HIV InfectionsPhase 1NCT00486408
Expanded Characterization of Immune Response to Merck Adenovirus 5 Gag/Pol/Nef Vaccine Given to HIV Uninfected Adults
A Phase 1 study testing MRKAd5 HIV-1 gag/pol/nef in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
The purpose of this study is to intensively characterize the immune response, particularly the T-cell response, to a three-dose regimen of an adenovirus-based HIV-1 vaccine in HIV-uninfected adults. 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
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2007to Nov 2012
- 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
- Good general health
- HIV uninfected
- Weight of 110 pounds or greater
- Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed during the study
- Willing to receive HIV test results
- Understand the vaccination procedure
- Willing to use acceptable methods of contraception for at least 21 days prior to study entry and until the last study visit
Who cannot join
- HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
- Immunosuppressive medications within 168 days prior to first study vaccination
- Blood products within 90 days prior to first study vaccination or within 14 days after the injection
- Immunoglobulin within 90 days prior to first study vaccination or within 14 days after the injection
- Live attenuated vaccines within 42 days prior to first study vaccination or within 14 days after the injection
- Investigational research agents within 30 days prior to first study vaccination
Show all 21Show fewer
- Medically indicated subunit or killed vaccines within 5 days prior to first study vaccination or within 14 days after the injection
- Allergy treatment with antigen injections within 30 days prior to first study vaccination
- Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
- Any medical, psychiatric, or social condition that, in the opinion of the investigator, would interfere with the study.
- History of anaphylaxis and/or allergy to vaccine components
- Autoimmune disease or immunodeficiency
- Uncontrolled hypertension
- Bleeding disorder
- Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
- Seizure disorder
- Absence of the spleen
- Abnormal laboratory values
- Mental illness that would interfere with the study
- Hysterectomy
- Pregnancy or breastfeeding
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Alabama Vaccine CRS
Birmingham, Alabama, 35294
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, 37232-2582
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, 14642
Seattle Vaccine and Prevention CRS
Seattle, Washington, 98109-1024
About this study
Official title: A Phase 1B Open-label Clinical Trial to Expand the Characterization of the Immune Responses to the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy, HIV-1-uninfected Adult Participants
The purpose of this study is to intensively characterize the immune response, particularly the T-cell response, to a three-dose regimen of an adenovirus-based HIV-1 vaccine in HIV-uninfected adults.
Read the detailed description
This study will look for relationships among the immune responses induced by MRKAd5 HIV-1 gag/pol/nef vaccine. The study will also determine if the T cells that respond to different vaccine epitopes have correspondingly different functional profiles. The study will evaluate the safety and tolerability of the vaccine regimen as well.
This study will last 60 weeks. All enrolled participants will receive vaccinations at Weeks 0, 4, and 26. There will be between 8 and 20 study visits including the screening visit, depending on the site location. A physical exam, interview, and blood collection will occur at most or all visits. All participants will undergo leukapheresis approximately 4 weeks after their last vaccination and at Week 52. Medical history, an HIV test, a pregnancy test, and HIV and risk reduction counseling will occur at selected visits. Additional blood collection is now occurring in this study to collect more information about the relationship between the immune response and efficacy to the vaccine.
- Conditions
- HIV Infections
- Being tested
- MRKAd5 HIV-1 gag/pol/nef
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine, Adenovirus
- Medical subject headings
- HIV Infections, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRKAd5 HIV-1 gag/pol/nefBiological
1.5x10^10 Ad vg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MRKAd5 HIV-1 gag/pol/nef vaccine administered as 1 ml in either deltoid at study entry and Weeks 4 and 26 Receives: Biological: MRKAd5 HIV-1 gag/pol/nef |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relatedness of different immune response to vaccine
Measured: Throughout study
Features and number of HIV-specific CD4 and CD8 T cells produced in response to the vaccine
Measured: Throughout study
Characterization of different functions of T cells that have responded to the vaccine
Measured: Throughout study
Safety and tolerability of three doses of vaccine
Measured: Throughout study
Secondary outcomes (3)
Changes in physical features of certain immune cells in response to the vaccine
Measured: Throughout study
Indications of an immune response to the vaccine
Measured: Throughout study
Presence of T cells in the genital tract
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2008
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network
- Responsible party
- Sponsor
- Investigators
- Ann Duerr, MD, PhD, MPH, Study chair, HVTN Core Operations Center, Fred Hutchinson Cancer Research Center (FHCRC)Mike Keefer, MD, Study chair, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486408
- Sponsor's protocol ID
- HVTN 071
- Other IDs
- 10503
- Status last verified
- Oct 2021
- First submitted
- 12 Jun 2007
- Last updated
- 14 Oct 2021
- Results posted
- No
Publications
Barouch DH, Nabel GJ. Adenovirus vector-based vaccines for human immunodeficiency virus type 1. Hum Gene Ther. 2005 Feb;16(2):149-56. doi: 10.1089/hum.2005.16.149.
PubMed 15761255Horton H, Russell N, Moore E, Frank I, Baydo R, Havenar-Daughton C, Lee D, Deers M, Hudgens M, Weinhold K, McElrath MJ. Correlation between interferon- gamma secretion and cytotoxicity, in virus-specific memory T cells. J Infect Dis. 2004 Nov 1;190(9):1692-6. doi: 10.1086/424490. Epub 2004 Sep 30.
