HIV InfectionsPhase 2NCT00865566
Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men
A Phase 2 study testing DNA plasmid vaccine and Recombinant adenoviral serotype 5 (rAD5) vector vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men. NOTES: As of April 2013, all vaccinations in this study have been stopped. As of June 2017, this study has been closed. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- DNA plasmid vaccine and Recombinant adenoviral serotype 5 (rAD5) vector vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,504 participants
- Where
- 22 sitesUnited States
- Study dates
- May 2009to 6 Oct 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV-1 and -2 negative
- Good general health
- Fully circumcised
- Experienced one or both of the following HIV risk criteria in the 6 months before study entry:
- Unprotected anal intercourse with one or more male or MTF transgender partner(s)
- Anal intercourse with two or more male or MTF transgender partners
Show all 14Show fewer
- Alanine aminotransferase (ALT) 2.5 or less times the upper limit of normal (ULN)
- Ad5 neutralizing antibody (nAb) titer less than 1:18
- Have access to a participating study site and are willing to be followed during the study
- Demonstrate understanding of the study
- Willing to receive HIV test results
- Willing to discuss HIV infection risks and amenable to risk-reduction counseling
- Agrees not to enroll in another study of an investigational research agent before unblinding of this study
- NOTE: MTF transgender volunteers who have undergone gender reassignment surgery (GRS) are eligible to participate if they provide documentation from a health care provider confirming that they were fully circumcised prior to GRS. MTF transgender volunteers who have not undergone GRS are eligible to participate if they meet all enrollment criteria. Receipt of hormonal therapy does not make a transgender volunteer ineligible.
Who cannot join
- HIV vaccines in prior HIV vaccine trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
- Used antiretroviral (ARV) drugs for the purpose of HIV-1 prophylaxis for greater than or equal to 50% of days during the 3 months prior to first vaccination or for 30 consecutive days within the 60 days prior to first vaccination
- Circumcised within 90 days prior to first vaccination or displays evidence that surgical site is not fully healed
- Immunosuppressive medications within 168 days prior to first study vaccination. Participants who have used corticosteroid nasal sprays for allergic rhinitis; topical corticosteroids for mild, uncomplicated dermatitis; or oral/parenteral corticosteroids for nonchronic conditions are not excluded.
- Blood products within 90 days prior to first study vaccination
- Immunoglobulin within 90 days prior to first study vaccination
Show all 22Show fewer
- Live attenuated vaccines other than influenza vaccine within 30 days prior to first study vaccination
- Investigational research agents within 90 days prior to first study vaccination
- Influenza vaccine or any vaccines that are not live attenuated within 14 days prior to first study vaccination
- Allergy treatment with antigen injections within 30 days prior to first study vaccination or that are scheduled within 14 days after first vaccination
- Clinically significant medical condition, physical examination findings, abnormal laboratory results, or past medical history that, in the judgment of the investigator, has significant implications for current health
- Any medical, psychiatric, or job-related responsibility that would interfere with the study. More information about this criterion can be found in the protocol.
- Any concern that, in the opinion of the investigator, may interfere with a participant's completion of the post-vaccination symptom log
- History of serious adverse reactions to vaccinations, including anaphylaxis or allergy to any of the vaccine's components
- Current anti-tuberculosis prophylaxis or therapy
- Autoimmune disease. People with mild, stable, and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate reactogenicity and adverse event assessments are not excluded.
- Immunodeficiency
- Bleeding disorder
- History of malignancy
- Seizure disorder. People with a history of seizures who have had no seizures within the 3 years prior to study entry are not excluded.
