Trial Outcomes & Findings for Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea (NCT NCT02067676)
NCT ID: NCT02067676
Last Updated: 2018-02-23
Results Overview
Vaccine safety will be assessed by evaluating post-vaccination local and systemic reactions through targeted physical exams, symptom surveys, and other adverse event (AE) monitoring. All subjects will be observed in the clinic for at least 30 minutes after receipt of the investigational product. Approximately 48 hours after vaccination, subjects will return to the Clinical Trials Center for observation and reporting of any local and/or systemic AEs. Seven days after vaccine administration, subjects will return to the Clinical Trials Center to review their memory aids with study personnel and to report any AEs. In addition to planned visits, if a subject experiences any unanticipated AE, the subject will be seen by one of the study investigators. All AEs will be coded for onset date, duration, severity, and potential relationship to the investigational product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
up to 7 days
Results posted on
2018-02-23
Participant Flow
48 subjects participated at the Walter Reed Army Institute of Research (WRAIR), Clinical Trials Center (CTC).
Participant milestones
| Measure |
CJCV1 2 μg / Alum 0 μg (1A)
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 2 μg / Alum 125 μg (1B)
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 5 μg / Alum 0 μg (2A)
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 5 μg / Alum 125 μg (2B)
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 10 μg / Alum 0 μg (3A)
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 10 μg / Alum 125 μg (1A)
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
CJCV1 2 μg / Alum 0 μg (1A)
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 2 μg / Alum 125 μg (1B)
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 5 μg / Alum 0 μg (2A)
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 5 μg / Alum 125 μg (2B)
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 10 μg / Alum 0 μg (3A)
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 10 μg / Alum 125 μg (1A)
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea
Baseline characteristics by cohort
| Measure |
CJCV1 2 μg / Alum 0 μg (1A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 2 μg / Alum 125 μg (1B)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 5 μg / Alum 0 μg (2A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 5 μg / Alum 125 μg (2B)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 10 μg / Alum 0 μg (3A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 10 μg / Alum 125 μg (1A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Age 18 to 50 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
8 participants
n=8 Participants
|
48 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: up to 7 daysPopulation: Rates of all AEs were analyzed by Pearson's Chi-square test (or Fisher's exact test if assumptions were not met for Pearson's Chi-square) to compare groups.
Vaccine safety will be assessed by evaluating post-vaccination local and systemic reactions through targeted physical exams, symptom surveys, and other adverse event (AE) monitoring. All subjects will be observed in the clinic for at least 30 minutes after receipt of the investigational product. Approximately 48 hours after vaccination, subjects will return to the Clinical Trials Center for observation and reporting of any local and/or systemic AEs. Seven days after vaccine administration, subjects will return to the Clinical Trials Center to review their memory aids with study personnel and to report any AEs. In addition to planned visits, if a subject experiences any unanticipated AE, the subject will be seen by one of the study investigators. All AEs will be coded for onset date, duration, severity, and potential relationship to the investigational product.
Outcome measures
| Measure |
CJCV1 2 μg / Alum 0 μg (1A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 2 μg / Alum 125 μg (1B)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 5 μg / Alum 0 μg (2A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 5 μg / Alum 125 μg (2B)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 10 μg / Alum 0 μg (3A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 10 μg / Alum 125 μg (1A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
|---|---|---|---|---|---|---|
|
Safety: Presence of Related/Not Related Local and/or Systemic Reactogenicity (Adverse Events)
AE's Related to Study Vaccine
|
10 Adverse Events
|
17 Adverse Events
|
10 Adverse Events
|
29 Adverse Events
|
20 Adverse Events
|
16 Adverse Events
|
|
Safety: Presence of Related/Not Related Local and/or Systemic Reactogenicity (Adverse Events)
Not Related to Study Vaccine
|
12 Adverse Events
|
22 Adverse Events
|
8 Adverse Events
|
3 Adverse Events
|
20 Adverse Events
|
9 Adverse Events
|
SECONDARY outcome
Timeframe: Study Days 0-56Population: Campylobacter jejuni conjugate vaccine (1CJCV1); antibody-secreting cell(s) (ASCs); Peripheral blood mononuclear cell (PBMCs)
Primary immunologic parameters, serum samples were assessed for the antibody titers against Campylobacter jejuni conjugate vaccine1 (CJCV1) using ELISA (enzyme-linked immunosorbent assay) based methods. Antibody-secreting cell(s) (ASCs): \>0.5 per 10(6) Peripheral blood mononuclear cell (PBMCs) in the baseline sample. When the number of baseline ASCs is less than 0.5 per 10(6) PBMCs, a subject was considered a responder if the post-vaccination value was greater than 1.0 per 10(6) PBMCs. ((6) is superscript). 1. = Seroconversion was defined as \>4fold increase in endpoint titer between pre- and post-vaccine samples and a post-vaccine reciprocal titer \>10. 2. = Response is defined as a \>2fold increase over the baseline value of ASC per 10(6) PBMCs, when the number of ASCs is \>0.5 per 10(6) PBMCs in the baseline sample. When the number of baseline ASCs is less than 0.5 per 10(6) PBMCs, a subject was considered a responder if the post-vaccine value was greater than 1.0 per 10(6) PBMCs.
Outcome measures
| Measure |
CJCV1 2 μg / Alum 0 μg (1A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 2 μg / Alum 125 μg (1B)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 5 μg / Alum 0 μg (2A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 5 μg / Alum 125 μg (2B)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 10 μg / Alum 0 μg (3A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 10 μg / Alum 125 μg (1A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
|---|---|---|---|---|---|---|
|
Frequency (%) of Vaccine-specific Immune Responses by Assay and Antigen Using Enzyme-linked Immunosorbent Assay (ELISA)
IgG ASCs (CPS-BSA) (b)
|
0 % of immune response
|
0 % of immune response
|
12.5 % of immune response
|
25.0 % of immune response
|
25.0 % of immune response
|
37.5 % of immune response
|
|
Frequency (%) of Vaccine-specific Immune Responses by Assay and Antigen Using Enzyme-linked Immunosorbent Assay (ELISA)
Serum IgG (CPS-BSA) (a)
|
12.5 % of immune response
|
0 % of immune response
|
12.5 % of immune response
|
25.0 % of immune response
|
12.5 % of immune response
|
12.5 % of immune response
|
|
Frequency (%) of Vaccine-specific Immune Responses by Assay and Antigen Using Enzyme-linked Immunosorbent Assay (ELISA)
Serum IgG (CRM197) (a)
|
25.0 % of immune response
|
75.0 % of immune response
|
62.5 % of immune response
|
75.0 % of immune response
|
75.0 % of immune response
|
75.0 % of immune response
|
|
Frequency (%) of Vaccine-specific Immune Responses by Assay and Antigen Using Enzyme-linked Immunosorbent Assay (ELISA)
IgG ASCs (CRM197) (b)
|
87.5 % of immune response
|
100 % of immune response
|
87.5 % of immune response
|
100 % of immune response
|
100 % of immune response
|
87.5 % of immune response
|
SECONDARY outcome
Timeframe: Study Days 0-56Anti-CPS IgG ASC Responses - GMTs with 95% CI. A positive immunoglobulin A (IgA)-ASC response will be defined as a \> twofold increase over the baseline value of the ASCs per 10\^6 peripheral blood mononuclear cells (PBMCs). A subject will be considered a responder if the post-vaccination value is greater than 2.0 per 10\^6 PBMCs. Blood samples will also be utilized to explore in vitro production of interferon (IFN)-(gamma).
Outcome measures
| Measure |
CJCV1 2 μg / Alum 0 μg (1A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 2 μg / Alum 125 μg (1B)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 5 μg / Alum 0 μg (2A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 5 μg / Alum 125 μg (2B)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 10 μg / Alum 0 μg (3A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 10 μg / Alum 125 μg (1A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
|---|---|---|---|---|---|---|
|
Vaccine-specific Geometric Mean Titers (GMT) of Anti-CPS IgG Antibody-secreting Cells
|
0 GMTs
Interval 0.0 to 0.0
|
1.1 GMTs
Interval 0.7 to 1.8
|
1.1 GMTs
Interval 0.6 to 2.2
|
1.9 GMTs
Interval 0.1 to 45.0
|
1.5 GMTs
Interval 0.4 to 5.9
|
1.3 GMTs
Interval 0.6 to 2.7
|
SECONDARY outcome
Timeframe: Study Days 0-56Anti-CRM\^197 IgG ASC Responses - GMTs with 95% CI. A positive immunoglobulin A (IgA)-ASC response will be defined as a \> twofold increase over the baseline value of the ASCs per 10\^6 peripheral blood mononuclear cells (PBMCs). A subject will be considered a responder if the post-vaccination value is greater than 2.0 per 10\^6 PBMCs. Blood samples will also be utilized to explore in vitro production of interferon (IFN)-(gamma).