PubMed 15478077Tobery TW, Dubey SA, Anderson K, Freed DC, Cox KS, Lin J, Prokop MT, Sykes KJ, Mogg R, Mehrotra DV, Fu TM, Casimiro DR, Shiver JW. A comparison of standard immunogenicity assays for monitoring HIV type 1 gag-specific T cell responses in Ad5 HIV Type 1 gag vaccinated human subjects. AIDS Res Hum Retroviruses. 2006 Nov;22(11):1081-90. doi: 10.1089/aid.2006.22.1081.
PubMed 17147493
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B Open-label Clinical Trial to Expand the Characterization of the Immune Responses to the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy, HIV-1-uninfected Adult Participants
- ClinicalTrials.gov ID
- NCT00486408
- Acronym / sponsor ID
- HVTN 071
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine, Adenovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network
- Study start
- Jul 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Jun 2007 (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.
The purpose of this study is to intensively characterize the immune response, particularly the T-cell response, to a three-dose regimen of an adenovirus-based HIV-1 vaccine in HIV-uninfected adults.
Detailed description
This study will look for relationships among the immune responses induced by MRKAd5 HIV-1 gag/pol/nef vaccine. The study will also determine if the T cells that respond to different vaccine epitopes have correspondingly different functional profiles. The study will evaluate the safety and tolerability of the vaccine regimen as well.
This study will last 60 weeks. All enrolled participants will receive vaccinations at Weeks 0, 4, and 26. There will be between 8 and 20 study visits including the screening visit, depending on the site location. A physical exam, interview, and blood collection will occur at most or all visits. All participants will undergo leukapheresis approximately 4 weeks after their last vaccination and at Week 52. Medical history, an HIV test, a pregnancy test, and HIV and risk reduction counseling will occur at selected visits. Additional blood collection is now occurring in this study to collect more information about the relationship between the immune response and efficacy to the vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MRKAd5 HIV-1 gag/pol/nefMRKAd5 HIV-1 gag/pol/nef vaccine administered as 1 ml in either deltoid at study entry and Weeks 4 and 26 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Good general health
- HIV uninfected
- Weight of 110 pounds or greater
- Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed during the study
- Willing to receive HIV test results
Key exclusion criteria (21 listed)
- HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
- Immunosuppressive medications within 168 days prior to first study vaccination
- Blood products within 90 days prior to first study vaccination or within 14 days after the injection
- Immunoglobulin within 90 days prior to first study vaccination or within 14 days after the injection
- Live attenuated vaccines within 42 days prior to first study vaccination or within 14 days after the 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 |
|---|---|---|
| MRKAd5 HIV-1 gag/pol/nef1.5x10^10 Ad vg | Biological | 1 |
Primary outcome
Relatedness of different immune response to vaccine
Time frame: Throughout study
Features and number of HIV-specific CD4 and CD8 T cells produced in response to the vaccine
Time frame: Throughout study
Characterization of different functions of T cells that have responded to the vaccine
Time frame: Throughout study
Safety and tolerability of three doses of vaccine
Time frame: Throughout study
3 secondary outcomes
Changes in physical features of certain immune cells in response to the vaccine
Time frame: Throughout study
Indications of an immune response to the vaccine
Time frame: Throughout study
Presence of T cells in the genital tract
Time frame: Throughout study
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 14 Oct 2021.
- Background: PubMed 15761255Barouch DH, Nabel GJ. Adenovirus vector-based vaccines for human immunodeficiency virus type 1. Hum Gene Ther. 2005 Feb;16(2):149-56. doi: 10.1089/hum.2005.16.149.
- Background: PubMed 15478077Horton H, Russell N, Moore E, Frank I, Baydo R, Havenar-Daughton C, Lee D, Deers M, Hudgens M, Weinhold K, McElrath MJ. Correlation between interferon- gamma secretion and cytotoxicity, in virus-specific memory T cells. J Infect Dis. 2004 Nov 1;190(9):1692-6. doi: 10.1086/424490. Epub 2004 Sep 30.
- Background: PubMed 17147493Tobery TW, Dubey SA, Anderson K, Freed DC, Cox KS, Lin J, Prokop MT, Sykes KJ, Mogg R, Mehrotra DV, Fu TM, Casimiro DR, Shiver JW. A comparison of standard immunogenicity assays for monitoring HIV type 1 gag-specific T cell responses in Ad5 HIV Type 1 gag vaccinated human subjects. AIDS Res Hum Retroviruses. 2006 Nov;22(11):1081-90. doi: 10.1089/aid.2006.22.1081.
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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.
Ann Duerr, MD, PhD, MPH study chair
HVTN Core Operations Center, Fred Hutchinson Cancer Research Center (FHCRC)
Mike Keefer, MD study chair
University of Rochester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRKAd5 HIV-1 gag/pol/nef in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
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 7 inclusion and 21 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Relatedness of different immune response to vaccine (time frame: Throughout study). 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 NCT00486408, which also lists 3 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 14 Oct 2021.