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A Phase I Clinical Trial to Evaluate the Safety of a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Administered to Healthy, HIV-1 Uninfected, Adult Participants Who Received DNA Plasmid Vaccine or Placebo in the HVTN 052 Clinical Trial

Phase 1
18 Years
50 Years
Not Enrolling
HIV Infections

Thank you

Trial Information

A Phase I Clinical Trial to Evaluate the Safety of a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Administered to Healthy, HIV-1 Uninfected, Adult Participants Who Received DNA Plasmid Vaccine or Placebo in the HVTN 052 Clinical Trial

The worldwide HIV epidemic highlights the importance of developing an affordable, globally
successful vaccine for HIV prevention. The VRC-HIVADV014-00-VP adenoviral vector vaccine
used in this study was developed to stimulate strong virus-specific CD8 cytotoxic
T-lymphocyte (CTL) responses thought to be crucial in an effective preventive HIV vaccine.
The purpose of this study is to determine the safety and immunogenicity of a
VRC-HIVADV014-00-VP vaccine boost given to healthy, HIV uninfected individuals who
participated in HVTN 052, which evaluated the VRC-HIVDNA009-00-VP DNA plasmid vaccine. In
that study, participants received either 3 injections of vaccine, 2 injections of vaccine
and 1 injection of placebo, or 3 injections of placebo over a 2-month period.

This study will last one year. Participants will be randomly assigned to receive vaccine
boost or placebo by intramuscular injection. The injections will be given 6 to 9 months
after each participant's first HVTN 052 study injection, preferably as close to 6 months
after the first HVTN 052 injection as possible. After a screening visit, study visits will
occur at enrollment (when the injection will be given), at Week 2, and at Months 1, 3, 6,
and 12. Blood collection, physical exam, and medication assessment will occur at every study
visit; urine collection will occur at selected visits.

Inclusion Criteria:

- Previously enrolled in and have completed all 3 study vaccine injections for HVTN 052

- Understanding of vaccination procedure

- Good general health

- HIV uninfected

- Hepatitis B surface antigen negative

- Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the
anti-HCV is positive

- Willing to use acceptable forms of contraception

Exclusion Criteria:

- Immunosuppressive medications within 168 days prior to study

- Blood products within 120 days prior to study

- Immunoglobulin within 60 days prior to study

- Live attenuated vaccines within 30 days prior to study

- Investigational research agents within 30 days prior to study

- Medically indicated subunit or killed vaccines within 14 days prior to study

- Allergy shots within 30 days prior to study

- Current anti-tuberculosis prophylaxis or therapy

- Anaphylaxis or other serious adverse reactions 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

- Unstable asthma (e.g., daily symptoms; use of oral or orally inhaled corticosteroids
or other treatments; emergent care, urgent care, hospitalization, or intubation
during the past 2 years)

- Diabetes mellitus. A participant with past gestational diabetes is not excluded.

- Thyroid disease, including removal of thyroid and diagnoses requiring medication. A
participant not requiring thyroid medication during the last year is not excluded.

- Serious angioedema. A participant who has had an episode of angioedema over 3 years
prior to the study, and has not required medications for at least 2 years, is not

- Uncontrolled hypertension

- Diagnosis of bleeding disorder

- Malignancy, except those with a surgical excision that has a reasonable assurance of
sustained cure and/or is unlikely to recur during the period of the study

- Seizure disorder requiring medication within the last 3 years

- Absence of the spleen

- Mental illness that would interfere with compliance with the protocol

- Pregnancy or breastfeeding

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

Larry Peiperl, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Francisco Department of Public Health / University of California - San Francisco


United States: Food and Drug Administration

Study ID:

HVTN 057



Start Date:

Completion Date:

May 2006

Related Keywords:

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



Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore Baltimore, Maryland  21205
Fenway Community Health Clinical Research Site (FCHCRS) Boston, Massachusetts  02215
HIV Prevention & Treatment CRS New York, New York  10032
Univ. of Rochester HVTN CRS Rochester, New York  14642
Miriam Hospital's HVTU Providence, Rhode Island  02906
Vanderbilt Vaccine CRS Nashville, Tennessee  37232
FHCRC/UW Vaccine CRS Seattle, Washington  98104
Saint Louis Univ. School of Medicine, HVTU St Louis, Missouri  63110-2500