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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00119873

Purpose

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

Condition	Intervention	Phase
HIV Infections	Biological: VRC-HIVADV014-00-VP	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Safety Study
Official Title:	A Phase I Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade, Multivalent Recombinant Adenoviral Vector HIV Vaccine, VRC-HIVADV014-00-VP, in Healthy, HIV-1 Uninfected Adult Participants Who Have Low Titers of Pre-Existing Ad5 Neutralizing Antibodies

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Blood and chemical parameters for 12 months after injection
Local and systemic adverse reactions for 12 months after injection

Estimated Enrollment:	48
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119873

Locations

United States, California
San Francisco Department of Public Health
San Francisco, California, United States, 94102-6033
Mt. Zion Hospital - GCRC
San Francisco, California, United States, 94102-6033
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Laurence Peiperl, MD

San Francisco Department of Public Health

More Information

Additional Information:

Click here for more information on HIV preventive vaccines This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Publications:

Shiver J. A non-replicating adenoviral vector as a potential HIV vaccine. Res Initiat Treat Action. 2003 Spring;8(2):14-6.

Casimiro DR, Bett AJ, Fu TM, Davies ME, Tang A, Wilson KA, Chen M, Long R, McKelvey T, Chastain M, Gurunathan S, Tartaglia J, Emini EA, Shiver J. Heterologous human immunodeficiency virus type 1 priming-boosting immunization strategies involving replication-defective adenovirus and poxvirus vaccine vectors. J Virol. 2004 Oct;78(20):11434-8.

Shiver JW, Emini EA. Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annu Rev Med. 2004;55:355-72. Review.

Gomez-Roman VR, Robert-Guroff M. Adenoviruses as vectors for HIV vaccines. AIDS Rev. 2003 Jul-Sep;5(3):178-85. Review.

Study ID Numbers:	HVTN 054
Study First Received:	July 12, 2005
Last Updated:	September 23, 2009
ClinicalTrials.gov Identifier:	NCT00119873 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

HIV Preventive Vaccine
AIDS Vaccines
Adenoviridae

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010