Healthy Adult Volunteer Study for Two Doses of a Shigella Vaccine
This study has been completed.
Information provided by:
First received: September 13, 2005
Last updated: March 11, 2010
Last verified: March 2010
The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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.
|Study Start Date:||May 2005|
|Study Completion Date:||April 2007|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210288
|CIC de Vaccinologie Cochin Pasteur|
|75679 Paris Cedex 14, France|
|Dept of Cellular and Molecular Medicine, St George's Hospital Vaccine Institute|
|London, United Kingdom, SW17 0QT|
Sponsors and Collaborators
|Principal Investigator:||Dr Odile Launay, MD||Hôpital Cochin - Bâtiment Modulaire, France|
|Principal Investigator:||Dr David Lewis, MD||St George's Hospital Vaccine Institute, UK|