This Phase 1 study, conducted in malaria-naïve adults in Australia, was designed to determine the safety, reactogenicity, and immunogenicity of the apical membrane antigen 1-combination 1 (AMA1-C1) vaccine, formulated with the water-in-oil adjuvant ISA 720.
Volunteers were divided into three dose-escalating groups (5 µg, 12 µg, and 80 µg), and received multiple intramuscular vaccinations of AMA1-C1 adjuvanted in ISA 720 on a 0,84,168-day schedule.
The study was designed with two objectives:
- Assess the safety and reactogenicity of the AMA1-C1/ISA 720 vaccine in malaria-naïve adults by monitoring for occurrence of solicited signs and symptoms, occurrence of unsolicited symptoms, and the occurrence of serious adverse events during the study period.
- Quantify humoral immune response via antibody titer.
Outcomes/Next steps: Findings were published in Vaccine in 2010.
AMA1-C1/ISA 720 was found to be immunogenic, however; antibody responses were relatively short-lived. Although the vaccine was reasonably tolerated, some transient, severe, local reactions were observed in subjects.
View detailed study record on clinicaltrials.gov
Pierce MA, Ellis RD, Martin LB, Malkin E, Tierney E, et al. Phase 1 safety and immunogenicity trial of the Plasmodium falciparum blood-stage malaria vaccine AMA1-C1/ISA 720 in Australian adults. Vaccine. 2010;28(10):2236-2242.