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Safety of and Immune Response to an HIV-1 Vaccine Boost (VRC-HIVADV014-00-VP) in HIV Uninfected Adults Who Participated in HVTN 052

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 Seronegativity, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Previously enrolled in and have completed all 3 study vaccine injections for HVTN 052 Understanding of vaccination procedure Good general health HIV uninfected Hepatitis B surface antigen negative Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive Willing to use acceptable forms of contraception Exclusion Criteria: Immunosuppressive medications within 168 days prior to study Blood products within 120 days prior to study Immunoglobulin within 60 days prior to study Live attenuated vaccines within 30 days prior to study Investigational research agents within 30 days prior to study Medically indicated subunit or killed vaccines within 14 days prior to study Allergy shots within 30 days prior to study Current anti-tuberculosis prophylaxis or therapy Anaphylaxis or other serious adverse reactions to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. Autoimmune disease or immunodeficiency Active syphilis infection Unstable asthma (e.g., daily symptoms; use of oral or orally inhaled corticosteroids or other treatments; emergent care, urgent care, hospitalization, or intubation during the past 2 years) Diabetes mellitus. A participant with past gestational diabetes is not excluded. Thyroid disease, including removal of thyroid and diagnoses requiring medication. A participant not requiring thyroid medication during the last year is not excluded. Serious angioedema. A participant who has had an episode of angioedema over 3 years prior to the study, and has not required medications for at least 2 years, is not excluded. Uncontrolled hypertension Diagnosis of bleeding disorder Malignancy, except those with a surgical excision that has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study Seizure disorder requiring medication within the last 3 years Absence of the spleen Mental illness that would interfere with compliance with the protocol Pregnancy or breastfeeding

Sites / Locations

  • Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
  • Fenway Community Health Clinical Research Site (FCHCRS)
  • Saint Louis Univ. School of Medicine, HVTU
  • HIV Prevention & Treatment CRS
  • Univ. of Rochester HVTN CRS
  • Miriam Hospital's HVTU
  • Vanderbilt Vaccine CRS
  • FHCRC/UW Vaccine CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2004
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
NCT00091416
Brief Title
Safety of and Immune Response to an HIV-1 Vaccine Boost (VRC-HIVADV014-00-VP) in HIV Uninfected Adults Who Participated in HVTN 052
Official Title
A Phase I Clinical Trial to Evaluate the Safety of a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Administered to Healthy, HIV-1 Uninfected, Adult Participants Who Received DNA Plasmid Vaccine or Placebo in the HVTN 052 Clinical Trial
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
May 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 test the safety of and immune response to an HIV-1 vaccine, VRC-HIVADV014-00-VP, when given as a vaccine booster to HIV uninfected adults who participated in HVTN 052.
Detailed Description
The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVADV014-00-VP adenoviral vector vaccine used in this study was developed to stimulate strong virus-specific CD8 cytotoxic T-lymphocyte (CTL) responses thought to be crucial in an effective preventive HIV vaccine. The purpose of this study is to determine the safety and immunogenicity of a VRC-HIVADV014-00-VP vaccine boost given to healthy, HIV uninfected individuals who participated in HVTN 052, which evaluated the VRC-HIVDNA009-00-VP DNA plasmid vaccine. In that study, participants received either 3 injections of vaccine, 2 injections of vaccine and 1 injection of placebo, or 3 injections of placebo over a 2-month period. This study will last one year. Participants will be randomly assigned to receive vaccine boost or placebo by intramuscular injection. The injections will be given 6 to 9 months after each participant's first HVTN 052 study injection, preferably as close to 6 months after the first HVTN 052 injection as possible. After a screening visit, study visits will occur at enrollment (when the injection will be given), at Week 2, and at Months 1, 3, 6, and 12. Blood collection, physical exam, and medication assessment will occur at every study visit; urine collection will occur at selected visits.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
VRC-HIVADV014-00-VP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Previously enrolled in and have completed all 3 study vaccine injections for HVTN 052 Understanding of vaccination procedure Good general health HIV uninfected Hepatitis B surface antigen negative Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive Willing to use acceptable forms of contraception Exclusion Criteria: Immunosuppressive medications within 168 days prior to study Blood products within 120 days prior to study Immunoglobulin within 60 days prior to study Live attenuated vaccines within 30 days prior to study Investigational research agents within 30 days prior to study Medically indicated subunit or killed vaccines within 14 days prior to study Allergy shots within 30 days prior to study Current anti-tuberculosis prophylaxis or therapy Anaphylaxis or other serious adverse reactions to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. Autoimmune disease or immunodeficiency Active syphilis infection Unstable asthma (e.g., daily symptoms; use of oral or orally inhaled corticosteroids or other treatments; emergent care, urgent care, hospitalization, or intubation during the past 2 years) Diabetes mellitus. A participant with past gestational diabetes is not excluded. Thyroid disease, including removal of thyroid and diagnoses requiring medication. A participant not requiring thyroid medication during the last year is not excluded. Serious angioedema. A participant who has had an episode of angioedema over 3 years prior to the study, and has not required medications for at least 2 years, is not excluded. Uncontrolled hypertension Diagnosis of bleeding disorder Malignancy, except those with a surgical excision that has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study Seizure disorder requiring medication within the last 3 years Absence of the spleen Mental illness that would interfere with compliance with the protocol Pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Peiperl, MD
Organizational Affiliation
San Francisco Department of Public Health / University of California - San Francisco
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julie McElrath, MD, PhD
Organizational Affiliation
Fred Hutchinson Cancer Research Center / University of Washington
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205-1901
Country
United States
Facility Name
Fenway Community Health Clinical Research Site (FCHCRS)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Saint Louis Univ. School of Medicine, HVTU
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-2500
Country
United States
Facility Name
HIV Prevention & Treatment CRS
City
New York
State/Province
New York
Country
United States
Facility Name
Univ. of Rochester HVTN CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-0001
Country
United States
Facility Name
Miriam Hospital's HVTU
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
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
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
11883691
Citation
McShane H. Prime-boost immunization strategies for infectious diseases. Curr Opin Mol Ther. 2002 Feb;4(1):23-7.
Results Reference
background
PubMed Identifier
14662882
Citation
Pinto AR, Fitzgerald JC, Giles-Davis W, Gao GP, Wilson JM, Ertl HC. Induction of CD8+ T cells to an HIV-1 antigen through a prime boost regimen with heterologous E1-deleted adenoviral vaccine carriers. J Immunol. 2003 Dec 15;171(12):6774-9. doi: 10.4049/jimmunol.171.12.6774.
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
Links:
URL
http://clinicaltrials.gov/show/NCT00071851
Description
Click here for more information about the HVTN 052 study

Learn more about this trial

Safety of and Immune Response to an HIV-1 Vaccine Boost (VRC-HIVADV014-00-VP) in HIV Uninfected Adults Who Participated in HVTN 052

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