Improving the Efficacy of Experimental Malaria Vaccine AMA1-C1/Alhydrogel® (Registered Trademark)
Status:
Completed
Trial end date:
2008-07-02
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and efficacy of the experimental malaria vaccine
AMA1-C1/Alhydrogel® (Registered Trademark) and determine whether a new, additional component
of the vaccine may increase its effectiveness. Malaria is a debilitating and potentially
fatal blood disease transmitted by a parasite found in certain mosquitoes. The AMA1-C1
vaccine has been designed to create an immune response against the parasite and prevent the
disease. The purpose of the study is to determine whether the additional component-protein
pieces known as CpG- improves the immune response to the vaccine without causing problematic
side effects.
Volunteers must be healthy adults between 18 and 45 years old. Individuals who have had
malaria in the past or have recently traveled to areas where malaria is endemic will be
excluded from the study. Candidates will be screened with a physical examination, blood
tests, and medical history.
Participants will be involved in a three-stage study. In the first stage, a group of
participants will receive either a high dose of the vaccine alone or a low dose combined with
the CpG protein. In the second stage, a different group of participants will receive a high
dose of the vaccine alone or a high dose combined with CpG. In the third stage, a larger
group of participants will receive a high dose of the vaccine alone or a high dose combined
with CpG. The vaccine will be injected into the muscle of the upper arm, and all participants
will receive three doses of the vaccine with 28 days between doses to monitor possible
reactions and side effects. Participants will be monitored for 30 minutes after each
injection and will record any symptoms they experience over the six days after receiving
their dose. In addition, participants will be examined over the course of six months during
and after the trial with physical exams and blood and urine tests.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)