- Asthma other than mild, well-controlled asthma
- Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic angioedema
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Care-Id Crs
Annandale, Virginia, 22003
University of Colorado Hospital CRS
Aurora, Colorado, 80045
VRC Clinical Trials Core CRS
Bethesda, Maryland, 20816
Alabama CRS
Birmingham, Alabama, 35294
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, 02115-6110
Fenway Health (FH) CRS
Boston, Massachusetts, 02215-4302
UIC Project WISH CRS
Chicago, Illinois, 60612
Case Clinical Research Site
Cleveland, Ohio, 44106
University of Texas Southwestern CRS
Dallas, Texas, 75235
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, 30030
Baylor Vaccine Research Center CRS
Houston, Texas, 77030
The AIDS Research Alliance of America CRS
Los Angeles, California, 90015
UCLA CARE Center CRS
Los Angeles, California, 90035
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, 37232-2582
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Columbia P&S CRS
New York, New York, 10032-3732
New York Blood Center CRS
New York, New York, 10065
Orlando Immunology Center CRS
Orlando, Florida, 32803
Penn Prevention CRS
Philadelphia, Pennsylvania, 19104
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, 14642
Bridge HIV CRS
San Francisco, California, 94143
Seattle Vaccine and Prevention CRS
Seattle, Washington, 98109-1024
About this study
Official title: Phase 2b, Randomized, Placebo-Controlled Test-of-Concept Trial to Evaluate the Safety and Efficacy of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by a Multiclade HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Adenovirus Type 5 Neutralizing Antibody Negative, Circumcised Men and Male-to-Female (MTF) Transgender Persons, Who Have Sex With Men
The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men.
NOTES:
As of April 2013, all vaccinations in this study have been stopped.
As of June 2017, this study has been closed.
Read the detailed description
In 2007, the Joint United Nations Programme on HIV/AIDS estimated that 33.2 million people were living with HIV/AIDS globally. The U.S. HIV prevalence data reported in October 2008 by the Centers for Disease Control and Prevention estimate that 1.1 million adults and adolescents were living with diagnosed or undiagnosed HIV infection in the United States at the end of 2006. Nearly half of all U.S. HIV infections (48.1%) were found in men who have sex with men (MSM). Given the difficulty of maintaining behaviors that prevent HIV transmission over a lifetime and the occurrence of nonconsensual sex, the need for a safe and effective vaccine is clear. The primary purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, at-risk, circumcised men and MTF transgender persons who have sex with men.
Participants will be randomly assigned to one of two arms. Participants in Arm 1 will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. Participants in Arm 2 will receive placebo injections at study entry and on Days 28, 56, and 168.
Participants who do not become HIV infected will be actively followed for a minimum of 24 months and will continue to be followed by the study for long-term safety surveillance for a total of 5 years following enrollment. Participants will be contacted annually during the period of long-term safety surveillance.
Participants who are found to be HIV infected prior to receiving their first injection or who receive their first injection but were HIV infected prior to study start will be followed on a modified schedule.
Participants who become HIV infected will be followed for 6 months post-diagnosis.
At most study visits, participants will undergo a physical exam and blood draw.
NOTES:
As of April 2013, all vaccinations in this study have been stopped. Participants have been notified of whether they received the study vaccines or placebo. Participants diagnosed with HIV infection will attend study visits for 6 months for health monitoring. Participants who are not diagnosed with HIV infection will attend planned study visits for 24 months and will be followed by the study clinic at least annually for a total of 5 years following study enrollment.
As of June 2017, this study has been closed. Therefore, to avoid further burden on study participants, further participant follow-up for the study is suspended.
- Conditions
- HIV Infections
- Being tested
- DNA plasmid vaccine, Recombinant adenoviral serotype 5 (rAD5) vector vaccine, DNA vaccine placebo, HIV-1 recombinant adenovirus vaccine placebo
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine, HIV Treatment 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.
DNA plasmid vaccineBiological
Also called VRC-HIVDNA016-00-VP
4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid
Recombinant adenoviral serotype 5 (rAD5) vector vaccineBiological
Also called VRC-HIVADV014-00-VP
1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
DNA vaccine placeboBiological
Also called VRC-PBSPLA043-00-VP, phosphate buffered saline (PBS)
1 mL IM via Biojector® in either deltoid
HIV-1 recombinant adenovirus vaccine placeboBiological
Also called VRC-DILUENT013-DIL-VP, final formulation buffer (FFB)
1 mL administered IM by needle and syringe in either deltoid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. Receives: Biological: DNA plasmid vaccine; Biological: Recombinant adenoviral serotype 5 (rAD5) vector vaccine |
| 2 | Placebo comparator | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. Receives: Biological: DNA vaccine placebo; Biological: HIV-1 recombinant adenovirus vaccine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Dropout Through Month 48
For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.
