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

Brief Title

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

Official Title

A Phase III Randomized, Double-blind, Placebo-controlled Study in Older Adults to Assess Immunogenicity and Clinical Acceptability of a Single-dose of the Live Oral Cholera Vaccine Candidate PXVX0200 O1 Serotype Inaba Strain CVD 103-HgR

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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Seroconversion Rate at Day 11

Secondary Outcome

 Geometric Mean Titer (GMT)

Condition

Cholera

Intervention

PXVX0200

Study Arms / Comparison Groups

 PXVX0200 in Older Adults

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

398

Start Date

May 2014

Completion Date

June 2015

Primary Completion Date

February 2015

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:

          1. Currently active unstable or undiagnosed medical conditions including
             immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder,
             liver disease, renal disease, gastrointestinal disease, neurologic illness,
             psychiatric disorder requiring hospitalization, current drug or alcohol abuse.
             Examples of unstable or undiagnosed medical conditions including unstable angina
             pectoris, shortness of breath on exertion without clear etiology and chronic renal
             failure requiring dialysis. Examples of conditions that do not meet exclusion criteria
             include mild controlled hypertension, mild controlled asthma, and treated depression
             without hospitalization.

          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.
      

Gender

All

Ages

46 Years - 64 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

James McCarty, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT02100631

Organization ID

PXVX-VC-200-005

Responsible Party

Sponsor

Study Sponsor

Emergent BioSolutions

Study Sponsor

James McCarty, MD, Study Director, Emergent Travel Health Inc.

Verification Date

April 2021