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

NCT02100631 | Completed Phase 3 Results

• 1 other identifier: PXVX-VC-200-005
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 16

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.

Conditions

Cholera

Outcome Measures

Primary Outcomes (1)

• Seroconversion Rate at Day 11

  The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.

  Day 11

Secondary Outcomes (1)

• Geometric Mean Titer (GMT)

  Day 11

Other Outcomes (4)

• Cumulative Seroconversion Through Day 29 Compared to Day 11 for Younger Adults

  Day 29

• Mean Fold Change in Vibriocidal Antibody Titer Between Day 1 and Day 11

  Day 11

• Seroconversion Against Other V. Cholerae Biotypes/Serotypes

  Day 11

Study Arms (3)

PXVX0200 in Older Adults

EXPERIMENTAL

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

Biological: PXVX0200

Placebo in Older Adults

PLACEBO COMPARATOR

Placebo physiological saline

Biological: Placebo

Historical Control: Adults Aged 18-45

OTHER

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

Biological: PXVX0200

Interventions

PXVX0200 BIOLOGICAL

Historical Control: Adults Aged 18-45; PXVX0200 in Older Adults

Placebo BIOLOGICAL

Placebo in Older Adults

Eligibility Criteria

• Age: 46 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to understand the study and give written consent.
• Healthy male and female adults, age 46-64 years (inclusive) without significant medical history, physical, or abnormal screening laboratory test results at screening.
• 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.
• Willing and able to comply with the study requirements and procedures.

You may not qualify if:

• Abnormal stool pattern defined as fewer than 3 stools per week or more than 2 stools per day in past 6 months.
• Regular use of laxatives in the past 6 months.
• Previously received a licensed or investigational cholera vaccine.
• History of cholera or enterotoxigenic E. coli infection (natural infection or experimental challenge).
• Travel to a cholera-endemic area in the previous 5 years.
• 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.
• Received or plans to receive antibiotics or chloroquine within 14 days prior to the study vaccination through to 29 days after vaccination.
• Recipient of bone marrow or solid organ transplant.
• Use of systemic chemotherapy in the previous 5 years prior to the study.
• Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years.
• 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.
• History of Guillain-Barré Syndrome.
• Pregnant or nursing.

Sponsors & Collaborators

• Bavarian Nordic: lead
• Emergent BioSolutions: collaborator

Study Sites (16)

Coastal Clinical Research

Mobile, Alabama, 36608, United States

Location

Avail Clinical

DeLand, Florida, 32720, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Palm Beach Research Center

Palm Beach, Florida, 33409, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Heartland Research

Wichita, Kansas, 67207, United States

Location

Central Kentucky Research

Lexington, Kentucky, 40509, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Boston University

Boston, Massachusetts, 02218, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

St. Louis University

St Louis, Missouri, 63104, United States

Location

Coastal Carolina Research

Mt. Pleasant, South Carolina, 29464, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

• 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.

  PMID: 30772070 RESULT

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: David Cassie, Scientist, Clinical Research
• Organization: Emergent BioSolutions Canada Inc.

dcassie@ebsi.com

Study Officials

• James McCarty, MD

  Emergent Travel Health Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: April 1, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 28, 2023
• Results First Posted: April 30, 2021

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)