Measured: Enrollment through Month 48 visit
Participant Dropout Prior to Unblinding
The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.
For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.
Measured: Enrollment until the date of dropout, through April 22, 2013 (up to Month 24 visit)
Participant Dropout After Unblinding
The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.
For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.
Measured: April 23, 2013 through trial closure (up to Month 48 visit)
HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit
For time-to-event analysis, an event is defined as HIV-1 infection and participants are censored if they dropped out early or completed the trial. HIV-1 diagnosis date is defined as the date of the earliest specimen collection yielding a positive HIV test. Participants remaining uninfected were censored at the latest specimen collection with a negative HIV-1 test.
Measured: Enrollment through Month 48 visit
HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit
For time-to-event analysis, an event is defined as HIV-1 infection and participants remaining uninfected through the month 24 visit were censored. HIV-1 diagnosis date is defined as the date of the earliest specimen collection at or prior to month 24 which yielded a positive HIV test. Participants remaining uninfected through the month 24 visit were censored at the latest specimen collection with a negative HIV-1 test at or prior to the month 24 visit.
Measured: Enrollment through Month 24 visit
Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness
For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.
Measured: Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination
Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration
For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.
Measured: Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination
Number of Participants Experiencing Systemic Reactogenicity
For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Systemic reactogenicity parameters are malaise/fatigue, myalgia, headache, nausea, vomiting, chills, and arthralgia. We present the maximum grade calculated over these parameters.
Measured: Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startMay 2009
- Primary completion6 Oct 2017
- Study completion6 Oct 2017
Why it stopped: The trial was stopped for efficacy futility
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 (4)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,504 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network
- Responsible party
- Sponsor
- Investigators
- Scott Hammer, Study chair, Columbia UniversityMagdalena Sobieszczyk, Study chair, Columbia UniversityMichael Yin, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865566
- Sponsor's protocol ID
- HVTN 505
- Other IDs
- 10753
- Status last verified
- Oct 2021
- First submitted
- 17 Mar 2009
- Last updated
- 15 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lu S. Immunogenicity of DNA vaccines in humans: it takes two to tango. Hum Vaccin. 2008 Nov-Dec;4(6):449-52. doi: 10.4161/hv.4.6.6179. Epub 2008 Nov 28.
PubMed 18443427Patterson S, Papagatsias T, Benlahrech A. Use of adenovirus in vaccines for HIV. Handb Exp Pharmacol. 2009;(188):275-93. doi: 10.1007/978-3-540-71029-5_13.
PubMed 19031031Benmira S, Bhattacharya V, Schmid ML. An effective HIV vaccine: A combination of humoral and cellular immunity? Curr HIV Res. 2010 Sep;8(6):441-9. doi: 10.2174/157016210793499286.
PubMed 20636279Hammer SM, Sobieszczyk ME, Janes H, Karuna ST, Mulligan MJ, Grove D, Koblin BA, Buchbinder SP, Keefer MC, Tomaras GD, Frahm N, Hural J, Anude C, Graham BS, Enama ME, Adams E, DeJesus E, Novak RM, Frank I, Bentley C, Ramirez S, Fu R, Koup RA, Mascola JR, Nabel GJ, Montefiori DC, Kublin J, McElrath MJ, Corey L, Gilbert PB; HVTN 505 Study Team. Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. N Engl J Med. 2013 Nov 28;369(22):2083-92. doi: 10.1056/NEJMoa1310566. Epub 2013 Oct 7.
