![]() Part II (Group 4) of this study is a randomized, double blind evaluation of the rAd35-EnvA vaccine in comparison to and in combination with a rAd5-EnvA vaccine in prime-boost schedules. Subjects in Group 3 will receive one vaccination of rAd35-EnvA 10(11) PU. ![]() Subjects in Group 2 will receive one vaccination of rAd35-EnvA 10(10) PU. Subjects in Group 1 will receive one vaccination of rAd35-EnvA 10(9) PU. Part I of this study is an open label, dose escalation evaluation of an HIV-1 adenoviral vector serotype 35 vaccine (rAd35-EnvA). The VRC recombinant adenoviral vector serotype 5 (rAd5) multiclade vaccine has been previously shown to elicit immune responses to HIV-1-specific peptides when administered intramuscularly (IM) alone and in prime-boost schedules with the greatest magnitude and frequency of response to the Envelope A immunogen (EnvA). Condition or diseaseĭrug: VRC-HIVADV027-00-VP Drug: VRC-HIVADV038-00-VP Subjects are asked about any social effects they may have experienced from their participation in this study. Throughout the study, participants are counseled on HIV risk reduction. They are tested for HIV several times and asked questions about their sexual behavior and drug use. Urine samples are collected and blood is drawn at some visits. They are asked how they are feeling and if they have taken any medications. At each clinic visit, participants are checked for health changes or problems. Subjects in Part 2 have about eight clinic visits over 36 weeks.Īll vaccinations are given as injections in the upper arm. Everyone in study Part 2 receives the rAd35-EnvA vaccine at the middle dose tested in Part 1. In this schedule, the first vaccination primes the immune system and then the immune response is boosted 12 weeks later with a different vaccine. The other group receives the vaccines in reverse order that is, first the rAd5-EnvA vaccine, followed 12 weeks later with the rAd35-EnvA vaccine. One group receives the rAd35-EnvA vaccine first, followed 12 weeks later with the rAd5-EnvA vaccine. Subjects in Part 2 are randomly assigned to one of two vaccination schedules. Part II of the study starts after all injections in Part 1 are given. Subjects in Part I have about five clinic visits over 24 weeks. ![]() If this dose is safe, then the last 5 people enrolled receive the highest study dose. If this dose is safe, then the next five people enrolled receive a higher dose. The first five people enrolled receive the lowest study dose of the vaccine. Part 1 participants receive only the rAd35-EnvA vaccine. Healthy normal volunteers between 18 and 50 years of age may be eligible for this 2-part study. The vaccines cannot cause HIV or adenoviral infections. The vaccines are made using an adenovirus (virus that normally causes respiratory infections and colds) that has been modified to contain DNA that codes for HIV proteins. The experimental vaccines in this study are the VRC-HIVADV027-00-VP (also called the rAd35-EnvA vaccine) and VRC-HIVADV038-00-VP (also called the rAd5-EnvA vaccine). It will examine the body s immune response to the vaccines and monitor the social impact, if any, of being in an HIV vaccine study. This study will test whether two experimental HIV vaccines are safe and whether they cause any side effects in healthy adults. Why Should I Register and Submit Results?.
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