A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults
Condition: Cholera
MeSH terms: Cholera
Intervention: PXVX0200; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 398.0
Sex: All
Minimum age: 46 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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.