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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00479999 |
This study will test whether two experimental HIV vaccines are safe and whether they cause any side effects in healthy adults. 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. 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). 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 vaccines cannot cause HIV or adenoviral infections.
Healthy normal volunteers between 18 and 50 years of age may be eligible for this 2-part study. Part 1 includes 15 people. Part 2 includes 20 people.
Part 1 participants receive only the rAd35-EnvA vaccine. The first five people enrolled receive the lowest study dose of the vaccine. If this dose is safe, then the next five people enrolled receive a higher dose. If this dose is safe, then the last 5 people enrolled receive the highest study dose.
Subjects in Part I have about five clinic visits over 24 weeks.
Part II of the study starts after all injections in Part 1 are given. Subjects in Part 2 are randomly assigned to one of two vaccination schedules. One group receives the rAd35-EnvA vaccine first, followed 12 weeks later with the rAd5-EnvA 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. In this schedule, the first vaccination primes the immune system and then the immune response is boosted 12 weeks later with a different vaccine. Everyone in study Part 2 receives the rAd35-EnvA vaccine at the middle dose tested in Part 1. Subjects in Part 2 have about eight clinic visits over 36 weeks.
All vaccinations are given as injections in the upper arm. At each clinic visit, participants are checked for health changes or problems. They are asked how they are feeling and if they have taken any medications. Urine samples are collected and blood is drawn at some visits. They are tested for HIV several times and asked questions about their sexual behavior and drug use. Throughout the study, participants are counseled on HIV risk reduction.
Subjects are asked about any social effects they may have experienced from their participation in this study.
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Condition | Intervention | Phase |
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AIDS Vaccines HIV Infections HIV-1 |
Drug: VRC-HIVADV027-00-VP Drug: VRC-HIVADV038-00-VP |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | VRC 012: A Phase I Clinical Trial of the Safety and Immunogenicity of an HIV-1 Adenoviral Vector Serotype 35 Vaccine: Dose Escalation as a Single Agent and Prime-Boost Schedules With an HIV-1 Adenoviral Vector Serotype 5 Vaccine in Uninfected Adults |
Estimated Enrollment: | 35 |
Study Start Date: | May 2007 |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
A participant must meet all of the following criteria:
Willing to discuss HIV infection risks, amenable to risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit and assessed by the clinic staff as being at low risk of HIV infection on the basis of behaviors in the 12 months prior to enrollment as follows:
Sexually abstinent
OR
Had two or fewer mutually monogamous relationships with partners believed to be HIV-uninfected and who did not use injection drugs, crack cocaine or methamphetamine
OR
Had three or fewer partners believed to be HIV-uninfected and who did not use injection drugs, crack cocaine or methamphetamine and with whom he/she regularly used condoms for vaginal or anal intercourse.
Physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment.
Laboratory Criteria within 28 days prior to enrollment:
Negative anti-hepatitis C virus (HCV) antibody and negative HCV PCR.
Laboratory Criteria within 84 days prior to enrollment:
Seronegative for Ad35 antibody if enrolled in Part I after the Version 2.0 amendment and seronegative for both Ad5 and Ad35 antibody if in Part II.
Female-Specific Criteria:
No reproductive potential because of menopause [one year without menses] or because of a hysterectomy, bilateral oophorectomy, or tubal ligation,
or
Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 12 of the study for subjects in Part I and through Week 24 of the study for subjects in Part II,
or
Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 12 of the study for subjects in Part I or through Week 24 of the study for subjects in Part II by one of the following methods:
EXCLUSION CRITERIA:
A volunteer will be excluded if one or more of the following conditions apply:
Women:
Woman who is breast-feeding or planning to become pregnant during the 12 weeks of study participation for subjects in Part I and 24 weeks of study participation for subjects in Part II.
Volunteer has received any of the following substances:
Current anti-tuberculosis prophylaxis or therapy.
Volunteer has a history of any of the following clinically significant conditions:
BMI greater than or equal to 40; OR BMI greater than or equal to 35 AND with one or more of the following:
Within the 12 months prior to enrollment, one or more of the following:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 070167, 07-I-0167 |
Study First Received: | May 26, 2007 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00479999 History of Changes |
Health Authority: | United States: Federal Government |
HIV-Negative Healthy Immunity Preventive |
Virus Healthy Volunteer HV HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |