Clinical trial NCT02100631: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholera
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
Collaborators: name: Emergent BioSolutions
First posted: 2014-04-01
Enrollment: 398
Sex: ALL
Minimum age (years): 46
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Seroconversion Rate at Day 11
timeFrame: Day 11
Secondary outcomes:
measure: Geometric Mean Titer (GMT)
timeFrame: Day 11
Other outcomes:
measure: Cumulative Seroconversion Through Day 29 Compared to Day 11 for Younger Adults
timeFrame: Day 29
measure: Mean Fold Change in Vibriocidal Antibody Titer Between Day 1 and Day 11
timeFrame: Day 11
measure: Seroconversion Against Other V. Cholerae Biotypes/Serotypes
timeFrame: Day 11
measure: Anti-CT Antibody Response in Older Adults
timeFrame: Day 11
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research
state: Alabama
city: DeLand
country: United States
facility: Avail Clinical
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Wichita
country: United States
facility: Heartland Research
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research
state: South Carolina
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: Emergent Travel Health Inc.
name: James McCarty, MD
role: STUDY_DIRECTOR
References:
citation: 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.