Safety and Immune Response to a Recombinant Adenovirus HIV-1 Vaccine in Healthy Adults
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ClinicalTrials.gov Identifier: NCT00695877 |
Recruitment Status
:
Active, not recruiting
First Posted
: June 12, 2008
Last Update Posted
: March 14, 2018
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Tracking Information | |||||||
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First Submitted Date ICMJE | June 10, 2008 | ||||||
First Posted Date ICMJE | June 12, 2008 | ||||||
Last Update Posted Date | March 14, 2018 | ||||||
Study Start Date ICMJE | February 2009 | ||||||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Local and systemic adverse reactions [ Time Frame: Throughout study ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00695877 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Safety and Immune Response to a Recombinant Adenovirus HIV-1 Vaccine in Healthy Adults | ||||||
Official Title ICMJE | A Phase I Randomized, Double-blind, Placebo Controlled Dose Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Adenovirus Serotype 5 HVR48 HIV-1 Vaccine (Ad5HVR48.ENVA.01) in Healthy, HIV-1 Uninfected Adults (Ad5HVR48.ENVA.01 (rAd5HVR48) HIV-1/IPCAVD-002 Vaccine Study) | ||||||
Brief Summary | Successful control of the HIV epidemic will require a safe and effective vaccine to be developed. A successful vaccine will need to stimulate a widespread immune response. The purpose of this study is to determine the safety of and immune response to an adenovirus serotype HIV vaccine in HIV uninfected adults. | ||||||
Detailed Description | Control of the HIV pandemic can only be achieved with the development of a safe and effective preventive HIV vaccine. A vaccine that will prevent HIV infection will elicit a strong immune response from both CD4 and CD8 cells. Recombinant adenovirus serotype vectors have been shown to elicit just such a response. The purpose of this study is to determine the safety and immunogenicity of the recombinant adenovirus serotype 5 preventive HIV-1 vaccine. This study will last 18 to 24 months. Participants will be randomly assigned to one of four arms that will receive vaccine or placebo administered via intramuscular injection. Participants in Arms 1, 2, and 3 will all receive 3 injections. Participants in Arm 4 will receive one injection. For most participants, there will be 10 study visits in this study; for participants in Arm 4, there will be only 7 visits. For Arms 1, 2, and 3, study visits will occur at baseline and on Days 0, 14, 28, 42, 56, 168, 182,196, and 365. Participants in Arms 1, 2, and 3 will receive injections on Days 0, 28, and 168. For participants in Arm 4, study visits will occur at baseline and on Days 0, 14, 28, 56, 168 and 365. Participants in Arm 4 will receive one injection only, on Day 0. Participants will be asked to record their temperature and other side effects in a symptom log for 3 days after each injection. Risk reduction/pregnancy prevention counseling and physical exams will occur at all visits. At most visits, blood, urine, and oral swab collection will occur. Samples collected will be stored for future testing. HIV testing and pregnancy testing will occur at select visits. At Years 2, 3, 4, and 5, participants will be followed-up by telephone, e-mail, or study visit to collect vital status, and information about any development of significant disability or incapacity, hospitalizations, or congenital anomalies. At these follow-up visits, blood collection will be optional. |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 1 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Prevention |
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Condition ICMJE | HIV Infections | ||||||
Intervention ICMJE | Biological: Ad5.ENVA.48 HIV-1 vaccine
Recombinant adenovirus serotype 5 HIV-1 vaccine |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
48 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Study Completion Date | Not Provided | ||||||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00695877 | ||||||
Other Study ID Numbers ICMJE | Ad5HVR48.ENVA.01/IPCAVD-002 10701 ( Registry Identifier: DAIDS ES Registry Number ) Ad5HVR48.ENVA.01/ IPCAVD-002 |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||
Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||
Verification Date | March 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |