A Worldwide, Phase I, Dose-Escalating Study of a 3-Dose Regimen of the MRKAd5 (Clade B) Vaccine in Healthy Adults (V520-018)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00849732
First Posted: February 24, 2009
Last Update Posted: February 27, 2015
Collaborators:
HIV Vaccine Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Purpose
This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine. In Stage I subjects will be randomized to receive the vaccine at 1x10^9 viral particles/dose (vp/d) or placebo. In Stage II subjects will be randomized to receive the vaccine at 1x10^10 vp/d or placebo. In Stage III subjects will be randomized to receive the vaccine at 1x10^9 vp/d, at 1x10^10 vp/d, or placebo. Immunogenicity of the single dose regimen of MRKAd5 HIV-1 Gag Vaccine will also be measured.
| Condition | Intervention | Phase |
|---|---|---|
| HIV-1 HIV Infections | Biological: V520 Biological: Comparator: V520 (1x10^9 vp/d) Biological: Comparator: V520 (1x10^10 vp/d) Biological: Comparator: Placebo | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
| Official Title: | A Worldwide, Phase I, Dose-Escalating Study of Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Healthy Adults |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine [ Time Frame: 4 weeks after third vaccination ]
Secondary Outcome Measures:
- breadth of immune response measured by several assays [ Time Frame: 4 weeks after third vaccination ]
| Enrollment: | 360 |
| Study Start Date: | June 2003 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
V520 (1x10^9 vp/d)
|
Biological: V520
Intentionally Blank
Biological: Comparator: V520 (1x10^9 vp/d)
1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^9 vp/d given at Day 1, Week 4, and Week 26
|
|
Experimental: 2
V520 (1x10^10 vp/d)
|
Biological: Comparator: V520 (1x10^10 vp/d)
1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^10 vp/d given at Day 1, Week 4, and Week 26
|
|
Placebo Comparator: 3
Placebo to V520
|
Biological: Comparator: Placebo
Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at Day 1, Week 4, and Week 26
|
Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subject is in good general health
- Subject tests negative for Hepatitis B, Hepatitis C, and HIV
- Subjects of reproductive potential agree to use an accepted method of birth control through the entire study
Exclusion Criteria:
- Subject has a recent history of fever at time of vaccination
- Subject has received immune globulin or blood product 3 months prior to injection
- Subject has been vaccinated with live virus vaccine 30 days prior to receipt of first dose
- Subject has been vaccinated with inactivated vaccine with 14 days prior to receipt of first dose
- Subject has a chronic medical condition that is considered progressive
- Subject has history of malignancy
- Subject weighs less than 105 lb.
- Female subject is pregnant or breast feeding, Male subject is planning to impregnate during the first year of study
- Subject has contraindication to intramuscular injection
- Subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study
- Subject has a tattoo on the deltoid region of the arm or the injection of Depo-Provera
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849732
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
HIV Vaccine Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00849732 History of Changes |
| Other Study ID Numbers: |
V520-018 2009_549 |
| First Submitted: | February 20, 2009 |
| First Posted: | February 24, 2009 |
| Last Update Posted: | February 27, 2015 |
| Last Verified: | February 2015 |
Keywords provided by Merck Sharp & Dohme Corp.:
|
HIV Seronegativity Preventive Vaccine |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |