AIDSPhase 2NCT00095576
Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)
A Phase 2 study testing Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose) in people with AIDS and HIV Infections, run by Merck Sharp & Dohme LLC.
Trial summary
This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- AIDS, HIV Infections
- What is being tested?
- Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Sep 2009
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, HIV seronegative adults at high risk of acquiring HIV infection
- Cannot have previously received an investigational vaccine
Who cannot join
- In a monogamous relationship with an HIV-1 seronegative partner for > 1 year
- History of anaphylaxis and/or allergy to vaccine components, including Tris buffer, MgCl2, and polysorbate 80 (TWEEN)
- Received an immune globulin or blood derived products 3 months before injection with the first dose of vaccine/placebo or scheduled within 14 days after injection
- Previously vaccinated with a live virus vaccine within 30 days before injection with the first dose of vaccine or scheduled within 14 days after injection
- Previously vaccinated with an inactivated vaccine within 5 days before injection with the first dose of vaccine or scheduled within 14 days after injection
- Known history of immunodeficiency
Show all 13Show fewer
- History of malignancy (with some exceptions)
- Contraindication to intramuscular (IM) injection such as anticoagulant therapy or thrombocytopenia
- Female subject who is pregnant or breast feeding, or expecting to conceive or donate eggs through Week 30 of the study
- Male subject who is planning to impregnate or provide sperm donation through Week 30 of the study
- Previously received an investigational HIV vaccine
- Has active drug or alcohol abuse or dependence that would interfere with adherence to study requirements, or endanger the subject's health while on the study
- Has a condition that might endanger the subject's health or interfere with the evaluation of the study objectives
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine (MRK AD5 HIV-1 Gag/Pol/Nef) in Adults at High Risk of HIV-1 Infection
This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected.
On September 18, 2007 the Protocol V520-023 DSMB (Data \& Safety Monitoring Board) reviewed data from a planned interim analysis. These data demonstrated that the investigational vaccine candidate was not effective, and all vaccinations in the study were halted.
Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective.
Read the detailed description
No further treatment was given in V520-023, however participants were followed. V520-023 protocol ended earlier than originally planned per protocol and participants (HIV infected and uninfected) had the option of participating in an observational long term follow up protocol called V520-030/HVTN 504, which served as an extension of V520-023 and would continue through the end of 2009.
- Conditions
- AIDS, HIV Infections
- Being tested
- Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose), Comparator: placebo
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)Biological
Also called V520
Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 adenovirus genomes [ad-vg]/dose).
This dose is equivalent to 3x10^10 vp/dose used in study V520-016.
Comparator: placeboDrug
Placebo to Trivalent MRKAd5 HIV-1 gag/pol/nef in three 1 mL doses at Day 1, Week 4, and Week 26 administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Trivalent MRKAd5 HIV-1 gag/pol/nef | Experimental | Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26. Receives: Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose) |
| Placebo | Placebo comparator | Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26. Receives: Drug: Comparator: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Adverse Experiences
Number of participants with non-serious AEs with an incidence cut-off of 5% (>5% in at least one treatment group) and number of participants with >1 SAE following administration of study vaccine.
AEs collected include serious and non-serious systemic AEs, and injection-site AEs. All systemic AEs were collected up to 14 days after any vaccine dose, and serious AEs were collected for the entire study period (up to Week 210).
Injection-site AEs are any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to Day 4 after any vaccine dose.
Measured: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)
Number of Participants With Laboratory Adverse Experiences
Number of participants with laboratory adverse experiences with an incidence cut-off of 5% (events occurring > 5% in at least one treatment group) following administration of the first dose of study vaccine.
Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body.
All laboratory AEs were collected up to 14 days after any vaccine dose.
Measured: Day 1 to Week 208
Number of Participants With HIV-1 Infections
The number of participants with HIV-1 infections was to be determined with a periodic HIV-1 screening test to detect antibodies to recombinant HIV-1 envelope protein in the participants' serum.
Measured: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)
HIV-1 Viral Load in Infected Participants
Plasma HIV-1 viral RNA was to be measured using a ribonucleic acid polymerase chain reaction (RNA PCR) on the last archived sample, and at Weeks 1, 2, 8, 12, and 26 post-HIV-1 infection, and subsequently every 6 months.
