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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01887912
Registration number
NCT01887912
Ethics application status
Date submitted
20/06/2013
Date registered
27/06/2013
Titles & IDs
Public title
Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
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Scientific title
Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)
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Secondary ID [1]
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2013-000775-32
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Secondary ID [2]
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H-030-014
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Clostridium Difficile Infection
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0
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Condition category
Condition code
Infection
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0
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0
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Studies of infection and infectious agents
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Infection
0
0
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0
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Other infectious diseases
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Infection
0
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0
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Sexually transmitted infections
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - C. difficile Toxoid Vaccine
Treatment: Other - Placebo: 0.9% normal saline
Experimental: C. difficile Vaccine Group - Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
Placebo comparator: Placebo Group - Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
Treatment: Other: C. difficile Toxoid Vaccine
0.5 mL, Intramuscular
Treatment: Other: Placebo: 0.9% normal saline
0.5 mL, Intramuscular
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Symptomatic Polymerase Chain Reaction (PCR)-Confirmed Primary C. Difficile Infection (CDI) Cases
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Assessment method [1]
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Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \>= 3 loose stools in \<= 24 hours, loose stools (defined as type 6 \[fluffy pieces with ragged edges, mushy\] or type 7 \[watery, no solid pieces\] according to the Bristol Stool Chart) lasting \>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.
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Timepoint [1]
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Up to 3 years post injection 1
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Secondary outcome [1]
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Number of Participants With Severe PCR-Confirmed Primary CDI Cases
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Assessment method [1]
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Severe CDI cases were defined as number of participants with at least one of the following symptoms: fever \>= 38.5 degree Celsius (°C), white blood cell count \>= 15,000 cells/mm\^3, ileus, pseudomembranous colitis, serum albumin \<3 gram per deciliter, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis.
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Timepoint [1]
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Up to 3 years post injection 1
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Secondary outcome [2]
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Number of Participants With Loose Stool Episodes
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Assessment method [2]
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Loose stools were defined as type 6 (fluffy pieces with ragged edges, mushy) or type 7 (watery, no solid pieces) according to the Bristol Stool Chart. In this outcome measure, participants with number of loose stool episodes (categorized as: loose stool episodes less than 3, 3 to 6, 7 to 10, 11 to 15 and greater than 15) were reported.
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Timepoint [2]
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Up to 3 years post injection 1
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Secondary outcome [3]
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Number of Participants With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population
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Assessment method [3]
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Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \>= 3 loose stools in \<= 24 hours, loose stools (defined as type 6 \[fluffy pieces with ragged edges, mushy\] or type 7 \[watery, no solid pieces\] according to the Bristol Stool Chart) lasting \>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. Analysis was performed on per-protocol efficacy analysis set (PPEAS).
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Timepoint [3]
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Up to 3 years post injection 1
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Secondary outcome [4]
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Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
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Assessment method [4]
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Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as geometric mean concentration (GMC). The 2-sided 95% Confidence Interval (CI) of GMC was based on the Student t-distribution. Analysis was performed on Per Protocol Immunogenicity Analysis Set, which included participants who had at least 1 injection, no relevant protocol deviations (not met inclusion criteria/ met exclusion criteria, not received vaccine/ not received in proper time window, received different vaccine than randomized, preparation and/ or administration of vaccine not per protocol, protocol-restricted therapy, not provided post-dose serology sample/serology sample did not produced a valid test result).
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Timepoint [4]
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Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110
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Secondary outcome [5]
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Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA
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Assessment method [5]
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Percentage of Participants with \>= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by ELISA. The 2-sided 95% Cl of the percentage was based on Exact method calculations.
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Timepoint [5]
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Day 60
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Secondary outcome [6]
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Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI
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Assessment method [6]
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Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as GMC. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \>= 3 loose stools in \<= 24 hours, loose stools (defined as type 6 \[fluffy pieces with ragged edges, mushy\] or type 7 \[watery, no solid pieces\] according to the Bristol Stool Chart) lasting \>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.
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Timepoint [6]
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Day 0 and Day 60
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Secondary outcome [7]
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Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
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Assessment method [7]
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Serum antibody concentrations against toxins A and B were measured by TNA and expressed as geometric mean titer (GMT). The 2-sided 95% Cl of GMT was based on the Student t-distribution.
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Timepoint [7]
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Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110
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Secondary outcome [8]
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Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA
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Assessment method [8]
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Percentage of Participants with \>= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by TNA. The 2-sided 95% CI of the percentage was based on Exact method calculations.
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Timepoint [8]
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Day 60
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Secondary outcome [9]
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Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI
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Assessment method [9]
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Serum antibody concentrations against toxins A and B were measured by TNA and were expressed as GMT. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \>= 3 loose stools in \<= 24 hours, loose stools (defined as type 6 \[fluffy pieces with ragged edges, mushy\] or type 7 \[watery, no solid pieces\] according to the Bristol Stool Chart) lasting \>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.