Outcome measures
| Measure |
CJCV1 2 μg / Alum 0 μg (1A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 2 μg / Alum 125 μg (1B)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 5 μg / Alum 0 μg (2A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 5 μg / Alum 125 μg (2B)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 10 μg / Alum 0 μg (3A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 10 μg / Alum 125 μg (1A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
|---|---|---|---|---|---|---|
|
Vaccine-specific Anti-CRM^197 IgA Antibody-secreting Cell (ASC) Responses
|
8.7 GMTs
Interval 0.2 to 308.3
|
16.0 GMTs
Interval 2.3 to 109.5
|
14.9 GMTs
Interval 0.8 to 272.3
|
35.3 GMTs
Interval 5.1 to 244.2
|
4.8 GMTs
Interval 0.9 to 24.7
|
10.2 GMTs
Interval 0.4 to 249.8
|
SECONDARY outcome
Timeframe: Day 0, 28 and 56CRM197-specific interferon-y (IFNy) responses measured from PBMC on day0, 28 and 56
Outcome measures
| Measure |
CJCV1 2 μg / Alum 0 μg (1A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 2 μg / Alum 125 μg (1B)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 5 μg / Alum 0 μg (2A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 5 μg / Alum 125 μg (2B)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 10 μg / Alum 0 μg (3A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 10 μg / Alum 125 μg (1A)
n=8 Participants
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
|---|---|---|---|---|---|---|
|
Interferon Titers Among All Cohorts
|
44.3 GMTs
Interval 0.3 to 6920.3
|
45.5 GMTs
Interval 0.4 to 5657.0
|
154.9 GMTs
Interval 7.6 to 3174.0
|
195.4 GMTs
Interval 9.4 to 4076.3
|
153.5 GMTs
Interval 58.4 to 403.9
|
242.4 GMTs
Interval 37.1 to 1583.7
|
Adverse Events
CJCV1 2 μg / Alum 0 μg (1A)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
CJCV1 2 μg / Alum 125 μg (1B)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
CJCV1 5 μg / Alum 0 μg (2A)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
CJCV1 5 μg / Alum 125 μg (2B)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
CJCV1 10 μg / Alum 0 μg (3A)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
CJCV1 10 μg / Alum 125 μg (1A)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CJCV1 2 μg / Alum 0 μg (1A)
n=8 participants at risk
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 2 μg / Alum 125 μg (1B)
n=8 participants at risk
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 5 μg / Alum 0 μg (2A)
n=8 participants at risk
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 5 μg / Alum 125 μg (2B)
n=8 participants at risk
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 10 μg / Alum 0 μg (3A)
n=8 participants at risk
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 10 μg / Alum 125 μg (1A)
n=8 participants at risk
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute pericarditis
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
Other adverse events
| Measure |
CJCV1 2 μg / Alum 0 μg (1A)
n=8 participants at risk
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 2 μg / Alum 125 μg (1B)
n=8 participants at risk
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 5 μg / Alum 0 μg (2A)
n=8 participants at risk
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 5 μg / Alum 125 μg (2B)
n=8 participants at risk
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
CJCV1 10 μg / Alum 0 μg (3A)
n=8 participants at risk
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
|
CJCV1 10 μg / Alum 125 μg (1A)
n=8 participants at risk
Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Adbominal pain
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
General disorders
Fatigue
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Nervous system disorders
Headache
|
50.0%
4/8 • Number of events 4 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
|
Gastrointestinal disorders
Loose stool
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
|
General disorders
LUE pain
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
General disorders
LUE tenderness
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • up to 7 days post-vaccination
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
General disorders
Phantom sensation LUE
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
General disorders
Sweats
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Skin and subcutaneous tissue disorders
Vaccine site ecchymosis
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
|
Skin and subcutaneous tissue disorders
Vaccine site erythema
|
37.5%
3/8 • Number of events 3 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
62.5%
5/8 • Number of events 5 • up to 7 days post-vaccination
|
50.0%
4/8 • Number of events 4 • up to 7 days post-vaccination
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
|
General disorders
Vaccine site induration
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
37.5%
3/8 • Number of events 3 • up to 7 days post-vaccination
|
37.5%
3/8 • Number of events 3 • up to 7 days post-vaccination
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
|
Skin and subcutaneous tissue disorders
Vaccine site nodule
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
General disorders
Vaccine site pain
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
37.5%
3/8 • Number of events 3 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
75.0%
6/8 • Number of events 6 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
|
General disorders
Vaccine site swelling
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
|
General disorders
Vaccine site tenderness
|
37.5%
3/8 • Number of events 3 • up to 7 days post-vaccination
|
75.0%
6/8 • Number of events 6 • up to 7 days post-vaccination
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
100.0%
8/8 • Number of events 8 • up to 7 days post-vaccination
|
87.5%
7/8 • Number of events 7 • up to 7 days post-vaccination
|
100.0%
8/8 • Number of events 8 • up to 7 days post-vaccination
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
|
Cardiac disorders
Acute pericarditis
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Immune system disorders
Allergic rhinitis
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
|
Nervous system disorders
Allergy headache
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Injury, poisoning and procedural complications
Ankel sprain-right
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Investigations
Decreased blood glucose
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Investigations
Decreased platelets
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Skin and subcutaneous tissue disorders
Ecchymosis LUE
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Investigations
Elevated ALT
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Investigations
Elevated AST
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Investigations
Elevated blood glucose
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Investigations
Elevated cosinophils
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Investigations
Elevated WBC
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
General disorders
Feverish chills
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Gastrointestinal disorders
Gastric pain
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Gastrointestinal disorders
Gastroenteritis
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
General disorders
Hangover symptoms
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Investigations
Hemoglobin decrease
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Investigations
Increased cosinophil
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Nervous system disorders
Left eyelid twitching
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Nervous system disorders
Right fingertip pareshesias
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Soft tissue chest muscle pain
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/8 • up to 7 days post-vaccination
|
25.0%
2/8 • Number of events 2 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection symptoms
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
12.5%
1/8 • Number of events 1 • up to 7 days post-vaccination
|
0.00%
0/8 • up to 7 days post-vaccination
|
Additional Information
Ramiro Gutierrez, MD
Enteric Disease Department, Naval Medical Research Center
Phone: 301-319-3193
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place