NCT00000798

Brief Summary

To evaluate the safety and immunogenicity of a new microparticulate formulation of an HIV-1 MN PND peptide for oral administration in healthy, HIV-1 seronegative adult volunteers at low risk for infection. Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite characteristics of an effective HIV vaccine, such as induction of mucosal immunity, production of cytotoxic T cells, and ease of administration. An oral microparticulate vaccine containing a prototype synthetic peptide has been developed. The microparticles can be degraded over time, inducing both secretory and systemic immune responses.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

2 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

June 24, 2005

Status Verified

October 1, 2002

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Vaccines, SyntheticHIV-1Administration, OralAIDS VaccinesHIV SeronegativityHIV Preventive Vaccine

Interventions

HIV-1 Peptide Vaccine, Microparticulate MonovalentBIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Subjects must have:
  • Normal history and physical exam.
  • HIV negativity by ELISA within 8 weeks of study entry.
  • Absolute CD4 count \>= 400 cells/mm3.
  • Normal urine dipstick with esterase and nitrite.
  • Lower or intermediate risk sexual behavior.
  • NOTE:
  • No more than 10 percent of subjects may be over 50 years of age.

You may not qualify if:

  • Co-existing Condition:
  • Subjects with the following symptoms or conditions are excluded:
  • Positive hepatitis B surface antigen.
  • Medical or psychiatric condition (such as psychosis or suicidal tendencies) or occupational responsibilities that preclude study compliance.
  • Active syphilis. NOTE: Subjects whose 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.
  • Subjects with the following prior conditions are excluded:
  • History of immunodeficiency, chronic illness, or autoimmune disease.
  • History of anaphylaxis or other serious reactions to vaccines.
  • History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy.
  • History of acute gastroenteritis within the past month or gastrointestinal surgery within the past year.
  • History of cancer unless there has been surgical excision with reasonable assurance of cure.
  • History of serious allergic reaction.
  • Prior Medication:
  • Excluded:
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Univ / Ctr for Immunological Research

Baltimore, Maryland, 21205, United States

Location

Univ of Rochester Med Ctr

Rochester, New York, 14642, United States

Location

Related Publications (2)

  • Kelleher AD, Emery S, Cunningham P, Duncombe C, Carr A, Golding H, Forde S, Hudson J, Roggensack M, Forrest BD, Cooper DA. Safety and immunogenicity of UBI HIV-1MN octameric V3 peptide vaccine administered by subcutaneous injection. AIDS Res Hum Retroviruses. 1997 Jan 1;13(1):29-32. doi: 10.1089/aid.1997.13.29.

    PMID: 8989424BACKGROUND

  • Kahn J, Murcar N, Elbeik T, Staprans S, Hanson C, Mayer Y, Doyle R, Gonzalez L, Koff W. UBI HIV-1MN octameric V3 peptide vaccine in HIV-1 negative humans. Conf Adv AIDS Vaccine Dev. 1996 Feb 11-15:167 [Poster 47]

    BACKGROUND

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

  • Lambert J

    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

June 24, 2005

Record last verified: 2002-10

Locations

US(2)