Campylobacter InfectionPhase 1CJCV1-01NCT02067676
Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea
A Phase 1 study testing Capsule-Conjugate Campylobacter Vaccine (CJCV1) and Alhydrogel®, aluminum hydroxide adjuvant (alum) in people with Campylobacter Infection, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Campylobacter Infection
- What is being tested?
- Capsule-Conjugate Campylobacter Vaccine (CJCV1) and Alhydrogel®, aluminum hydroxide adjuvant (alum)
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2014to 22 Jan 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult, male or female, age 18 to 50 years (inclusive) at the time of enrollment.
- Completion and review of comprehension test (achieved 70% accuracy).
- Signed informed consent document.
- Available for the required follow-up period and scheduled clinic visits and telephone follow-up.
- Women: Negative pregnancy test with understanding (through informed consent) to not become pregnant during the study or within three months after the last vaccine dose (Day 28). Sexually active females, unless surgically sterile or at least one year postmenopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner, or sterile sexual partner) prior to dosing of study vaccine. Female subjects unable to bear children must have a note from a primary care provider or obstetrics and gynaecology (OB/GYN) as proof of documentation (eg, tubal ligation or hysterectomy). If a volunteer becomes pregnant during the study, the PI will notify the study monitor, the sponsor, and the local institutional review board (IRB). The volunteer will be asked to provide serial follow-ups, including copies of clinic visits on the status of her pregnancy as well as health information on her infant following delivery.
Who cannot join
- Health
- Health problems affecting study participation from medical history (specifically to include chronic medical conditions such as diabetes mellitus and hypertension or any other condition requiring daily therapy that would place the volunteer at increased risk of adverse events (AEs). Study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the research monitor as appropriate.
- Clinically significant abnormalities on physical examination
- Use of immunosuppressive drugs, such as corticosteroids and chemotherapy, during the course of the study or immunosuppressive illness, including IgA deficiency (defined by serum IgA below level of detection)
- Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last vaccine dose and currently nursing women
- Participation in research involving another investigational product 30 days before the planned date of first vaccination until the last study safety visit.
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- Positive blood test for HIV-1 (the human immunodeficiency virus and cause of AIDS)
- Positive blood test for hepatitis B surface antigen (HBsAG; the virus causing hepatitis B)
- Positive blood test for anti-HCV antibody (the virus causing hepatitis C)
- Clinically significant abnormalities on basic laboratory screening
- Presence of significant unexplained laboratory abnormalities that in the opinion of the PI may potentially confound the analysis of the study results Research Specific
- Regular use (weekly or more often) of anti-diarrheal, anti-constipation, or antacid therapy
- Abnormal bowel habits as defined by fewer than 3 stools per week or more than 3 loose/liquid stools per day
- Personal or family history of inflammatory arthritis
- Personal history of irritable bowel syndrome
- Positive blood test for HLA-B27
- History of allergy to any vaccine
- History of allergy to alum
- History of Guillain-Barré Syndrome or other neuroimmunological disorders Prior Exposure to Campylobacter
- History of travelers' diarrhea or residence (> 2 months) in the past 3 years in a country with potentially higher Campylobacter rates to include Africa, South America, Central America, and Asia (except Japan).
- Occupation involving handling of Campylobacter bacteria or vaccine products currently or in the past 3 years.
- History of microbiologically confirmed Campylobacter infection.
- Received previous experimental Campylobacter vaccine or live Campylobacter challenge.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910
About this study
Official title: Safety and Immunogenicity Evaluation of an Intramuscular Capsule-Conjugate Campylobacter Vaccine (CJCV1)
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.
Read the detailed description
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).
- Conditions
- Campylobacter Infection
- Being tested
- Capsule-Conjugate Campylobacter Vaccine (CJCV1), Alhydrogel®, aluminum hydroxide adjuvant (alum)
- Keywords
- Campylobacter jejuni
- Medical subject headings
- Campylobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
Alhydrogel®, aluminum hydroxide adjuvant (alum)Drug
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1) |
| 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) Receives: Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1); Drug: 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) Receives: Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1) |
| 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) Receives: Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1); Drug: Alhydrogel®, aluminum hydroxide adjuvant (alum) |
| 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) Receives: Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1) |
| 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) Receives: Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1); Drug: Alhydrogel®, aluminum hydroxide adjuvant (alum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 7 days
Secondary outcomes (4)
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).
- = Seroconversion was defined as >4fold increase in endpoint titer between pre- and post-vaccine samples and a post-vaccine reciprocal titer >10.
- = 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.
Measured: 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).
Measured: 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).
