NCT03724357

Blood Donor CVD 9000

Terminated Phase 4 Results posted Last updated 2 February 2023

What this trial tests

Phase 4 trial testing Vaxchora in Cholera Vaccination in 3 participants. Terminated before completion.

Timeline

4 November 2018

Primary endpoint
28 October 2021

28 October 2021

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	3
Start date	4 November 2018
Primary completion	28 October 2021
Estimated completion	28 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Vaxchora — full drug profile →

Conditions studied

• Cholera Vaccination — all drugs for Cholera Vaccination →

Sponsor

University of Maryland, Baltimore

Who can join

Adults 18 to 64, any sex, with Cholera Vaccination. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells Primary · 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.

Group	Value	95% CI
Vaccination With Oral Cholera Vaccine (Vaxchora)	-0.013	± 0.023

Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells Primary · Baseline and Day 5

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.

Group	Value	95% CI
Vaccination With Oral Cholera Vaccine (Vaxchora)	0.013	± 0.061

Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells Primary · Baseline and Day 8

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.

Group	Value	95% CI
Vaccination With Oral Cholera Vaccine (Vaxchora)	0.013	± 0.050

Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells Primary · Baseline and Day 10

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.

Group	Value	95% CI
Vaccination With Oral Cholera Vaccine (Vaxchora)	0.153	± 0.045

Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells Primary · Baseline and Day 15

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.

Group	Value	95% CI
Vaccination With Oral Cholera Vaccine (Vaxchora)	0.047	± 0.015

Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells Primary · 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.

Group	Value	95% CI
Vaccination With Oral Cholera Vaccine (Vaxchora)	0.043	± 0.035

Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 Primary · Baseline and Day 1

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.

Group	Value	95% CI
Vaccination With Oral Cholera Vaccine (Vaxchora)	0.01	± 0.01

Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 Primary · Baseline and Day 3

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.

Group	Value	95% CI
Vaccination With Oral Cholera Vaccine (Vaxchora)	1.06	± 0.98

Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 Primary · Baseline and Day 5

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.

Group	Value	95% CI
Vaccination With Oral Cholera Vaccine (Vaxchora)	0.32	± 0.25

Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 Primary · Baseline and Day 8

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.

Group	Value	95% CI
Vaccination With Oral Cholera Vaccine (Vaxchora)	0.18	± 0.16

Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 Primary · Baseline and Day 10

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.

Group	Value	95% CI
Vaccination With Oral Cholera Vaccine (Vaxchora)	0.10	± 0.18

Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154 Primary · Baseline and Day 15

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.

Group	Value	95% CI
Vaccination With Oral Cholera Vaccine (Vaxchora)	0.27	± 0.36

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.