Safety and Efficacy Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella Infection Using cGMP

This study has been completed.
Sponsor:
Collaborator:
PATH
Information provided by (Responsible Party):
Karen Kotloff, MD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01531530
First received: October 26, 2011
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Shigella
Biological: CVD 1208S, a Shigella flexneri 2a live, oral vaccine
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety, Clinical Tolerance, and Immunogenicity of CVD 1208S, a Delta guaBA, Delta Sen, Delta Set, Live, Oral Shigella Flexneri 2a Vaccine Manufactured Using cGMP

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Number of participants with reactions and adverse events [ Time Frame: 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). ] [ Designated as safety issue: Yes ]
    occurence of diarrhea, dysentery and fever.

  • Number of participants who receive the vaccine who get immunity to shigella [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of participants who pass the vaccine in their stool [ Time Frame: The first 84 days after vaccination ] [ Designated as safety issue: Yes ]
    Volunteers' stool will be tested to see if the vaccine is present. This will tell whether the vaccine is able to stick to the intestine and grow there. We will see whether this information predicts the strength of the immune responses to the vaccine and whether the vaccine could potentially be passed to close contacts.

  • The number of participants who develop various types of immune responses [ Time Frame: The first 84 days of the study ] [ Designated as safety issue: No ]
    We will look at the ability of the vaccine to evoke different types of responses in blood and stool that might protect them against Shigella infections in the future.


Enrollment: 26
Study Start Date: July 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine-recipients Biological: CVD 1208S, a Shigella flexneri 2a live, oral vaccine
The vaccine is mixed with salt water and given by mouth.
Placebo Comparator: Placebo Other: Placebo
Corn starch and baking soda are mixed with salt water and given by mouth.

Detailed Description:

There are two purposes for conducting this Vaccine Study to evaluate an experimental vaccine called CVD 1208S (Center for Vaccine Development 1208S): 1) to learn whether CVD 1208S causes side effects, and 2) to learn whether the CVD 1208S gives people immunity to Shigella.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Results of blood tests as defined by protocol
  • Positive pregnancy test during medical screening or within 24 hours of inoculation or current breast feeding (women).
  • Failure to attain a score of at least 70% on the written examination (two attempts permitted)
  • During the past 3 years, developed diarrhea during travel to a developing country, or within 1 week of returning home.
  • Receipt of any of the following:

    • Any vaccine or investigational drug within 30 days of study vaccine
    • A live, attenuated vaccine within 30 days of the study vaccine
    • A subunit or killed vaccine within 14 days of the study vaccine
    • A blood product in the 90 days before the study vaccine
  • Receipt of antibiotics within 7 days of inoculation (or within 21 days if the antibiotic was azithromycin).
  • Loose stools or any other acute illness such as fever >100.0 degrees F during the 48 hours before vaccination.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531530

Locations
United States, Maryland
University of Maryland, Baltimore Center for Vaccine Development
Baltimore, Maryland, United States, 21201
Shin Nippon Biomedical Laboratories, LTD. (SNBL) Inpatient Facility
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
PATH
Investigators
Principal Investigator: Karen L. Kotloff, M.D. University of Maryland,Baltimore Center for Vaccine Development
  More Information

No publications provided

Responsible Party: Karen Kotloff, MD, Associate Director for Clinical Research, University of Maryland
ClinicalTrials.gov Identifier: NCT01531530     History of Changes
Other Study ID Numbers: HP-00049727, Shigella CVD 28000
Study First Received: October 26, 2011
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
Shigella
Vaccine
Mucosal immunity

Additional relevant MeSH terms:
Dysentery, Bacillary
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Dysentery
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014