Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009_551 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to assess the general safety and tolerability of the administration of the 3-dose regimen of the MRKAd5+6 trigene vaccine
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MRKAd6 Trigene 0.5x10^9 Ad6 vg |
|
| 2 | Experimental | MRKAd6 Trigene 0.5x10^10 Ad6 vg |
|
| 3 | Experimental | MRKAd6 Trigene 0.5x10^11 Ad6 vg |
|
| 4 | Experimental | MRKAd5 Trigene 0.5x10^10 Ad5 vg |
|
| 5 | Experimental | MRKAd5 Trivalent 1.5x10^10 Ad5 vg |
|
| 6 | Experimental | MRKAd5+6 Trigene 1x10^9 Ad vg |
|
| 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V526 | Biological | 0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs | Week 30 | |
| Immune response to MRKAd5+6 trigene vaccine | 30 week |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6 | Week 30 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19605598 | Result | Harro C, Sun X, Stek JE, Leavitt RY, Mehrotra DV, Wang F, Bett AJ, Casimiro DR, Shiver JW, DiNubile MJ, Quirk E; Merck V526-001 Study Group. Safety and immunogenicity of the Merck adenovirus serotype 5 (MRKAd5) and MRKAd6 human immunodeficiency virus type 1 trigene vaccines alone and in combination in healthy adults. Clin Vaccine Immunol. 2009 Sep;16(9):1285-92. doi: 10.1128/CVI.00144-09. Epub 2009 Jul 15. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
MRKAd5+6 Trigene 1x10^10 Ad vg |
|
| 8 | Placebo Comparator | Placebo |
|
| Comparator: Placebo to V526 | Biological | 0.5 mL intramuscular injections of placebo to MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4, and Week 26. |
|
| 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 |