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

Cholera Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100631
• Other study ID #: PXVX-VC-200-005
• Status: Completed
• Phase: Phase 3
• Start date: May 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2023
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 46 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholera

Intervention

Biological:
• PXVX0200

• Placebo

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Boston University	Boston	Massachusetts
United States	University of Vermont	Burlington	Vermont
United States	Research Across America	Dallas	Texas
United States	Avail Clinical	DeLand	Florida
United States	Center for Pharmaceutical Research	Kansas City	Missouri
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Central Kentucky Research	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	Miami Research Associates	Miami	Florida
United States	Coastal Clinical Research	Mobile	Alabama
United States	Coastal Carolina Research	Mount Pleasant	South Carolina
United States	Palm Beach Research Center	Palm Beach	Florida
United States	St. Louis University	Saint Louis	Missouri
United States	Jean Brown Research	Salt Lake City	Utah
United States	Heartland Research	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Bavarian Nordic	Emergent BioSolutions

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cumulative Seroconversion Through Day 29 Compared to Day 11 for Younger Adults	The cumulative seroconversion through Day 29 for older adults was compared to the Day 11 seroconversion for the younger adults aged 18 - 45 yrs. Seroconversion is defined as a 4-fold rise in antibody titer relative to baseline values.	Day 29
Other	Mean Fold Change in Vibriocidal Antibody Titer Between Day 1 and Day 11	The mean log2 fold change between Day 1 and Day 11 in classical Inaba vibriocidal antibody titer attained by older adults was compared to the younger adults aged 18 - 45 yrs.	Day 11
Other	Seroconversion Against Other V. Cholerae Biotypes/Serotypes	Seroconversion of the vibriocidal antibody response against 4 V. cholerae biotypes/serotypes - classical Inaba, El Tor Inaba, classical Ogawa and El Tor Ogawa was assessed.	Day 11
Other	Anti-CT Antibody Response in Older Adults	The seroconversion of anti-Cholera Toxin (CT) antibody response in older adults was assessed.; Seroconversion is defined as a 4-fold rise in anti-CT antibody titer relative to baseline values.	Day 11
Primary	Seroconversion Rate at 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.	Day 11
Secondary	Geometric Mean Titer (GMT)	The Day 11 vibriocidal GMTs were compared between older and younger adults.	Day 11