Clinical trial NCT01887912: Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
Official title: Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Clostridium Difficile Infection
Keywords: Clostridium difficile Toxoid Vaccine
Clostridium difficile infection
Cdiffense
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 9302
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was observer-blind. The vaccine preparer and administrator may have been unblinded to treatment assignment due to the steps necessary for vaccine preparation. However, the participant, the Investigator, and study staff members who collected the safety data and laboratory personnel who analyzed the blood and stool samples were all blinded to the group assignment.
Primary purpose: PREVENTION

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.

Detailed description: The study was designed as an event-driven group sequential protocol with 4 interim analyses at defined information milestones and a final analysis when a specific number of clinical endpoints are reached. Analyses of trial futility (non-efficacy) were to be performed at the first 2 interim analyses, and the study was to be stopped if either of those analyses provided robust and compelling evidence that meaningful levels of vaccine efficacy (VE) would not be demonstrated.

Following completion of the first interim analysis (50 cases of confirmed CDI observed), the futility criterion was met and in accordance with IDMC recommendation, enrollment and further vaccination ceased in November 2017.

Due to the early termination of the study, some of the planned secondary efficacy endpoints could not be analyzed as all planned data were not collected.

Participants were randomized to receive either the candidate vaccine or a placebo that was to be administered in a 3-dose schedule. At the time of group assignment, 928 participants (10% of total enrollment) were randomized to an immunogenicity subset; and 1859 participants (20% of total enrollment) were randomized to a reactogenicity subset.

