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A Phase 1B Open-label Clinical Trial to Expand the Characterization of the Immune Responses to the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy, HIV-1-uninfected Adult Participants


Phase 1
18 Years
50 Years
Not Enrolling
Both
HIV Infections

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Trial Information

A Phase 1B Open-label Clinical Trial to Expand the Characterization of the Immune Responses to the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy, HIV-1-uninfected Adult Participants


This study will look for relationships among the immune responses induced by MRKAd5 HIV-1
gag/pol/nef vaccine. The study will also determine if the T cells that respond to different
vaccine epitopes have correspondingly different functional profiles. The study will evaluate
the safety and tolerability of the vaccine regimen as well.

This study will last 60 weeks. All enrolled participants will receive vaccinations at Weeks
0, 4, and 26. There will be between 8 and 20 study visits including the screening visit,
depending on the site location. A physical exam, interview, and blood collection will occur
at most or all visits. All participants will undergo leukapheresis approximately 4 weeks
after their last vaccination and at Week 52. Medical history, an HIV test, a pregnancy test,
and HIV and risk reduction counseling will occur at selected visits. Additional blood
collection is now occurring in this study to collect more information about the relationship
between the immune response and efficacy to the vaccine.


Note: As of 09/19/07, enrollment and vaccinations have been discontinued.

Inclusion Criteria:



- Good general health

- HIV uninfected

- Weight of 110 pounds or greater

- Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be
followed during the study

- Willing to receive HIV test results

- Understand the vaccination procedure

- Willing to use acceptable methods of contraception for at least 21 days prior to
study entry and until the last study visit

Exclusion Criteria:

- HIV vaccines or placebos in prior HIV trial. Participants who can provide
documentation that they received a placebo in a prior HIV trial may be eligible.

- Immunosuppressive medications within 168 days prior to first study vaccination

- Blood products within 90 days prior to first study vaccination or within 14 days
after the injection

- Immunoglobulin within 90 days prior to first study vaccination or within 14 days
after the injection

- Live attenuated vaccines within 42 days prior to first study vaccination or within 14
days after the injection

- Investigational research agents within 30 days prior to first study vaccination

- Medically indicated subunit or killed vaccines within 5 days prior to first study
vaccination or within 14 days after the injection

- Allergy treatment with antigen injections within 30 days prior to first study
vaccination

- 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, in the opinion of the
investigator, would interfere with the study.

- History of anaphylaxis and/or allergy to vaccine components

- Autoimmune disease or immunodeficiency

- Uncontrolled hypertension

- Bleeding disorder

- Cancer. Participants with surgically removed cancer that is unlikely to recur are not
excluded.

- Seizure disorder

- Absence of the spleen

- Abnormal laboratory values

- Mental illness that would interfere with the study

- Hysterectomy

- Pregnancy or breastfeeding

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Relatedness of different immune response to vaccine

Outcome Time Frame:

Throughout study

Safety Issue:

No

Principal Investigator

Ann Duerr, MD, PhD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

HVTN Core Operations Center, Fred Hutchinson Cancer Research Center (FHCRC)

Authority:

United States: Food and Drug Administration

Study ID:

HVTN 071

NCT ID:

NCT00486408

Start Date:

July 2007

Completion Date:

Related Keywords:

  • HIV Infections
  • HIV Seronegativity
  • HIV Preventive Vaccine
  • Adenovirus
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Adenoviridae Infections

Name

Location

Alabama Vaccine CRS Birmingham, Alabama  35294
Univ. of Rochester HVTN CRS Rochester, New York  14642
Vanderbilt Vaccine CRS Nashville, Tennessee  37232
FHCRC/UW Vaccine CRS Seattle, Washington  98104