Safety and Efficacy Challenge Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella: Phase IIb

NCT00866242 | Terminated Phase 2 DMC

• 2 other identifiers: HP-00040710 Phase IIbShigella CVD 27000
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 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.

Conditions

Shigella

Keywords

Shigella; Vaccine; Mucosal immunity

Outcome Measures

Primary Outcomes (1)

• To measure the protective efficacy of 3 spaced doses of vaccine against experimental challenge with wild type S. flexneri 2a 2457T

  approximately October 2010

Secondary Outcomes (3)

• To assess the fecal shedding of wild type S. flexneri 2a in vaccinees and controls following challenge

  approximately October 2010

• To elucidate the systemic and mucosal immune responses in vaccinees and control subjects following challenge with wild type S. flexneri 2a

  approximately October 2009, January 2010, and August - October 2010

• To examine which immune responses correlate with protection against experimental challenge

  approximately October 2010

Study Arms (1)

Challenge-recipients

EXPERIMENTAL

Biological: CVD 1208S, Challenge strain of wild-type Shigella flexneri 2a

Interventions

CVD 1208S, Challenge strain of wild-type Shigella flexneri 2a BIOLOGICAL

The challenge strain consists of freshly harvested Shigella flexneri 2a strain 2457T diluted in phosphate buffered saline to reach the desired inoculum Form: liquid Dose 10 to the 3rd power CFU in 1.0 ml Route: oral.

Challenge-recipients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 45 years, inclusive
• Good general health as determined by a screening evaluation within 45 days before inoculation
• 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, which may require separate IRB approval
• Agrees not to participate in another investigational vaccine or drug trial during the 6-month study
• Has no childbearing potential, i.e., either surgically sterilized or 1 year postmenopausal, or agrees to abstain from becoming pregnant from the day of screening (at least 14 days before vaccination) through Day 42 of the trial by using one of the following methods of birth control:
• Abstinence
• Intrauterine contraceptive device
• Oral contraceptives or equivalent hormonal contraception, e.g., progestogen-only implantable, cutaneous hormonal patch, injectable contraceptives, or Nuvaring (vaginal hormonal ring)
• Diaphragm in combination with contraceptive jelly, cream, or foam
• Condoms with spermicide

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. This includes, but is not limited to:
• Chronic liver disease, renal insufficiency, unstable or progressive neurological disorders, diabetes mellitus, collagen vascular disease (such as lupus), active neoplastic disease (not cured or in remission), or previous hematological malignancy
• Repeated (two or more) seizures occurring after 5 years of age, and not related to a concussion
• Any of the following in the past 10 years: Crohn's disease, ulcerative colitis, irritable bowel disease, celiac disease, stomach or intestinal ulcers, or 2 or more episodes of arthritis (joint pain and swelling);
• Recurrent infections (more than 1 hospitalization for invasive bacterial infections, e.g., pneumonia, meningitis)
• G6PD deficiency
• Any current illness requiring daily medication (vitamins, birth control pills, nasal or topical medications, allowed)
• Blood in stool on more than 2 occasions (other than small amounts from straining) in past 12 months
• Recurrent diarrhea (more than 5 episodes in past 6 months, each lasting 3 days or more)
• Immunosuppression as a result of an underlying illness or treatment within the preceding 36 months,
• long term use of steroids, or high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed)
• History of the following types of abdominal surgery:
• Any major gastrointestinal surgery (e.g., intestinal resection or splenectomy)
• A laparotomy for any reason (e.g., hysterectomy, Caesarian section, appendectomy, or herniorrhaphy) within the last 3 years
• Laparoscopic abdominal surgery within the past year

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• PATH: collaborator

Study Sites (2)

Shin Nippon Biomedical Laboratories (SNBL) Inpatient Facility

Baltimore, Maryland, 21201, United States

Location

University of Maryland, Baltimore Center for Vaccine Development

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Dysentery, Bacillary

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Karen L Kotloff, M.D.

  University of Maryland, Baltimore Center for Vaccine Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Medicine

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: January 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

US (2)