NCT00002428

Brief Summary

To evaluate the safety and immunogenicity of a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in intermediate or higher risk HIV-negative volunteers.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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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

June 24, 2005

Status Verified

March 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Vaccines, SyntheticHIV-1HIV Envelope Protein gp120AIDS VaccinesHIV Seronegativity

Interventions

HIV-1 Peptide Vaccine, Microparticulate MonovalentBIOLOGICAL
rgp120/HIV-1MN Monovalent Octameric V3 Peptide VaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers must have:
  • Normal history and physical exam.
  • HIV negativity.
  • CD4 count \>= 400 cells/mm3.
  • Intermediate or high risk sexual behavior or a history of injection drug use within 12 months prior to study entry.
  • Normal urine dipstick with esterase and nitrite.

You may not qualify if:

  • Co-existing Condition:
  • Volunteers with the following symptoms or conditions are excluded:
  • Active tuberculosis.
  • Occupational or other responsibilities that would prevent completion of study.
  • Volunteers with the following prior conditions are excluded:
  • History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
  • Psychiatric, medical, or substance abuse problems within the past 6 months that would affect ability to participate in study.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy.
  • Acute gastroenteritis or gastrointestinal surgery within the past 12 months.
  • Prior Medication:
  • Excluded:
  • Live or attenuated vaccine within the past 60 days.
  • Illicit or experimental agents within the past 30 days. Intermediate or high risk sexual behavior. Injection drug use within the past 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ of California at San Francisco Gen Hosp

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • Lambert JS, Keefer M, Mulligan MJ, Schwartz D, Mestecky J, Weinhold K, Smith C, Hsieh R, Moldoveanu Z, Fast P, Forrest B, Koff W. A Phase I safety and immunogenicity trial of UBI microparticulate monovalent HIV-1 MN oral peptide immunogen with parenteral boost in HIV-1 seronegative human subjects. Vaccine. 2001 Apr 30;19(23-24):3033-42. doi: 10.1016/s0264-410x(01)00051-2.

    PMID: 11311997BACKGROUND

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 Design

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

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1996-03

Locations

US(1)