Extended Follow-Up Following a Phase 2b Randomized Trial of the Candidate Malaria Vaccines FP9 ME-TRAP and MVA ME-TRAP among Children in Kenya
2007

Follow-Up Study of Malaria Vaccines in Kenyan Children

Sample size: 405 publication Evidence: moderate

Author Information

Author(s): Bejon Philip, Ogada Edna, Mwangi Tabitha, Milligan Paul, Lang Trudie, Fegan Greg, Gilbert Sarah C., Peshu Norbert, Marsh Kevin, Hill Adrian V.S.

Primary Institution: Kenya Medical Research Institute, Centre for Geographical Medicine Research (Coast), Kilifi, Kenya

Hypothesis

Does the FFM ME-TRAP malaria vaccine provide protection against malaria in children?

Conclusion

The FFM ME-TRAP vaccine did not provide protection against malaria, with similar incidence rates in both vaccine and control groups.

Supporting Evidence

  • The incidence of malaria was slightly higher in children who received the vaccine, but this was not statistically significant.
  • During the 18 months of monitoring, there were 63 malaria events in the vaccine group and 60 in the control group.
  • The hazard ratio for the effect of vaccination was 1.2, indicating no significant difference in malaria incidence.

Takeaway

The study tested a malaria vaccine on kids in Kenya, but it didn't help them avoid getting malaria any better than a regular vaccine.

Methodology

The study was a randomized, controlled, double-blind trial with follow-up monitoring for 18 months.

Potential Biases

Potential bias due to unblinding and the influence of knowledge about vaccine allocation on health-seeking behavior.

Limitations

The study was unblinded after the first 9 months, which may have influenced health-seeking behavior.

Participant Demographics

Children aged 1-6 years from rural Kenya.

Statistical Information

P-Value

0.35

Confidence Interval

0.84-1.73

Statistical Significance

p=0.35

Digital Object Identifier (DOI)

10.1371/journal.pone.0000707

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