|
Protocol Number: 06-I-0149 
Healthy volunteers 18-50 years old may be eligible for this 42-week study. Participants are screened for antibodies to adenovirus, a common virus that causes upper respiratory infections, such as the common cold. Half of the participants selected will be positive and half will be negative for antibodies to the virus. The vaccines used in this study are known as VRC-HIVDNA016-00-VP (called the "DNA vaccine") and VRC-HIVADV014-00-VP (called the "rAd5 vaccine"). The DNA vaccine codes for four HIV proteins. The rAd5 vaccine is made using an adenovirus that has been modified to contain DNA that codes for three HIV proteins. These vaccines cannot cause HIV or adenoviral infections. Participants are randomly assigned to one of six possible vaccination schedules that include "prime" and "booster" vaccines. The first vaccinations prime the immune system and the immune response is then boosted later. The groups differ in the type of vaccines given (DNA vaccine prime with rAd5 booster or rAd5 prime with rAd5 booster), in how the vaccine is administered (intramuscularly, subcutaneously or intradermally) and in the schedule of administration. All shots are given in the upper arm. Subjects fill out a diary card at home for 5 days after each vaccination, recording their temperature and any symptoms. The cards are turned in to the clinic at the first visit after all 5 days are completed. Subjects return for clinic visits about 3 days after each prime vaccination and either come in or call the clinic about 7 days after the injection. They call a study nurse 1 or 2 days after the booster vaccination. Participants have 15-20 clinic visits during the course of the study, depending on their vaccination schedule. At each visit, they are checked for health changes or problems, asked how they are feeling and if they have taken any medications or other treatments, including over-the-counter medicines, herbal supplements, etc. Blood and urine samples are collected at some visits. Subjects are tested for HIV several times and asked questions about their sexual behavior and drug use. Throughout the study they are counseled on HIV risk reduction. Women are asked about their pregnancy prevention method. Subjects are asked about any social effects (e.g., problems with insurance, health care, friends, family, employment, housing education or government agencies) they may have experienced from participating in the study. These effects are monitored to make sure participants receive any needed assistance and to learn ways to prevent these problems in the future. One year after the last visit (week 42) subjects either have an extra clinic visit or are contacted by telephone, email, or postal mail to answer questions about their health. Those who come to the clinic may be asked to provide a blood sample.
Search The Studies | Help | Questions |
|
||
National Institutes of Health Clinical Center