Safety of and Immune Response to an HIV-1 Vaccine Boost (VRC-HIVADV014-00-VP) in HIV Uninfected Adults Who Participated in HVTN 052

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVADV014-00-VP, when given as a vaccine booster to HIV uninfected adults who participated in HVTN 052.

Key facts

Study ID

NCT00091416

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

70

Expected to finish

2006-05-01

Last updated by the study team

2021-10-14

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 excluded.
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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