Phase 1 Study of the Safety, Reactogenicity, and Immunogenicity of AMA1-C1/ISA 720: Blood Stage Vaccine for Plasmodium Falciparum
This study will evaluate the safety and effectiveness of a vaccine called AMA1-C1/ISA. Malaria is a serious infection of red blood cells caused by a parasite. There are 300 to 500 million malaria cases worldwide each year. About 2 to 3 million deaths annually are from malaria alone or along with other diseases. Researchers hope to find a vaccine to fight malaria.
Patients ages 18 to 45 who are in good health, are not pregnant or breast feeding, have no history of malaria, and have not lived for more than 1 month in an area where malaria is prevalent may be eligible for this study. There will be 28 participants, each assigned to one of three dose groups: 12 get 5 microg, 12 get 20 microg, and 4 get 80 microg of AMA 1-C1 formulated in ISA 720. The vaccine might block the parasite from entering red blood cells and causing disease. This study is the first time the vaccine will be given to human beings for testing.
Patients will have a medical history, physical exam, laboratory tests, and pregnancy tests. The study will last 48 weeks. One or two vaccinations are given by injection, at least 12 weeks apart. After each vaccination, patients will be asked to stay in the clinic for at least 30 minutes for observation. They will return to the clinic on Days 1, 3, 7, 14, 28, and 56 after each vaccination. There will be a check of vital signs, brief physical exam, history of symptoms and medications taken since the last visit, and blood tests to check for vaccine safety and effectiveness. Photographs of the injection site on the arm may be taken. Patients will receive a thermometer, diary card, and plastic measuring device. Each day they will record their temperatures and any symptoms, and measure the size of any reactions at the vaccination site. They will be asked to do this for 27 days after vaccinations.
After injections, there may be pain, swelling, and redness at the vaccination site, and limitation of arm movement. General side effects from the vaccine may be fever, chills, headache, fatigue, and muscle and joint pain. Patients will be asked if they agree to have researchers keep any unused serum samples, for use only in research into malaria and other diseases. Genetic testing would not be done on those samples. Stored samples will be labeled with a code, and information is kept private.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase 1 Study of the Safety, Reactogenicity and Immunogenicity of AMA1-C1/ISA 720: A Blood Stage Vaccine for Plasmodium Falciparum|
- Assessment of the safety and reactogenicity of the AMA1-C1/ISA 720 vaccine; and to determine the frequency of systemic and local AEs as recorded for 28 days following each vaccination.
- Assessment of the level, kinetics and the in-vitro biological activity of the antibody response to AMA1-FVO and AMA1-3D7.
|Study Start Date:||June 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Drug: AMA1-C1/ISA 720
AMA1-C1 with Montanide ISA 720, is a blood stage malaria vaccine candidate. The objectives of this phase 1 trial are to study the safety, reactogenicity, and immunogenicity of this vaccine and to assess the level, kinetics, and the in vitro biological activity of the antibody response it induces. The study is an open label, dose escalation, phase 1 clinical trial in healthy adult volunteers. Volunteers will be screened and 28 participants will be enrolled into 3 dose cohorts. Cohort 1 will receive 5 micrograms of AMA1-C1/ISA 720 at each injection, Cohort 2 will receive 20 micrograms, and Cohort 3 will receive 80 micrograms. Cohorts 1 and 2 will receive 2 injections, 3 months apart. Cohort 3 will receive only 1 vaccination. 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 parasite growth inhibition assay (GIA), and will be compared among dose groups.
|QIMR - CLive Berghofer Cancer Research Centre|