A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults
- Conditions
- Cholera
- Interventions
- Biological: PXVX0200Biological: Placebo
- Registration Number
- NCT02100631
- Lead Sponsor
- Bavarian Nordic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 398
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PXVX0200 in Older Adults PXVX0200 PXVX0200 Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension Placebo in Older Adults Placebo Placebo physiological saline Historical Control: Adults Aged 18-45 PXVX0200 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
- Primary Outcome Measures
Name Time Method Seroconversion Rate at Day 11 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.
- Secondary Outcome Measures
Name Time Method Geometric Mean Titer (GMT) Day 11 The Day 11 vibriocidal GMTs were compared between older and younger adults.
Trial Locations
- Locations (16)
Central Kentucky Research
🇺🇸Lexington, Kentucky, United States
Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
St. Louis University
🇺🇸Saint Louis, Missouri, United States
Coastal Carolina Research
🇺🇸Mount Pleasant, South Carolina, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
Coastal Clinical Research
🇺🇸Mobile, Alabama, United States
Research Across America
🇺🇸Dallas, Texas, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Johnson County Clin-Trials
🇺🇸Lenexa, Kansas, United States
Heartland Research
🇺🇸Wichita, Kansas, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
Palm Beach Research Center
🇺🇸Palm Beach, Florida, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Avail Clinical
🇺🇸DeLand, Florida, United States
Boston University
🇺🇸Boston, Massachusetts, United States