of the technical jargon or adding parenthetical explanations for key terms.

Would you recommend this preprint to others?

Yes, it’s of high quality

This preprint reports on a well-designed and executed clinical trial with important implications for malaria vaccine development. The methods are rigorous, the results are clearly presented, and the discussion provides valuable context and future directions.

Is it ready for attention from an editor, publisher or broader audience?

Yes, as it is

The preprint is well-structured, comprehensive, and reports on important findings from a rigorously conducted clinical trial. While the peer review may suggest some minor revisions or additional analyses, the core content and conclusions are likely to remain unchanged and are of immediate interest to the scientific community.

Competing interests

The authors declare that they have no competing interests.