Measured: Study Days 0-56
Interferon Titers Among All Cohorts
CRM197-specific interferon-y (IFNy) responses measured from PBMC on day0, 28 and 56
Measured: Day 0, 28 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study start21 Apr 2014
- Primary completion24 Sep 2014
- Study completion22 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Campylobacter InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- Ramiro Gutierrez, MD, Principal investigator, Enteric Disease Department, Naval Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067676
- Sponsor's protocol ID
- S-13-09
- Other IDs
- NMRC.2013.0021
- Acronym
- CJCV1-01
- Status last verified
- Jan 2018
- First submitted
- 18 Feb 2014
- Last updated
- 23 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: WRAIR
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Evaluation of an Intramuscular Capsule-Conjugate Campylobacter Vaccine (CJCV1)
- ClinicalTrials.gov ID
- NCT02067676
- Acronym / sponsor ID
- CJCV1-01 / S-13-09
- Conditions
- Campylobacter Infection
- Keywords
- Campylobacter jejuni
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- 21 Apr 2014 (actual)
- Primary completion
- 24 Sep 2014 (actual)
- Study completion
- 22 Jan 2016 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Posted 25 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CJCV1 2 μg / Alum 0 μg (1A) | Experimental | Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1)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 | Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1), Drug: Alhydrogel®, aluminum hydroxide adjuvant (alum)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 | Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1)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 | Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1), Drug: Alhydrogel®, aluminum hydroxide adjuvant (alum)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) |
| CJCV1 10 μg / Alum 0 μg (3A) | Experimental | Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1)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 | Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1), Drug: Alhydrogel®, aluminum hydroxide adjuvant (alum)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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult, male or female, age 18 to 50 years (inclusive) at the time of enrollment.
- Completion and review of comprehension test (achieved 70% accuracy).
- Signed informed consent document.
- Available for the required follow-up period and scheduled clinic visits and telephone follow-up.
- Women: Negative pregnancy test with understanding (through informed consent) to not become pregnant during the study or within three months after the last vaccine dose (Day 28). Sexually active females, unless surgically sterile or at least one year postmenopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner, or sterile sexual partner) prior to dosing of study vaccine. Female subjects unable to bear children must have a note from a primary care provider or obstetrics and gynaecology (OB/GYN) as proof of documentation (eg, tubal ligation or hysterectomy). If a volunteer becomes pregnant during the study, the PI will notify the study monitor, the sponsor, and the local institutional review board (IRB). The volunteer will be asked to provide serial follow-ups, including copies of clinic visits on the status of her pregnancy as well as health information on her infant following delivery.
Key exclusion criteria (23 listed)
- Health
- Health problems affecting study participation from medical history (specifically to include chronic medical conditions such as diabetes mellitus and hypertension or any other condition requiring daily therapy that would place the volunteer at increased risk of adverse events (AEs). Study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the research monitor as appropriate.
- Clinically significant abnormalities on physical examination
- Use of immunosuppressive drugs, such as corticosteroids and chemotherapy, during the course of the study or immunosuppressive illness, including IgA deficiency (defined by serum IgA below level of detection)
- Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last vaccine dose and currently nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Biological | CJCV1 10 μg / Alum 0 μg (3A), CJCV1 10 μg / Alum 125 μg (1A), CJCV1 2 μg / Alum 0 μg (1A), CJCV1 2 μg / Alum 125 μg (1B), CJCV1 5 μg / Alum 0 μg (2A), CJCV1 5 μg / Alum 125 μg (2B) |
| Alhydrogel®, aluminum hydroxide adjuvant (alum) | Drug | CJCV1 10 μg / Alum 125 μg (1A), CJCV1 2 μg / Alum 125 μg (1B), CJCV1 5 μg / Alum 125 μg (2B) |
Primary outcome
Safety: Presence of Related/Not Related Local and/or Systemic Reactogenicity (Adverse Events)
Time frame: up to 7 days
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.
4 secondary outcomes
Frequency (%) of Vaccine-specific Immune Responses by Assay and Antigen Using Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: Study Days 0-56
Vaccine-specific Geometric Mean Titers (GMT) of Anti-CPS IgG Antibody-secreting Cells
Time frame: Study Days 0-56
Vaccine-specific Anti-CRM^197 IgA Antibody-secreting Cell (ASC) Responses
Time frame: Study Days 0-56
Interferon Titers Among All Cohorts
Time frame: Day 0, 28 and 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. WRAIR
Related trials for Campylobacter Infection
RecruitingObservational study
Mucosal and Microbiota Changes During Acute Campylobacteriosis
Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramiro Gutierrez, MD principal investigator
Enteric Disease Department, Naval Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Capsule-Conjugate Campylobacter Vaccine (CJCV1) and Alhydrogel®, aluminum hydroxide adjuvant (alum) in people with Campylobacter Infection, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Presence of Related/Not Related Local and/or Systemic Reactogenicity (Adverse Events) (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.