Measured: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2004 (estimated)
- Study startNov 2004
- Primary completionSep 2007
- Study completionSep 2009
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AIDSStudies 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
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HIV Vaccine Trials Network
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095576
- Sponsor's protocol ID
- V520-023
- Other IDs
- 2004_091
- Status last verified
- Oct 2015
- First submitted
- 5 Nov 2004
- Last updated
- 6 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PB, Lama JR, Marmor M, Del Rio C, McElrath MJ, Casimiro DR, Gottesdiener KM, Chodakewitz JA, Corey L, Robertson MN; Step Study Protocol Team. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008 Nov 29;372(9653):1881-1893. doi: 10.1016/S0140-6736(08)61591-3. Epub 2008 Nov 13.
PubMed 19012954Janes H, Friedrich DP, Krambrink A, Smith RJ, Kallas EG, Horton H, Casimiro DR, Carrington M, Geraghty DE, Gilbert PB, McElrath MJ, Frahm N. Vaccine-induced gag-specific T cells are associated with reduced viremia after HIV-1 infection. J Infect Dis. 2013 Oct 15;208(8):1231-9. doi: 10.1093/infdis/jit322. Epub 2013 Jul 21.
PubMed 23878319Duerr A, Huang Y, Buchbinder S, Coombs RW, Sanchez J, del Rio C, Casapia M, Santiago S, Gilbert P, Corey L, Robertson MN; Step/HVTN 504 Study Team. Extended follow-up confirms early vaccine-enhanced risk of HIV acquisition and demonstrates waning effect over time among participants in a randomized trial of recombinant adenovirus HIV vaccine (Step Study). J Infect Dis. 2012 Jul 15;206(2):258-66. doi: 10.1093/infdis/jis342. Epub 2012 May 4.
PubMed 22561365Barnabas RV, Wasserheit JN, Huang Y, Janes H, Morrow R, Fuchs J, Mark KE, Casapia M, Mehrotra DV, Buchbinder SP, Corey L; NIAID HIV Vaccine Trials Network. Impact of herpes simplex virus type 2 on HIV-1 acquisition and progression in an HIV vaccine trial (the Step study). J Acquir Immune Defic Syndr. 2011 Jul 1;57(3):238-44. doi: 10.1097/QAI.0b013e31821acb5.
PubMed 21860356Fitzgerald DW, Janes H, Robertson M, Coombs R, Frank I, Gilbert P, Loufty M, Mehrotra D, Duerr A; Step Study Protocol Team. An Ad5-vectored HIV-1 vaccine elicits cell-mediated immunity but does not affect disease progression in HIV-1-infected male subjects: results from a randomized placebo-controlled trial (the Step study). J Infect Dis. 2011 Mar 15;203(6):765-72. doi: 10.1093/infdis/jiq114.
PubMed 21343146
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine (MRK AD5 HIV-1 Gag/Pol/Nef) in Adults at High Risk of HIV-1 Infection
- ClinicalTrials.gov ID
- NCT00095576
- Acronym / sponsor ID
- V520-023
- Conditions
- AIDS, HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- HIV Vaccine Trials Network
- Study start
- Nov 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Nov 2004 (estimated)
- Results
- Posted 15 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected.
On September 18, 2007 the Protocol V520-023 DSMB (Data \& Safety Monitoring Board) reviewed data from a planned interim analysis. These data demonstrated that the investigational vaccine candidate was not effective, and all vaccinations in the study were halted.
Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective.
Detailed description
No further treatment was given in V520-023, however participants were followed. V520-023 protocol ended earlier than originally planned per protocol and participants (HIV infected and uninfected) had the option of participating in an observational long term follow up protocol called V520-030/HVTN 504, which served as an extension of V520-023 and would continue through the end of 2009.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trivalent MRKAd5 HIV-1 gag/pol/nef | Experimental | Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26. |
| Placebo | Placebo comparator | Drug: Comparator: placeboParticipants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy, HIV seronegative adults at high risk of acquiring HIV infection
- Cannot have previously received an investigational vaccine
Key exclusion criteria (13 listed)
- In a monogamous relationship with an HIV-1 seronegative partner for > 1 year
- History of anaphylaxis and/or allergy to vaccine components, including Tris buffer, MgCl2, and polysorbate 80 (TWEEN)
- Received an immune globulin or blood derived products 3 months before injection with the first dose of vaccine/placebo or scheduled within 14 days after injection
- Previously vaccinated with a live virus vaccine within 30 days before injection with the first dose of vaccine or scheduled within 14 days after injection
- Previously vaccinated with an inactivated vaccine within 5 days before injection with the first dose of vaccine or scheduled within 14 days after injection
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 |
|---|---|---|
| Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)Also: V520Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 adenovirus genomes [ad-vg]/dose). This dose is equivalent to 3x10^10 vp/dose used in study V520-016. | Biological | Trivalent MRKAd5 HIV-1 gag/pol/nef |
| Comparator: placeboPlacebo to Trivalent MRKAd5 HIV-1 gag/pol/nef in three 1 mL doses at Day 1, Week 4, and Week 26 administered intramuscularly. | Drug | Placebo |
Primary outcome
Number of Participants With Clinical Adverse Experiences
Time frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)
Number of participants with non-serious AEs with an incidence cut-off of 5% (>5% in at least one treatment group) and number of participants with >1 SAE following administration of study vaccine. AEs collected include serious and non-serious systemic AEs, and injection-site AEs. All systemic AEs were collected up to 14 days after any vaccine dose, and serious AEs were collected for the entire study period (up to Week 210). Injection-site AEs are any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to Day 4 after any vaccine dose.
