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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_549 |
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| Name | Class |
|---|---|
| HIV Vaccine Trials Network | NETWORK |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine. In Stage I subjects will be randomized to receive the vaccine at 1x10^9 viral particles/dose (vp/d) or placebo. In Stage II subjects will be randomized to receive the vaccine at 1x10^10 vp/d or placebo. In Stage III subjects will be randomized to receive the vaccine at 1x10^9 vp/d, at 1x10^10 vp/d, or placebo. Immunogenicity of the single dose regimen of MRKAd5 HIV-1 Gag Vaccine will also be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | V520 (1x10^9 vp/d) |
|
| 2 | Experimental | V520 (1x10^10 vp/d) |
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| 3 | Placebo Comparator | Placebo to V520 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V520 | Biological | Intentionally Blank |
| |
| Comparator: V520 (1x10^9 vp/d) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine | 4 weeks after third vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| breadth of immune response measured by several assays | 4 weeks after third vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20854108 | Result | Nicholson O, DiCandilo F, Kublin J, Sun X, Quirk E, Miller M, Gray G, Pape J, Robertson MN, Mehrotra DV, Self S, Turner K, Sanchez J, Pitisuttithum P, Duerr A, Dubey S, Kierstead L, Casimiro D, Hammer For The Merck V/Hiv Vaccine Trials Network Study Team SM. Safety and Immunogenicity of the MRKAd5 gag HIV Type 1 Vaccine in a Worldwide Phase 1 Study of Healthy Adults. AIDS Res Hum Retroviruses. 2011 May;27(5):557-567. doi: 10.1089/AID.2010.0151. Epub 2010 Nov 23. | |
| 21533229 |
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| Biological |
1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^9 vp/d given at Day 1, Week 4, and Week 26 |
|
| Comparator: V520 (1x10^10 vp/d) | Biological | 1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^10 vp/d given at Day 1, Week 4, and Week 26 |
|
| Comparator: Placebo | Biological | Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at Day 1, Week 4, and Week 26 |
|
| Derived |
| Pine SO, Kublin JG, Hammer SM, Borgerding J, Huang Y, Casimiro DR, McElrath MJ. Pre-existing adenovirus immunity modifies a complex mixed Th1 and Th2 cytokine response to an Ad5/HIV-1 vaccine candidate in humans. PLoS One. 2011 Apr 13;6(4):e18526. doi: 10.1371/journal.pone.0018526. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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