NCT00001053

Brief Summary

To evaluate the safety and immunogenicity of HIV p17/p24:Ty-VLP (virus-like particles) vaccine in uninfected volunteers. Specifically, to determine whether the vaccine formulated with and without alum induces CD8+ cytotoxic T lymphocytes ( CTLs ) that may be cross-reactive against multiple HIV-1 stains. Also, to determine whether boosting with the vaccine orally or rectally will help induce mucosal antibody responses. Induction of CD8+ CTL activity is considered a critical property for a candidate vaccine. Additionally, since the majority of HIV-1 infections occur after inoculation of a mucosal surface, it is desirable to induce mucosal immunity as well as systemic immunity. The HIV p17/p24:Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against HIV-1.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 hiv-infections

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

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, SyntheticRecombinant ProteinsHIV-1AIDS VaccinesHIV Core Protein p24p24-VLP vaccineGene Products, gagHIV SeronegativityHIV Preventive Vaccine

Interventions

HIV p17/p24:Ty-VLPBIOLOGICAL
Aluminum hydroxideBIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication: Required:
  • Omeprazole given concurrently in patients receiving the oral vaccine dose.
  • Volunteers must have:
  • HIV-1 negativity.
  • Normal history and physical exam.
  • Lower risk for HIV infection.
  • CD4 count \>= 400 cells/mm3.
  • Normal urine dipstick with esterase and nitrite.
  • NOTE:
  • No more than 10 percent of volunteers may be over age 50.

You may not qualify if:

  • Co-existing Condition:
  • Volunteers with the following conditions are excluded:
  • Positive for hepatitis B surface antigen.
  • Medical or psychiatric condition (including recent suicidal ideation or present psychosis) that precludes compliance.
  • Occupational responsibilities that preclude compliance.
  • Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (\> 6 months) infection, subject is eligible).
  • Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible).
  • Volunteers with the following prior conditions are excluded:
  • History of immunodeficiency, chronic illness, malignancy, autoimmune disease, or use of immunosuppressive medications.
  • History of cancer unless surgically excised with reasonable assurance of cure.
  • History of suicide attempts or past psychosis.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • History of serious allergic reaction requiring hospitalization or emergent medical care.
  • Prior Medication:
  • Excluded:
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ. of Rochester AVEG

Rochester, New York, 14642, United States

Location

Related Publications (3)

  • Martin SJ, Weber J, Roitt I, Matear P, Jones K, Vyakarnam A. Recombinant HIV-1 gag p24-Ty virus-like particles (VLP's) induce HIV-1 p24-specific T helper cells in seronegative volunteers vaccinated with these particles. Int Conf AIDS. 1992 Jul 19-24;8(2):A35 (abstract no PoA 2194)

    BACKGROUND

  • Weber J, Cheinsong-Popov R, Callow D, Adams S, Patou G, Hodgkin K, Martin S, Gotch F, Kingsman A. Immunogenicity of the yeast recombinant p17/p24:Ty virus-like particles (p24-VLP) in healthy volunteers. Vaccine. 1995 Jun;13(9):831-4. doi: 10.1016/0264-410x(94)00061-q.

    PMID: 7483805BACKGROUND

  • Martin SJ, Vyakarnam A, Cheingsong-Popov R, Callow D, Jones KL, Senior JM, Adams SE, Kingsman AJ, Matear P, Gotch FM, et al. Immunization of human HIV-seronegative volunteers with recombinant p17/p24:Ty virus-like particles elicits HIV-1 p24-specific cellular and humoral immune responses. AIDS. 1993 Oct;7(10):1315-23.

    PMID: 8267904BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Aluminum Hydroxide

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 CompoundsAnionsIonsElectrolytes

Study Officials

  • Spearman P

    STUDY CHAIR

  • Graham B

    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(1)