Trial Outcomes & Findings for Immunologic Responses to a Live Attenuated Oral Cholera Vaccine (NCT NCT03251495)
NCT ID: NCT03251495
Last Updated: 2026-02-13
Results Overview
Antibody response is evaluated as the level of antibody titers in serum. Higher vibriocidal antibody titers indicate greater protection against cholera.
COMPLETED
PHASE2
34 participants
Day 1 (pre-vaccination), Day 29
2026-02-13
Participant Flow
Participants were recruited at The Hope Clinic of Emory University in Atlanta, Georgia, USA. Participant enrollment began August 29, 2017 and follow up for the Day 29 study visit concluded on December 10, 2024.
Participant milestones
| Measure |
Vaxchora Vaccination
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Vaxchora Vaccination
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Immunologic Responses to a Live Attenuated Oral Cholera Vaccine
Baseline characteristics by cohort
| Measure |
Vaxchora Vaccination
n=34 Participants
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 8.5 • n=41 Participants
|
|
Sex/Gender, Customized
Female
|
17 Participants
n=41 Participants
|
|
Sex/Gender, Customized
Male
|
13 Participants
n=41 Participants
|
|
Sex/Gender, Customized
Unknown/Not reported
|
4 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination), Day 29Population: This analysis includes participants who provided samples resulting in usable laboratory data for both the Baseline and Day 29 visit.
Antibody response is evaluated as the level of antibody titers in serum. Higher vibriocidal antibody titers indicate greater protection against cholera.
Outcome measures
| Measure |
Vaxchora Vaccination
n=26 Participants
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Level of Antibody Titers in Serum
Day 29
|
2671 Vibriocidal antibody titer
Standard Deviation 2552.8
|
|
Level of Antibody Titers in Serum
Day 1, pre-vaccination
|
76 Vibriocidal antibody titer
Standard Deviation 80.9
|
SECONDARY outcome
Timeframe: Day 1 (pre-vaccination), Day 8, Day 29Population: This analysis includes participants who provided samples resulting in usable laboratory data for both the Baseline and Day 29 visit.
Plasmablasts are collected via blood draw and isolated and assessed for counts by the study team.
Outcome measures
| Measure |
Vaxchora Vaccination
n=26 Participants
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Plasmablast Levels
Day 1, pre-vaccination
|
2.0 percent of CD19+ lymphocytes
Standard Deviation 1.9
|
|
Plasmablast Levels
Day 8
|
5.3 percent of CD19+ lymphocytes
Standard Deviation 5.5
|
|
Plasmablast Levels
Day 29
|
1.2 percent of CD19+ lymphocytes
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Day 1 (pre-vaccination), Day 8, Day 29Population: This analysis includes participants who provided samples resulting in usable laboratory data for both the Baseline and Day 29 visit.
Activated B cells are collected via blood draw and isolated and assessed for counts by the study team.
Outcome measures
| Measure |
Vaxchora Vaccination
n=26 Participants
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Activated B Cell Levels
Day 8
|
0.7 percent of CD19+ lymphocytes
Standard Deviation 0.5
|
|
Activated B Cell Levels
Day 29
|
0.7 percent of CD19+ lymphocytes
Standard Deviation 0.6
|
|
Activated B Cell Levels
Day 1, pre-vaccination
|
0.8 percent of CD19+ lymphocytes
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Day 1 (pre-vaccination), Day 29Population: This analysis includes participants who provided samples resulting in usable laboratory data for both the Baseline and Day 29 visit.
Memory B cells are collected via blood draw and isolated and assessed for counts by the study team. The level of memory B cells is evaluated as the percentage of antigen specific immunoglobulin (Ig) secreting cells divided by the total Ig secreting cells.
Outcome measures
| Measure |
Vaxchora Vaccination
n=26 Participants
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Memory B Cell Levels
Day 1, pre-vaccination
|
NA % antigen specific cells/total cells
Standard Deviation NA
undetectable level
|
|
Memory B Cell Levels
Day 29
|
NA % antigen specific cells/total cells
Standard Deviation NA
undetectable level
|
SECONDARY outcome
Timeframe: Day 8Population: This analysis includes a subset of participants.
The number of antigen-specific monoclonal antibodies (mAbs) was assessed in a subset of participants on Day 8 post-vaccination. Peripheral blood mononuclear cells (PBMCs) were isolated, and antigen-specific plasmablasts were single-cell sorted using fluorescently labeled V. cholerae antigens (e.g., CTB and LPS). Paired immunoglobulin heavy and light chain variable regions were amplified by RT-PCR, cloned into expression vectors, and expressed in mammalian cells. The number of unique antigen-specific monoclonal antibodies was determined by binding assays (e.g., ELISA).
Outcome measures
| Measure |
Vaxchora Vaccination
n=149 Total monoclonals
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Number of Monoclonal Antibodies Produced Per Participant
|
24.83 monoclonal antibodies (mAbs)
Standard Deviation 6.80
|
SECONDARY outcome
Timeframe: Day 8Population: This analysis includes a subset of participants.
The monoclonal antibodies obtained were characterized as cholera toxin B (CTB) specific monoclonals and lipopolysaccharide (LPS) specific monoclonals. The characterization of monoclonal antibodies against V. cholerae is assessed in a subset of participants.
Outcome measures
| Measure |
Vaxchora Vaccination
n=65 Total CTB specific monoclonals
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Number of Cholera Toxin B (CTB) Specific Monoclonals and Lipopolysaccharide (LPS) Specific Monoclonal Antibodies Per Participant
Cholera Toxin B (CTB) specific monoclonals
|
1.67 monoclonal antibodies (mAbs)
Standard Deviation 2.34
|
|
Number of Cholera Toxin B (CTB) Specific Monoclonals and Lipopolysaccharide (LPS) Specific Monoclonal Antibodies Per Participant
Lipopolysaccharide (LPS) specific monoclonals
|
9.17 monoclonal antibodies (mAbs)
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: Up to Day 8, Up to Day 29The number of solicited and unsolicited adverse events were collected.
Outcome measures
| Measure |
Vaxchora Vaccination
n=34 Participants
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Number of Adverse Events
Days 1 - 8
|
77 count of events
|
|
Number of Adverse Events
Days 9 - 29
|
1 count of events
|
SECONDARY outcome
Timeframe: Up to Day 365The number of serious adverse events were collected during the duration of the study.
Outcome measures
| Measure |
Vaxchora Vaccination
n=34 Participants
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Number of Serious Adverse Events
Up to Day 29
|
0 count of events
|
|
Number of Serious Adverse Events
Day 30 to Day 365
|
1 count of events
|
Adverse Events
Vaxchora Vaccination
Serious adverse events
| Measure |
Vaxchora Vaccination
n=34 participants at risk
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Cardiac disorders
Hypertension urgency
|
2.9%
1/34 • Information on adverse events was collected beginning at the baseline assessment and continued through Day 29 (for a total of 29 days). Information on serious adverse events was collected up to Day 365 (for a total of 365 days).
|
Other adverse events
| Measure |
Vaxchora Vaccination
n=34 participants at risk
Healthy participants receive a single dose of oral live cholera vaccine. Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants receive one single oral dose of 100 mL.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
26.5%
9/34 • Information on adverse events was collected beginning at the baseline assessment and continued through Day 29 (for a total of 29 days). Information on serious adverse events was collected up to Day 365 (for a total of 365 days).
|
|
General disorders
Headache
|
32.4%
11/34 • Information on adverse events was collected beginning at the baseline assessment and continued through Day 29 (for a total of 29 days). Information on serious adverse events was collected up to Day 365 (for a total of 365 days).
|
|
General disorders
Fatigue
|
23.5%
8/34 • Information on adverse events was collected beginning at the baseline assessment and continued through Day 29 (for a total of 29 days). Information on serious adverse events was collected up to Day 365 (for a total of 365 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
6/34 • Information on adverse events was collected beginning at the baseline assessment and continued through Day 29 (for a total of 29 days). Information on serious adverse events was collected up to Day 365 (for a total of 365 days).
|
|
General disorders
Lack of appetite
|
5.9%
2/34 • Information on adverse events was collected beginning at the baseline assessment and continued through Day 29 (for a total of 29 days). Information on serious adverse events was collected up to Day 365 (for a total of 365 days).
|
|
Cardiac disorders
Tachycardia
|
2.9%
1/34 • Information on adverse events was collected beginning at the baseline assessment and continued through Day 29 (for a total of 29 days). Information on serious adverse events was collected up to Day 365 (for a total of 365 days).
|
|
Skin and subcutaneous tissue disorders
Bruise
|
2.9%
1/34 • Information on adverse events was collected beginning at the baseline assessment and continued through Day 29 (for a total of 29 days). Information on serious adverse events was collected up to Day 365 (for a total of 365 days).
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
1/34 • Information on adverse events was collected beginning at the baseline assessment and continued through Day 29 (for a total of 29 days). Information on serious adverse events was collected up to Day 365 (for a total of 365 days).
|
|
Gastrointestinal disorders
Nausea/vomiting
|
17.6%
6/34 • Information on adverse events was collected beginning at the baseline assessment and continued through Day 29 (for a total of 29 days). Information on serious adverse events was collected up to Day 365 (for a total of 365 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place