A Phase 1 Trial of MSP2-C1, a Blood-Stage Malaria Vaccine Containing 2 Isoforms of MSP2 Formulated with Montanide® ISA 720
2011

Phase 1 Trial of MSP2-C1 Malaria Vaccine

Sample size: 45 publication 10 minutes Evidence: moderate

Author Information

Author(s): McCarthy James S., Marjason Joanne, Elliott Suzanne, Fahey Paul, Bang Gilles, Malkin Elissa, Tierney Eveline, Aked-Hurditch Hayley, Adda Christopher, Cross Nadia, Richards Jack S., Fowkes Freya J. I., Boyle Michelle J., Long Carole, Druilhe Pierre, Beeson James G., Anders Robin F.

Primary Institution: Queensland Institute of Medical Research (QIMR), University of Queensland, Brisbane, Australia

Hypothesis

Can the MSP2-C1 vaccine induce a significant immune response in healthy adults?

Conclusion

The MSP2-C1 vaccine induced significant antibody responses but had unacceptable reactogenicity, necessitating further development with an alternative adjuvant.

Supporting Evidence

  • Participants showed significant IgG responses to both MSP2 isoforms.
  • Antibody levels were higher in the 40 µg cohort compared to the 10 µg cohort.
  • Vaccine-induced antibodies recognized native protein in parasite extracts.
  • ADCI activity was observed in the majority of subjects vaccinated.
  • Local reactions were common, with pain reported by nearly all subjects.
  • Two severe local reactions led to the decision to halt the trial for the highest dose cohort.
  • Further development of the vaccine will require a different adjuvant.

Takeaway

This study tested a malaria vaccine and found it made people's bodies produce antibodies, but it also caused some painful reactions, so they need to change how they make it.

Methodology

The trial was a dose-escalating, double-blinded, placebo-controlled study with three dose cohorts of the MSP2-C1 vaccine.

Potential Biases

Potential bias in self-reported adverse events and the small sample size may affect the generalizability of the results.

Limitations

The trial was terminated early due to reactogenicity concerns, limiting the data on the 80 µg dose.

Participant Demographics

45 healthy, malaria-naïve adults aged 18-45, predominantly Caucasian.

Statistical Information

P-Value

p=0.024

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pone.0024413

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