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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00141024
First received: August 30, 2005
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: EP HIV-1043
Biological: EP HIV-1090
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity as assessed by HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and intracellular cytokine staining [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Social impacts as assessed by negative experiences or problems reported by the participants [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: January 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: EP HIV-1043

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.
Biological: EP HIV-1043

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.
Biological: EP HIV-1043

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.
Biological: EP HIV-1090
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.
Biological: EP HIV-1043

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.

Biological: EP HIV-1090
DNA plasmid vaccine containing the genes Gag, Pol, Vpr, Nef, Rev, and Env. The vaccine is provided in single-use 1.1-mL vials.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141024

Locations
United States, California
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States, 94102-6033
United States, Maryland
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States, 21201
United States, New York
Univ. of Rochester HVTN CRS
Rochester, New York, United States, 14642-0001
Sponsors and Collaborators
Investigators
Study Chair: Xia Jin, MD, PhD University of Rochester
Study Chair: Jorge Sanchez, MD Asociación Civil Impacta Salud y Educación (IMPACTA)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00141024     History of Changes
Other Study ID Numbers: HVTN 064, 10059
Study First Received: August 30, 2005
Last Updated: August 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity
HIV Preventive Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 23, 2014