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Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years

NCT02787109 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-08-10

No results posted yet for this study

Summary

The present trial is a phase I first in human, double blind, parallel and placebo controlled trial of SSI's adjuvanted chlamydia vaccine CTH522: CTH522-CAF01 (CAF01 is an adjuvant system) and CTH522-Al(OH)3. The trial will be conducted at Imperial College Research site in the United Kingdom.

Subjects are randomly assigned to one of the following three treatment groups in a ratio of 3:3:1.

This trial consisted of 10 visits and 5 telephonic interviews

Conditions

  • Chlamydia Trachomatis

Interventions

BIOLOGICAL

CTH522-CAF01

CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration

BIOLOGICAL

CTH522-Al(OH)3

CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration

BIOLOGICAL

Placebo

Saline

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Sonya Abraham · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT02787109 on ClinicalTrials.gov