Malaria Vaccine FMP1/AS02 Does Not Protect Young Children
Author Information
Author(s): Ogutu Bernhards R., Apollo Odika J., McKinney Denise, Okoth Willis, Siangla Joram, Dubovsky Filip, Tucker Kathryn, Waitumbi John N., Diggs Carter, Wittes Janet, Malkin Elissa, Leach Amanda, Soisson Lorraine A., Milman Jessica B., Otieno Lucas, Holland Carolyn A., Polhemus Mark, Remich Shon A., Ockenhouse Christian F., Cohen Joe, Ballou W. Ripley, Martin Samuel K., Angov Evelina, Stewart V. Ann, Lyon Jeffrey A., Heppner D. Gray Jr, Withers Mark R., for the MSP-1 Malaria Vaccine Working Group
Primary Institution: US Army Medical Research Unit-Kenya and the Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya
Hypothesis
Does the FMP1/AS02 malaria vaccine provide protection against P. falciparum malaria in young children?
Conclusion
The FMP1/AS02 malaria vaccine did not provide protection against malaria in young children in Western Kenya.
Supporting Evidence
- 374 of 400 children received all three doses and completed six months of follow-up.
- Geometric mean anti-MSP-142 antibody concentrations increased significantly in the vaccine group.
- Overall vaccine efficacy was only 5.1%, indicating no significant protection.
Takeaway
The malaria vaccine tested in this study didn't help protect young kids from getting sick with malaria, even though it made their bodies produce antibodies.
Methodology
A randomized, double-blind, Phase IIb trial with 400 children aged 12-47 months, comparing FMP1/AS02 vaccine to a rabies vaccine.
Potential Biases
Potential bias in participant selection and reporting of adverse events.
Limitations
The study did not assess the vaccine's efficacy against severe malaria due to low incidence rates.
Participant Demographics
Children aged 12-47 months, predominantly from the Luo tribe in Western Kenya.
Statistical Information
P-Value
0.7
Confidence Interval
95% CI: −26% to +28%
Statistical Significance
p=0.7
Digital Object Identifier (DOI)
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