Know Cancer

forgot password

A Phase IB Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, Administered at 2 Different Dosing Schedules, in HIV-1-Uninfected Adult Participants

Phase 1/Phase 2
18 Years
50 Years
Not Enrolling
HIV Infections

Thank you

Trial Information

A Phase IB Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, Administered at 2 Different Dosing Schedules, in HIV-1-Uninfected Adult Participants

The worldwide HIV epidemic highlights the importance of developing an affordable, globally
successful vaccine for HIV prevention. The VRC-HIVDNA009-00-VP vaccine used in this study
was developed to incorporate HIV genes from multiple virus clades, representing the viral
subtypes responsible for about 90% of new HIV infections in the world. The purpose of this
study is to determine the safety and immunogenicity of VRC-HIVDNA009-00-VP in healthy, HIV
uninfected individuals.

Participants will be randomly assigned to one of three groups and will be followed for one
year. Study injections will be given by needle-free intramuscular injection at the start of
study and at Months 1 and 2. Group 1 will receive 3 injections of the study vaccine; Group
2 will receive 2 injections of the study vaccine (at start and Month 2) and injection of
placebo (at Month 1); Group 3 will receive 3 injections of placebo. After a screening visit,
study visits will occur at enrollment (initial injection) followed by 5 visits every 14 days
for the first 2.5 months, with three additional visits at Months 6, 9, and 12. All
participants will undergo physical exams, blood and urine tests to assess measures of
health, and blood tests to assess HIV infection and immune response to the injections.

Inclusion Criteria

Inclusion Criteria

- Understanding of vaccination procedure

- Willing to receive HIV test results and provide informed consent

- Good general health

- HIV negative

- Hepatitis B surface antigen negative

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

- Not pregnant and agrees to use acceptable forms of contraception

Exclusion Criteria

- HIV vaccines or placebo in a prior HIV vaccine trial

- 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

- 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., use of oral, orally inhaled, or intravenous corticosteroids,
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

- Serious angioedema

- Hypertension

- Diagnosis of bleeding disorder

- Malignancy, except those with a surgical excision and subsequent observation period
that in the investigator's estimate 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

- Pregnant or breastfeeding

- Two or more elevated liver function tests

Type of Study:


Study Design:

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

Principal Investigator

Julie McElrath

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center / University of Washington


United States: Food and Drug Administration

Study ID:

HVTN 052



Start Date:

December 2003

Completion Date:

October 2005

Related Keywords:

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



Alabama Vaccine CRS Birmingham, Alabama  35294
San Francisco Vaccine and Prevention CRS San Francisco, California  94102
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore Baltimore, Maryland  21205
Project Brave HIV Vaccine CRS Baltimore, Maryland  21201
Brigham and Women's Hosp. CRS Boston, Massachusetts  02115
Fenway Community Health Clinical Research Site (FCHCRS) Boston, Massachusetts  02215
NY Blood Ctr./Bronx CRS Bronx, New York  10455
HIV Prevention & Treatment CRS New York, New York  10032
NY Blood Ctr./Union Square CRS New York, New York  10003
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