Initiation date: 2002
End date: 2003
Past project identifier: NCT00587249
Partner trial identifier: VAC022
Official title: Phase I Trial of ICC-1132, a Candidate Vaccine Against Plasmodium Falciparum Malaria Based on a Viral-like Particle Comprising Recombinant Hepatitis B Core Antigen and Circumsporozoite Epitopes, to Assess Vaccine Safety and Immunogenicity in Healthy Adult Volunteers
Project description: Study of the ICC-1132 candidate vaccine against Plasmodium falciparum malaria*

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:

  1. 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.

  2. Quantify the humoral immune response via antibody titer.

Enrollment: 75

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.

Based on the outcomes of this study, the PATH Malaria Vaccine Initiative did not make further investments.

View detailed study record on

Related resources:
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.


*Source:; date accessed January 24, 2018.