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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) HIV Vaccine Trials Network |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00801697 |
This study will evaluate the safety and preliminary immune response to recombinant adenoviral serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.
Condition | Intervention | Phase |
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HIV Infections |
Biological: DNA Vaccine Biological: DNA Vaccine placebo Biological: rAd35 Biological: rAd35 placebo Biological: rAd5 Biological: rAd5 placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment |
Official Title: | A Phase 1B Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Adenoviral Subtype 35 (rAd35) and Subtype 5 (rAd5) HIV-1 Vaccines When Given as a Heterologous Prime-Boost Regimen or as Boosts to a Recombinant DNA Vaccine in Healthy, Ad5-Naïve and Ad5-Exposed, Low Risk, HIV-1 Uninfected Adult Participants |
Estimated Enrollment: | 192 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1A: Experimental
rAD5-naive participants will receive rAd35 intramuscularly at study entry and rAd5 intramuscularly at Month 6
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Biological: rAd35
VRC-HIVADV027-00-VP 1 x 10^10 PU administered as 1 mL
Biological: rAd5
4 mg VRC-HIVADV038-00-VP administered as 1 mL
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1B: Placebo Comparator
Participants will receive rAd35 placebo intramuscularly at study entry and rAd5 placebo intramuscularly at Month 6
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Biological: rAd35 placebo
1 mL VRC-PBSPLA043-00-0VP
Biological: rAd5 placebo
1 mL VRC-DILUENT013-DIL-VP
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2A: Experimental
rAD5-naive participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd5 intramuscularly at Month 6
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Biological: DNA Vaccine
4 mg VRC-HIVDNA044-00-VP administered as 1 mL
Biological: rAd5
4 mg VRC-HIVADV038-00-VP administered as 1 mL
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2B: Placebo Comparator
Participants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd5 placebo intramuscularly at Month 6
|
Biological: DNA Vaccine placebo
1 mL VRC-PBSPLA043-00-VP
Biological: rAd5 placebo
1 mL VRC-DILUENT013-DIL-VP
|
3A: Experimental
Participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd35 intramuscularly at Month 6
|
Biological: DNA Vaccine
4 mg VRC-HIVDNA044-00-VP administered as 1 mL
Biological: rAd35
VRC-HIVADV027-00-VP 1 x 10^10 PU administered as 1 mL
|
3B: Placebo Comparator
Participants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd35 placebo intramuscularly at Month 6
|
Biological: DNA Vaccine placebo
1 mL VRC-PBSPLA043-00-VP
Biological: rAd35 placebo
1 mL VRC-PBSPLA043-00-0VP
|
4A: Experimental
Participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd35 intramuscularly at Month 6
|
Biological: DNA Vaccine
4 mg VRC-HIVDNA044-00-VP administered as 1 mL
Biological: rAd35
VRC-HIVADV027-00-VP 1 x 10^10 PU administered as 1 mL
|
4B: Placebo Comparator
Participants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd35 placebo intramuscularly at Month 6
|
Biological: DNA Vaccine placebo
1 mL VRC-PBSPLA043-00-VP
Biological: rAd35 placebo
1 mL VRC-PBSPLA043-00-0VP
|
One of the more promising approaches in the development of a preventive HIV vaccine uses a DNA plasmid to prime the immune response to an adenoviral vector boost. This primary purpose of this study is to evaluate the safety, tolerability, and immune response to recombinant adenoviral serotype 35 (rAd35) and serotype 5 (rAD5) HIV-1 vaccines in Ad-5 naive and Ad-5 exposed HIV-uninfected adults.
This study will last approximately 12 months. Participants will include those who are both rAD5-naive and rAD5-exposed and will be stratified into one of four groups. Each group will consist of two arms, one interventional and one control. Participants in Groups 1, 2, and 3 will be rAD5-naive. Participants in Group 4 will be rAD5-exposed.
Participants in Group 1 will receive an injection of rAD35 vaccine or placebo at study entry and an injection of rAD5 vaccine or placebo at Month 6 with nine follow-up visits through Month 12. Participants in Groups 2, 3, and 4 will injections of DNA vaccinations or placebo at study entry and at Months 1 and 2, and an injection of rAD35 vaccine, rAD5 vaccine, or placebo at Month 6 with twelve follow-up visits though Month 12. A physical, questionnaire, and counseling will occur at all visits. Blood and urine collection will occur at most visits. A rectal swab will occur at selected visits. For females, a pregnancy test will occur at all visits.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | HVTN 077 |
Study First Received: | December 2, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00801697 |
Health Authority: | United States: Food and Drug Administration |
HIV Seronegativity HIV Preventive Vaccine Adenovirus |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Adenoviridae Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |