MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)
|Study Design:||Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment|
Biological: MRKAd5 HIV-1 gag vaccine (V520)
Biological: Comparator: Placebo
Biological: Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed
|Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations|
|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.|
|Significant events and approaches for the overall study following participant enrollment, but prior to group assignment|
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|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose||Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.|
|MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose||
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.
|Placebo||Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.|
|Open Label Tetanus and Diptheria Toxoids Adsorbed||
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.
Participant Flow: Overall Study
|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|
|Lost to Follow-up||1||0||0||0|
|1. Primary:||Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) [ 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 ]|
|2. Secondary:||Number of Participants With Systemic and Laboratory Adverse Events (AE) [ 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 ]|
|3. Secondary:||Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen [ Time Frame: Week 30 (4 weeks after boost injection) ]|
Limitations and Caveats
|Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data|
|An interim analysis of a related study, V520 Protocol 023 (NCT00095576), showed that the MRKAd5 vaccine used in Protocol 022 (NCT00857311) was not efficacious; therefore, only a high level summary of the safety data was performed.|