Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers

NCT00062530 | Unknown Phase 1

• 1 other identifier: P01AI047490
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the safety of and immune response to an oral HIV vaccine in healthy volunteers. The vaccine in this study uses a weakened bacterium called Salmonella typhi to deliver an HIV gene into the body through the mouth. The body then produces an HIV protein from the gene; this protein stimulates an anti-HIV immune response. The vaccine contains only one of the many substances that HIV needs to make more copies of itself, so the vaccine itself cannot cause HIV or AIDS.

Conditions

HIV Infections

Keywords

AIDS; HIV seronegativity; HIV preventive vaccine

Outcome Measures

Primary Outcomes (1)

• Safety, as judged by the lack of an immune response to CD4 epitopes or other significant adverse events as defined by the HVTN toxicity tables

  Throughout study

Secondary Outcomes (1)

• Neutralizing antibody response against HIV-1

  Throughout study

Study Arms (1)

1

EXPERIMENTAL

All participants will receive oral vaccine at study entry, although dosage will vary

Biological: SCBaL/M9

Interventions

SCBaL/M9 BIOLOGICAL

Oral recombinant Salmonella typhi HIV-1 gp120 vaccine

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HIV uninfected
• Low risk sexual behavior
• Negative for Hepatitis B surface antigen
• Negative for Hepatitis C viral sequences and antibody
• Availability for follow-up for planned duration of the study (12 months)
• Acceptable methods of contraception

You may not qualify if:

• Receipt of HIV vaccines or placebo in a previous HIV vaccine trial
• History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications
• History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure
• Medical or psychiatric condition or occupational responsibilities which preclude compliance with the protocol
• History of suicide attempts, recent suicidal ideation, or psychosis
• High risk behavior for HIV infection as determined by screening questionnaire
• History of injection drug use within 12 months of study entry
• Use of experimental agents within 30 days of study entry
• Receipt of blood products or immunoglobulin within 6 months of study entry
• Active syphilis
• Active tuberculosis
• History of anaphylaxis or serious adverse reactions to vaccines
• History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension)
• Pregnant or breastfeeding

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

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; Slow Virus Diseases

Study Officials

• George K. Lewis, PhD

  Univesity of Maryland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George K. Lewis, PhD

CONTACT

410- 706-4688; lewisg@umbi.umd.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 9, 2003
• First Posted: June 12, 2003
• Last Updated: September 26, 2008

Record last verified: 2008-09

Locations

US (1)