Virosome-Formulated Plasmodium falciparum AMA-1 & CSP Derived Peptides as Malaria Vaccine: Randomized Phase 1b Trial in Semi-Immune Adults & Children
2011

Virosome-Formulated Malaria Vaccine Trial

Sample size: 50 publication 10 minutes Evidence: moderate

Author Information

Author(s): Cech Patrick Georges, Aebi Thomas, Abdallah Mwanajaa Shomari, Mpina Maxmillian, Machunda Ester Barnabas, Westerfeld Nicole, Stoffel Sabine Alexandra, Zurbriggen Rinaldo, Pluschke Gerd, Tanner Marcel, Daubenberger Claudia, Genton Blaise, Abdulla Salim

Primary Institution: Swiss Tropical and Public Health Institute, Basel, Switzerland

Hypothesis

The trial aimed to evaluate the safety and immunogenicity of two virosome formulated malaria peptides in semi-immune adults and children.

Conclusion

The findings support the further development of multivalent virosomal malaria peptide vaccines.

Supporting Evidence

  • No serious or severe adverse events related to the vaccines were observed.
  • The incidence rate of clinical malaria episodes in children vaccinees was half the rate of the control children.
  • IgG ELISA endpoint titers specific for the AMA-1 and CSP peptide antigens were significantly higher in the PEV3B group.

Takeaway

This study tested a new malaria vaccine on adults and children who have some immunity to malaria, and it showed that the vaccine is safe and helps the body fight malaria better.

Methodology

A prospective randomized, double-blind, controlled, age-deescalating study with two immunizations.

Potential Biases

The small number of adult subjects limits the ability to draw strong conclusions about adult responses.

Limitations

The study was not powered to assess efficacy as malaria morbidity was not the primary outcome.

Participant Demographics

10 adult male volunteers aged 18-45 and 40 children aged 5-9 years.

Statistical Information

P-Value

p=0.02

Confidence Interval

95%-CI: 0.29–0.88

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pone.0022273

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