A Study to Evaluate the Safety and Effectiveness of HIV-1 LAI gp120 (an HIV Vaccine) Given With or Without HIV-1 MN rgp120 (Another HIV Vaccine) to HIV-Negative Volunteers

NCT00000868 | Completed Phase 1

• 2 other identifiers: AVEG 02810578
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of giving healthy volunteers a new oral HIV vaccine which has been incorporated into a bacterial cell. This oral vaccine (HIV-1 LAI gp120) will be given with or without a different injected HIV vaccine (HIV-1 MN rgp120). Vaccines are preparations that are introduced into the body to try to prevent infection or create resistance to infection. This study examines a new oral vaccine to see if it can improve the immune system's ability to fight the HIV virus when given alone or with another injected vaccine.

Conditions

HIV Infections; HIV Seronegativity

Keywords

Vaccines, Synthetic; HIV-1; Administration, Oral; AIDS Vaccines; HIV Seronegativity; HIV Envelope Protein gp120; Recombination, Genetic; Salmonella typhi; HIV Preventive Vaccine

Interventions

Salmonella typhi CVD 908-HIV-1 LAI gp 120 (VVG 203) BIOLOGICAL

Aluminum hydroxide BIOLOGICAL

MF59 BIOLOGICAL

rgp120/HIV-1MN BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• You may be eligible for this study if you:
• Are 18-50 years old.
• Are HIV-negative.
• Are healthy and have a normal history and physical exam.
• Agree to practice abstinence or use of effective birth control for 1 month before and during the study.

You may not qualify if:

• You will not be eligible for this study if you:
• Have a history of immune deficiency, chronic illness, or autoimmune disease.
• Have received immunosuppressive medications, blood products, trial drugs, immunoglobulins, or an HIV or typhoid vaccine.
• Have a history of severe allergic reactions.
• Have had prior suicidal attempts or have a psychiatric condition or job commitments which would prevent you from completing the study.
• Have a history of cancer (unless the cancer has been successfully cured), gallbladder disease, typhoid fever, migraines or other severe headaches, cardiac valve defects, or congenital heart disease.
• Have active syphilis or tuberculosis.
• Are allergic to certain medications.
• Are pregnant or breast-feeding.
• Have household contact with infants or persons who are pregnant, immunodeficient, or HIV-positive.
• Are unavailable for 12 months of follow-up.
• Have hepatitis B.
• Have a history of injection drug use within 12 months of enrollment or have higher or intermediate risk sexual behavior.

Sponsors & Collaborators

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

Study Sites (1)

JHU AVEG

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Aluminum Hydroxide; MF59 oil emulsion

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

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Study Officials

• M Clements

  STUDY CHAIR

• D Schwartz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: May 1, 2000
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

US (1)