PubMed 24099601
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b, Randomized, Placebo-Controlled Test-of-Concept Trial to Evaluate the Safety and Efficacy of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by a Multiclade HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Adenovirus Type 5 Neutralizing Antibody Negative, Circumcised Men and Male-to-Female (MTF) Transgender Persons, Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT00865566
- Acronym / sponsor ID
- HVTN 505
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine, HIV Treatment Vaccine, Adenovirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was stopped for efficacy futility
- Enrolment
- 2,504 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network
- Study start
- May 2009
- Primary completion
- 6 Oct 2017 (actual)
- Study completion
- 6 Oct 2017 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Posted 27 Feb 2019
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 determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men.
NOTES:
As of April 2013, all vaccinations in this study have been stopped.
As of June 2017, this study has been closed.
Detailed description
In 2007, the Joint United Nations Programme on HIV/AIDS estimated that 33.2 million people were living with HIV/AIDS globally. The U.S. HIV prevalence data reported in October 2008 by the Centers for Disease Control and Prevention estimate that 1.1 million adults and adolescents were living with diagnosed or undiagnosed HIV infection in the United States at the end of 2006. Nearly half of all U.S. HIV infections (48.1%) were found in men who have sex with men (MSM). Given the difficulty of maintaining behaviors that prevent HIV transmission over a lifetime and the occurrence of nonconsensual sex, the need for a safe and effective vaccine is clear. The primary purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, at-risk, circumcised men and MTF transgender persons who have sex with men.
Participants will be randomly assigned to one of two arms. Participants in Arm 1 will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. Participants in Arm 2 will receive placebo injections at study entry and on Days 28, 56, and 168.
Participants who do not become HIV infected will be actively followed for a minimum of 24 months and will continue to be followed by the study for long-term safety surveillance for a total of 5 years following enrollment. Participants will be contacted annually during the period of long-term safety surveillance.
Participants who are found to be HIV infected prior to receiving their first injection or who receive their first injection but were HIV infected prior to study start will be followed on a modified schedule.
Participants who become HIV infected will be followed for 6 months post-diagnosis.
At most study visits, participants will undergo a physical exam and blood draw.
NOTES:
As of April 2013, all vaccinations in this study have been stopped. Participants have been notified of whether they received the study vaccines or placebo. Participants diagnosed with HIV infection will attend study visits for 6 months for health monitoring. Participants who are not diagnosed with HIV infection will attend planned study visits for 24 months and will be followed by the study clinic at least annually for a total of 5 years following study enrollment.
As of June 2017, this study has been closed. Therefore, to avoid further burden on study participants, further participant follow-up for the study is suspended.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: DNA plasmid vaccine, Biological: Recombinant adenoviral serotype 5 (rAD5) vector vaccineParticipants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. |
| 2 | Placebo comparator | Biological: DNA vaccine placebo, Biological: HIV-1 recombinant adenovirus vaccine placeboParticipants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- HIV-1 and -2 negative
- Good general health
- Fully circumcised
- Experienced one or both of the following HIV risk criteria in the 6 months before study entry:
- Alanine aminotransferase (ALT) 2.5 or less times the upper limit of normal (ULN)
Key exclusion criteria (22 listed)
- HIV vaccines in prior HIV vaccine trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
- Used antiretroviral (ARV) drugs for the purpose of HIV-1 prophylaxis for greater than or equal to 50% of days during the 3 months prior to first vaccination or for 30 consecutive days within the 60 days prior to first vaccination
- Circumcised within 90 days prior to first vaccination or displays evidence that surgical site is not fully healed
- Immunosuppressive medications within 168 days prior to first study vaccination. Participants who have used corticosteroid nasal sprays for allergic rhinitis; topical corticosteroids for mild, uncomplicated dermatitis; or oral/parenteral corticosteroids for nonchronic conditions are not excluded.
