Healthy Adult Volunteer Study for Two Doses of a Shigella Vaccine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00210288|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 12, 2010
|Condition or disease||Intervention/treatment||Phase|
|Shigella Infection||Biological: SC599||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||111 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||April 2007|
- Immune response assessed by the proportion of Immunoglobulin A (IgA) anti-Lipopolysaccharide (LPS) Antibody-Secreting Cells (ASC) responders.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Principal Investigator:||Dr Odile Launay, MD||Hôpital Cochin - Bâtiment Modulaire, France|
|Principal Investigator:||Dr David Lewis, MD||St George's Hospital Vaccine Institute, UK|