Escherichia Coli Infection
Conditions
Brief summary
The purpose of the study is to determine if immunization with a chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.
Detailed description
The purpose of the study is to evaluate the safety and immunogenicity of dsc14cfaEsCTA2/LTB5 (Chimera) and dscCfaE administered with and without LTR192G by intradermal (ID) immunization and to gather additional data on the administration of dsCfaE and LTR192G via transcutaneous immunization (TCI) route. If vaccines are found to be safe and adequately immunogenic in humans, a down-selection would occur and a phase 2b vaccination/challenge study would be undertaken to further evaluate vaccine safety and allow a preliminary assessment of efficacy of one of these candidates by the ID or TCI route. With favorable evidence for safety, immunogenicity, efficacy, complemented by advances in standard methodology to combine multiple adhesins with an appropriate LT enterotoxoid form, a multivalent vaccine would be constructed and evaluated for further clinical development.
Interventions
BIOLOGICALRecombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
BIOLOGICALRecombinant fimbrial adhesin dscCfaE
Sponsors
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, adult, male or female, age 18 to 45 years (inclusive) at the time of enrollment. * Completion and review of comprehension test (achieved \> 70% accuracy). * Signed informed consent document. * Available for the required follow-up period and scheduled clinic visits. * Women: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following study completion.
Exclusion criteria
* Health problems (for example, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension or any other conditions that might place the subjects at increased risk of adverse events. Study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate. * Clinically significant abnormalities on physical examination. * Use of immunosuppressive medications (systemic corticosteroids or chemotherapeutics that may influence antibody development), or immunosuppressive illness, including IgA deficiency (defined by serum IgA below the detectable limit). * Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last study safety visit and currently nursing women. * Participation in research involving another investigational product (defined as receipt of investigational product or exposure to invasive investigational device) 30 days before planned date of first vaccination or anytime through the last study safety visit. * Positive blood test for HBsAg, HCV, HIV-1. * Clinically significant abnormalities on basic laboratory screening. * Exclusionary skin history/findings that would confound assessment or prevent appropriate local monitoring of AEs, or possibly increase the risk of an AE. * History of chronic skin disease (clinician judgment). * History of atopy such as active eczema. * Acute skin infection/eruptions on the upper arms including fungal infections, severe acne or active contact dermatitis. * Allergies that may increase the risk of AEs. * Regular use (weekly or more often) of antidiarrheal, anti-constipation, or antacid therapy. * Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on a regular basis; loose or liquid stools on other than an occasional basis. * Prior exposure to ETEC or Vibrio cholera. * History of microbiologically confirmed ETEC or cholera infection. * Travel to countries where ETEC or V. cholera or other enteric infections are endemic (most of the developing world) within two years prior to dosing clinician judgment). * Received previous experimental ETEC or V. cholera vaccine or live ETEC or V. cholera challenge. * Occupation involving handling of ETEC or V. cholera currently, or in the past 3 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Occurrence of Adverse Events | 1 year | Occurrence of related and unrelated to vaccine AE's |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Immune Responses to Vaccine Antigens | baseline and post dose | Number of participants with immune responses to vaccine antigens from baseline. Peripheral blood mononuclear cells (PBMCs) were collected to determine IgA antibody secreting cells (ASC) responses to dscCfaE and LTB. For each antigen, pre-and post-dosing samples were tested for total and vaccine-specific numbers of IgA-ASCs using the ELISPOT assay. A positive IgA-ASC response was defined as a \> 2-fold increase over the baseline value of the ASC per 10\^6 PBMC, when the number of ASC was \>0.5 per 10\^6 in the baseline sample. When the number of baseline ASCs was less than 0.5 per 10 PBMC, a subject was considered a responder if the post-vaccination value was greater than 1.0 per 10\^6 PBMC. |
| Antigen-Specific IgA Geometric Mean Titers | Day 0, 21,42, 56, 70 | Antigen-Specific IgA Geometric Mean Titers as defined by Fecal IgA. Final Clinical Study Report (FCSR) highlighted titer numbers only; no numbers for measure of dispersion/precision were given; no explanation as to why standard deviation information is not present in the FCSR. |
Countries
United States
Participant flow
Recruitment details
57 subjects were enrolled. An additional 2 subjects per cohort for Cohorts A-C and 2 subjects per group in Cohort D were included as alternates.
Participants by arm
| Arm | Count |
|---|---|
| All Study Cohorts Baseline data within Final Clinical Study Report was not broken out by groups or cohorts. No randomization was presented to detail which subject was in which group or cohort. Data is presented as it was detailed in the FCSR. | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Family emergency | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Relocation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Undisclosed Medical History | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Study Cohorts |
|---|---|
| Age, Customized Age 18 - 45 years | 57 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 57 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 7 | 0 / 7 | 0 / 10 | 0 / 8 |
| other Total, other adverse events | 5 / 5 | 5 / 5 | 5 / 5 | 5 / 5 | 5 / 5 | 7 / 7 | 7 / 7 | 10 / 10 | 8 / 8 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 7 | 0 / 7 | 0 / 10 | 0 / 8 |
Outcome results
Primary
Safety - Occurrence of Adverse Events
Occurrence of related and unrelated to vaccine AE's
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A-1 | Safety - Occurrence of Adverse Events | Related to Vaccine | 7 Number of Adverse Events |
| Group A-1 | Safety - Occurrence of Adverse Events | Unrelated to Vaccine | 17 Number of Adverse Events |
| Group A-2 | Safety - Occurrence of Adverse Events | Related to Vaccine | 21 Number of Adverse Events |
| Group A-2 | Safety - Occurrence of Adverse Events | Unrelated to Vaccine | 14 Number of Adverse Events |
| Group A-3 | Safety - Occurrence of Adverse Events | Related to Vaccine | 19 Number of Adverse Events |
| Group A-3 | Safety - Occurrence of Adverse Events | Unrelated to Vaccine | 16 Number of Adverse Events |
| Group B-1 | Safety - Occurrence of Adverse Events | Related to Vaccine | 20 Number of Adverse Events |
| Group B-1 | Safety - Occurrence of Adverse Events | Unrelated to Vaccine | 14 Number of Adverse Events |
| Group B-2 | Safety - Occurrence of Adverse Events | Related to Vaccine | 18 Number of Adverse Events |
| Group B-2 | Safety - Occurrence of Adverse Events | Unrelated to Vaccine | 10 Number of Adverse Events |
| Group C-1 | Safety - Occurrence of Adverse Events | Unrelated to Vaccine | 20 Number of Adverse Events |
| Group C-1 | Safety - Occurrence of Adverse Events | Related to Vaccine | 23 Number of Adverse Events |
| Group C-2 | Safety - Occurrence of Adverse Events | Unrelated to Vaccine | 8 Number of Adverse Events |
| Group C-2 | Safety - Occurrence of Adverse Events | Related to Vaccine | 25 Number of Adverse Events |
| Group D-1 | Safety - Occurrence of Adverse Events | Related to Vaccine | 38 Number of Adverse Events |
| Group D-1 | Safety - Occurrence of Adverse Events | Unrelated to Vaccine | 20 Number of Adverse Events |
| Group D-2 | Safety - Occurrence of Adverse Events | Related to Vaccine | 25 Number of Adverse Events |
| Group D-2 | Safety - Occurrence of Adverse Events | Unrelated to Vaccine | 26 Number of Adverse Events |
Secondary
Antigen-Specific IgA Geometric Mean Titers
Antigen-Specific IgA Geometric Mean Titers as defined by Fecal IgA. Final Clinical Study Report (FCSR) highlighted titer numbers only; no numbers for measure of dispersion/precision were given; no explanation as to why standard deviation information is not present in the FCSR.
Time frame: Day 0, 21,42, 56, 70
Population: Only subjects receiving at least 2 vaccine doses were included in this assessment. Final Clinical Study Report (FCSR) highlighted titer numbers only; no numbers for measure of dispersion/precision were given; no explanation on not presenting standard deviation information is present in the FCSR.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A-1 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group A-1 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group A-1 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-LT | 33.30 Geometric Mean Titers |
| Group A-1 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-LT | 15.00 Geometric Mean Titers |
| Group A-1 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-LT | 13.15 Geometric Mean Titers |
| Group A-1 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-LT | 22.70 Geometric Mean Titers |
| Group A-1 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-LT | 12.37 Geometric Mean Titers |
| Group A-1 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group A-1 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group A-1 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group A-2 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group A-2 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group A-2 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-LT | 98.89 Geometric Mean Titers |
| Group A-2 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-LT | 83.68 Geometric Mean Titers |
| Group A-2 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-LT | 74.60 Geometric Mean Titers |
| Group A-2 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-CfaE | 8.77 Geometric Mean Titers |
| Group A-2 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-LT | 189.39 Geometric Mean Titers |
| Group A-2 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-LT | 43.05 Geometric Mean Titers |
| Group A-2 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-CfaE | 9.47 Geometric Mean Titers |
| Group A-2 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group A-3 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group A-3 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group A-3 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group A-3 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group A-3 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-CfaE | 8.63 Geometric Mean Titers |
| Group A-3 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-LT | 16.62 Geometric Mean Titers |
| Group A-3 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-LT | 13.89 Geometric Mean Titers |
| Group A-3 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-LT | 15.87 Geometric Mean Titers |
| Group A-3 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-LT | 18.16 Geometric Mean Titers |
| Group A-3 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-LT | 9.54 Geometric Mean Titers |
| Group B-1 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-LT | 46.07 Geometric Mean Titers |
| Group B-1 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group B-1 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-LT | 28.66 Geometric Mean Titers |
| Group B-1 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-LT | 28.66 Geometric Mean Titers |
| Group B-1 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-CfaE | 44.22 Geometric Mean Titers |
| Group B-1 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group B-1 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-LT | 31.53 Geometric Mean Titers |
| Group B-1 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group B-1 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-LT | 7.59 Geometric Mean Titers |
| Group B-1 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group B-2 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-CfaE | 4.29 Geometric Mean Titers |
| Group B-2 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-LT | 44.93 Geometric Mean Titers |
| Group B-2 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group B-2 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group B-2 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group B-2 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-LT | 31.27 Geometric Mean Titers |
| Group B-2 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-LT | 7.59 Geometric Mean Titers |
| Group B-2 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-LT | 40.24 Geometric Mean Titers |
| Group B-2 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-CfaE | 5.94 Geometric Mean Titers |
| Group B-2 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-LT | 19.82 Geometric Mean Titers |
| Group C-1 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-LT | 19.78 Geometric Mean Titers |
| Group C-1 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-CfaE | 18.12 Geometric Mean Titers |
| Group C-1 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-CfaE | 9.56 Geometric Mean Titers |
| Group C-1 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group C-1 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-LT | 9.85 Geometric Mean Titers |
| Group C-1 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-LT | 23.00 Geometric Mean Titers |
| Group C-1 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group C-1 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-LT | 13.40 Geometric Mean Titers |
| Group C-1 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-CfaE | 52.52 Geometric Mean Titers |
| Group C-1 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-LT | 17.38 Geometric Mean Titers |
| Group C-2 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-LT | 16.56 Geometric Mean Titers |
| Group C-2 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group C-2 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-CfaE | 8.98 Geometric Mean Titers |
| Group C-2 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-CfaE | 9.63 Geometric Mean Titers |
| Group C-2 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-LT | 7.59 Geometric Mean Titers |
| Group C-2 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-LT | 82.77 Geometric Mean Titers |
| Group C-2 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-LT | 19.48 Geometric Mean Titers |
| Group C-2 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group C-2 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-LT | 23.35 Geometric Mean Titers |
| Group C-2 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-CfaE | 12.06 Geometric Mean Titers |
| Group D-1 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-LT | 137.37 Geometric Mean Titers |
| Group D-1 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-CfaE | 190.44 Geometric Mean Titers |
| Group D-1 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-CfaE | 59.75 Geometric Mean Titers |
| Group D-1 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-LT | 114.77 Geometric Mean Titers |
| Group D-1 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-LT | 266.20 Geometric Mean Titers |
| Group D-1 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-CfaE | 22.99 Geometric Mean Titers |
| Group D-1 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-CfaE | 43.66 Geometric Mean Titers |
| Group D-1 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-CfaE | 23.47 Geometric Mean Titers |
| Group D-1 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-LT | 142.69 Geometric Mean Titers |
| Group D-1 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-LT | 126.85 Geometric Mean Titers |
| Group D-2 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-CfaE | 162.67 Geometric Mean Titers |
| Group D-2 | Antigen-Specific IgA Geometric Mean Titers | Day 42 - Anti-LT | 321.36 Geometric Mean Titers |
| Group D-2 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group D-2 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-LT | 59.38 Geometric Mean Titers |
| Group D-2 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-CfaE | 7.59 Geometric Mean Titers |
| Group D-2 | Antigen-Specific IgA Geometric Mean Titers | Day 56 - Anti-LT | 27.83 Geometric Mean Titers |
| Group D-2 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-CfaE | 16.95 Geometric Mean Titers |
| Group D-2 | Antigen-Specific IgA Geometric Mean Titers | Day 70 - Anti-LT | 95.03 Geometric Mean Titers |
| Group D-2 | Antigen-Specific IgA Geometric Mean Titers | Day 0 - Anti-CfaE | 11.34 Geometric Mean Titers |
| Group D-2 | Antigen-Specific IgA Geometric Mean Titers | Day 21 - Anti-LT | 51.60 Geometric Mean Titers |
Secondary
Number of Participants With Immune Responses to Vaccine Antigens
Number of participants with immune responses to vaccine antigens from baseline. Peripheral blood mononuclear cells (PBMCs) were collected to determine IgA antibody secreting cells (ASC) responses to dscCfaE and LTB. For each antigen, pre-and post-dosing samples were tested for total and vaccine-specific numbers of IgA-ASCs using the ELISPOT assay. A positive IgA-ASC response was defined as a \> 2-fold increase over the baseline value of the ASC per 10\^6 PBMC, when the number of ASC was \>0.5 per 10\^6 in the baseline sample. When the number of baseline ASCs was less than 0.5 per 10 PBMC, a subject was considered a responder if the post-vaccination value was greater than 1.0 per 10\^6 PBMC.
