A Phase 2b Randomised Trial of the Candidate Malaria Vaccines FP9 ME-TRAP and MVA ME-TRAP among Children in Kenya
2006

Malaria Vaccine Trial in Kenyan Children

Sample size: 405 publication 10 minutes Evidence: low

Author Information

Author(s): Bejon Philip, Mwacharo Jedidah, Kai Oscar, Mwangi Tabitha, Milligan Paul, Todryk Stephen, Keating Sheila, Lang Trudie, Lowe Brett, Gikonyo Caroline, Molyneux Catherine, 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

The vaccination regimen FFM ME-TRAP will prevent episodes of clinical malaria among children in a malaria endemic area.

Conclusion

The FFM ME-TRAP vaccine did not provide protection against febrile malaria in children.

Supporting Evidence

  • The vaccine was moderately immunogenic but did not protect against malaria.
  • More malaria episodes were observed in the vaccine group, but the difference was not statistically significant.
  • Safety data showed similar adverse events between the vaccine and control groups.
  • Immunogenicity was lower than in previous studies with adults.

Takeaway

The study tested a malaria vaccine on young children, but it didn't work as hoped and didn't stop them from getting sick.

Methodology

The trial was randomised, double-blinded, and involved monitoring children for malaria episodes after vaccination.

Potential Biases

There may be bias in the active case detection method used to identify malaria episodes.

Limitations

The immune response was lower than in previous studies, and the trial was underpowered due to lower than expected malaria incidence.

Participant Demographics

Children aged 1-6 years from a malaria-endemic area in Kenya.

Statistical Information

P-Value

0.14

Confidence Interval

95% CI 1.0–2.3

Statistical Significance

p = 0.14

Digital Object Identifier (DOI)

10.1371/journal.pctr.0010029

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication