Trial Outcomes & Findings for Blood Donor CVD 9000 (NCT NCT03724357)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

Baseline and Day 3

Results posted on

2023-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Blood Donor CVD 9000

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in the Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells	-0.013 percentage of CD25 positive cells Standard Deviation 0.023

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells	0.013 percentage of CD25 positive cells Standard Deviation 0.061

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells	0.013 percentage of CD25 positive cells Standard Deviation 0.050

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells	0.153 percentage of CD25 positive cells Standard Deviation 0.045

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells	0.047 percentage of CD25 positive cells Standard Deviation 0.015

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells	0.043 percentage of CD25 positive cells Standard Deviation 0.035

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154	0.01 percentage of CD25 positive cells Standard Deviation 0.01

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154	1.06 percentage of CD25 positive cells Standard Deviation 0.98

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154	0.32 percentage of CD25 positive cells Standard Deviation 0.25

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154	0.18 percentage of CD25 positive cells Standard Deviation 0.16

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154	0.10 percentage of CD25 positive cells Standard Deviation 0.18

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154	0.27 percentage of CD25 positive cells Standard Deviation 0.36

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vaccination With Oral Cholera Vaccine (Vaxchora) n=3 Participants Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits. Vaxchora: 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.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154	0.00 percentage of CD25 positive cells Standard Deviation 0.00

Adverse Events

Vaccination With Oral Cholera Vaccine (Vaxchora)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marcelo Sztein, MD

University of Maryland, Baltimore

Phone: 410-706-5328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place