Safety of and Immune Response to an Experimental HIV Vaccine (VRC-HIVADV014-00-VP) in HIV Uninfected Adults

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

NCT00119873

10121 (Registry Identifier)

HVTN 054

Details and patient eligibility

About

The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine in HIV uninfected individuals.

Full description

The HIV epidemic is a major global health challenge. People in developing nations have limited access to life-sustaining antiretrovirals and account for over 95% of the 5 million new HIV infections annually. The development of a safe, effective, and widely accessible HIV vaccine is paramount in these areas. The adenoviral vector vaccine VRC-HIVADV014-00-VP has been shown to elicit a CD8 cytotoxic lymphocyte (CTL) response believed to be crucial in an effective preventive HIV vaccine. The purpose of this study is to determine the safety and immunogenicity of VRC-HIVADV014-00-VP in HIV uninfected adults. In this study, HIV uninfected individuals with low levels of pre-existing adenovirus neutralizing antibodies will receive different doses of the preventive vaccine to determine its safety, tolerability, and immunogenicity.

This study will last 1 year. Participants will be randomly assigned to one of two groups. At study entry, participants in each group will receive a single injection of either one of two doses of the adenoviral vector vaccine or placebo. Participants will record their temperature and other side effects in a symptom log on the day of vaccination and for 3 days thereafter. Participants will have seven clinic visits over 12 months. A physical exam, HIV and pregnancy prevention counseling, and blood and urine collection will occur at each visit. Participants will also be asked about side effects they may be experiencing and medications they are taking.

Enrollment

48 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Have access to a participating site and are willing to be followed for the duration of the study
Willing to receive HIV test results
Able to understand and comply with study requirements
In good general health
Have neutralizing adenovirus antibody levels that are less than a 1:12 ratio
Agree to use acceptable methods of contraception for at least 21 days prior to study start and for the duration of the study.

Exclusion criteria

HIV infected
Positive hepatitis B surface antigen
Positive anti-hepatitis C virus antibodies
Prior receipt of an HIV vaccine
Immunosuppressive drugs within 168 days prior to first vaccination
Have received donated blood within 120 days prior to first vaccination
Have received immunoglobulin within 60 days of the first vaccination
Live attenuated vaccines or investigational research agents within 30 days prior to first vaccination
Subunit or killed vaccines within 14 days prior to first vaccination
Current preventive or therapeutic anti-tuberculosis (TB) treatment
Any medical, psychiatric, or social condition that would interfere with the study
Any occupational or other responsibility that would interfere with the study
Serious adverse reactions to vaccines
Autoimmune disease
Immunodeficiency
Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
Asthma. Participants who have had completely resolved childhood asthma are not excluded.
Diabetes mellitus type I or II. Participants who have had isolated gestational diabetes are not excluded.
Thyroid disease or removal of the thyroid
Blood vessel swelling within the last 3 years
Uncontrolled hypertension
Body mass index (BMI) of 40 or higher
Bleeding disorder
Cancer. Participants whose cancer has been removed and is unlikely to recur during the study are not excluded.
Seizure disorder. Participants who have not required medication or had a seizure for 3 years prior to study entry are not excluded.
Removal of the spleen or have a nonfunctioning spleen
Psychiatric conditions that may interfere with the study
Pregnancy, breastfeeding, or plan to become pregnant during the study