Healthy Adult Volunteer Study for Two Doses of a Shigella Vaccine

August 7, 2018 updated by: Institut Pasteur

A Comparative Double Blind Placebo-Controlled Study of Immunogenicity and Safety of Two Doses 10^5 and 10^7 CFU of SC599 Oral Vaccine, a Live Attenuated Shigella Dysenteriae 1 Vaccine Strain in Healthy Human Adult Volunteers

The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • CIC de Vaccinologie Cochin Pasteur
  • United Kingdom
      • London, United Kingdom, SW17 0QT
        • Dept of Cellular and Molecular Medicine, St George's Hospital Vaccine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult volunteers age 18 to 50
  • Signed Informed Consent form following a detailed written explanation of participation in the protocol
  • Volunteers who are in good health as determined by medical history, physical examination and clinical judgement
  • Volunteers who will be available and "normally reside within the M25" (England) or in Paris and Paris suburb (France) and not leave England or France for the duration of the study
  • Women who agree to have a pregnancy test immediately before immunisation and to use effective contraception during the study period
  • Volunteers eligible for free NHI treatment (England), volunteers who are covered by social security (France)

Exclusion Criteria:

  • Individuals who have hypersensitivity to any component of the vaccines used in this study.
  • Individuals who have hypersensitivity to ciprofloxacin
  • Individuals who are found to be HIV or HCV antibody positive or Hepatitis B surface antigen positive at the time of initial screening
  • Individuals who are found to have HLA-B27 tissue type at the time of initial screening
  • Individuals with a known or suspected history of gastrointestinal disease or abnormality
  • Concomitant therapy with antibiotics, iron, zinc, H2-receptor antagonists or proton pump inhibitors
  • Individuals who have received any vaccine against Shigella or had proven or suspected shigellosis (bloody diarrhoea with fever) within 6 months prior to study entry
  • Individuals with a significant level of immunity against Shigella detected at the screening visit (defined as serum ELISA anti-LPS IgG antibody titre greater than 3 S.D. above the mean background activity of a bank of healthy human sera)
  • A Clinically significant amount of protein or haemoglobin in the urine sample at the screening visit
  • A Clinically significant abnormality in the haematological or biochemical assays (an abnormal value will be defined by the ranges quoted in each centre) at the screening visit
  • A positive Shigella stool culture at the screening visit
  • Individuals with a known impairment of immune function or those receiving immunosuppressive therapy (including systemic corticosteroids). Inhaled or topical steroid preparation are not a non-inclusion criterion
  • Individuals with acute infections (including fever > 37.5°C oral temperature)at the time of immunisation or any chronic disease
  • Women capable of becoming pregnant who do not agree to have pregnancy testing before immunisation, or who do not agree to take effective contraception during the study period
  • Breastfeeding women
  • Individuals with a current problem with substance abuse or with a history of substance abuse which in the opinion of the investigator, might interfere with participation in the study
  • Individuals with any condition which, in the opinion of the investigator, might interfere with the evaluation with the study objectives
  • Individuals who have received an investigational product within 30 days prior to entry
  • Individuals who cannot read, speak fluent French or English according to the investigational site setting
  • Individuals who are planning to leave England or France prior to the end of the study period or who are likely not to complete the study
  • Individuals who have persons living with them who in the opinion of the investigator may be at risk of disease if exposed to the vaccine strain or whose occupation may bring them into contact with persons at risk of disease or who are food handlers by occupation
  • Individuals with close household contact with child younger than 5 years or a person with immunodeficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Immune response assessed by the proportion of Immunoglobulin A (IgA) anti-Lipopolysaccharide (LPS) Antibody-Secreting Cells (ASC) responders.

Secondary Outcome Measures

Outcome Measure
1) Immune Response:
-Proportion of volunteers who have a B subunit antibody response
-Proportion of volunteers who have a LPS response
2) SC599 Shedding
-Proportion of volunteers who will excrete the vaccine strain and by the duration of the SC5999 shedding, defined as the time (days) between the first an last stool that were positive for SC599.
3) Safety Assessment
-The safety will be evaluated by the proportions of clinical and biological adverse events. Illness after vaccination will be defined as either diarrhoea or fever.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Investigators

  • Principal Investigator: Dr Odile Launay, MD, Hôpital Cochin - Bâtiment Modulaire, France
  • Principal Investigator: Dr David Lewis, MD, St George's Hospital Vaccine Institute, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBM 2004.20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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