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History of Changes for Study: NCT00865566
Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men
Latest version (submitted October 13, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 18, 2009 None (earliest Version on record)
2 April 30, 2009 Eligibility, Study Status and Study Identification
3 May 29, 2009 Study Status and Contacts/Locations
4 June 12, 2009 Study Status and Contacts/Locations
5 June 19, 2009 Contacts/Locations and Study Status
6 June 24, 2009 Contacts/Locations and Study Status
7 July 6, 2009 Recruitment Status, Study Status and Contacts/Locations
8 August 24, 2009 Contacts/Locations, Study Identification and Study Status
9 September 23, 2009 Contacts/Locations and Study Status
10 November 24, 2009 Eligibility, Study Description and Study Status
11 January 27, 2010 Study Description, Study Status, Study Identification, Eligibility and Outcome Measures
12 April 14, 2010 Study Description, Study Status, Study Identification and Eligibility
13 June 16, 2010 Contacts/Locations and Study Status
14 August 5, 2010 References and Study Status
15 August 9, 2010 Contacts/Locations and Study Status
16 November 11, 2010 Study Status and Eligibility
17 March 1, 2011 Contacts/Locations and Study Status
18 November 10, 2011 Outcome Measures, Study Status, Eligibility, Study Design, Study Description, Oversight and Study Identification
19 February 7, 2012 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Status, Sponsor/Collaborators, Study Description and Study Identification
20 February 10, 2012 Outcome Measures, Arms and Interventions, Eligibility, Study Description and Study Status
21 February 14, 2012 Contacts/Locations and Study Status
22 May 14, 2012 Study Status
23 June 1, 2012 Study Status
24 September 11, 2012 Study Status
25 September 14, 2012 Study Design, Study Description and Study Status
26 May 9, 2013 Recruitment Status, Study Status and Contacts/Locations
27 June 5, 2013 Recruitment Status and Study Status
28 June 12, 2013 Contacts/Locations and Study Status
29 July 31, 2013 Outcome Measures, Study Status, Study Design, Study Description and Arms and Interventions
30 November 12, 2013 Study Status
31 February 26, 2014 Contacts/Locations and Study Status
32 March 6, 2014 Study Status
33 May 15, 2014 Contacts/Locations and Study Status
34 May 27, 2014 Contacts/Locations and Study Status
35 August 12, 2014 Study Status and Contacts/Locations
36 September 5, 2014 Outcome Measures, Study Status and Study Description
37 October 7, 2014 Study Status
38 November 4, 2014 Study Status
39 December 2, 2014 Study Status
40 January 8, 2015 Study Status
41 February 2, 2015 Study Status
42 March 16, 2015 Study Status and Contacts/Locations
43 May 15, 2015 Study Status
44 July 21, 2015 Study Status and Contacts/Locations
45 September 21, 2016 Study Status
46 June 6, 2017 Study Status
47 December 5, 2017 Recruitment Status, Study Status and Study Description
48 March 5, 2018 Study Status
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Results Submission Events
49 February 1, 2019 Recruitment Status, Study Status, Outcome Measures, Document Section and Results
50 October 13, 2021 Study Status and Study Identification
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Study NCT00865566
Submitted Date:  March 18, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: HVTN 505
Brief Title: Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men
Official Title: Phase 2, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Effect on Post-HIV Acquisition Viremia of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by a Multiclade HIV-1 Recombinant Adenoviral Vector Vaccine in HIVuninfected, Adenovirus Type 5 Neutralizing Antibody Negative, Circumcised Men
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2009
Overall Status: Not yet recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: March 17, 2009
First Submitted that
Met QC Criteria:
March 18, 2009
First Posted: March 19, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 18, 2009
Last Update Posted: March 19, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party:
Collaborators: HIV Vaccine Trials Network
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men who have sex with men.
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 US HIV prevalence data reported in October 2008 by the Centers for Disease Control and Prevention estimates 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 US 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 non-consensual 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 MSM.

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.