- Blood products within 90 days prior to first study vaccination
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 |
|---|---|---|
| DNA plasmid vaccineAlso: VRC-HIVDNA016-00-VP4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid | Biological | 1 |
| Recombinant adenoviral serotype 5 (rAD5) vector vaccineAlso: VRC-HIVADV014-00-VP1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | Biological | 1 |
| DNA vaccine placeboAlso: VRC-PBSPLA043-00-VP, phosphate buffered saline (PBS)1 mL IM via Biojector® in either deltoid | Biological | 2 |
| HIV-1 recombinant adenovirus vaccine placeboAlso: VRC-DILUENT013-DIL-VP, final formulation buffer (FFB)1 mL administered IM by needle and syringe in either deltoid | Biological | 2 |
Primary outcome
Participant Dropout Through Month 48
Time frame: Enrollment through Month 48 visit
For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.
Participant Dropout Prior to Unblinding
Time frame: Enrollment until the date of dropout, through April 22, 2013 (up to Month 24 visit)
The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time. For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.
Participant Dropout After Unblinding
Time frame: April 23, 2013 through trial closure (up to Month 48 visit)
The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time. For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.
HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit
Time frame: Enrollment through Month 48 visit
For time-to-event analysis, an event is defined as HIV-1 infection and participants are censored if they dropped out early or completed the trial. HIV-1 diagnosis date is defined as the date of the earliest specimen collection yielding a positive HIV test. Participants remaining uninfected were censored at the latest specimen collection with a negative HIV-1 test.
HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit
Time frame: Enrollment through Month 24 visit
For time-to-event analysis, an event is defined as HIV-1 infection and participants remaining uninfected through the month 24 visit were censored. HIV-1 diagnosis date is defined as the date of the earliest specimen collection at or prior to month 24 which yielded a positive HIV test. Participants remaining uninfected through the month 24 visit were censored at the latest specimen collection with a negative HIV-1 test at or prior to the month 24 visit.
Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness
Time frame: Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination
For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.
Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration
Time frame: Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination
For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.
Number of Participants Experiencing Systemic Reactogenicity
Time frame: Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination
For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Systemic reactogenicity parameters are malaise/fatigue, myalgia, headache, nausea, vomiting, chills, and arthralgia. We present the maximum grade calculated over these parameters.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18443427Lu S. Immunogenicity of DNA vaccines in humans: it takes two to tango. Hum Vaccin. 2008 Nov-Dec;4(6):449-52. doi: 10.4161/hv.4.6.6179. Epub 2008 Nov 28.
- Background: PubMed 19031031Patterson S, Papagatsias T, Benlahrech A. Use of adenovirus in vaccines for HIV. Handb Exp Pharmacol. 2009;(188):275-93. doi: 10.1007/978-3-540-71029-5_13.
- Results publication: PubMed 20636279Benmira S, Bhattacharya V, Schmid ML. An effective HIV vaccine: A combination of humoral and cellular immunity? Curr HIV Res. 2010 Sep;8(6):441-9. doi: 10.2174/157016210793499286.
- Derived from this study: PubMed 24099601Hammer SM, Sobieszczyk ME, Janes H, Karuna ST, Mulligan MJ, Grove D, Koblin BA, Buchbinder SP, Keefer MC, Tomaras GD, Frahm N, Hural J, Anude C, Graham BS, Enama ME, Adams E, DeJesus E, Novak RM, Frank I, Bentley C, Ramirez S, Fu R, Koup RA, Mascola JR, Nabel GJ, Montefiori DC, Kublin J, McElrath MJ, Corey L, Gilbert PB; HVTN 505 Study Team. Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. N Engl J Med. 2013 Nov 28;369(22):2083-92. doi: 10.1056/NEJMoa1310566. Epub 2013 Oct 7.
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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.
Scott Hammer study chair
Columbia University
Magdalena Sobieszczyk study chair
Columbia University
Michael Yin study chair
Columbia University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DNA plasmid vaccine and Recombinant adenoviral serotype 5 (rAD5) vector vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 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 14 inclusion and 22 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 15 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 22 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. 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 27 Feb 2019). 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?
Participant Dropout Through Month 48 (time frame: Enrollment through Month 48 visit). The study lists 8 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 NCT00865566, which also lists 4 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 15 Oct 2021.