Phase I Study of Safety and Immunogenicity of AMA1-C1Alhydrogel + CPG 7909 Vaccine for Malaria

Phase 1

Completed

• Conditions: Malaria

• Registration Number: NCT00414336
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

This study will evaluate the safety of an experimental vaccine can protect people from malaria and study its effects. Malaria, which affects many people in Mali and other countries in Africa, is caused by germs spread by mosquito bites. In Mali, the disease is the leading cause of death. Researchers at the Malaria Research and Training Center at the University of Bamako are working with NIH to develop an experimental vaccine against the disease. The vaccine, called AMA1-C1Alhydrogel (or AMA1-C1), contains a small part of the malaria-causing germ. CPG-7909 is a product to improve the body's reactions to vaccines.

Patients ages 18 to 45 who are in good health, who live in Don gu bougou, Mali, and plan to stay there for the study duration, and who are not pregnant or breast feeding may be eligible for this study. There will be 24 participants.

At an initial evaluation of 2 to 3 hours, patients will have a physical examination and undergo blood and urine tests regarding the blood, kidneys, and liver. During the study, patients will receive two injections of one of the two experimental malaria vaccines. Injections of the same vaccine each time, 4 weeks apart, are given in an arm muscle. Patients will receive either AMA1-C1 or AMA1-C1 with CPG-7909 but will not know which of the vaccines they receive until the study's end. After each injection, patients will stay in the clinic for 30 minutes for observation. They will return after 1, 2, 3, 7, and 14 days to be examined and report how they are feeling. Blood and urine samples will be collected at some visits. Each clinic visit takes 1 to 2 hours. If for some reason a patient receives only one injection, he or she will be asked to return to the clinic for routine visits until the study's end. After the first 2 months, patients will return to the clinic once a month for 30 weeks. In that period, 12 blood samples will be taken. Researchers want to be sure that the vaccine is not harmful as well as to measure the vaccine's effects.

Risks in this study include pain, swelling, and redness at the injection site; fever; and gastrointestinal problems. Some people have had a temporary decrease in white blood cells after receiving the vaccine. There is a small chance of a severe allergic reaction. However, researchers will closely watch patients immediately after each injection and will give treatment if a serious reaction occurs.

Participants will receive 75 kilos of rice and 75 kilos of millet (165 lb. of ...

Detailed Description

AMA1-C1 + CPG 7909 is a blood stage malaria vaccine candidate. The primary objective of this Phase 1 study is to evaluate safety and reactogenicity of the vaccine in semi-immune adults in Mali. Secondary objectives are to evaluate the immunogenicity of the vaccine. The study is a double blind Phase 1 clinical trial in healthy adult volunteers. Volunteers will be screened and 24 participants will be enrolled and randomly assigned to one of the two groups: 12 volunteers will receive two doses of 80 microgram AMA1-C1/Alhydrogel + 500 microgram CPG; 12 volunteers will receive 80 microgram AMA1-C1/Alhydrogel, both at a 1-month dosing interval. Safety outcome measures are local and systemic (including laboratory) adverse events. Immune responses to vaccination will be measured by enzyme-linked immunosorbent assay (ELISA) and growth inhibition assay (GIA), and will be compared between groups. Peripheral blood lymphocytes will be assayed for the presence of AMA-1-specific memory B cells and for the total number of memory B cells.

Study Timeline

• Study Start: 2006-12-15
• Primary Completion: 2006-12-15
• Study Completion: 2006-12-15
• Study First Submitted: 2006-12-20
• Study First Submitted QC: 2006-12-20
• Study First Posted: 2006-12-21
• Status Verified: 2009-08-04
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and reactogenicity.

Secondary Outcome Measures

Name	Time	Method
To determine the level and kinetics of the antibody response elicited by AMA1-C1/Alhydrogel + CPG

Trial Locations

Locations (1)

Doneguebougou Malaria Vaccine Center; 🇲🇱 Doneguebougou, Mali