Time frame: baseline and post dose
Population: A total of 55 subjects across cohorts received the minimum required 2 doses of investigation product(s) and were evaluable for the immunology analysis per protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aCfaE) - >4-fold rise in baseline titer | 0 Participants |
| Group A-1 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aLT) - >2-fold increase over baseline | 2 Participants |
| Group A-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aLT) - >4-fold rise in baseline titer | 0 Participants |
| Group A-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aCfaE) - >4-fold rise in baseline titer | 0 Participants |
| Group A-1 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aCfaE) - >2-fold increase over baseline | 0 Participants |
| Group A-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aLT) - >4-fold risein baseline titer | 0 Participants |
| Group A-2 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aLT) - >2-fold increase over baseline | 5 Participants |
| Group A-2 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aCfaE) - >2-fold increase over baseline | 1 Participants |
| Group A-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aLT) - >4-fold rise in baseline titer | 5 Participants |
| Group A-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aLT) - >4-fold risein baseline titer | 3 Participants |
| Group A-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aCfaE) - >4-fold rise in baseline titer | 1 Participants |
| Group A-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aCfaE) - >4-fold rise in baseline titer | 5 Participants |
| Group A-3 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aCfaE) - >4-fold rise in baseline titer | 0 Participants |
| Group A-3 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aCfaE) - >2-fold increase over baseline | 0 Participants |
| Group A-3 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aLT) - >2-fold increase over baseline | 5 Participants |
| Group A-3 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aLT) - >4-fold risein baseline titer | 3 Participants |
| Group A-3 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aCfaE) - >4-fold rise in baseline titer | 0 Participants |
| Group A-3 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aLT) - >4-fold rise in baseline titer | 5 Participants |
| Group B-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aLT) - >4-fold rise in baseline titer | 5 Participants |
| Group B-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aCfaE) - >4-fold rise in baseline titer | 4 Participants |
| Group B-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aCfaE) - >4-fold rise in baseline titer | 3 Participants |
| Group B-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aLT) - >4-fold risein baseline titer | 4 Participants |
| Group B-1 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aCfaE) - >2-fold increase over baseline | 3 Participants |
| Group B-1 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aLT) - >2-fold increase over baseline | 5 Participants |
| Group B-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aCfaE) - >4-fold rise in baseline titer | 4 Participants |
| Group B-2 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aCfaE) - >2-fold increase over baseline | 2 Participants |
| Group B-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aCfaE) - >4-fold rise in baseline titer | 2 Participants |
| Group B-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aLT) - >4-fold risein baseline titer | 4 Participants |
| Group B-2 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aLT) - >2-fold increase over baseline | 4 Participants |
| Group B-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aLT) - >4-fold rise in baseline titer | 4 Participants |
| Group C-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aLT) - >4-fold risein baseline titer | 5 Participants |
| Group C-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aCfaE) - >4-fold rise in baseline titer | 7 Participants |
| Group C-1 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aCfaE) - >2-fold increase over baseline | 2 Participants |
| Group C-1 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aLT) - >2-fold increase over baseline | 6 Participants |
| Group C-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aCfaE) - >4-fold rise in baseline titer | 3 Participants |
| Group C-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aLT) - >4-fold rise in baseline titer | 7 Participants |
| Group C-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aCfaE) - >4-fold rise in baseline titer | 3 Participants |
| Group C-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aLT) - >4-fold rise in baseline titer | 7 Participants |
| Group C-2 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aLT) - >2-fold increase over baseline | 7 Participants |
| Group C-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aLT) - >4-fold risein baseline titer | 7 Participants |
| Group C-2 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aCfaE) - >2-fold increase over baseline | 4 Participants |
| Group C-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aCfaE) - >4-fold rise in baseline titer | 7 Participants |
| Group D-1 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aCfaE) - >2-fold increase over baseline | 6 Participants |
| Group D-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aLT) - >4-fold risein baseline titer | 7 Participants |
| Group D-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aCfaE) - >4-fold rise in baseline titer | 5 Participants |
| Group D-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aLT) - >4-fold rise in baseline titer | 9 Participants |
| Group D-1 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aLT) - >2-fold increase over baseline | 10 Participants |
| Group D-1 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aCfaE) - >4-fold rise in baseline titer | 9 Participants |
| Group D-2 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aLT) - >2-fold increase over baseline | 6 Participants |
| Group D-2 | Number of Participants With Immune Responses to Vaccine Antigens | IgA ASC (aCfaE) - >2-fold increase over baseline | 0 Participants |
| Group D-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aCfaE) - >4-fold rise in baseline titer | 7 Participants |
| Group D-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aLT) - >4-fold risein baseline titer | 6 Participants |
| Group D-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgA (aCfaE) - >4-fold rise in baseline titer | 0 Participants |
| Group D-2 | Number of Participants With Immune Responses to Vaccine Antigens | Serum IgG (aLT) - >4-fold rise in baseline titer | 3 Participants |