CompletedPhase 3

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

United States398 participantsStarted 2014-05

Plain-language 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.

Who can participate

Age range46 Years – 64 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Seroconversion Rate at Day 11

Timeframe: Day 11

Trial details

NCT IDNCT02100631

SponsorBavarian Nordic

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-02

Results submitted2018-07-02

View on ClinicalTrials.gov More Cholera trials