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Measuring Responses to Sublingual Antigens

NCT00949572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2011-01-27

No results posted yet for this study

Summary

This study is a preliminary investigation of immune responses, in the blood and in cervical \& vaginal secretions, to proteins ("antigens") taken up across the undersurface of the tongue.

Conditions

  • Sexually Transmitted Diseases, Viral

Interventions

BIOLOGICAL

Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads

1 intramuscular dose (0.5 ml) on month 0, 1 and 4 containing approximately: Human Papillomavirus Type 6 L1 protein 20 micrograms Human Papillomavirus Type 11 L1 protein 40 micrograms Human Papillomavirus Type 16 L1 protein 40 micrograms Human Papillomavirus Type 18 L1 protein 20 micrograms

BIOLOGICAL

Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads

1 sublingual application on month 0, 1 and 4 of 0.5 ml containing approximately: Human Papillomavirus Type 6 L1 protein 20 micrograms Human Papillomavirus Type 11 L1 protein 40 micrograms Human Papillomavirus Type 16 L1 protein 40 micrograms Human Papillomavirus Type 18 L1 protein 20 micrograms

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • St George's, University of London

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-06-30
Completion
2011-01-31

Countries

  • United Kingdom

Study Locations

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Entities

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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 NCT00949572 on ClinicalTrials.gov