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Timepoint [9]
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Day 0 and Day 60
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Secondary outcome [10]
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Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions
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Assessment method [10]
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Solicited injection site reactions: pain, erythema, and swelling. Pain: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Erythema and swelling: Grade 1: \>= 25 to \<=50 mm, Grade 2: \>51 to \<=100 mm, Grade 3: \>100 mm. Solicited systemic reactions: fever, headache, malaise, myalgia, and arthralgia. Fever: Grade 1: \>= 38.0°C to \<=38.4°C or \>= 100.4° Fahrenheit (F) to \<=101.1°F, Grade 2: \>=38.5°C to \<= 38.9°C or \>=101.2°F to \<=102.0°F, Grade 3: \>=39.0°C or \>=102.1°F. Headache, malaise, and myalgia: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Arthralgia: Grade 1: free range of motion but complains of pain or discomfort, Grade 2: decreased range of motion due to pain or discomfort, Grade 3: unwilling to move due to pain.
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Timepoint [10]
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Day 0 to Day 6 after any vaccination
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Eligibility
Key inclusion criteria
* Aged >= 50 years on the day of inclusion
* Informed consent form had been signed and dated.
* Attended all scheduled visits and complied with all trial procedures.
* Covered by health insurance (if required).
* Must fulfill at least 1 of the following criteria
Risk Stratum 1:
* Had at least 2 hospital stays, each lasting at least >= 24 hours, in the 12 months before enrollment, and
* Had received systemic (not topical) antibiotics in the 12 months before enrollment, or
Risk Stratum 2:
* Was anticipated to have an in-patient hospitalization for a planned surgical procedure within 60 days of enrollment. The impending hospital stay was planned to be >= 72 hours for a surgery involving 1 of the following:
* Kidney/bladder/urinary system
* Musculoskeletal system
* Respiratory system
* Circulatory system
* Central nervous system.
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Minimum age
50
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination).
* Participation in the 4 weeks preceding the first trial vaccination or participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for influenza (seasonal or pandemic) and pneumococcal vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
* Previous vaccination against C. difficile with either the trial vaccine, another vaccine, or monoclonal antibodies.
* Diarrhea on day of enrollment.
* Self-reported current or prior CDI episode.
* Anticipated or current receipt of kidney dialysis treatment.
* History of gastrointestinal surgery for gastrointestinal malignancy (Note: Colonoscopy, polypectomy, and appendectomy are not exclusion criteria).
* History of inflammatory bowel disease, irritable bowel syndrome (must include diarrhea as a symptom), colostomy, or small or large intestine bowel surgery where resection was performed.
* Receiving enteral feeding (e.g., nasogastric, gastrostomy, and jejunostomy tube feeding).
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
* Self-reported thrombocytopenia, contraindicating intramuscular vaccination.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures in the opinion of the Investigator.
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [>= 100.4°Fahrenheit]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/07/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/06/2018
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Sample size
Target
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Accrual to date
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Final
9302
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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- Westmead
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Recruitment hospital [2]
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Investigational Site 401 - Cairns
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Recruitment hospital [3]
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- Woolloongabba
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Recruitment hospital [4]
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Investigational Site 404 - Bedford Park
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Recruitment hospital [5]
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Investigational Site 403 - Clayton
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Recruitment hospital [6]
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- Nedlands
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Recruitment hospital [7]
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- Subiaco
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4870 - Cairns
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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5042 - Bedford Park
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment postcode(s) [7]
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6008 - Subiaco
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Recruitment outside Australia
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United States of America
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Alabama
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GO
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Funding & Sponsors
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Commercial sector/industry
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Name
Sanofi Pasteur, a Sanofi Company
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Ethics approval
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Summary
Brief summary
The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need. Primary objective: * To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged \>= 50 years who are at risk for CDI and have received at least 1 injection. Secondary Objectives: Efficacy: * To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days. * To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections. Immunogenicity: * To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60. Safety: * To describe the safety profile of all participants who received at least 1 injection.
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Trial website
https://clinicaltrials.gov/study/NCT01887912
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Trial related presentations / publications
de Bruyn G, Gordon DL, Steiner T, Tambyah P, Cosgrove C, Martens M, Bassily E, Chan ES, Patel D, Chen J, Torre-Cisneros J, Fernando De Magalhaes Francesconi C, Gesser R, Jeanfreau R, Launay O, Laot T, Morfin-Otero R, Oviedo-Orta E, Park YS, Piazza FM, Rehm C, Rivas E, Self S, Gurunathan S. Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial. Lancet Infect Dis. 2021 Feb;21(2):252-262. doi: 10.1016/S1473-3099(20)30331-5. Epub 2020 Sep 15.
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Public notes
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Contacts
Principal investigator
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Medical Director
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Sanofi Pasteur Inc.
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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When will data be available (start and end dates)?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/12/NCT01887912/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/12/NCT01887912/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01887912