Number of Participants With Laboratory Adverse Experiences
Time frame: Day 1 to Week 208
Number of participants with laboratory adverse experiences with an incidence cut-off of 5% (events occurring > 5% in at least one treatment group) following administration of the first dose of study vaccine. Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body. All laboratory AEs were collected up to 14 days after any vaccine dose.
Number of Participants With HIV-1 Infections
Time frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)
The number of participants with HIV-1 infections was to be determined with a periodic HIV-1 screening test to detect antibodies to recombinant HIV-1 envelope protein in the participants' serum.
HIV-1 Viral Load in Infected Participants
Time frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)
Plasma HIV-1 viral RNA was to be measured using a ribonucleic acid polymerase chain reaction (RNA PCR) on the last archived sample, and at Weeks 1, 2, 8, 12, and 26 post-HIV-1 infection, and subsequently every 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19012954Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PB, Lama JR, Marmor M, Del Rio C, McElrath MJ, Casimiro DR, Gottesdiener KM, Chodakewitz JA, Corey L, Robertson MN; Step Study Protocol Team. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008 Nov 29;372(9653):1881-1893. doi: 10.1016/S0140-6736(08)61591-3. Epub 2008 Nov 13.
- Derived from this study: PubMed 23878319Janes H, Friedrich DP, Krambrink A, Smith RJ, Kallas EG, Horton H, Casimiro DR, Carrington M, Geraghty DE, Gilbert PB, McElrath MJ, Frahm N. Vaccine-induced gag-specific T cells are associated with reduced viremia after HIV-1 infection. J Infect Dis. 2013 Oct 15;208(8):1231-9. doi: 10.1093/infdis/jit322. Epub 2013 Jul 21.
- Derived from this study: PubMed 22561365Duerr A, Huang Y, Buchbinder S, Coombs RW, Sanchez J, del Rio C, Casapia M, Santiago S, Gilbert P, Corey L, Robertson MN; Step/HVTN 504 Study Team. Extended follow-up confirms early vaccine-enhanced risk of HIV acquisition and demonstrates waning effect over time among participants in a randomized trial of recombinant adenovirus HIV vaccine (Step Study). J Infect Dis. 2012 Jul 15;206(2):258-66. doi: 10.1093/infdis/jis342. Epub 2012 May 4.
- Derived from this study: PubMed 21860356Barnabas RV, Wasserheit JN, Huang Y, Janes H, Morrow R, Fuchs J, Mark KE, Casapia M, Mehrotra DV, Buchbinder SP, Corey L; NIAID HIV Vaccine Trials Network. Impact of herpes simplex virus type 2 on HIV-1 acquisition and progression in an HIV vaccine trial (the Step study). J Acquir Immune Defic Syndr. 2011 Jul 1;57(3):238-44. doi: 10.1097/QAI.0b013e31821acb5.
- Derived from this study: PubMed 21343146Fitzgerald DW, Janes H, Robertson M, Coombs R, Frank I, Gilbert P, Loufty M, Mehrotra D, Duerr A; Step Study Protocol Team. An Ad5-vectored HIV-1 vaccine elicits cell-mediated immunity but does not affect disease progression in HIV-1-infected male subjects: results from a randomized placebo-controlled trial (the Step study). J Infect Dis. 2011 Mar 15;203(6):765-72. doi: 10.1093/infdis/jiq114.
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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 2 study testing Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose) in people with AIDS 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 13 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 6 Oct 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 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 15 Aug 2011). 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 Participants With Clinical Adverse Experiences (time frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)). The study lists 4 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 NCT00095576, which also lists 5 linked publications.
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 6 Oct 2015; AzTrials last refreshed its copy on 8 Nov 2026.