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Register:	EUCTR
Last refreshed on:	25 November 2019
Main ID:	EUCTR2004-001915-78-GB
Date of registration:	22/02/2005
Prospective Registration:	Yes
Primary sponsor:	Institut Pasteur
Public 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 » - Oral Shigella SC599 vaccine Phase 2a study
Scientific 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 » - Oral Shigella SC599 vaccine Phase 2a study
Date of first enrolment:	06/12/2005
Target sample size:	111
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001915-78
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment
United Kingdom

Contacts

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Key inclusion & exclusion criteria

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.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Product Name: live attenuated shigella dysenteriae type 1 vaccine
Product Code: SC599
Pharmaceutical Form: Oral suspension
Current Sponsor code: SC599
Concentration type: equal
Concentration number: 10^5 CFU-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use

Product Name: live attenuated shigella dysenteriae type 1 vaccine
Product Code: SC599
Pharmaceutical Form: Oral suspension
Current Sponsor code: SC599
Concentration type: equal
Concentration number: 10^7 CFU-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The primary outcome is the immune response assessed by the proportion of ImmunoglobulinA (IgA) anti-LPS ASC responders.

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.

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 Outcome(s)

Secondary ID(s)

RBM/2004.20

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
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Date Completed:
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