Blood Donor CVD 9000

Phase 4

Terminated

• Conditions: Cholera Vaccination
• Interventions: Drug: Vaxchora

• Registration Number: NCT03724357
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Study Start: 2018-11-04
• Primary Completion: 2021-10-28
• Study Completion: 2021-10-28
• Results First Submitted: 2022-03-30
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Results First Posted: 2023-02-02
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

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

Exclusion Criteria

• 1. 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
• 2. Close contact within 7 days following study vaccination with a person who has an immunodeficiency or immunosuppression from illness or treatment
• 3. History of cholera infection or cholera vaccination
• 4. 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)
  • Hemoglobin <0.91 x LLN or >1.18 x ULN (women) or <0.92 x LLN or >1.18 x ULN (men)
  • Platelet count <0.8 x LLN or > 1.2 x ULN
• 5. Any of the following laboratory abnormalities during screening:
  • serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) >1.5 times normal
  • Positive serology for HIV antibody
• 6. Poor peripheral venous access for blood donation
• 7. Other condition that the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or interfere with the scientific integrity of study
• 8. Positive urine pregnancy test (HCG) on the day of vaccination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccination with Oral Cholera Vaccine (Vaxchora)	Vaxchora	Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits.

Primary Outcome Measures

Name	Time	Method
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells	Baseline and Day 29	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.
Change in the Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells	Baseline and Day 3	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.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154	Baseline and Day 29	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.

Trial Locations

Locations (1)

University of Maryland, Baltimore, Center for Vaccine Development and Global Health; 🇺🇸 Baltimore, Maryland, United States