ICC-1132 - Candidate Vaccine Against P Falciparum Malaria

Plasmodium Falciparum Malaria Clinical Trial

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

Status Completed

Clinical Trial Summary

The purposes of this study are to evaluate the safety and immune responses (the body's defense system) to an investigational malaria vaccine called ICC-1132. Three different doses of the vaccine will be studied in 3 groups of people, and the results will be compared. The study will involve about 80 healthy volunteers, 18-45 years of age, who will receive an injection of a specific dose of the vaccine in their arm on 2 or 3 different days. Blood samples will be collected approximately 15 times for laboratory studies. Volunteers will record their temperature twice per day. Volunteers will complete a daily symptom diary for 7 days after each vaccination. Volunteers will participate in the study for up to 13 months.

Clinical Trial Description

This is a Phase I, dose-escalating clinical trial of a candidate malaria vaccine, ICC-1132. The primary objective is to assess and compare the safety, reactogenicity, and immunogenicity of 3 intramuscular injections of ICC-1132. The vaccine is absorbed to alhydrogel adjuvant. Three dose levels, 10 mcg, 20 mcg, and 50 mcg, will be compared. Vaccine will be injected intramuscularly on study days 0, 56 +/- 4 and 168 +/- 14, with the exception of the 10 mcg dose cohort which will receive only 2 injections, 1 each at 0 and 2 months. The study was originally designed as a blinded, dose-escalating trial comparing 3 doses (10, 20, and 50 mcg) of ICC-1132 in saline to 3 doses of ICC-1132 + alhydrogel (10, 20, and 50 mcg). Prior to removing the saline formulated ICC-1132 from the trial, the first 16 eligible volunteers were assigned to the 10 mcg cohort, with 8 receiving ICC-1132 in saline and 8 receiving ICC-1132 + alhydrogel. The next 3 eligible volunteers were assigned to the 20 mcg cohort and were randomly assigned to receive ICC-1132 in saline or ICC-1132 + alhydrogel. The study will continue with vaccinations using only the alhydrogel formulation of the vaccine. Subjects will be observed for immediate localized or systemic reactions for 30 minutes before being released from the clinic. Vital signs and a post-vaccination arm check will be performed approximately 30 minutes after vaccine administration. Subjects will return to the outpatient clinic for clinical examinations at 24 +/- 6 and 48 +/- 6 hours, and at days 7 +/- 1, 14 +/- 2, and 28 +/- 4 after each vaccination. Volunteers will complete a daily symptom diary for 7 days after each vaccination. Additional follow up visits will be done 84 +/- 7 days after the second vaccine and 56 +/- 7 days after the third vaccine. A telephone interview will be done at day 4 +/- 1 after each immunization and 168 +/- 14 days after the third immunization. Participants will be involved in study related procedures for up to 393 days. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

• NCT number: NCT00587249
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: July 2002
• Completion date: July 2005