search
Back to results

Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Uninfected Adults

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
EP HIV-1090
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, HIV Seronegativity, HIV-1, AIDS Vaccines, Vaccines, DNA, Dose-Response Relationship, Immunologic, CD4-Positive T-Lymphocytes, CD8-Positive T-Lymphocytes, Epitopes

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria HIV negative Positive for one or more of the following HLA supertypes: -A2, -A3, or -B7 Willing to receive HIV test results Good general health Acceptable methods of contraception for females of reproductive potential Hepatitis B surface antigen negative Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive Exclusion Criteria HIV vaccines or placebos in prior HIV vaccine trial Immunosuppressive medications within 168 days prior to first study vaccine administration Blood products within 120 days prior to first study vaccine administration Immunoglobulin within 60 days prior to first study vaccine administration Live attenuated vaccines within 30 days prior to first study vaccine administration Investigational research agents within 30 days prior to first study vaccine administration Subunit or killed vaccines within 14 days prior to first study vaccine administration Current tuberculosis prophylaxis or therapy Active syphilis Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. Autoimmune disease or immunodeficiency Unstable asthma Type 1 or Type 2 Diabetes Mellitus Thyroid disease requiring treatment Serious angioedema within the past 3 years Uncontrolled hypertension Bleeding disorder Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period Seizure disorder requiring medication within the past 3 years Asplenia Mental illness that would interfere with compliance with the protocol Other conditions that, in the judgment of the investigator, would interfere with the study Pregnant or breast-feeding

Sites / Locations

  • Brigham and Women's Hosp. CRS
  • Fenway Community Health Clinical Research Site (FCHCRS)
  • Saint Louis Univ. School of Medicine, HVTU
  • Miriam Hospital's HVTU
  • Gaborone Prevention/Treatment Trials CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 11, 2003
Last Updated
October 13, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00054860
Brief Title
Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Uninfected Adults
Official Title
A Phase I Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of the EP HIV-1090 DNA Vaccine in Healthy, HIV-1-Uninfected Adult Participants
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
September 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 an HIV DNA vaccine (EP HIV-1090) and to test whether or not the vaccine can stimulate immune system responses in HIV uninfected people. This vaccine uses only parts of the virus's DNA and cannot cause HIV infection.
Detailed Description
Epidemiological and animal model data support the hypothesis that HIV specific cytotoxic T lymphocyte (CTL) responses contribute to control and clearance of the virus. Vaccines designed specifically to induce CTL responses are likely to be well suited for protection against HIV infection and disease progression. EP HIV-1090 is a DNA vaccine composed of 21 highly specific CTL epitopes. The vaccine is designed to optimize the immune response in people expressing one of three HLA Class I antigen subtypes: HLA-A2, -A3, and -B7. This design is predicted to induce an immune response in 85% of individuals in the general population. There is also a helper T lymphocyte (HTL) facilitating epitope (PADRE) in the vaccine. The vaccine is formulated with a water soluble polymer (polyvinylpyrrolidone) that protects the DNA and facilitates cellular uptake. This study will assess the safety of and immune response to different doses of EP HIV-1090 in healthy, HIV uninfected adults. Participants in this study will be randomized to receive either one of three different doses of vaccine or placebo. Participants will receive vaccinations or placebo at study entry and Months 1, 3, and 6. Both vaccinations and placebo are administered by intramuscular injection. Participants will be followed for 18 months and will have 12 study visits. Each study visit will include a physical exam, medical history, and blood and urine tests. Each participant will have four HIV tests during the study. Women will have at least five pregnancy tests during the study.

