This Phase 1 study, conducted in malaria-naïve adults in the United States, was designed to determine the safety, reactogenicity, and immunogenicity of the recombinant virus-like particle malaria vaccine candidate ICC-1132, formulated with the aluminum hydroxide adjuvant Alhydrogel®, manufactured by Brenntag Biosector A/S.
Volunteers were divided into three dose-escalating groups (10 µg, 20 µg, and 50 µg), and received multiple intramuscular vaccinations of ICC-1132 adjuvanted in Alhydrogel on a 0,56,168-day schedule.
The study was designed with two objectives:
- Assess the safety and reactogenicity of ICC-1132 Alhydrogel and ICC-1132 alone 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 the humoral immune response via antibody titer.
Outcomes/Next steps: Findings were published in PLoS ONE in 2008.
ICC-1132 Alhydrogel was found to be well-tolerated, with low systemic reactogenicity in subjects, but was poorly immunogenic.
Gregson AL, Oliveira G, Othoro C, Calvo-Calle JM, Thorton GB, et al. Phase I trial of an Alhydrogel adjuvanted hepatitis B core virus-like particle containing epitopes of Plasmodium falciparum circumsporozoite protein. PLoS ONE. 2008;3(2):e1556.