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| ID | Type | Description | Link |
|---|---|---|---|
| NMRC.2013.0021 | Other Identifier | Naval Medical Research Center IRB |
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| Name | Class |
|---|---|
| Walter Reed Army Institute of Research (WRAIR) | FED |
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The purpose of this study is to assess the safety of increasing doses of a potential vaccine against Campylobacter with and without Alhydrogel®, an aluminum hydroxide adjuvant. This study will also assess immune responses induced by the vaccine.
This is an open-label, dose-escalating study in which a total of 48 healthy volunteers will receive 2 vaccinations (one on Day 0 and one on Day 28 ± 2 days).
There are 3 cohorts (dose levels) with 2 groups of 8 volunteers in each cohort. A cohort will be administered one of 3 intramuscular (IM) doses at 2 μg, 5 μg, or 10 μg of Capsule-Conjugate Campylobacter Vaccine (CJCV1) with or without Alhydrogel®, aluminum hydroxide adjuvant (alum) at 125 μg.
An interval no less than 1 week will separate the last dose of a volunteer group from the first dose of the next volunteer group (receiving different CJCV1 doses). Blood specimens will be collected at intervals to examine systemic and mucosal antigen-specific immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days (± 2 days) following the second vaccination and complete the study with a telephone follow-up approximately 6 months (± 1 month) after the first vaccination. The total duration of participation in this study is up to 270 days (including screening).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJCV1 2 μg / Alum 0 μg (1A) | Experimental | 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) |
|
| CJCV1 2 μg / Alum 125 μg (1B) | Experimental | 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) |
|
| CJCV1 5 μg / Alum 0 μg (2A) | Experimental | 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) |
|
| CJCV1 5 μg / Alum 125 μg (2B) | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsule-Conjugate Campylobacter Vaccine (CJCV1) | Biological | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Presence of Related/Not Related Local and/or Systemic Reactogenicity (Adverse Events) | 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. | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency (%) of Vaccine-specific Immune Responses by Assay and Antigen Using Enzyme-linked Immunosorbent Assay (ELISA) | 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).
|
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Inclusion Criteria:
Exclusion Criteria:
Health
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| Name | Affiliation | Role |
|---|---|---|
| Ramiro Gutierrez, MD | Enteric Disease Department, Naval Medical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Institute of Research | Silver Spring | Maryland | 20910 | United States |
WRAIR
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48 subjects participated at the Walter Reed Army Institute of Research (WRAIR), Clinical Trials Center (CTC).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| FG002 | 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) |
| FG003 | 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) |
| FG004 | 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) |
| FG005 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety: Presence of Related/Not Related Local and/or Systemic Reactogenicity (Adverse Events) | 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. | 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. | Posted | Number | Adverse Events | up to 7 days |
up to 7 days post-vaccination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute pericarditis | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adbominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ramiro Gutierrez, MD | Enteric Disease Department, Naval Medical Research Center | 301-319-3193 | ramiro.l.gutierrez.mil@mail.mil |
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| ID | Term |
|---|---|
| D002169 | Campylobacter Infections |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000536 | Aluminum Hydroxide |
| C041524 | aluminum sulfate |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017607 | Aluminum Compounds |
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| CJCV1 10 μg / Alum 0 μg (3A) | Experimental | 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) |
|
| CJCV1 10 μg / Alum 125 μg (1A) | Experimental | 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) |
|
| Alhydrogel®, aluminum hydroxide adjuvant (alum) | Drug |
|
| Study Days 0-56 |
| Vaccine-specific Geometric Mean Titers (GMT) of Anti-CPS IgG Antibody-secreting Cells | Anti-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). | Study Days 0-56 |
| Vaccine-specific Anti-CRM^197 IgA Antibody-secreting Cell (ASC) Responses | Anti-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). | Study Days 0-56 |
| Interferon Titers Among All Cohorts | CRM197-specific interferon-y (IFNy) responses measured from PBMC on day0, 28 and 56 | Day 0, 28 and 56 |
| BG001 | 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) |
| BG002 | 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) |
| BG003 | 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) |
| BG004 | 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) |
| BG005 | 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) |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 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) |
| OG001 | 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) |
| OG002 | 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) |
| OG003 | 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) |
| OG004 | 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) |
| OG005 | 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) |
|
|
| Secondary | Frequency (%) of Vaccine-specific Immune Responses by Assay and Antigen Using Enzyme-linked Immunosorbent Assay (ELISA) | 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).
| Campylobacter jejuni conjugate vaccine (1CJCV1); antibody-secreting cell(s) (ASCs); Peripheral blood mononuclear cell (PBMCs) | Posted | Number | % of immune response | Study Days 0-56 |
|
|
|
| Secondary | Vaccine-specific Geometric Mean Titers (GMT) of Anti-CPS IgG Antibody-secreting Cells | Anti-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). | Posted | Geometric Mean | 95% Confidence Interval | GMTs | Study Days 0-56 |
|
|
|
| Secondary | Vaccine-specific Anti-CRM^197 IgA Antibody-secreting Cell (ASC) Responses | Anti-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). | Posted | Geometric Mean | 95% Confidence Interval | GMTs | Study Days 0-56 |
|
|
|
| Secondary | Interferon Titers Among All Cohorts | CRM197-specific interferon-y (IFNy) responses measured from PBMC on day0, 28 and 56 | Posted | Geometric Mean | 95% Confidence Interval | GMTs | Day 0, 28 and 56 |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| 8 |
| 8 |
| EG001 | 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) | 0 | 8 | 0 | 8 | 8 | 8 |
| EG002 | 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) | 0 | 8 | 0 | 8 | 8 | 8 |
| EG003 | 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) | 0 | 8 | 0 | 8 | 8 | 8 |
| EG004 | 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) | 0 | 8 | 0 | 8 | 8 | 8 |
| EG005 | 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) | 0 | 8 | 0 | 8 | 8 | 8 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Loose stool | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| LUE pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| LUE tenderness | General disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Phantom sensation LUE | General disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Sweats | General disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Vaccine site ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Vaccine site erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Vaccine site induration | General disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Vaccine site nodule | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Vaccine site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Vaccine site swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Vaccine site tenderness | General disorders | MedDRA (Unspecified) | Systematic Assessment | Related |
|
| Abdominal pain/cramping | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Acute pericarditis | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Allergic rhinitis | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Allergy headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Ankel sprain-right | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Decreased blood glucose | Investigations | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Decreased platelets | Investigations | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Dental caries | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Ecchymosis LUE | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Elevated ALT | Investigations | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Elevated AST | Investigations | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Elevated blood glucose | Investigations | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Elevated cosinophils | Investigations | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Elevated WBC | Investigations | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Epigastric pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Feverish chills | General disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Gastric pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Hangover symptoms | General disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Hemoglobin decrease | Investigations | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Increased cosinophil | Investigations | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Left eyelid twitching | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Loose stool | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Low back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Right fingertip pareshesias | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Soft tissue chest muscle pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Sweats | General disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Upper respiratory infection symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Unrelated |
|
Not provided
Not provided
| D000838 |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| Serum IgG (CRM197) (a) |
|
| IgG ASCs (CPS-BSA) (b) |
|
| IgG ASCs (CRM197) (b) |
|