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

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