NCT00001019

Brief Summary

Part A: To compare the safety and immunogenicity of two dose levels of gp120 (CHO) in MF59 emulsion alone or with MTP-PE/MF59 adjuvant, administered at 0, 1, and 6 months. Part B: To evaluate the safety and immunogenicity of gp120 in MF59 when administered in five monthly injections. One experimental AIDS vaccine is the gp120 vaccine. The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen. Antibodies directed against gp120 can neutralize HIV-1, and gp120 can also stimulate certain types of cell-mediated immune responses. Because many immunogens, including candidate HIV vaccines, may evoke relatively weak immune responses, the use of adjuvants, or substances that augment immune responses to vaccines, is of interest. MTP-PE/MF59, composed of the immunomodulator MTP-PE combined with MF59 emulsion, appears to be a promising adjuvant and has been selected for studies with the gp120 vaccine.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

4 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

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

October 30, 2012

Status Verified

October 1, 2012

First QC Date

November 2, 1999

Last Update Submit

October 29, 2012

Conditions

HIV Infections

Keywords

Vaccines, SyntheticAdjuvants, ImmunologicHIV Envelope Protein gp120AIDS VaccinesHIV SeronegativityHIV Preventive Vaccine

Interventions

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:

  • Patients must have:
  • Normal history and physical exam.
  • No identifiable high-risk behavior for HIV infection.
  • Negative ELISA for HIV.
  • Normal cell-mediated immune responses using Merieux skin test.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Significant evidence of depression.
  • Positive syphilis serology (e.g., RPR) that is documented not to be a false positive or from a remote (\> 6 months) treated infection.
  • Circulating Hepatitis B antigenemia.
  • More than two sexual partners, or sexual contact with a high-risk partner, within the past 6 months.
  • Patients with the following prior conditions are excluded:
  • History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
  • Significant evidence of depression or under treatment for psychiatric problems within the past year.
  • History of anaphylaxis or other adverse vaccine reactions.
  • Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) within the past 6 months.
  • Prior Medication:
  • Excluded:
  • Immunoglobulin or vaccines within the past 2 months.
  • Experimental agents within the past 30 days.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St Louis Univ School of Medicine

St Louis, Missouri, 63104, United States

Location

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt Univ Hosp

Nashville, Tennessee, 37232, United States

Location

Children's Hospital & Medical Center / Seattle ACTU

Seattle, Washington, 981050371, United States

Location

Related Publications (2)

  • Graham BS, Keefer MC, McElrath MJ, Gorse GJ, Schwartz DH, Weinhold K, Matthews TJ, Esterlitz JR, Sinangil F, Fast PE. Safety and immunogenicity of a candidate HIV-1 vaccine in healthy adults: recombinant glycoprotein (rgp) 120. A randomized, double-blind trial. NIAID AIDS Vaccine Evaluation Group. Ann Intern Med. 1996 Aug 15;125(4):270-9. doi: 10.7326/0003-4819-125-4-199608150-00003.

    PMID: 8678389BACKGROUND

  • Kahn JO, Sinangil F, Baenziger J, Murcar N, Wynne D, Coleman RL, Steimer KS, Dekker CL, Chernoff D. Clinical and immunologic responses to human immunodeficiency virus (HIV) type 1SF2 gp120 subunit vaccine combined with MF59 adjuvant with or without muramyl tripeptide dipalmitoyl phosphatidylethanolamine in non-HIV-infected human volunteers. J Infect Dis. 1994 Nov;170(5):1288-91. doi: 10.1093/infdis/170.5.1288.

    PMID: 7963729BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Graham B

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

October 30, 2012

Record last verified: 2012-10

Locations

US(4)