HIV InfectionsPhase 2NCT00350623

Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)

A Phase 2 study testing MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520), MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520) and MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520) in people with HIV Infections, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520), MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520) and MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: No sites listed yet
Study dates: Oct 2006to May 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Demonstrates good general health
Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), and Hepatitis C (HCV) seronegative
Low risk of acquiring HIV infection
ALT lab value within normal range

Who cannot join

Previously received an investigational HIV vaccine
Has a known or suspected impairment of immunologic function
Has a clinically significant chronic medical condition that is considered progressive
Has a major psychiatric illness
Has any history of malignancy, with the exception of basal cell or squamous cell skin cancer
Weighs less than 105 lbs.

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Has a recent (within two years) history of chronic alcohol abuse
Has a contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
Female is pregnant or breast feeding, or expecting to conceive or donate eggs during the study
Male subject is planning to impregnate or provide sperm donation during the study

About this study

Official title: A Phase IIa Dose-Refinement Study of the Safety and Immunogenicity of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy Adults

Conditions: HIV Infections
Being tested: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520), MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520), MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)
Keywords: AIDS
Medical subject headings: HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)Biological
Also called V520
3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)Biological
Also called V520
3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)Biological
Also called V520
3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Study groups in NCT00350623
Study group	Role	What they receive
MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose	Experimental	MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. Receives: Biological: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)
MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose	Experimental	MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. Receives: Biological: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose	Experimental	MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. Receives: Biological: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks
Measured: 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006May 2008

First posted11 Jul 2006 (estimated)
Study startOct 2006
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionsStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00350623
Sponsor's protocol ID: V520-027
Other IDs: 2006_501
Status last verified: Aug 2015
First submitted: 7 Jul 2006
Last updated: 25 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa Dose-Refinement Study of the Safety and Immunogenicity of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy Adults
ClinicalTrials.gov ID: NCT00350623
Acronym / sponsor ID: V520-027
Conditions: HIV Infections
Keywords: AIDS
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 210 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 11 Jul 2006 (estimated)
Results: Posted 4 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose	Experimental	Biological: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose	Experimental	Biological: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose	Experimental	Biological: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Demonstrates good general health
Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), and Hepatitis C (HCV) seronegative
Low risk of acquiring HIV infection
ALT lab value within normal range

Key exclusion criteria (10 listed)

Previously received an investigational HIV vaccine
Has a known or suspected impairment of immunologic function
Has a clinically significant chronic medical condition that is considered progressive
Has a major psychiatric illness
Has any history of malignancy, with the exception of basal cell or squamous cell skin cancer

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
MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)Also: V5203-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.	Biological	MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose
MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)Also: V5203-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.	Biological	MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)Also: V5203-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.	Biological	MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose

Primary outcome

Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks
Time frame: 30 weeks

Results and safety

Results posted to the registry on 4 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose	71	63
MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose	71	67
MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose	68	62

Primary outcome: Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks

Time frame: 30 weeks

Population analysed: No data analysis was performed.

Adverse events

Time frame: Non-Serious and Serious AEs were collected for 14 days following each vaccination.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose	0 of 71 (0%)	56 of 71 (78.9%)	Not reported
MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose	0 of 71 (0%)	63 of 71 (88.7%)	Not reported
MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose	2 of 68 (2.9%)	60 of 68 (88.2%)	Not reported

Limitations and caveats (from the sponsor): An interim analysis of a related study, V520-023 (NCT00095576), showed that the vaccine used in V520-027 (NCT00350623) was not efficacious; therefore, vaccinations in V520-027 were stopped and only a high level summary of safety data was performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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?

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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 25 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks (time frame: 30 weeks). 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 NCT00350623.

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 25 Aug 2015.