A Phase 1 interventional study of MRKAd5 HIV-1 gag vaccine (V520) and Comparator: Placebo in Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-08-25.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
A Study to assess the general safety and tolerability of the administration of a 3-dose prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis C virus infection.
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This study's enrollment of 17 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
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Exclusion Criteria:
Participants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
Biological: MRKAd5 HIV-1 gag vaccine (V520)
Participants were to be administered MRKAd5 HIV-1 gag 1x10\^10 vp/dose (V520) on Day 1, Week 4, and Week 26. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10\^10 vp/dose.
Biological: MRKAd5 HIV-1 gag vaccine (V520)
Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
Biological: Comparator: Placebo
Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group.
Biological: Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed
3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10\^9 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26
1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26
0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only
3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10\^10 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)
Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect 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. Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine.
Time frame: up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs
Number of Participants With Systemic and Laboratory Adverse Events (AE)
Adverse experiences collected include serious and non serious systemic AEs, injection-site AEs, and laboratory 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.
Time frame: up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs
Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen
Participants expressing HIV antigens (gag) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag-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 (NCT00857311) proved it was not efficacious.
Time frame: Week 30 (4 weeks after boost injection)
All participants had to be at low risk of acquiring human immunodeficiency virus (HIV) infection, and had to meet a number of laboratory criteria. They could not have received treatment for hepatitis C virus infection in the 3 months prior to enrollment and must not anticipate to begin treatment with in 1 year after enrollment.
| Milestone | MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose | MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose | Placebo | Open Label Tetanus and Diptheria Toxoids Adsorbed |
|---|---|---|---|---|
| Started | 9 | 0 | 8 | 0 |
| Completed | 8 | 0 | 8 | 0 |
| Not completed | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 |
Adverse experiences collected include serious and non serious systemic AEs, injection-site AEs, and laboratory 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.
| Participants | MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose | Placebo |
|---|---|---|
| With non-serious systemic AEs | 8 | 6 |
| With serious systemic AEs | 2 | 2 |
| With non-serious injection-site AEs | 3 | 1 |
| With serious injection-site AEs | 0 | 0 |
| With non-serious laboratory AEs | 4 | 1 |
| With serious laboratory AEs | 0 | 0 |
Participants expressing HIV antigens (gag) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag-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 (NCT00857311) proved it was not efficacious.
No measurements were reported for this outcome.
Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect 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. Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine.
| Participants | MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose | Placebo |
|---|---|---|
| With non-serious vaccine-related (VR) clinical AEs | 5 | 1 |
| ---With non-serious VR systemic AEs | 3 | 1 |
| ---With non-serious VR injection-site AEs | 3 | 1 |
| With serious VR clinical AEs | 0 | 0 |
| ---With serious VR systemic AEs | 0 | 0 |
| ---With serious VR injection-site AEs | 0 | 0 |
| With non-serious VR laboratory AEs | 2 | 0 |
| With serious VR laboratory AEs | 0 | 0 |
| discontinued due to non-serious VR clinical AE | 0 | 0 |
| discontinued due to serious VR clinical AE | 0 | 0 |
| discontinued due to VR non-serious laboratory AE | 0 | 0 |
| discontinued due to VR serious laboratory AE | 0 | 0 |
Collected over Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose | — | 2/9 (22.2%) | 9/9 (100%) |
| Placebo | — | 2/8 (25%) | 6/8 (75%) |
| Event | MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose | Placebo |
|---|---|---|
| Hepatitis CInfections and infestations | 0/9 | 1/8 |
| Alcohol abusePsychiatric disorders | 0/9 | 1/8 |
| Multiple fracturesInjury, poisoning and procedural complications | 1/9 | 0/8 |
| Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/9 | 0/8 |
| Event | MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 3/9 | 1/8 |
| Injection Site PainGeneral disorders | 3/9 | 1/8 |
| PyrexiaGeneral disorders | 3/9 | 1/8 |
| Aspartate aminotransferase increasedInvestigations | 3/9 | 0/8 |
| VomitingGastrointestinal disorders | 2/9 | 1/8 |
| ChillsGeneral disorders | 2/9 | 1/8 |
| Injection Site ErythemaGeneral disorders | 2/9 | 0/8 |
| MyalgiaMusculoskeletal and connective tissue disorders | 2/9 | 0/8 |
| DizzinessNervous system disorders | 2/9 | 0/8 |
| HeadacheNervous system disorders | 2/9 | 1/8 |
| Age, Customized(years) | MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose | MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose | Placebo | Open Label Tetanus and Diptheria Toxoids Adsorbed | Total |
|---|---|---|---|---|---|
| Mean | 41.4 (33 to 54) | — | 39.3 (22 to 49) | — | 40.4 (22 to 54) |
| Gender(participants) | MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose | MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose | Placebo | Open Label Tetanus and Diptheria Toxoids Adsorbed | Total |
|---|---|---|---|---|---|
| Female | 5 | — | 4 | — | 9 |
| Male | 4 | — | 4 | — | 8 |
| Region of Enrollment(participants) | MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose | MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose | Placebo | Open Label Tetanus and Diptheria Toxoids Adsorbed | Total |
|---|---|---|---|---|---|
| United States | 9 | — | 8 | — | 17 |
No study locations are listed for this record.
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Merck Sharp & Dohme LLC