This is an event-driven study. Participants will be tested for HIV approximately every 3 months until a sufficient number of HIV infections have accumulated for assessment of the primary endpoints.

Participants who do not become HIV-infected will be actively followed for a minimum of 12 months and will continue to be contacted 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 become HIV-infected prior to the primary evaluation time point and primary data analysis will be followed for 18 months post-diagnosis.

Participants who are infected after that point will be offered follow-up through another study.

Open or close this module Conditions
Conditions: HIV Infections
Keywords: HIV Seronegativity
HIV Preventive Vaccine
HIV Treatment Vaccine
Adenovirus
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Care Provider)
Allocation: Randomized
Enrollment: 1350 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 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
Biological: DNA plasmid vaccine
4mg injection administered as 1 mL intramuscularly via Biojector® in either deltoid
Other Names:
  • VRC-HIVDNA016-00-VP
Biological: HIV-1 recombinant adenovirus vaccine
1 x 10^10 PU administered as 1 mL intramuscularly by needle and syringe in either deltoid
Other Names:
  • VRC-HIVADV014-00-VP
Placebo Comparator: 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
Biological: DNA plasmid vaccine placebo
1 mL administered via Biojector® in either deltoid
Other Names:
  • VRC-PBSPLA043-00-VP
  • phosphate buffered saline
Biological: HIV-1 recombinant adenovirus vaccine placebo
1 mL administered intramuscularly by needle and syringe in either deltoid
Other Names:
  • VRC-DILUENT013-DIL-VP
  • final formulation buffer
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Ability of VRC DNA/rAd5 vaccine regimen to reduce HIV-1 viral load setpoint compared with placebo
[ Time Frame: Throughout study ]

2. Differences in safety parameters between vaccine and placebo recipients
[ Time Frame: Throughout study ]

Secondary Outcome Measures:
1. Effect of the VRC DNA/rAd5 vaccine regimen on the disease course of HIV-1 disease in vaccine recipients compared to placebo recipients who become HIV-infected on-study
[ Time Frame: Throughout study ]

2. Effect of the VRC DNA/rAd5 vaccine regimen on the rate of HIV-1 acquisition in vaccine recipients compared to placebo recipients
[ Time Frame: Throughout study ]

3. HIV-1 specific immunogenicity of the VRC DNA/rAd5 vaccine regimen
[ Time Frame: Throughout study ]

4. Immune responses to the Ad5 vector
[ Time Frame: Throughout study ]

5. Social impact of participation in this trial
[ Time Frame: Throughout study ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 45 Years
Sex: Male
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • HIV-1 and -2 negative
  • Good general health
  • Circumcised
  • Anal intercourse within 24 weeks prior to study entry. More information on this criterion can be found in the protocol.
  • ALT less than 2.6 times the upper limit of normal (ULN)
  • Ad5 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

Exclusion Criteria:

  • 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 PEP more than 2 times within 12 months or has used PEP within 60 days prior to first vaccination
  • Used PrEP more than 5 times within 6 months or for 30 consecutive days within 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 non-chronic 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 within 30 days prior to first study vaccination
  • Investigational research agents within 90 days prior to first study vaccination
  • 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, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
  • 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 anaphylaxis or allergy to any of the vaccine's components
  • Autoimmune disease
  • Immunodeficiency
  • Bleeding disorder
  • History of malignancy
  • Seizure disorder
  • Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the protocol.
  • Angioedema within the last 3 years if episodes are considered serious or have required medication within the last 2 years prior to study entry
Open or close this module Contacts/Locations
Study Officials: Scott Hammer
Study Chair
Columbia University
Magdalena Sobieszczyk
Study Chair
Columbia University
Michael Yin
Study Chair
Columbia University
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Lu S. Immunogenicity of DNA vaccines in humans: it takes two to tango. Hum Vaccin. 2008 Nov-Dec;4(6):449-52. Epub 2008 Nov 28. Review. PubMed 18443427
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. Review. PubMed 19031031
Links:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services