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

NCT00415649 | Withdrawn Phase 2

• 2 other identifiers: IAVI V00210419
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV Infections

Keywords

HIV Preventive Vaccine; HIV Seronegativity

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability, as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse events

  throughout study

• 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

  throughout study

Secondary Outcomes (2)

• Recruitment, enrollment, and retention rates by gender and risk category for participating trial sites

  throughout study

• safety, tolerability, and immunogenicity endpoints in participants with varying pre-existing immunity to adenovirus

  throughout study

Study Arms (2)

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

Interventions

VRC-HIVDNA016-00-VP BIOLOGICAL

A

VRC-HIVADV014-00-VP BIOLOGICAL

A

Vaccine placebo BIOLOGICAL

Placebo comparator

B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• International AIDS Vaccine Initiative: collaborator

Related Publications (3)

• Barouch DH. Rational design of gene-based vaccines. J Pathol. 2006 Jan;208(2):283-9. doi: 10.1002/path.1874.

  PMID: 16362986 BACKGROUND

• 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. doi: 10.1086/509258. Epub 2006 Nov 8.

  PMID: 17109335 BACKGROUND

• 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. doi: 10.1128/JVI.75.13.5721-5729.2001. No abstract available.

  PMID: 11390574 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 25, 2006
• Last Updated: November 1, 2021

Record last verified: 2021-10