search
Back to results

Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HIV CTL MEP administered with RC529-SE adjuvant
GM-CSF
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, Granulocyte-Macrophage Colony-Stimulating Factor, AIDS Vaccines, HIV-1, HIV Seronegativity, Injections, Intramuscular, RC529, Epitopes, T-Lymphocytes, Cytotoxic

Eligibility Criteria

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

Inclusion Criteria: HIV uninfected Willing to receive HIV test results Good general health One of the following major histocompatibility (MHC) alleles: HLA A3, B7, or B8 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 Access to participating site and available for follow-up during the 15 month study 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 Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. Hypersensitivity to egg products or yeast-derived products Autoimmune disease or immunodeficiency Active syphilis Unstable asthma Type 1 or Type 2 diabetes mellitus Thyroid disease requiring treatment in the past 12 months 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

  • Alabama Vaccine CRS
  • San Francisco Vaccine and Prevention CRS
  • Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
  • Saint Louis Univ. School of Medicine, HVTU
  • Univ. of Rochester HVTN CRS
  • Vanderbilt Vaccine CRS
  • FHCRC/UW Vaccine CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 13, 2004
Last Updated
October 13, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00076037
Brief Title
Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP
Official Title
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a CTL Multi-Epitope Peptide HIV Vaccine Formulated With RC529-SE, With or Without GM-CSF, 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
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 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 effectiveness of a vaccine can be improved by using a "prime boost strategy" or by using an adjuvant. A prime boost strategy is the administration of one type of vaccine (the primer) followed by the administration of another type vaccine (the booster). An adjuvant is a substance that can enhance the immune response when given at the same time as a vaccine. This study will evaluate the safety of and immune response to a vaccine designed to be used as part of a prime boost strategy. The study will also evaluate the vaccine when given with an adjuvant. The vaccine in this study is not produced from live HIV or from infected cells. It does not contain HIV, and it cannot cause HIV infection.
Detailed Description
Prime-boost vaccine strategies are aimed at inducing different types of immune responses and enhancing the overall immune response, a result that may not occur with a single type of vaccine. This trial will evaluate the safety and immunogenicity of an HIV multi-epitope peptide cytotoxic T lymphocyte (HIV CTL MEP) vaccine developed as part of a prime-boost strategy and designed to be administered in combination with an HIV DNA vaccine. The HIV CTL MEP vaccine is a mixture of four synthetic peptides, each containing one of three different HIV CTL epitopes derived from env or gag. The use of multiple conserved CTL epitopes will address the extraordinary diversity found among HIV strains. The vaccine is administered with RC529-SE, an analogue of monophosphoryl lipid A. The vaccine/adjuvant combination will be evaluated with or without coadministration of granulocyte-macrophage colony-stimulating factor (GM-CSF). Participants will be randomly assigned to receive either the vaccine with the RC529-SE adjuvant, the vaccine with both adjuvants (RC529-SE and GM-CSF), or a placebo. The vaccine, adjuvants, and placebo will all be given as an injection into the upper arm. Participants will have 11 study visits. Study visits will include a physical exam, medical interview, and blood and urine tests. Participants will receive an injection at three of these visits: study entry and Months 1 and 3. Participants will be followed for 1 year after the last injection.

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, Granulocyte-Macrophage Colony-Stimulating Factor, AIDS Vaccines, HIV-1, HIV Seronegativity, Injections, Intramuscular, RC529, Epitopes, T-Lymphocytes, Cytotoxic

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
HIV CTL MEP administered with RC529-SE adjuvant
Intervention Type
Drug
Intervention Name(s)
GM-CSF

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 uninfected Willing to receive HIV test results Good general health One of the following major histocompatibility (MHC) alleles: HLA A3, B7, or B8 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 Access to participating site and available for follow-up during the 15 month study 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 Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. Hypersensitivity to egg products or yeast-derived products Autoimmune disease or immunodeficiency Active syphilis Unstable asthma Type 1 or Type 2 diabetes mellitus Thyroid disease requiring treatment in the past 12 months 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
Paul Spearman, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Spyros Kalams, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Vaccine CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-2041
Country
United States
Facility Name
San Francisco Vaccine and Prevention CRS
City
San Francisco
State/Province
California
Country
United States
Facility Name
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
City
Baltimore
State/Province
Maryland
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
Univ. of Rochester HVTN CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
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
12450697
Citation
Somani J, Lonial S, Rosenthal H, Resnick S, Kakhniashvili I, Waller EK. A randomized, placebo-controlled trial of subcutaneous administration of GM-CSF as a vaccine adjuvant: effect on cellular and humoral immune responses. Vaccine. 2002 Dec 13;21(3-4):221-30. doi: 10.1016/s0264-410x(02)00463-2.
Results Reference
background
PubMed Identifier
12798637
Citation
Gilbert PB, Chiu YL, Allen M, Lawrence DN, Chapdu C, Israel H, Holman D, Keefer MC, Wolff M, Frey SE; NIAID HIV Vaccine Trials Network. Long-term safety analysis of preventive HIV-1 vaccines evaluated in AIDS vaccine evaluation group NIAID-sponsored Phase I and II clinical trials. Vaccine. 2003 Jun 20;21(21-22):2933-47. doi: 10.1016/s0264-410x(03)00158-0.
Results Reference
background

Learn more about this trial

Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP

We'll reach out to this number within 24 hrs