HIVPhase 1NCT00850616
Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)
A Phase 1 study testing V526 in people with HIV and HIV Infections, run by Merck Sharp & Dohme LLC.
Trial summary
A study to assess the general safety and tolerability of the administration of the 3-dose regimen of the MRKAd5+6 trigene vaccine Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- V526
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
A study to assess the general safety and tolerability of the administration of the 3-dose regimen of the MRKAd5+6 trigene vaccine
- Conditions
- HIV, HIV Infections
- Being tested
- V526, Comparator: Placebo to V526
- Keywords
- HIV, HIV Seronegativity, Preventive Vaccine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V526Biological
0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.
Comparator: Placebo to V526Biological
0.5 mL intramuscular injections of placebo to MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4, and Week 26.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MRKAd6 Trigene 0.5x10^9 Ad6 vg Receives: Biological: V526 |
| 2 | Experimental | MRKAd6 Trigene 0.5x10^10 Ad6 vg Receives: Biological: V526 |
| 3 | Experimental | MRKAd6 Trigene 0.5x10^11 Ad6 vg Receives: Biological: V526 |
| 4 | Experimental | MRKAd5 Trigene 0.5x10^10 Ad5 vg Receives: Biological: V526 |
| 5 | Experimental | MRKAd5 Trivalent 1.5x10^10 Ad5 vg Receives: Biological: V526 |
| 6 | Experimental | MRKAd5+6 Trigene 1x10^9 Ad vg Receives: Biological: V526 |
| 7 | Experimental | MRKAd5+6 Trigene 1x10^10 Ad vg Receives: Biological: V526 |
| 8 | Placebo comparator | Placebo Receives: Biological: Comparator: Placebo to V526 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs
Measured: Week 30
Immune response to MRKAd5+6 trigene vaccine
Measured: 30 week
Secondary outcomes (1)
Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6
Measured: Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startApr 2005
- Primary completionAug 2006
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850616
- Sponsor's protocol ID
- V526-001
- Other IDs
- 2009_551
- Status last verified
- Oct 2015
- First submitted
- 24 Feb 2009
- Last updated
- 2 Nov 2015
- Results posted
- No
Publications
Harro C, Sun X, Stek JE, Leavitt RY, Mehrotra DV, Wang F, Bett AJ, Casimiro DR, Shiver JW, DiNubile MJ, Quirk E; Merck V526-001 Study Group. Safety and immunogenicity of the Merck adenovirus serotype 5 (MRKAd5) and MRKAd6 human immunodeficiency virus type 1 trigene vaccines alone and in combination in healthy adults. Clin Vaccine Immunol. 2009 Sep;16(9):1285-92. doi: 10.1128/CVI.00144-09. Epub 2009 Jul 15.
PubMed 19605598
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00850616
- Acronym / sponsor ID
- V526-001
- Conditions
- HIV, HIV Infections
- Keywords
- HIV, HIV Seronegativity, Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess the general safety and tolerability of the administration of the 3-dose regimen of the MRKAd5+6 trigene vaccine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: V526MRKAd6 Trigene 0.5x10^9 Ad6 vg |
| 2 | Experimental | Biological: V526MRKAd6 Trigene 0.5x10^10 Ad6 vg |
| 3 | Experimental | Biological: V526MRKAd6 Trigene 0.5x10^11 Ad6 vg |
| 4 | Experimental | Biological: V526MRKAd5 Trigene 0.5x10^10 Ad5 vg |
| 5 | Experimental | Biological: V526MRKAd5 Trivalent 1.5x10^10 Ad5 vg |
| 6 | Experimental | Biological: V526MRKAd5+6 Trigene 1x10^9 Ad vg |
| 7 | Experimental | Biological: V526MRKAd5+6 Trigene 1x10^10 Ad vg |
| 8 | Placebo comparator | Biological: Comparator: Placebo to V526Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V5260.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26. | Biological | 1, 2, 3, 4, 5, 6, 7 |
| Comparator: Placebo to V5260.5 mL intramuscular injections of placebo to MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4, and Week 26. | Biological | 8 |
Primary outcome
Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs
Time frame: Week 30
Immune response to MRKAd5+6 trigene vaccine
Time frame: 30 week
1 secondary outcome
Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6
Time frame: Week 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Results publication: PubMed 19605598Harro C, Sun X, Stek JE, Leavitt RY, Mehrotra DV, Wang F, Bett AJ, Casimiro DR, Shiver JW, DiNubile MJ, Quirk E; Merck V526-001 Study Group. Safety and immunogenicity of the Merck adenovirus serotype 5 (MRKAd5) and MRKAd6 human immunodeficiency virus type 1 trigene vaccines alone and in combination in healthy adults. Clin Vaccine Immunol. 2009 Sep;16(9):1285-92. doi: 10.1128/CVI.00144-09. Epub 2009 Jul 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V526 in people with HIV and HIV Infections, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs (time frame: Week 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00850616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.