HIV-1 InfectionPhase 1NCT00894114
A Study of Safety, Tolerability and Immunogenicity of a 1-Dose Regimen of MRKAd5 HIV-1 Gag Vaccine Versus the ALVAC_HIV Vaccine (V520-019)
A Phase 1 study testing V520 and Comparator: ALVAC-HIV vaccine in people with HIV-1 Infection, run by Merck Sharp & Dohme LLC.
Trial summary
This study is designed to determine whether patients previously primed with Ad5 of MRKAd5 HIV-1 gag vaccine respond better when boosted with ALVAC-HIV vaccine than when boosted with MKRAd5 HIV-1 gag vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- V520 and Comparator: ALVAC-HIV vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Jun 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject was previously enrolled in Merck HIV Vaccine study V520 Protocol 007 or 012, and received the complete 3-dose regimen during participation
- Subject is in good general health
- Subject is not infected with HIV
- Subject agrees not to donate blood during the first 52 weeks of the study
- Subject agrees not to donate sperm during the first 12 weeks of the study
- Subject who is of reproductive potential agrees to use an acceptable method of birth control through Week 12 of the study
Who cannot join
- Subject has been administered immune globulin or blood product 3 months prior to receiving study vaccination
- Subject has been vaccinated with a live virus vaccine in the past 30 days
- Subject has been vaccinated with an inactivated vaccine in the past 14 days
- Subject has an active medical disease
- Subject is taking daily required prescription drugs
- Female subject is pregnant, breastfeeding or expecting to conceive
Show all 17Show fewer
- Subject is positive for HIV
- Subject has used injection drug within the past year
- Subject has a sexual partner that is infected with HIV
- Subject has a sexual partner that is an active injection drug user
- Subject has been treated for or diagnosed with a new sexually transmitted disease in the past 6 months
- Subject engaged in unprotected intercourse with more than 2 persons in the previous 6 months
- Subject engaged in protected intercourse with more than 4 persons in the previous 6 months
- Subject has previously participated in an HIV vaccine clinical trial (other than Merck V520 Protocols 007 and 012)
- Subject weighs less than 110 lbs.
- Subject has a recent history of alcohol abuse
- Subject intends to donate blood in the first 52 weeks of the trial
About this study
Official title: A Probe Study of the Safety, Tolerability, and Immunogenicity of a 1-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine Versus the ALVAC-HIV (vCP205) Vaccine in Healthy Adults Who Previously Received a 3-Dose Regimen of MRKAd5, Ad5, or Placebo in Merck V520 Protocols 007 or 012
This study is designed to determine whether patients previously primed with Ad5 of MRKAd5 HIV-1 gag vaccine respond better when boosted with ALVAC-HIV vaccine than when boosted with MKRAd5 HIV-1 gag vaccine.
- Conditions
- HIV-1 Infection
- Being tested
- V520, Comparator: ALVAC-HIV vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V520Biological
MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection
Comparator: ALVAC-HIV vaccineBiological
A single dose 0.1 intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Stratum 1 | Other | Placebo recipients in the parent protocol (Merck V520 Protocols 007 or 012) will receive ALVAC-HIV Vaccine Receives: Biological: Comparator: ALVAC-HIV vaccine |
| Stratum 2 | Experimental | Nonresponders who received active vaccine in parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine Receives: Biological: V520; Biological: Comparator: ALVAC-HIV vaccine |
| Stratum 3 | Experimental | Low responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine Receives: Biological: V520; Biological: Comparator: ALVAC-HIV vaccine |
| Stratum 4 | Experimental | High responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine Receives: Biological: V520; Biological: Comparator: ALVAC-HIV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ALVAC-HIV or MRKAd5 HIV-1 vaccine in subjects who previously received a 3-dose regimen of Ad5 HIV-1 gag vaccine measured by number of injection-site adverse experiences (AE), non serious systemic AE, lab AE, serious AE.
Measured: Injection-site AE up to 5 days after vaccination, non-serious systemic AE and Lab AE up to 29 days after vaccination, serious AE for the entire study period (Week 260).
