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Safety of and Immune Response to an Experimental HIV Vaccine (VRC-HIVADV014-00-VP) in HIV Uninfected Adults

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VRC-HIVADV014-00-VP
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Preventive Vaccine, AIDS Vaccines, Adenoviridae

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Have access to a participating site and are willing to be followed for the duration of the study Willing to receive HIV test results Able to understand and comply with study requirements In good general health Have neutralizing adenovirus antibody levels that are less than a 1:12 ratio Agree to use acceptable methods of contraception for at least 21 days prior to study start and for the duration of the study. Exclusion Criteria: HIV infected Positive hepatitis B surface antigen Positive anti-hepatitis C virus antibodies Prior receipt of an HIV vaccine Immunosuppressive drugs within 168 days prior to first vaccination Have received donated blood within 120 days prior to first vaccination Have received immunoglobulin within 60 days of the first vaccination Live attenuated vaccines or investigational research agents within 30 days prior to first vaccination Subunit or killed vaccines within 14 days prior to first vaccination Current preventive or therapeutic anti-tuberculosis (TB) treatment Any medical, psychiatric, or social condition that would interfere with the study Any occupational or other responsibility that would interfere with the study Serious adverse reactions to vaccines Autoimmune disease Immunodeficiency Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded. Asthma. Participants who have had completely resolved childhood asthma are not excluded. Diabetes mellitus type I or II. Participants who have had isolated gestational diabetes are not excluded. Thyroid disease or removal of the thyroid Blood vessel swelling within the last 3 years Uncontrolled hypertension Body mass index (BMI) of 40 or higher Bleeding disorder Cancer. Participants whose cancer has been removed and is unlikely to recur during the study are not excluded. Seizure disorder. Participants who have not required medication or had a seizure for 3 years prior to study entry are not excluded. Removal of the spleen or have a nonfunctioning spleen Psychiatric conditions that may interfere with the study Pregnancy, breastfeeding, or plan to become pregnant during the study

Sites / Locations

  • San Francisco Vaccine and Prevention CRS
  • Vanderbilt Vaccine CRS
  • FHCRC/UW Vaccine CRS

Outcomes

Primary Outcome Measures

Blood and chemical parameters for 12 months after injection
Local and systemic adverse reactions for 12 months after injection

Secondary Outcome Measures

Full Information

First Posted
July 12, 2005
Last Updated
October 13, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00119873
Brief Title
Safety of and Immune Response to an Experimental HIV Vaccine (VRC-HIVADV014-00-VP) in HIV Uninfected Adults
Official Title
A Phase I Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade, Multivalent Recombinant Adenoviral Vector HIV Vaccine, VRC-HIVADV014-00-VP, in Healthy, HIV-1 Uninfected Adult Participants Who Have Low Titers of Pre-Existing Ad5 Neutralizing Antibodies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine in HIV uninfected individuals.
Detailed Description
The HIV epidemic is a major global health challenge. People in developing nations have limited access to life-sustaining antiretrovirals and account for over 95% of the 5 million new HIV infections annually. The development of a safe, effective, and widely accessible HIV vaccine is paramount in these areas. The adenoviral vector vaccine VRC-HIVADV014-00-VP has been shown to elicit a CD8 cytotoxic lymphocyte (CTL) response believed to be crucial in an effective preventive HIV vaccine. The purpose of this study is to determine the safety and immunogenicity of VRC-HIVADV014-00-VP in HIV uninfected adults. In this study, HIV uninfected individuals with low levels of pre-existing adenovirus neutralizing antibodies will receive different doses of the preventive vaccine to determine its safety, tolerability, and immunogenicity. This study will last 1 year. Participants will be randomly assigned to one of two groups. At study entry, participants in each group will receive a single injection of either one of two doses of the adenoviral vector vaccine or placebo. Participants will record their temperature and other side effects in a symptom log on the day of vaccination and for 3 days thereafter. Participants will have seven clinic visits over 12 months. A physical exam, HIV and pregnancy prevention counseling, and blood and urine collection will occur at each visit. Participants will also be asked about side effects they may be experiencing and medications they are taking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Preventive Vaccine, AIDS Vaccines, Adenoviridae

