Protocol Number: 07-I-0083
Healthy people between 18 and 50 years of age may be eligible for this 7-month study. Participants are randomly assigned to one of four treatment groups (A, B, C or D below). All receive two vaccinations, given as a shot in the upper arm either 1 or 2 months apart, as shown: -Group A: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-P at Day 0 and Day 28 (1-month interval) -Group B: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-S at Day 0 and Day 28 (1-month interval) -Group C: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-P at Day 0 and Day 56 (2-month interval) -Group D: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-S at Day 0 and Day 56 (2-month interval) Group A and B participants return to the clinic for checkups at 3, 7, and 14 days after each vaccination and again at months 2, 3, 4, 5, and 7. Group C and D participants come to the clinic at 3, 7, and 14 days after each vaccination and again at months 3, 4, 5, and 7. In addition to the vaccinations, the study includes the following procedures: -Photographs of the subject's arm where the vaccination is given if a rash develops. -Daily temperature and symptoms record for the first 6 days after each of the 2 vaccinations, and at any other time there is concern about fever or other symptoms. -Blood draws about 12 times during the study to check for safety and to measure the antibody response and the effect of the study vaccine. Some participants may be asked to undergo plasmapheresis, a procedure for collecting plasma, the liquid part of the blood. This is done by using a machine called a blood cell separator. Blood is collected through a needle placed in a vein in the arm and flows into the cell separator machine. The plasma is separated from the cells by a spinning procedure called centrifugation. The plasma is removed while the remaining cells are returned to the subject, either through the same needle or through a second needle in the other arm.
Search The Studies | Help | Questions |
National Institutes of Health Clinical Center |
||