Secondary outcomes (1)
immunogenicity of a single-dose regimen of the ALVAC-HIV vaccine or MRKAd5 HIV-1 vaccine measured by various assays
Measured: 4 weeks following vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startMay 2003
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies 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
- 250 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
- NCT00894114
- Sponsor's protocol ID
- V520-019
- Other IDs
- 2009_585
- Status last verified
- May 2015
- First submitted
- 4 May 2009
- Last updated
- 28 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Probe Study of the Safety, Tolerability, and Immunogenicity of a 1-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine Versus the ALVAC-HIV (vCP205) Vaccine in Healthy Adults Who Previously Received a 3-Dose Regimen of MRKAd5, Ad5, or Placebo in Merck V520 Protocols 007 or 012
- ClinicalTrials.gov ID
- NCT00894114
- Acronym / sponsor ID
- V520-019
- Conditions
- HIV-1 Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 6 May 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.
This study is designed to determine whether patients previously primed with Ad5 of MRKAd5 HIV-1 gag vaccine respond better when boosted with ALVAC-HIV vaccine than when boosted with MKRAd5 HIV-1 gag vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stratum 1 | Other | Biological: Comparator: ALVAC-HIV vaccinePlacebo recipients in the parent protocol (Merck V520 Protocols 007 or 012) will receive ALVAC-HIV Vaccine |
| Stratum 2 | Experimental | Biological: V520, Biological: Comparator: ALVAC-HIV vaccineNonresponders who received active vaccine in parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine |
| Stratum 3 | Experimental | Biological: V520, Biological: Comparator: ALVAC-HIV vaccineLow responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine |
| Stratum 4 | Experimental | Biological: V520, Biological: Comparator: ALVAC-HIV vaccineHigh responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject was previously enrolled in Merck HIV Vaccine study V520 Protocol 007 or 012, and received the complete 3-dose regimen during participation
- Subject is in good general health
- Subject is not infected with HIV
- Subject agrees not to donate blood during the first 52 weeks of the study
- Subject agrees not to donate sperm during the first 12 weeks of the study
Key exclusion criteria (17 listed)
- Subject has been administered immune globulin or blood product 3 months prior to receiving study vaccination
- Subject has been vaccinated with a live virus vaccine in the past 30 days
- Subject has been vaccinated with an inactivated vaccine in the past 14 days
- Subject has an active medical disease
- Subject is taking daily required prescription drugs
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 |
|---|---|---|
| V520MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection | Biological | Stratum 2, Stratum 3, Stratum 4 |
| Comparator: ALVAC-HIV vaccineA single dose 0.1 intramuscular injection | Biological | Stratum 1, Stratum 2, Stratum 3, Stratum 4 |
Primary outcome
Safety and tolerability of ALVAC-HIV or MRKAd5 HIV-1 vaccine in subjects who previously received a 3-dose regimen of Ad5 HIV-1 gag vaccine measured by number of injection-site adverse experiences (AE), non serious systemic AE, lab AE, serious AE.
Time frame: Injection-site AE up to 5 days after vaccination, non-serious systemic AE and Lab AE up to 29 days after vaccination, serious AE for the entire study period (Week 260).
1 secondary outcome
immunogenicity of a single-dose regimen of the ALVAC-HIV vaccine or MRKAd5 HIV-1 vaccine measured by various assays
Time frame: 4 weeks following vaccination
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 28 May 2015.
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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 V520 and Comparator: ALVAC-HIV vaccine in people with HIV-1 Infection, 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 6 inclusion and 17 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 28 May 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. 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 ALVAC-HIV or MRKAd5 HIV-1 vaccine in subjects who previously received a 3-dose regimen of Ad5 HIV-1 gag vaccine measured by number of injection-site adverse experiences (AE), non serious systemic AE, lab AE, serious AE. (time frame: Injection-site AE up to 5 days after vaccination, non-serious systemic AE and Lab AE up to 29 days after vaccination, serious AE for the entire study period (Week 260).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2015.