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

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) International AIDS Vaccine Initiative
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00415649

Purpose

The purpose of this study is to evaluate the safety and tolerability of and immune response to an HIV DNA vaccine followed by an adenoviral vector HIV vaccine in healthy African adults at risk for HIV infection.

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

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Phase II, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine in Healthy Adult Volunteers at Risk for HIV Infection

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

Primary Outcome Measures:

Safety and tolerability, as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
immunogenicity as assessed by the proportion of participants who develop HIV-specific T-cell responses and/or to ENV A-, B-, or C-specific antibodies and magnitude of those responses [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Recruitment, enrollment, and retention rates by gender and risk category for participating trial sites [ Time Frame: throughout study ] [ Designated as safety issue: No ]
safety, tolerability, and immunogenicity endpoints in participants with varying pre-existing immunity to adenovirus [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:

300

Arms	Assigned Interventions
A: Experimental DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6.	Biological: VRC-HIVDNA016-00-VP Biological: VRC-HIVADV014-00-VP
B: Placebo Comparator Placebo vaccine	Biological: Vaccine placebo Placebo comparator

Detailed Description:

Due to the availability of antiretroviral therapy, AIDS-related deaths have lessened in the United States. However, these therapies are widely inaccessible to the developing world. The need for a safe and affordable vaccine that will prevent HIV infection is of utmost importance. To generate a broadly protective vaccine, it is necessary to develop a multivalent vaccine containing a defined combination of immunogens from the most globally prevalent HIV subtypes. This study will evaluate the safety, tolerability, and immunogenicity of a multiclade HIV-1 DNA plasmid vaccine,VRC-HIVDNA016-00-VP, followed by a multiclade recombinant HIV-1 adenoviral vector vaccine, HIVADV014-00-VP.

This study will last about 27 months. Participants will be randomly assigned to one of two groups. Group A will receive the DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6; Group B will receive placebo. There will be 20 study visits over 2 years. Physical exams, vital signs measurements, adverse event evaluation, and medical and medication history will occur at each visit. HIV testing and counseling and 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:

At risk for HIV
Have had sexual intercourse with an HIV infected partner OR have had sexual intercourse with more than one person within the 3 months prior to study entry OR infected with a sexually transmitted disease within the 3 months prior to study entry
Willing to comply with the protocol
Willing to undergo HIV testing and HIV counseling and receive HIV test results
Willing to use acceptable forms of contraception

Exclusion Criteria:

HIV-1 or HIV-2 infected
History of immunodeficiency or autoimmune disease
Use of corticosteroids or immunosuppressive, antiviral, anticancer, or other medications considered significant by investigator within 6 months prior to study entry
Certain abnormal laboratory values
Acute or chronic medical condition considered progressive
Hepatitis B or hepatitis C virus infection or untreated syphilis
Live attenuated vaccine within 30 days prior to study
Planned receipt of investigational product within 30 days after first vaccination
Other medically indicated subunit or killed vaccine within 14 days prior to study entry
Planned receipt of other medically killed vaccine investigational product within 14 days after first vaccination
Blood transfusion within 120 days of study entry
Immunoglobulin within 60 days of study entry
Participation within the last 3 months, or planned participation in another clinical study of investigational product currently or during the course of this study
Another investigational HIV vaccine at any time
History of severe local or systemic reactogenicity to vaccines
History of severe allergic reactions
History of recurrent urticaria
Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or ideation in the 3 years prior to study entry
Uncontrolled hypertension
Pregnant, breastfeeding, or planning to become pregnant within 4 months following last study vaccination

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415649

Locations

Kenya
Project San Francisco
Nairobi, Kenya, 19676
Uganda
UVRI-IAVI Entebbe
Entebbe, Uganda

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

International AIDS Vaccine Initiative

Investigators

Study Chair:

Pontiano Kaleebu, MD, PhD

Medical Research Council/Uganda Viral Research Institute (UVRI) Uganda Research Unit on AIDS, UVRI/International AIDS Vaccine Initiative HIV Vaccine Program

More Information

Click here for more information on preventive HIV 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:

Barouch DH. Rational design of gene-based vaccines. J Pathol. 2006 Jan;208(2):283-9. Review.

Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK, Butman BT, Gall JG, King CR, Andrews CA, Sheets R, Gomez PL, Mascola JR, Nabel GJ, Graham BS; Vaccine Research Center 006 Study Team. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. J Infect Dis. 2006 Dec 15;194(12):1638-49. Epub 2006 Nov 8.

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.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	IAVI V002
Study First Received:	December 21, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00415649
Health Authority:	United States: Food and Drug Administration

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

HIV Preventive Vaccine
HIV Seronegativity

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:

Communicable Diseases
RNA Virus Infections
Slow Virus Diseases

Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009