Healthy Adult Volunteer Study for Two Doses of a Shigella Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00210288
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Institut Pasteur
• Public title: Healthy Adult Volunteer Study for Two Doses of a Shigella Vaccine
• 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
• Date of first enrolment: May 2005
• Target sample size: 111
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00210288
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double.
• Phase: Phase 2

Countries of recruitment

France, United Kingdom

Contacts

• Name: Dr David Lewis, MD
• Affiliation: St George's Hospital Vaccine Institute, UK

• Name: Dr Odile Launay, MD
• Affiliation: Hôpital Cochin - Bâtiment Modulaire, France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Shigella Infection

Intervention(s)

Biological: SC599

Primary Outcome(s)

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

Secondary Outcome(s)

-Proportion of volunteers who have a B subunit antibody response

-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.

-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.

-Proportion of volunteers who have a LPS response

3) Safety Assessment

1) Immune Response:

2) SC599 Shedding

Secondary ID(s)

RBM 2004.20

Source(s) of Monetary Support

Please refer to primary and secondary sponsors