A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults

NCT ID: NCT02100631

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-06-30

Brief Summary

Demonstrate that the vaccine offers protection based on antibody levels in older adults and is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.

Detailed Description

Demonstrate that seroconversion by classical Inaba vibriocidal antibody at Day 11 in older adults ages 46-64 years (inclusive) was non inferior to seroconversion at Day 11 in younger adults ages 18-45 years following vaccination with PXVX0200.

Conditions

Cholera

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

PXVX0200 in Older Adults

PXVX0200 Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension

Group Type: EXPERIMENTAL

PXVX0200

Intervention Type: BIOLOGICAL

Placebo in Older Adults

Placebo physiological saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Historical Control: Adults Aged 18-45

This arm consists of historical data from subjects who received a single dose of PXVX0200 in study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118

Group Type: OTHER

PXVX0200

Intervention Type: BIOLOGICAL

Interventions

PXVX0200

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Able to understand the study and give written consent.

2. Healthy male and female adults, age 46-64 years (inclusive) without significant medical history, physical, or abnormal screening laboratory test results at screening.

3. Women of childbearing potential must have had a negative urine pregnancy test at screening, prior to vaccination. Female subjects must be of non-childbearing potential (as defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential must be practicing abstinence or using an effective licensed method of birth control (eg, use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], cervical sponges, diaphragms, condoms with spermicidal agents; or must have a vasectomized partner) within 2 months of vaccination and must agree to continue such precautions during the study.

4. Willing and able to comply with the study requirements and procedures.

Exclusion Criteria

2. Abnormal stool pattern defined as fewer than 3 stools per week or more than 2 stools per day in past 6 months.

3. Regular use of laxatives in the past 6 months.

4. Previously received a licensed or investigational cholera vaccine.

5. History of cholera or enterotoxigenic E. coli infection (natural infection or experimental challenge).

6. Travel to a cholera-endemic area in the previous 5 years.

7. Received or plans to receive any other licensed vaccines, except for seasonal influenza vaccine, from 14 days prior to the study vaccination through to 29 days after vaccination.

8. Received or plans to receive antibiotics or chloroquine within 14 days prior to the study vaccination through to 29 days after vaccination.

9. Recipient of bone marrow or solid organ transplant.

10. Use of systemic chemotherapy in the previous 5 years prior to the study.

11. Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years.

12. Received or plans to receive systemic immunosuppressive therapy, radiation therapy, parenteral or high-dosage inhaled steroids (>800 µg/day of beclomethasone diproprionate or equivalent) within 6 months prior to the study vaccination through to Day 29.

13. History of Guillain-Barré Syndrome.

14. Pregnant or nursing.

• Minimum Eligible Age: 46 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emergent BioSolutions

INDUSTRY

Sponsor Role: collaborator

Bavarian Nordic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James McCarty, MD

Role: STUDY_DIRECTOR

Emergent Travel Health Inc.

Locations

Coastal Clinical Research

Mobile, Alabama, United States

Avail Clinical

DeLand, Florida, United States

Miami Research Associates

Miami, Florida, United States

Palm Beach Research Center

Palm Beach, Florida, United States

Emory University

Atlanta, Georgia, United States

Johnson County Clin-Trials

Lenexa, Kansas, United States

Heartland Research

Wichita, Kansas, United States

Central Kentucky Research

Lexington, Kentucky, United States

University of Kentucky

Lexington, Kentucky, United States

Boston University

Boston, Massachusetts, United States

Center for Pharmaceutical Research

Kansas City, Missouri, United States

St. Louis University

St Louis, Missouri, United States

Coastal Carolina Research

Mt. Pleasant, South Carolina, United States

Research Across America

Dallas, Texas, United States

Jean Brown Research

Salt Lake City, Utah, United States

University of Vermont

Burlington, Vermont, United States

Countries

United States

References

McCarty JM, Lock MD, Bennett S, Hunt KM, Simon JK, Gurwith M. Age-related immunogenicity and reactogenicity of live oral cholera vaccine CVD 103-HgR in a randomized, controlled clinical trial. Vaccine. 2019 Mar 7;37(11):1389-1397. doi: 10.1016/j.vaccine.2019.01.077. Epub 2019 Feb 13.

Reference Type: RESULT

PMID: 30772070 (View on PubMed)

Other Identifiers

PXVX-VC-200-005

Identifier Type: -

Identifier Source: org_study_id