Healthy Adult Volunteer Study for Two Doses of a Shigella Vaccine

NCT00210288 | Completed Phase 2

• 1 other identifier: RBM 2004.20
• Study Type: interventional
• Target: 111
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Shigella Infection

Keywords

Healthy Volunteer; Shigella; Oral Vaccine; Double Blind; Placebo; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

• 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.

Interventions

SC599 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (2)

CIC de Vaccinologie Cochin Pasteur

Paris, 75014, France

Location

Dept of Cellular and Molecular Medicine, St George's Hospital Vaccine Institute

London, SW17 0QT, United Kingdom

Location

MeSH Terms

Conditions

Dysentery, Bacillary

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Dr Odile Launay, MD

  Hôpital Cochin - Bâtiment Modulaire, France

  PRINCIPAL INVESTIGATOR

• Dr David Lewis, MD

  St George's Hospital Vaccine Institute, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: April 1, 2007
• Last Updated: August 8, 2018

Record last verified: 2010-03

Locations

GB (1); FR (1)