Healthy Adult Volunteer Study for Two Doses of a Shigella Vaccine - Full Text View

Sponsor:	Institut Pasteur
Information provided by:	Institut Pasteur
ClinicalTrials.gov Identifier:	NCT00210288

Purpose

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

Condition	Intervention	Phase
Shigella Infection	Biological: SC599	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	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

Further study details as provided by Institut Pasteur:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	111
Study Start Date:	May 2005
Study Completion Date:	April 2007
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210288

Locations

France
CIC de Vaccinologie Cochin Pasteur
75679 Paris Cedex 14, France
United Kingdom
Dept of Cellular and Molecular Medicine, St George's Hospital Vaccine Institute
London, United Kingdom, SW17 0QT

Sponsors and Collaborators

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00210288 History of Changes
Other Study ID Numbers:	RBM 2004.20
Study First Received:	September 13, 2005
Last Updated:	March 11, 2010
Health Authority:	France:Agence Française de sécurité des Produits de Santé (Afssaps); United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Institut Pasteur:

Healthy Volunteer
Shigella
Oral Vaccine
Double Blind

Placebo
Immunogenicity
Safety

Additional relevant MeSH terms:

Dysentery, Bacillary
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Dysentery

Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012