Safety was assessed in all participants in terms of unsolicited adverse events from Day 0 to Day 60, as well as serious adverse events (SAEs) throughout the study. Solicited adverse reactions were collected for 6 days following each injection in the reactogenicity subset.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Number of Participants With Symptomatic Polymerase Chain Reaction (PCR)-Confirmed Primary C. Difficile Infection (CDI) Cases
timeFrame: Up to 3 years post injection 1
Secondary outcomes:
measure: Number of Participants With Severe PCR-Confirmed Primary CDI Cases
timeFrame: Up to 3 years post injection 1
measure: Number of Participants With Loose Stool Episodes
timeFrame: Up to 3 years post injection 1
measure: Number of Participants With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population
timeFrame: Up to 3 years post injection 1
measure: Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
timeFrame: Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110
measure: Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA
timeFrame: Day 60
measure: Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI
timeFrame: Day 0 and Day 60
measure: Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
timeFrame: Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110
measure: Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA
timeFrame: Day 60
measure: Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI
timeFrame: Day 0 and Day 60
measure: Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions
timeFrame: Day 0 to Day 6 after any vaccination
Other outcomes:
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city: Weston
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city: Woolloongabba
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city: Bedford Park
country: Australia
facility: Investigational Site 404
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city: Clayton
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state: Victoria
city: Nedlands
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state: Western Australia
city: Subiaco
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city: Salvador
country: Brazil
state: BA
city: Salvador
country: Brazil
state: BA
city: Aparecida de Goiânia
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city: Belo Horizonte
country: Brazil
state: MG
city: Belo Horizonte
country: Brazil
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city: Juiz De Fora
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city: Recife
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state: PE
city: Curitiba
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city: Nova Iguaçu
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city: Vancouver
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state: British Columbia
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state: Manitoba
city: Halifax
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state: Nova Scotia
city: Truro
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state: Nova Scotia
city: Guelph
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city: Toronto
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city: Montreal
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state: Quebec
city: Pierrefonds
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city: Québec
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city: Sherbrooke
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state: Quebec
city: Trois-Rivières
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state: Quebec
city: Barranquilla
country: Colombia
state: Alantico
city: Medellin
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state: Antioquia
city: Bogota
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state: Ditrito Capital
city: Bogota
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state: Ditrito
city: Armenia
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state: Quindio
city: Bucaramanga
country: Colombia
state: Santander
city: Floridablanca
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state: Santander
city: Yopal
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city: San José
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city: Aarhus
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city: Santo Domingo
country: Dominican Republic
facility: Investigational Site 347
city: Espoo
country: Finland
city: Helsinki
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city: Helsinki
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city: Järvenpää
country: Finland
facility: Investigational Site 203
city: Kokkola
country: Finland
city: Oulu
country: Finland
city: Pori
country: Finland
city: Seinajoki
country: Finland
city: Tampere
country: Finland
facility: Investigational Site 201
city: Turku
country: Finland
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city: Vantaa
country: Finland
city: Dijon
country: France
facility: Investigational Site 230
city: Lille
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Montpellier
country: France
city: Orleans
country: France
city: Paris
country: France
facility: Investigational Site 221
city: Pringy
country: France
facility: Investigational Site 229
city: Saint Etienne
country: France
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country: France
facility: Investigational Site 223
city: Tourcoing
country: France
city: Tours
country: France
facility: Investigational Site 232
city: Munich
country: Germany
state: Bavaria
city: Wurzburg
country: Germany
facility: Investigational Site 242
state: Bayern
city: Deggingen
country: Germany
facility: Investigational Site 244
state: BW
city: Cologne
country: Germany
state: NRW
city: Leipzig
country: Germany
state: Sachsen
city: Jena
country: Germany
state: Thuringia
city: Berlin
country: Germany
city: Berlin
country: Germany
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facility: Investigational Site 247
city: Hamburg
country: Germany
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city: Leipzig
country: Germany
city: Guatemala
country: Guatemala
city: Aichi
country: Japan
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city: Chiba
country: Japan
facility: Investigational Site 468
city: Fukui
country: Japan
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city: Fukuoka
country: Japan
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city: Fukuoka
country: Japan
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city: Fukuoka
country: Japan
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city: Gunma
country: Japan
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city: Hyōgo
country: Japan
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city: Ibaraki
country: Japan
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city: Kyoto
country: Japan
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city: Kyoto
country: Japan
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city: Nagano
country: Japan
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city: Nagano
country: Japan
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city: Nagano
country: Japan
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city: Okinawa
country: Japan
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city: Saitama
country: Japan
facility: Investigational Site 459
city: Shimonoseki
country: Japan
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city: Tokyo
country: Japan
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city: Yamaguchi
country: Japan
facility: Investigational Site 463
city: Ōsaka
country: Japan
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city: Seoul
country: Korea, Republic of
state: Gangnam-gu
city: Wŏnju
country: Korea, Republic of
facility: Investigational Site 407
state: Gangwon-do
city: Ansan
country: Korea, Republic of
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state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
state: Jung-Gu
city: Incheon
country: Korea, Republic of
facility: Investigational Site 427
state: Namdong-gu
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country: Korea, Republic of
state: Seocho-gu
city: Seoul
country: Korea, Republic of
state: Seodaemun-gu
city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
state: Seongdong-gu
city: Seoul
country: Korea, Republic of
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country: Korea, Republic of
facility: Investigational Site 446
city: Cheongju
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
facility: Investigational Site 439
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
facility: Investigational Site 438
city: Aguascalientes
country: Mexico
state: AGS
city: Tijuana
country: Mexico
state: Baja California
city: Mexico City
country: Mexico
facility: Investigational Site 325
state: D.f.
city: Mexico City
country: Mexico
facility: Investigational Site 329
state: D.f.
city: Ecatepec
country: Mexico
facility: Investigational Site 352
state: Estado De Mexico
city: Guadalajara
country: Mexico
facility: Investigational Site 324
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Investigational Site 351
state: Morelos
city: Monterrey
country: Mexico
state: NL
city: San Luis Potosi
country: Mexico
state: SLP
city: Ciudad Victoria
country: Mexico
facility: Investigational Site 363
state: Tamaulipas
city: Durango
country: Mexico
facility: Investigational Site 326
city: Morelos
country: Mexico
city: San Luis Potosi
country: Mexico
city: Panama City
country: Panama
facility: Investigational Site 354
city: Trujillo
country: Peru
facility: Investigational Site 364
state: La Libertad
city: Jesus Maria
country: Peru
facility: Investigational Site 332
state: Lima
city: Lima Cercado
country: Peru
state: Lima
city: San Martín de Porres
country: Peru
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state: Lima
city: Surquillo
country: Peru
state: Lima
city: Lima
country: Peru
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city: Lima
country: Peru
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city: Lima
country: Peru
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country: Peru
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city: Alabang
country: Philippines
city: Dasmarinas
country: Philippines
city: Manila
country: Philippines
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country: Philippines
city: Pasig City
country: Philippines
city: Quezon City
country: Philippines
city: Quezon City
country: Philippines
city: Bydgoszcz
country: Poland
facility: Investigational Site 284
city: Nowy Duninów
country: Poland
facility: Investigational Site 283
city: Bayamon
country: Puerto Rico
facility: Investigational Site 171
city: Bayamon
country: Puerto Rico
city: Singapore
country: Singapore
city: Singapore
country: Singapore
facility: Investigational Site 419
city: Singapore
country: Singapore
city: Singapore
country: Singapore
facility: Investigational Site 428
city: Singapore
country: Singapore
facility: Investigational Site 445
city: Cordoba
country: Spain
facility: Investigational Site 294
city: Santander
country: Spain
facility: Investigational Site 293
city: Terrassa
country: Spain
facility: Investigational Site 292
city: Vigo
country: Spain
facility: Investigational Site 295
city: Göthenburg
country: Sweden
state: SWE
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Kaohsiung
country: Taiwan
city: New Taipei City
country: Taiwan
facility: Investigational Site 426
city: New Taipei City
country: Taiwan
city: Taichung City
country: Taiwan
facility: Investigational Site 429
city: Tainan
country: Taiwan
facility: Investigational Site 421
city: Taipei
country: Taiwan
facility: Investigational Site 425
city: Tiachung
country: Taiwan
city: Bangkok
country: Thailand
facility: Investigational Site 443
city: Bangkok
country: Thailand
facility: Investigational Site 442
city: Khon Kaen
country: Thailand
facility: Investigational Site 441
city: Blackpool
country: United Kingdom
facility: Investigational Site 276
city: Blackpool
country: United Kingdom
city: Coventry
country: United Kingdom
facility: Investigational Site 277
city: Harrow
country: United Kingdom
city: Leeds
country: United Kingdom
facility: Investigational Site 281
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
facility: Investigational Site 271
city: Manchester
country: United Kingdom
city: Middlesex
country: United Kingdom
city: North Shields
country: United Kingdom
city: Penzance
country: United Kingdom
facility: Investigational Site 275
city: Stoke on Trent
country: United Kingdom
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.