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 » - Oral Shigella SC599 vaccine Phase 2a study

Phase 1

• Conditions: Healthy Volunteers

• Registration Number: EUCTR2004-001915-78-GB
• Lead Sponsor: Institut Pasteur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 111

Inclusion Criteria

·Adult volunteer 18 to 50 of age
·Volunteers who are in good health as determined by medical history, physical examination and clinical judgement.
·Women who agree to have a pregnancy test immediately before immunisation and to use effective contraception during the study period.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Individuals who have hypersensitivity to ciprofloxacin
·Individuals who are found to have HLA-B27 tissue type at the time of initial screening
·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 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 preparations 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
·Individuals who have received an investigational product within 30 days prior to entry
·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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to compare the immunogenicity of two doses 10^5 and 10^7 CFU of SC599 vaccine candidate to a placebo. ;Secondary Objective: Secondary objectives are to compare the clinical and biological tolerance of the two doses and to explore the duration of faecal shedding of SC599. ;Primary end point(s): The primary outcome is the immune response assessed by the proportion of ImmunoglobulinA (IgA) anti-LPS ASC responders.