Safety of and Immune Response to the Experimental Preventive HIV Vaccine, EP HIV-1090, in Healthy, HIV-1 Uninfected Adults

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Protein Vaccine EP-1043 and the DNA Vaccine EP HIV-1090 Given Alone or in Combination in Healthy, HIV-1-Uninfected Adult Participants

The purpose of the study is to determine the safety of and immune response to the investigational HIV vaccine, EP HIV-1090, in HIV uninfected adults.

Study Overview

Status

Completed

Conditions

Detailed Description

The worldwide HIV/AIDS epidemic may only be controlled through the development of a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, readily produced in large quantities, and stable for long periods of time. EP HIV-1090 is a DNA HIV CTL vaccine; the proteins for which its genes code are designed to interact with CD8 cells (CTL) and cause CD8 cell proliferation. The DNA plasmids in EP HIV-1090 code for proteins conserved among HIV subtypes A, B, C, D, F, and G, which encompass the HLA subtypes of 85% of the worldwide general population.

Participants will be enrolled in this study for 1 year. Group 4 participants will receive EP HIV-1090 or placebo at study entry and Months 1, 3, and 6. There will be 11 study visits that will occur at screening; study entry; and Months 0.5, 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. A physical exam and risk reduction/pregnancy prevention counseling will occur at each visit. Participants will be asked about their adverse experiences from vaccination at each visit. Blood and urine collection will occur at selected visits.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94102-6033
        • San Francisco Vaccine and Prevention CRS
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Project Brave HIV Vaccine CRS
    • New York
      • Rochester, New York, United States, 14642-0001
        • Univ. of Rochester HVTN CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Note: Groups 1, 2, 3, and 5 have permanently discontinued enrollment per the 12/26/06 letter of amendment.

Inclusion Criteria:

  • Good general health
  • Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed for the duration of the study
  • Willing to receive HIV test results
  • Have understanding of the study
  • Willing to use acceptable forms of contraception
  • Negative pregnancy test

Exclusion Criteria:

  • HIV vaccines in a prior HIV vaccine trial
  • Immunosuppressive medications within 168 days prior to first vaccination
  • Blood products within 120 days prior to first vaccination
  • Immunoglobulin within 60 days prior to first vaccination
  • Live attenuated vaccines within 30 days prior to first vaccination
  • Investigational research agents within 30 days prior to first vaccination
  • Medically indicated subunit or killed vaccines within 14 days prior to first study vaccine administration, or allergy treatment with antigen injections within 30 days prior to first vaccination
  • Current tuberculosis prophylaxis or therapy
  • Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
  • Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
  • Any job-related responsibility that would interfere with the study
  • 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
  • Active syphilis infection unless the participant has completed full treatment for syphilis 6 months prior to enrollment
  • Unstable asthma
  • Diabetes mellitus type 1 or 2
  • Thyroid disease or thyroidectomy requiring treatment
  • Serious angioedema within 3 years prior to enrollment
  • Uncontrolled hypertension
  • Body mass index (BMI) of 40 or greater
  • BMI of 35 or greater if the participant is older than 45 years, has systolic blood pressure greater than 140 mm Hg, has diastolic blood pressure greater than 90 mm Hg, smokes, or has known hyperlipidemia
  • 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 3 years prior to enrollment
  • Absence of the spleen
  • Mental illness that would interfere with the study
  • Other conditions that, in the judgment of the investigator, would interfere with the study
  • Pregnancy, breastfeeding, or plans to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Group 1 will receive 4 vaccinations of the EP-1043 vaccine or placebo. Vaccinations will be given at Months 0, 1, 3, and 6. This group was discontinued as of 12/26/06.

Recombinant protein vaccine containing the 18 HIV proteins from HIV genes Pol, Vpu, and Gag.

The vaccine is provided in single-use 1.1-mL vials.

Experimental: 2
Group 2 will receive 4 vaccinations of the EP-1043 vaccine or placebo. Vaccinations will be given at Months 0, 1, 3, and 6. This group was discontinued as of 12/26/06.

Recombinant protein vaccine containing the 18 HIV proteins from HIV genes Pol, Vpu, and Gag.

The vaccine is provided in single-use 1.1-mL vials.

Experimental: 3
In Part B, Group 3 will receive 4 vaccinations of either the EP-1043 vaccine or placebo. Vaccinations will occur at Months 0, 1, 3, and 6. This group was discontinued as of 12/26/06.

Recombinant protein vaccine containing the 18 HIV proteins from HIV genes Pol, Vpu, and Gag.

The vaccine is provided in single-use 1.1-mL vials.

Experimental: 4
In Part B, Group 4 will receive 4 vaccinations of either the DNA vaccine EP-HIV-1090 or placebo. Vaccinations will occur at Months 0, 1, 3, and 6.
DNA plasmid vaccine containing the genes Gag, Pol, Vpr, Nef, Rev, and Env. The vaccine is provided in single-use 1.1-mL vials.
Experimental: 5
In Part B, Group 5 will receive 4 vaccinations of either the protein vaccine EP-1043 plus DNA vaccine EP-HIV- 1090 or placebo. Vaccinations will occur at Months 0, 1, 3, and 6. This group was discontinued as of 12/26/06.

Recombinant protein vaccine containing the 18 HIV proteins from HIV genes Pol, Vpu, and Gag.

The vaccine is provided in single-use 1.1-mL vials.

DNA plasmid vaccine containing the genes Gag, Pol, Vpr, Nef, Rev, and Env. The vaccine is provided in single-use 1.1-mL vials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences
Time Frame: After each injection and for 12 months following the first injection
After each injection and for 12 months following the first injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity as assessed by HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and intracellular cytokine staining
Time Frame: Throughout the study
Throughout the study
Social impacts as assessed by negative experiences or problems reported by the participants
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Xia Jin, MD, PhD, University of Rochester
  • Study Chair: Jorge Sanchez, MD, Asociación Civil Impacta Salud y Educación (IMPACTA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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