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Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VRC-HIVDNA009-00-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 Understanding of vaccination procedure Willing to receive HIV test results and provide informed consent Good general health HIV negative Hepatitis B surface antigen negative Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive Not pregnant and agrees to use acceptable forms of contraception Exclusion Criteria HIV vaccines or placebo in a prior HIV vaccine trial 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 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., use of oral, orally inhaled, or intravenous corticosteroids, 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 Serious angioedema Hypertension Diagnosis of bleeding disorder Malignancy, except those with a surgical excision and subsequent observation period that in the investigator's estimate 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 Pregnant or breastfeeding Two or more elevated liver function tests

Sites / Locations

  • Alabama Vaccine CRS
  • San Francisco Vaccine and Prevention CRS
  • Project Brave HIV Vaccine CRS
  • Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
  • Brigham and Women's Hosp. CRS
  • Fenway Community Health Clinical Research Site (FCHCRS)
  • Saint Louis Univ. School of Medicine, HVTU
  • NY Blood Ctr./Bronx CRS
  • NY Blood Ctr./Union Square CRS
  • 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
November 3, 2003
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
NCT00071851
Brief Title
Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults
Official Title
A Phase IB Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, Administered at 2 Different Dosing Schedules, in HIV-1-Uninfected Adult Participants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (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-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will be tested.
Detailed Description
The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVDNA009-00-VP vaccine used in this study was developed to incorporate HIV genes from multiple virus clades, representing the viral subtypes responsible for about 90% of new HIV infections in the world. The purpose of this study is to determine the safety and immunogenicity of VRC-HIVDNA009-00-VP in healthy, HIV uninfected individuals. Participants will be randomly assigned to one of three groups and will be followed for one year. Study injections will be given by needle-free intramuscular injection at the start of study and at Months 1 and 2. Group 1 will receive 3 injections of the study vaccine; Group 2 will receive 2 injections of the study vaccine (at start and Month 2) and injection of placebo (at Month 1); Group 3 will receive 3 injections of placebo. After a screening visit, study visits will occur at enrollment (initial injection) followed by 5 visits every 14 days for the first 2.5 months, with three additional visits at Months 6, 9, and 12. All participants will undergo physical exams, blood and urine tests to assess measures of health, and blood tests to assess HIV infection and immune response to the injections.

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, Phase 2
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
VRC-HIVDNA009-00-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 Understanding of vaccination procedure Willing to receive HIV test results and provide informed consent Good general health HIV negative Hepatitis B surface antigen negative Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive Not pregnant and agrees to use acceptable forms of contraception Exclusion Criteria HIV vaccines or placebo in a prior HIV vaccine trial 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 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., use of oral, orally inhaled, or intravenous corticosteroids, 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 Serious angioedema Hypertension Diagnosis of bleeding disorder Malignancy, except those with a surgical excision and subsequent observation period that in the investigator's estimate 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 Pregnant or breastfeeding Two or more elevated liver function tests
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie McElrath
Organizational Affiliation
Fred Hutchinson Cancer Research Center / University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Larry Peiperl
Organizational Affiliation
San Francisco Department of Public Health / University of California - San Diego
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Vaccine CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
San Francisco Vaccine and Prevention CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Project Brave HIV Vaccine CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
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
Country
United States
Facility Name
Brigham and Women's Hosp. CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Fenway Community Health Clinical Research Site (FCHCRS)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Saint Louis Univ. School of Medicine, HVTU
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NY Blood Ctr./Bronx CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10455
Country
United States
Facility Name
NY Blood Ctr./Union Square CRS
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
HIV Prevention & Treatment CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univ. of Rochester HVTN CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
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
11498307
Citation
Mascola JR, Nabel GJ. Vaccines for the prevention of HIV-1 disease. Curr Opin Immunol. 2001 Aug;13(4):489-95. doi: 10.1016/s0952-7915(00)00246-6.
Results Reference
background
PubMed Identifier
10669329
Citation
Boyer JD, Cohen AD, Vogt S, Schumann K, Nath B, Ahn L, Lacy K, Bagarazzi ML, Higgins TJ, Baine Y, Ciccarelli RB, Ginsberg RS, MacGregor RR, Weiner DB. Vaccination of seronegative volunteers with a human immunodeficiency virus type 1 env/rev DNA vaccine induces antigen-specific proliferation and lymphocyte production of beta-chemokines. J Infect Dis. 2000 Feb;181(2):476-83. doi: 10.1086/315229.
Results Reference
background
PubMed Identifier
11390574
Citation
Moore JP, Parren PW, Burton DR. Genetic subtypes, humoral immunity, and human immunodeficiency virus type 1 vaccine development. J Virol. 2001 Jul;75(13):5721-9. doi: 10.1128/JVI.75.13.5721-5729.2001. No abstract available.
Results Reference
background
PubMed Identifier
11832690
Citation
Osmanov S, Pattou C, Walker N, Schwardlander B, Esparza J; WHO-UNAIDS Network for HIV Isolation and Characterization. Estimated global distribution and regional spread of HIV-1 genetic subtypes in the year 2000. J Acquir Immune Defic Syndr. 2002 Feb 1;29(2):184-90. doi: 10.1097/00042560-200202010-00013.
Results Reference
background
PubMed Identifier
11251382
Citation
Manam S, Ledwith BJ, Barnum AB, Troilo PJ, Pauley CJ, Harper LB, Griffiths TG 2nd, Niu Z, Denisova L, Follmer TT, Pacchione SJ, Wang Z, Beare CM, Bagdon WJ, Nichols WW. Plasmid DNA vaccines: tissue distribution and effects of DNA sequence, adjuvants and delivery method on integration into host DNA. Intervirology. 2000;43(4-6):273-81. doi: 10.1159/000053994.
Results Reference
background
PubMed Identifier
25820067
Citation
Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
Results Reference
derived

Learn more about this trial

Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults

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