NCT00001042

Brief Summary

To determine in healthy HIV-negative volunteers the safety and immunogenicity of rgp120/HIV-1SF2 (BIOCINE) formulated with each of seven adjuvants. PER AMENDMENT 3/6/96: Purpose of the extension study - To determine the ability of immunization with rgp 120/SF-2 to induce an HIV-1 envelope-specific delayed-type hypersensitivity (DTH) response in volunteers who receive rsgp 120/MN skin testing. One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant. Adjuvants may augment vaccine immunogenicity by several mechanisms, and as a result induce a more favorable antibody response with high titers, which appear earlier in the course of immunization and persist over time.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

March 1, 1996

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Vaccines, SyntheticDrug Therapy, CombinationAdjuvants, ImmunologicHIV Envelope Protein gp120Acetylmuramyl-Alanyl-Isoglutaminemonophosphoryl lipid AAIDS VaccinesHIV SeronegativityHIV Preventive Vaccine

Interventions

Aluminum hydroxideBIOLOGICAL
Lipid A, MonophosphorylBIOLOGICAL
Lipid A, Liposome-encapsulated monophosphorylBIOLOGICAL
Syntex adjuvant formulationBIOLOGICAL
MF59BIOLOGICAL
Threonyl Muramyl DipeptideBIOLOGICAL
rgp120/HIV-1 SF-2BIOLOGICAL
MTP-PE/MF59BIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects must have:
  • HIV negativity by ELISA.
  • Normal history and physical exam.
  • CD4 count \>= 400 cells/mm3.
  • Lower risk sexual behavior.
  • Normal urine dipstick with esterase and nitrite.
  • PER AMENDMENT 3/6/96:
  • Extension study -
  • Consenting Protocol 015 volunteers who have received four immunizations.

You may not qualify if:

  • Co-existing Condition:
  • Subjects with the following symptoms or conditions are excluded:
  • Hepatitis B surface antigen.
  • Active syphilis. NOTE:Subjects for whom serology is documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible.
  • Active tuberculosis. NOTE:Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
  • Medical or psychiatric condition or occupational responsibilities that would preclude compliance.
  • Subjects with the following prior conditions are excluded:
  • History of immunodeficiency, chronic illness, or autoimmune disease.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • PER AMENDMENT 3/6/96: Extension study -
  • History of eczema or allergic-type reactions to vaccine in Protocol 015.
  • Prior Medication:
  • Excluded:
  • Live attenuated vaccines within 60 days prior to study entry. (NOTE: Medically indicated subunit or killed vaccines, such as influenza or pneumococcal, are allowed but should be given at least 2 weeks prior to HIV immunizations.)
  • Experimental agents within 30 days prior to study entry.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, 63104, United States

Location

Univ. of Rochester AVEG

Rochester, New York, 14642, United States

Location

UW - Seattle AVEG

Seattle, Washington, 98144, United States

Location

Related Publications (1)

  • Zolla-Pazner S, Alving C, Belshe R, Berman P, Burda S, Chigurupati P, Clements ML, Duliege AM, Excler JL, Hioe C, Kahn J, McElrath MJ, Sharpe S, Sinangil F, Steimer K, Walker MC, Wassef N, Xu S. Neutralization of a clade B primary isolate by sera from human immunodeficiency virus-uninfected recipients of candidate AIDS vaccines. J Infect Dis. 1997 Apr;175(4):764-74. doi: 10.1086/513969.

    PMID: 9086128BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Aluminum Hydroxidemonophosphoryl lipid ALipid ASyntex adjuvant formulationMF59 oil emulsion

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAluminum CompoundsAnionsIonsElectrolytesLipopolysaccharidesPolysaccharides, BacterialPolysaccharidesCarbohydratesLipidsAntigens, BacterialAntigensBiological FactorsEndotoxinsBacterial ToxinsToxins, Biological

Study Officials

  • McElrath J

    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

March 1, 1996

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(3)