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Monovalent MRKAd5 HIV-1 gag vaccine · 1 trial · 2 indications
Adverse experiences (AE) collected include serious and non serious systemic AEs, and injection-site AEs. Systemic and Laboratory AEs include any unfavorable \& unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose.
Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body. All laboratory AEs were collected up to 29 days after any vaccine dose.
Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10\^6 peripheral blood mononuclear cells (SFC per million PBMCs).
Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10\^6 peripheral blood mononuclear cells (SFC per million PBMCs). No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants receiving 1.0 ml of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or the placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26 or a 2-dose regimen at Day 1 and Week 26 or Day 1 and Week 4. |
| Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) | EXPERIMENTAL | Participants receiving 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26. |
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) | EXPERIMENTAL | Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26. |
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) | EXPERIMENTAL | Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26. |
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) | EXPERIMENTAL | Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26. |
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) | EXPERIMENTAL | Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26. |
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) | EXPERIMENTAL | Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26, or in a 2-dose regimen at Day 1 and Week 4 (with no vaccine administered at Week 26) or Day 1 and Week 26 (with placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine administered at Week 4) |
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) | EXPERIMENTAL | Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26. |
| Name | Type | Description |
|---|---|---|
| Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine | OTHER | Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine. |
| Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) | BIOLOGICAL | Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose) |
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) | BIOLOGICAL | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose) |
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) | BIOLOGICAL | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose) |
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) | BIOLOGICAL | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose) |
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) | BIOLOGICAL | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose) |
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) | BIOLOGICAL | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose) |
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) | BIOLOGICAL | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose) |
| Comparator: Placebo to MRKAd5 HIV-1 gag vaccine | BIOLOGICAL | Placebo to the MRKAd5 HIV-1 gag vaccine. |
Inclusion Criteria: * Subjects 18 Years to 45 Years in Stages I-III and 18 Years to 50 Years in Stage IV. * Subject is in good general health * Subjects of reproductive potential agree to use acceptable method of birth control through study * Subject tests negative for Hepatitis B, Hepatitis C, and...