Safety and Efficacy Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella Infection Using cGMP
Safety, Clinical Tolerance, and Immunogenicity of CVD 1208S, a Delta guaBA, Delta Sen, Delta Set, Live, Oral Shigella Flexneri 2a Vaccine Manufactured Using cGMP
2 other identifiers
interventional
26
1 country
2
Brief Summary
The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral vaccine) is safe and effective in the prevention of Shigella infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 26, 2011
CompletedFirst Posted
Study publicly available on registry
February 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedApril 30, 2021
April 1, 2021
1.2 years
October 26, 2011
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with reactions and adverse events
occurence of diarrhea, dysentery and fever.
Reactions are evaluated for 7 days after each dose. Adverse events are evaluated for the entire study participation (6 months for cohort 1 and 8 months for all other cohorts).
Number of participants who receive the vaccine who get immunity to shigella
It is hoped that the vaccine will trigger the body's immune system to make specific responses such as antibodies (special proteins) and antibody-producing cells that are believed to protect against illness if a person is exposed to certain illness-causing Shigella in the future.
Immunity in the blood will be assessed using serial samples collected during the 84 days after the first vaccination. Immunity at the intestinal level will be assessed by collecting seral stool samples for 14 days after each vaccination.
Secondary Outcomes (2)
Number of participants who pass the vaccine in their stool
The first 84 days after vaccination
The number of participants who develop various types of immune responses
The first 84 days of the study
Study Arms (2)
Vaccine-recipients
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
The vaccine is mixed with salt water and given by mouth.
Eligibility Criteria
You may qualify if:
- Age 18 to 45 years, inclusive.
- Good general health
- Expressed interest and availability to fulfill study requirements
- Informed, written consent.
- Agrees to indefinite storage of unused clinical specimens at the CVD for use in future research
- Agrees not to participate in another investigational vaccine or drug trial during the study
- Has no childbearing potential or agrees to abstain from becoming pregnant from the day of screening (at least 14 days before vaccination) until 6 weeks after the final vaccination by using birth control
- Agrees not to donate blood to a blood bank for 12 months after receiving the vaccine.
You may not qualify if:
- An acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
- Any current illness requiring daily medication (vitamins, birth control pills, nasal or topical medications, allowed);
- Blood in stool on \>2 occasions (other than small amounts from straining) in past 12 months;
- Recurrent diarrhea (\>5 episodes in past 6 months, each lasting 3 days or more).
- Immunosuppression
- Long term (greater than 2 weeks) use of oral or injected steroids, or high-dose inhaled steroids (\>800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed).
- History of abdominal surgery
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- Known allergy or intolerance to ciprofloxacin, trimethoprim/sulfamethoxazole (or other sulfa antibiotic), ampicillin (for women) or corn.
- History of shigellosis or Shigella vaccination or challenge or a laboratory worker with known exposure to Shigella.
- Anticipates any of the following during the first 84 days (12 weeks) of the study (28 days, or 4 weeks for Cohort 1):
- Shares a household with a child \<3 years of age, a pregnant woman or a woman who plans to become pregnant during this time;
- Household or sexual contact with someone who has weakened immunity (such as someone with HIV infection, someone receiving treatment for cancer, or an elderly person \> 70 yrs);
- Occupation as a food-handler, childcare (for children \<3 years), or health care worker with direct patient contact.
- A clinically significant abnormality on physical examination
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Maryland, Baltimorelead
- PATHcollaborator
Study Sites (2)
Shin Nippon Biomedical Laboratories, LTD. (SNBL) Inpatient Facility
Baltimore, Maryland, 21201, United States
University of Maryland, Baltimore Center for Vaccine Development
Baltimore, Maryland, 21201, United States
Related Publications (1)
Toapanta FR, Bernal PJ, Kotloff KL, Levine MM, Sztein MB. T cell mediated immunity induced by the live-attenuated Shigella flexneri 2a vaccine candidate CVD 1208S in humans. J Transl Med. 2018 Mar 13;16(1):61. doi: 10.1186/s12967-018-1439-1.
PMID: 29534721DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen L. Kotloff, M.D.
University of Maryland,Baltimore Center for Vaccine Development
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
October 26, 2011
First Posted
February 13, 2012
Study Start
July 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
April 30, 2021
Record last verified: 2021-04