NCT00850616
Completed
Phase 1
A Phase I Dose Ranging Study of the Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Trigene and the MRKAd6 HIV-1 Trigene Vaccines Alone and in Combination in Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 147
- Primary Endpoint
- Immune response to MRKAd5+6 trigene vaccine
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
A study to assess the general safety and tolerability of the administration of the 3-dose regimen of the MRKAd5+6 trigene vaccine
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has negative tests for HIV, Hepatitis B, and Hepatitis C within 60 days of injection
- •Subject agrees to use an acceptable method of birth control through week 52 of the study
Exclusion Criteria
- •Subject has been given immune globulin or blood products within 30 days of first dose of study vaccine
- •Subject has been vaccinated with a live virus vaccine within 30 days or an inactivated vaccine within 5 days of first dose of study vaccine
- •Subject has known or suspected impaired immune function
- •Subject has participated in any other HIV vaccine trial
- •Female subject is pregnant or breastfeeding
Outcomes
Primary Outcomes
Immune response to MRKAd5+6 trigene vaccine
Time Frame: 30 week
Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs
Time Frame: Week 30
Secondary Outcomes
- Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6(Week 30)
Similar Trials
Completed
Phase 1
First-in-Human Study of BCX9930 in Healthy Volunteers and Patients With PNHParoxysmal Nocturnal HemoglobinuriaNCT04330534BioCryst Pharmaceuticals168
Completed
Phase 1
A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese ParticipantsHealthy VolunteersNCT05405543Bristol-Myers Squibb36
Withdrawn
Phase 1
A Phase 1 Study of PTX-35 in Healthy VolunteersHealthy VolunteerNCT05116969Heat Biologics
Recruiting
Phase 1
Phase I Study VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid TumorsSolid TumorNCT05266612Virogin Biotech Canada Ltd12
Terminated
Phase 2
A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal CancerColorectal CancerNCT02228785Cancer Advances Inc.5