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Reactogenicity and Immunogenicity of Vaginal CNgp140

NCT00637962 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2011-02-11

No results posted yet for this study

Summary

To determine the local (cervico-vaginal) and systemic (whole body) safety of vaginal immunisation with CN54gp140 glycoprotein administered 9 times over a 3 week period.

Conditions

  • HIV Infections
  • Acquired Immune Deficiency Syndrome

Interventions

BIOLOGICAL

HIV glycoprotein CN54gp140 (vaccine)

vaginal immunisation with 100ug CN54gp140 antigen in gel on 9 occasions in one menstrual cycle

BIOLOGICAL

Carbopol 974

vaginal immunisation with Carbopol 974 P 0.924%; benzyl alcohol 1.09%; sodium hydroxide 0.176%; and purified water 97.81%. alone on 9 occasions in one menstrual cycle

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • York Hospitals

    collaborator OTHER

  • St George's, University of London

    lead OTHER

Principal Investigators

  • David JM Lewis, MD · St George's, University of London, UK

  • Charles Lacey, MD · York Hospitals

  • David JM Lewis, MD · St George's, University of London, UK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-10-31
Completion
2009-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00637962 on ClinicalTrials.gov