Safety of and Immune Response to a DNA HIV Vaccine Followed By an Adenoviral Vector HIV Vaccine in Healthy Adults - Full Text View

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00125970

Purpose

The purpose of the study is to determine the safety of and immune response to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.

Condition	Intervention	Phase
HIV Infections	Biological: VRC-HIVDNA016-00-VP Biological: VRC-HIVADV014-00-VP Biological: VRC-HIVDNA016-00-VP placebo Biological: VRC-HIVADV014-00-VP placebo	Phase II

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed By a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRC-HIVADV014-00-VP, in HIV-1 Uninfected Adult Participants

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

Primary Outcome Measures:

Local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Immunogenicity [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Negative experiences or problems reported by the participants [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	480
Study Start Date:	September 2005
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental DNA HIV vaccine administered at study entry and at Months 1 and 2 and adenoviral vector HIV vaccine administered at Month 6	Biological: VRC-HIVDNA016-00-VP 4 mg administered in deltoid Biological: VRC-HIVADV014-00-VP 1 x 10^10 PU administered in deltoid
2: Placebo Comparator DNA HIV vaccine placebo administered at study entry and at Months 1 and 2 and adenoviral vector HIV vaccine placebo administered at Month 6	Biological: VRC-HIVDNA016-00-VP placebo 1 mL administered at study entry and Months 1 and 2 Biological: VRC-HIVADV014-00-VP placebo 1 mL administered at Month 6

Detailed Description:

The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, readily produced in large quantities, and stable for long periods of time. This study will evaluate the safety and immunogenicity of an experimental multiclade HIV vaccine, VRC-HIVDNA016-00-VP, followed by a similarly structured adenovirus-vectored vaccine boost, VRC-HIVADV014-00-VP, in HIV uninfected adults. The DNA plasmids in both the vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world. Participants in this study will be recruited in North America, South America, and Africa.

Each volunteer will participate in the study for 36 months. Participants will be randomly assigned to one of two groups. Group 1 participants will receive the DNA HIV vaccine at study entry and at Months 1 and 2. At Month 6, Group 1 participants will receive an injection of the adenoviral vector HIV vaccine. Group 2 participants will receive placebo at study entry and Months 1, 2, and 6. There will be 17 study visits, which will occur at study entry and every 2 weeks thereafter until Day 70; at Month 6 and every 2 weeks thereafter until Day 210; and Months 9.5, 12, 18, 24, 30, and 36. A physical exam, adverse events reporting, HIV and pregnancy prevention counseling, and medication history will occur at each visit. Blood and urine collection will occur at selected visits.

Eligibility

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

Criteria

Inclusion Criteria:

HIV uninfected
Has access to a participating HIV Vaccine Trials Unit (HVTU) and willing to be followed for the duration of the study
Willing to receive HIV test results
Good general health
Willing to use acceptable forms of contraception
Completed at least 12 years of schooling (South African participants only)

Exclusion Criteria:

HIV vaccines in prior HIV vaccine trial
Immunosuppressive medications within 168 days prior to first study vaccine administration
Blood products within 120 days prior to first study vaccine administration
Immunoglobulin within 60 days prior to first study vaccine administration
Live attenuated vaccines within 30 days prior to first study vaccine administration
Investigational research agents within 30 days prior to first study vaccine administration
Subunit or killed vaccines within 14 days prior to first study vaccine administration
Current tuberculosis prophylaxis or therapy
Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
Any job-related responsibility that would interfere with the study
Serious adverse reaction 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
Diabetes mellitus type 1 or 2
Thyroid disease requiring treatment
Serious angioedema within the past 3 years
Uncontrolled hypertension
Bleeding disorder
Cancer. If a participant has had surgery to remove the cancer and, in the opinion of the investigator, the cancer is not likely to recur during the study period, the participant is not excluded.
Seizure disorder
Asplenia
Mental illness that would interfere with compliance with the protocol
Other conditions that, in the judgment of the investigator, would interfere with the study
Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125970

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-2041
United States, Maryland
University of MD - Inst. of Human Virology (IHV)
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Harvard Medical School/Brigham & Womens Hospital
Boston, Massachusetts, United States, 02115
Miriam Hospital
Boston, Massachusetts, United States, 02115
United States, New York
University of Rochester
Rochester, New York, United States, 14642-0001
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Brazil, SP
Centro de Referencia e Treinamento-DST/AIDS
San Paulo, SP, Brazil
Jamaica
Ministry of Health, Comprehensive Health Center (C
Kingston, Jamaica
South Africa
Cape Town HVTU
Mowbray, South Africa
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital (PHRU)
Bertsham, South Africa
South Africa, North West
KOSH District HVTU
Orkney, PO Box 138, North West, South Africa, 2620 SF
United Kingdom, Nova
Hospital Escola Sao Francisco de Assis (HESFA)
Cidade, Nova, United Kingdom, 20210-303

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Michael Keefer, MD	University of Rochester
Study Chair:	Gavin Churchyard, MBBCh, FCP, MMed, PhD	Aurum Health Research Limited

More 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:

Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. Review.

Gaschen B, Taylor J, Yusim K, Foley B, Gao F, Lang D, Novitsky V, Haynes B, Hahn BH, Bhattacharya T, Korber B. Diversity considerations in HIV-1 vaccine selection. Science. 2002 Jun 28;296(5577):2354-60. Review.

Moore JP, Parren PW, Burton DR. Genetic subtypes, humoral immunity, and human immunodeficiency virus type 1 vaccine development. J Virol. 2001 Jul;75(13):5721-9. Review. No abstract available.

Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. Review.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	HVTN 204
Study First Received:	June 30, 2005
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00125970
Health Authority:	United States: Food and Drug Administration

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

HIV Seronegativity
HIV Preventive Vaccine

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Healthy
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009