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
NCT ID: NCT00865566
Last Updated: 2021-10-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
2504 participants
INTERVENTIONAL
2009-05-31
2017-10-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
NOTES:
As of April 2013, all vaccinations in this study have been stopped.
As of June 2017, this study has been closed.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
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.
DNA plasmid vaccine
4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid
Recombinant adenoviral serotype 5 (rAD5) vector vaccine
1 x 10\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
2
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.
DNA vaccine placebo
1 mL IM via Biojector® in either deltoid
HIV-1 recombinant adenovirus vaccine placebo
1 mL administered IM by needle and syringe in either deltoid
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DNA plasmid vaccine
4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid
Recombinant adenoviral serotype 5 (rAD5) vector vaccine
1 x 10\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
DNA vaccine placebo
1 mL IM via Biojector® in either deltoid
HIV-1 recombinant adenovirus vaccine placebo
1 mL administered IM by needle and syringe in either deltoid
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Good general health
* Fully circumcised
* Experienced one or both of the following HIV risk criteria in the 6 months before study entry:
1. Unprotected anal intercourse with one or more male or MTF transgender partner(s)
2. Anal intercourse with two or more male or MTF transgender partners
* 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.
Exclusion Criteria
* 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
* 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
18 Years
50 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HIV Vaccine Trials Network
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Scott Hammer
Role: STUDY_CHAIR
Columbia University
Magdalena Sobieszczyk
Role: STUDY_CHAIR
Columbia University
Michael Yin
Role: STUDY_CHAIR
Columbia University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alabama CRS
Birmingham, Alabama, United States
The AIDS Research Alliance of America CRS
Los Angeles, California, United States
UCLA CARE Center CRS
Los Angeles, California, United States
Bridge HIV CRS
San Francisco, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Orlando Immunology Center CRS
Orlando, Florida, United States
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States
UIC Project WISH CRS
Chicago, Illinois, United States
VRC Clinical Trials Core CRS
Bethesda, Maryland, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States
Fenway Health (FH) CRS
Boston, Massachusetts, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Columbia P&S CRS
New York, New York, United States
New York Blood Center CRS
New York, New York, United States
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States
Case Clinical Research Site
Cleveland, Ohio, United States
Penn Prevention CRS
Philadelphia, Pennsylvania, United States
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States
University of Texas Southwestern CRS
Dallas, Texas, United States
Baylor Vaccine Research Center CRS
Houston, Texas, United States
Care-Id Crs
Annandale, Virginia, United States
Seattle Vaccine and Prevention CRS
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Patterson 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.
Benmira 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.
Hammer 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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10753
Identifier Type: REGISTRY
Identifier Source: secondary_id
HVTN 505
Identifier Type: -
Identifier Source: org_study_id
NCT00919789
Identifier Type: -
Identifier Source: nct_alias