Shigella CVD 31000: Study of Responses With Shigella-ETEC Vaccine Strain CVD 1208S-122

NCT04634513 | Completed Phase 1 Results FDA Drug

• 1 other identifier: HP-00094148
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a live, oral, combined Shigella-ETEC vaccine candidate, known as strain CVD 1208S-122, is safe and immunogenic.

Conditions

Shigella Infection; Enterotoxigenic Escherichia Coli Infection

Keywords

vaccine; strain CVD 1208S-122

Outcome Measures

Primary Outcomes (4)

• Participants Experiencing Fever, Diarrhea, or Dysentery; Solicited Local Adverse Events; Solicited Systemic Adverse Events; and Clinical Safety Laboratory Adverse Events

  Participants experiencing fever, diarrhea, or dysentery; solicited local adverse events; solicited systemic adverse events; and clinical safety laboratory adverse events

  Solicited AEs: Cohorts 1-3 during 4 days of inpatient and memory aid for another 3 days; Cohort 4 memory aid over 7 days after each dose of study product Clinical Safety Labs: Cohorts 1-3: Day 1 and Day 8; Cohort 4: Days 1 and 29 and Days 8 and 36

• Vaccine Organisms Shed in Stools in Cohorts 1-3 - Cohorts 1-3

  Vaccine organisms shed in stools in Cohorts 1-3

  7 days

• Vaccine Organisms Shed in Stools in Cohort 4

  Vaccine organisms shed in stools in Cohort 4

  2 days

• Number of Participants With Genetically Stable Fecal Shed Organisms

  Fecal shed organisms found to be genetically stable, as defined as being PCR positive for Shigella (ipaH or virG), CFA/I (cfaB), and LTB (eltB)

  7 days

Secondary Outcomes (2)

• Participants With ELISA Antibody Responses

  28 days

• Participants With ASC Responses

  7 days

Study Arms (4)

Cohort 1: Shigella Vaccine at 10^8 cfu or Placebo

EXPERIMENTAL

3:1 randomization to one dose of vaccine or placebo (Cohort n=8)

Biological: strain CVD 1208S-122; Other: Placebo

Cohort 2: Shigella Vaccine at 10^9 cfu or Placebo

EXPERIMENTAL

3:1 randomization to one dose of vaccine or placebo (Cohort n=8)

Biological: strain CVD 1208S-122; Other: Placebo

Cohort 3: Shigella Vaccine at 10^10 cfu or Placebo

EXPERIMENTAL

3:1 randomization to one dose of vaccine or placebo (Cohort n=8)

Biological: strain CVD 1208S-122; Other: Placebo

Cohort 4: Shigella Vaccine or Placebo

EXPERIMENTAL

2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)

Biological: strain CVD 1208S-122; Other: Placebo

Interventions

strain CVD 1208S-122 BIOLOGICAL

Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli

Cohort 1: Shigella Vaccine at 10^8 cfu or Placebo; Cohort 2: Shigella Vaccine at 10^9 cfu or Placebo; Cohort 3: Shigella Vaccine at 10^10 cfu or Placebo; Cohort 4: Shigella Vaccine or Placebo

Placebo OTHER

Sodium bicarbonate buffer

Cohort 1: Shigella Vaccine at 10^8 cfu or Placebo; Cohort 2: Shigella Vaccine at 10^9 cfu or Placebo; Cohort 3: Shigella Vaccine at 10^10 cfu or Placebo; Cohort 4: Shigella Vaccine or Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, 18 - 49 years of age
• Written informed consent provided
• Determined to be in good health\* based on medical history and review of concomitant medications
• \*Good health as defined by an absence of an active chronic medical condition which requires daily prescription medication(s). Participants may be eligible if the medical condition only requires infrequent as needed (PRN) medication and if the investigator determines that the condition does not pose a risk to participant safety or the assessment of reactogenicity and immunogenicity. Any chronic medical condition which does not require a daily prescription medication but might pose a risk to a participant with rapid dehydration (i.e., rapid intravascular volume changes) would be ineligible to participate.
• Documented acceptable results from screening laboratory work (defined in Appendix B), including:
• Complete blood count (CBC) with differential for total white blood cell count (WBC), absolute neutrophil count (ANC), hemoglobin (Hg), platelet count
• Creatinine, alanine aminotransferase (ALT), total bilirubin
• Serum Immunoglobulin A (IgA) level
• Human immunodeficiency virus (HIV) antibody, Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV)
• HLA-B27 histocompatibility testing
• Serum Beta human chorionic gonadotropin (β-HCG) test, if the participant is a woman of child-bearing potential
• A passing score (≥70%) on a Comprehension Assessment Tool
• Agrees not to participate in another clinical trial during the study period
• Females of child-bearing potential† agree to use an acceptable form of birth control‡ from enrollment and through at least 4 weeks after vaccination
• †Females of child-bearing potential, defined as having not been sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year has passed since the last menses, if menopausal.

You may not qualify if:

• A positive pregnancy test at screening or within 24 h prior to study product dosing
• A female who is breastfeeding
• Poor venous access, as defined by inability to obtain venous blood, for screening labs, after 3 venipuncture attempts
• Abnormal vital signs, defined as:
• Systolic BP \>150 mmHg or Diastolic BP \>90 mmHg
• Resting heart rate \>100 bpm
• Oral temperature ≥38.0°C
• Having received prior vaccines for or have had prior infection with ETEC, LT, cholera, or Shigella, within the past 3 years
• History of diarrhea during travel to a developing country within the past 3 years
• History of chronic gastrointestinal illness, including severe dyspepsia, lactose intolerance, or another significant gastrointestinal tract disease (e.g., irritable bowel syndrome, inflammatory bowel syndrome, gastric ulcer disease)
• Regular use (≥once weekly) of laxatives, anti-diarrheal agents, anti-constipation agents, or antacid therapies
• History of major gastrointestinal surgery (uncomplicated laparoscopic appendectomy or cholecystectomy \>1-year prior is permitted)
• Abnormal bowel habits, as defined by \<3 stools per week or \>2 stools per day in the past 6 months
• Use of systemic antimicrobials§ within the past 2 weeks
• use of topical (skin), otic, or ophthalmic antibiotics is acceptable, if those doses are not expected to result in significant systemic absorption levels

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health

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

Results Point of Contact

• Title: Wilbur H. Chen, MD, MS, FACP, FIDSA
• Organization: University of Maryland, School of Medicine

wchen@som.umaryland.edu

410-706-5328

Study Officials

• Wilbur Chen, MD, MS

  Center for Vaccine Development and Global Health, University of Maryland School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 18, 2020
• Study Start: September 29, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 2, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-01

Locations

US (1)