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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Biological: VRC-HIVADV014-00-VP

Study type

Interventional

Funder types

NIH

Identifiers

NCT00091416

10123 (Registry Identifier)

HVTN 057

Details and patient eligibility

About

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.

Full description

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.

Enrollment

70 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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 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