Blood Donor CVD 9000

NCT03724357 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: HP-00082377
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, non-randomized study. Volunteers will be vaccinated with the oral cholera vaccine, Vaxchora. Vaxchora has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.

Conditions

Cholera Vaccination

Outcome Measures

Primary Outcomes (13)

• Change in the Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells

  Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 3 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 3

• Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells

  Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 5 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 5

• Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells

  Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 8 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 8

• Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells

  Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 10 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 10

• Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells

  Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 15 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 15

• Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells

  Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 29 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 29

• Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154

  Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 1 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 1

• Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154

  Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 3 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 3

• Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154

  Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 5 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 5

• Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154

  Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 8 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 8

• Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154

  Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 10 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 10

• Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154

  Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 15 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 15

• Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154

  Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 29 after immunization with the CVD103-HgR cholera vaccine.

  Baseline and Day 29

Study Arms (1)

Vaccination with Oral Cholera Vaccine (Vaxchora)

EXPERIMENTAL

Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits.

Drug: Vaxchora

Interventions

Vaxchora DRUG

One dose. Approximately 100 mL of cold or room temperature purified bottled water is placed into a clean disposable cup. The contents of the buffer sachet are added to the water and stirred. Then the contents of the active (lyophilized vaccine) sachet are added to the water and stirred for approximately 30 seconds. The reconstituted mixture should be completely ingested within 15 minutes.

Also known as: CVD 103-HgR

Vaccination with Oral Cholera Vaccine (Vaxchora)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Age 18 years to 64 years at the time of enrollment
• \. Good general health as determined by a screening evaluation within 28 days before blood donation or vaccination
• \. Provides written informed consent prior to initiation of any study procedures

You may not qualify if:

• \. History of any of the following medical conditions:
• Diabetes
• Cancer in past 5 years (except for basal cell carcinoma of the skin and cervical carcinoma in situ)
• Heart disease (e.g., hospitalization for a heart attack, coronary artery bypass graft, arrhythmia, or syncope, within past 5 years. Current symptoms of heart disease, such as dyspnea, angina, or orthopnea)
• Recurrent infections (e.g., more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
• Current drug or alcohol abuse
• Active ulcer disease or ongoing intestinal condition
• Treatment for anemia in last 6 months
• Treatment with anti-malarial drugs within ten days prior to study vaccination
• Treatment with antibiotics within 14 days prior to study vaccination
• Immunodeficiency or immunosuppression from illness or treatment
• \. Close contact within 7 days following study vaccination with a person who has an immunodeficiency or immunosuppression from illness or treatment
• \. History of cholera infection or cholera vaccination
• \. Any of the following complete blood count (CBC) abnormalities during screening:
• white blood cells (WBC) \<0.81 x lower limit of normal (LLN) or \> 1.09 x upper limit of normal (ULN)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Vaxchora; cholera vaccine CVD 103-HgR

Results Point of Contact

• Title: Marcelo Sztein, MD
• Organization: University of Maryland, Baltimore

msztein@som.umaryland.edu

410-706-5328

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Volunteers who choose to take part in this study will receive the licensed FDA-approved Oral Cholera Vaccine (Vaxchora).

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: November 4, 2018
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: February 2, 2023
• Results First Posted: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)