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
VRC-HIVADV014-00-VP
Primary Outcome Measure Information:
Title
Blood and chemical parameters for 12 months after injection
Title
Local and systemic adverse reactions for 12 months after injection

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have access to a participating site and are willing to be followed for the duration of the study Willing to receive HIV test results Able to understand and comply with study requirements In good general health Have neutralizing adenovirus antibody levels that are less than a 1:12 ratio Agree to use acceptable methods of contraception for at least 21 days prior to study start and for the duration of the study. Exclusion Criteria: HIV infected Positive hepatitis B surface antigen Positive anti-hepatitis C virus antibodies Prior receipt of an HIV vaccine Immunosuppressive drugs within 168 days prior to first vaccination Have received donated blood within 120 days prior to first vaccination Have received immunoglobulin within 60 days of the first vaccination Live attenuated vaccines or investigational research agents within 30 days prior to first vaccination Subunit or killed vaccines within 14 days prior to first vaccination Current preventive or therapeutic anti-tuberculosis (TB) treatment Any medical, psychiatric, or social condition that would interfere with the study Any occupational or other responsibility that would interfere with the study Serious adverse reactions to vaccines Autoimmune disease Immunodeficiency Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded. Asthma. Participants who have had completely resolved childhood asthma are not excluded. Diabetes mellitus type I or II. Participants who have had isolated gestational diabetes are not excluded. Thyroid disease or removal of the thyroid Blood vessel swelling within the last 3 years Uncontrolled hypertension Body mass index (BMI) of 40 or higher Bleeding disorder Cancer. Participants whose cancer has been removed and is unlikely to recur during the study are not excluded. Seizure disorder. Participants who have not required medication or had a seizure for 3 years prior to study entry are not excluded. Removal of the spleen or have a nonfunctioning spleen Psychiatric conditions that may interfere with the study Pregnancy, breastfeeding, or plan to become pregnant during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Peiperl, MD
Organizational Affiliation
San Francisco Department of Public Health
Official's Role
Study Chair
Facility Information:
Facility Name
San Francisco Vaccine and Prevention CRS
City
San Francisco
State/Province
California
Country
United States
Facility Name
Vanderbilt Vaccine CRS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
FHCRC/UW Vaccine CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12845771
Citation
Shiver J. A non-replicating adenoviral vector as a potential HIV vaccine. Res Initiat Treat Action. 2003 Spring;8(2):14-6.
Results Reference
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PubMed Identifier
15452269
Citation
Casimiro DR, Bett AJ, Fu TM, Davies ME, Tang A, Wilson KA, Chen M, Long R, McKelvey T, Chastain M, Gurunathan S, Tartaglia J, Emini EA, Shiver J. Heterologous human immunodeficiency virus type 1 priming-boosting immunization strategies involving replication-defective adenovirus and poxvirus vaccine vectors. J Virol. 2004 Oct;78(20):11434-8. doi: 10.1128/JVI.78.20.11434-11438.2004.
Results Reference
background
PubMed Identifier
14746526
Citation
Shiver JW, Emini EA. Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annu Rev Med. 2004;55:355-72. doi: 10.1146/annurev.med.55.091902.104344.
Results Reference
background
PubMed Identifier
14598567
Citation
Gomez-Roman VR, Robert-Guroff M. Adenoviruses as vectors for HIV vaccines. AIDS Rev. 2003 Jul-Sep;5(3):178-85.
Results Reference
background
PubMed Identifier
21048953
Citation
Peiperl L, Morgan C, Moodie Z, Li H, Russell N, Graham BS, Tomaras GD, De Rosa SC, McElrath MJ; NIAID HIV Vaccine Trials Network. Safety and immunogenicity of a replication-defective adenovirus type 5 HIV vaccine in Ad5-seronegative persons: a randomized clinical trial (HVTN 054). PLoS One. 2010 Oct 27;5(10):e13579. doi: 10.1371/journal.pone.0013579.
Results Reference
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Safety of and Immune Response to an Experimental HIV Vaccine (VRC-HIVADV014-00-VP) in HIV Uninfected Adults

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