Clostridium Difficile InfectionPhase 1CDVAXNCT02991417
Oral Vaccination Against Clostridium Difficile Infection
A Phase 1 study testing CDVAX in people with Clostridium Difficile Infection, run by Simon M. Cutting.
Trial summary
This clinical study is conducted to assess the safety and immunogenicity of a Clostridium difficile vaccine (CDVAX) in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- CDVAX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 8 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Male
- Age: 18-50 years (limits included)
- Body mass index within 18.5 and 29.9 kg/m²
- Ability to read and comprehend study information
- Non-smokers or light smokers (<4 cigarettes per day)
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- In good physical and mental health as determined by the following:
- Complete medical history
- Complete physical and neurological examination
- Vital signs including blood pressure, heart rate, respiratory rate, and temperature
- Standard 12-lead ECG
- Clinical laboratory (biochemistry, haematology and urinalysis) tests. Blood and urine samples may be drawn up to 3 weeks prior to the baseline visit of the study provided all data are available and evaluated prior to administration of study drug. Values of laboratory results outside normal reference ranges may be acceptable if the investigator considers that they do not compromise the safety of the subjects or the conduct of the study.
- Vital signs, clinical laboratory measurements, and ECG measurements may be repeated at the discretion of the investigator
Who cannot join
- Evidence of C. difficile infection
- Anti-C. difficile (Toxin A) immunoreactivity, suggesting previous C. difficile exposure
- Diarrhoea, active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhoea
- History of malignancy within 5 years
- History of anaphylaxis, asthma or severe vaccine or allergic drug reaction
- Known or suspected history of immunodeficiency, active or inactive immune-mediated or inflammatory disease
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- Receipt of antibiotic therapy, immunosuppressants, or corticosteroids within the previous 30 days
- Vaccination within the previous 30 days (except for influenza vaccination)
- Blood or organ donation within the previous 60 days
- Evidence of clinically significant psychiatric, gastrointestinal, neurologic, neuromuscular, hepatic, pulmonary, cardiovascular, or renal disease (as judged by the investigator)
- Use of prescription medication or regular use of over-the-counter medicines or herbal or dietary supplements. Acetaminophen/paracetamol may be used intermittently as needed for pain
- History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse
- Positive hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV)-1/2 antibodies
- Participation in any other investigational drug or device study within 60 days prior to the first study drug administration
- Relatives of, or staff directly reporting to the principal investigator
- Vulnerable subjects
About this study
Official title: Safety and Immunogenicity Study of a Clostridium Difficile Vaccine in Healthy Adult Volunteers
This clinical study is conducted to assess the safety and immunogenicity of a Clostridium difficile vaccine (CDVAX) in healthy adult volunteers.
- Conditions
- Clostridium Difficile Infection
- Being tested
- CDVAX
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDVAXBiological
| Study group | Role | What they receive |
|---|---|---|
| CDVAX | Experimental | Not described Receives: Biological: CDVAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Measured by routine physical and laboratory evaluations, adverse event monitoring, ECG and neurological examination
Measured: First treatment up to end of treatment + 28 days (70 days after treatment start)
Secondary outcomes (1)
Evaluation of specific mucosal and systemic immunity
Measured by specific secretory IgA, serum IgA and serum IgG
Measured: First treatment up to end of treatment + 14 days (56 days after starting study drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion14 Mar 2017
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon M. Cutting
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Simon M. Cutting, Royal Holloway University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991417
- Sponsor's protocol ID
- CDVAX
- Acronym
- CDVAX
- Status last verified
- Jul 2017
- First submitted
- 5 Dec 2016
- Last updated
- 25 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of a Clostridium Difficile Vaccine in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02991417
- Acronym / sponsor ID
- CDVAX / CDVAX
- Conditions
- Clostridium Difficile Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Simon M. CuttingUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 14 Mar 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is conducted to assess the safety and immunogenicity of a Clostridium difficile vaccine (CDVAX) in healthy adult volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDVAX | Experimental | Biological: CDVAX |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Written informed consent
- Male
- Age: 18-50 years (limits included)
- Body mass index within 18.5 and 29.9 kg/m²
- Ability to read and comprehend study information
Key exclusion criteria (16 listed)
- Evidence of C. difficile infection
- Anti-C. difficile (Toxin A) immunoreactivity, suggesting previous C. difficile exposure
- Diarrhoea, active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhoea
- History of malignancy within 5 years
- History of anaphylaxis, asthma or severe vaccine or allergic drug reaction
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 |
|---|---|---|
| CDVAX | Biological | CDVAX |
Primary outcome
Incidence and severity of adverse events
Time frame: First treatment up to end of treatment + 28 days (70 days after treatment start)
Measured by routine physical and laboratory evaluations, adverse event monitoring, ECG and neurological examination
1 secondary outcome
Evaluation of specific mucosal and systemic immunity
Time frame: First treatment up to end of treatment + 14 days (56 days after starting study drug)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDVAX in people with Clostridium Difficile Infection, run by Simon M. Cutting.
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 13 inclusion and 16 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: stopped early, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early. Results are not available in the source record.
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?
Incidence and severity of adverse events (time frame: First treatment up to end of treatment + 28 days (70 days after treatment start)). 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 25 Jul 2017.