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, HIV Seronegativity, HIV-1, AIDS Vaccines, Vaccines, DNA, Dose-Response Relationship, Immunologic, CD4-Positive T-Lymphocytes, CD8-Positive T-Lymphocytes, Epitopes

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
EP HIV-1090

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria HIV negative Positive for one or more of the following HLA supertypes: -A2, -A3, or -B7 Willing to receive HIV test results Good general health Acceptable methods of contraception for females of reproductive potential Hepatitis B surface antigen negative Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive Exclusion Criteria HIV vaccines or placebos in prior HIV vaccine trial Immunosuppressive medications within 168 days prior to first study vaccine administration Blood products within 120 days prior to first study vaccine administration Immunoglobulin within 60 days prior to first study vaccine administration Live attenuated vaccines within 30 days prior to first study vaccine administration Investigational research agents within 30 days prior to first study vaccine administration Subunit or killed vaccines within 14 days prior to first study vaccine administration Current tuberculosis prophylaxis or therapy Active syphilis Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. Autoimmune disease or immunodeficiency Unstable asthma Type 1 or Type 2 Diabetes Mellitus Thyroid disease requiring treatment Serious angioedema within the past 3 years Uncontrolled hypertension Bleeding disorder Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period Seizure disorder requiring medication within the past 3 years Asplenia Mental illness that would interfere with compliance with the protocol Other conditions that, in the judgment of the investigator, would interfere with the study Pregnant or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey J. Gorse, MD
Organizational Affiliation
St. Louis University
Official's Role
Study Chair
Facility Information:
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
02115
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
Miriam Hospital's HVTU
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Gaborone Prevention/Treatment Trials CRS
City
Gaborone
Country
Botswana

12. IPD Sharing Statement

Citations:
PubMed Identifier
7527444
Citation
Sette A, Vitiello A, Reherman B, Fowler P, Nayersina R, Kast WM, Melief CJ, Oseroff C, Yuan L, Ruppert J, Sidney J, del Guercio MF, Southwood S, Kubo RT, Chesnut RW, Grey HM, Chisari FV. The relationship between class I binding affinity and immunogenicity of potential cytotoxic T cell epitopes. J Immunol. 1994 Dec 15;153(12):5586-92.
Results Reference
background
PubMed Identifier
11152503
Citation
Altfeld MA, Livingston B, Reshamwala N, Nguyen PT, Addo MM, Shea A, Newman M, Fikes J, Sidney J, Wentworth P, Chesnut R, Eldridge RL, Rosenberg ES, Robbins GK, Brander C, Sax PE, Boswell S, Flynn T, Buchbinder S, Goulder PJ, Walker BD, Sette A, Kalams SA. Identification of novel HLA-A2-restricted human immunodeficiency virus type 1-specific cytotoxic T-lymphocyte epitopes predicted by the HLA-A2 supertype peptide-binding motif. J Virol. 2001 Feb;75(3):1301-11. doi: 10.1128/JVI.75.3.1301-1311.2001.
Results Reference
background
PubMed Identifier
10364278
Citation
Woodberry T, Gardner J, Mateo L, Eisen D, Medveczky J, Ramshaw IA, Thomson SA, Ffrench RA, Elliott SL, Firat H, Lemonnier FA, Suhrbier A. Immunogenicity of a human immunodeficiency virus (HIV) polytope vaccine containing multiple HLA A2 HIV CD8(+) cytotoxic T-cell epitopes. J Virol. 1999 Jul;73(7):5320-5. doi: 10.1128/JVI.73.7.5320-5325.1999.
Results Reference
background
PubMed Identifier
11535313
Citation
Livingston BD, Newman M, Crimi C, McKinney D, Chesnut R, Sette A. Optimization of epitope processing enhances immunogenicity of multiepitope DNA vaccines. Vaccine. 2001 Sep 14;19(32):4652-60. doi: 10.1016/s0264-410x(01)00233-x.
Results Reference
background
PubMed Identifier
10438842
Citation
Hanke T, Samuel RV, Blanchard TJ, Neumann VC, Allen TM, Boyson JE, Sharpe SA, Cook N, Smith GL, Watkins DI, Cranage MP, McMichael AJ. Effective induction of simian immunodeficiency virus-specific cytotoxic T lymphocytes in macaques by using a multiepitope gene and DNA prime-modified vaccinia virus Ankara boost vaccination regimen. J Virol. 1999 Sep;73(9):7524-32. doi: 10.1128/JVI.73.9.7524-7532.1999.
Results Reference
background

Learn more about this trial

Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Uninfected Adults

We'll reach out to this number within 24 hrs