Clinical trial NCT02725437: Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults
Official title: A Phase 1, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Two 3-dose Regimens Of Clostridium Difficile Vaccine Administered In Healthy Japanese Adults Aged 65 To 85 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clostridium Difficile Associated Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability, and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years.


Eligibility criteria: Inclusion Criteria:

1. Healthy male and female adults
2. Aged 65 to 85 years

Exclusion Criteria:

1. Proven or suspected prior episode of Clostridium difficile associated diarrhea
2. Unstable chronic medical condition
3. Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine
4. Serious chronic medical disorders
5. Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate intramuscular injection
6. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
7. Subjects with congenital or acquired immunodeficiency disorders
8. Subjects with rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications
9. Active or treated leukemia or lymphoma or bone marrow disorder
10. Residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living
11. Abnormality in screening hematology and/or blood chemistry laboratory values

Primary outcomes:
measure: Proportions of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self-reported on e-diaries
timeFrame: Up to 14 days after each vaccination
measure: Proportions of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self-reported on e-diaries
timeFrame: Up to 14 days after each vaccination
measure: Proportions of subjects reporting AEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
timeFrame: From the first vaccination up to 28 days after the last vaccination
measure: Proportions of subjects reporting SAEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
timeFrame: From the first vaccination until 6 months after the last vaccination
measure: Proportions of subjects with abnormal hematology and blood chemistry laboratory assessments
timeFrame: 7 days or 14 days after each vaccination
Secondary outcomes:
measure: Toxin A- and toxin B-specific neutralizing antibody levels, expressed as geometric mean concentrations
timeFrame: Up to 6 months after dose 3
measure: Geometric mean fold rises in toxin A- and toxin B-specific neutralizing antibody levels
timeFrame: Up to 6 months after dose 3
measure: Proportions of subjects in each vaccine group with toxin A-specific neutralizing antibody level ≥ the specified threshold for toxin A
timeFrame: Up to 6 months after dose 3
measure: Proportions of subjects in each vaccine group with toxin B-specific neutralizing antibody level ≥ the specified threshold for toxin B
timeFrame: Up to 6 months after dose 3
measure: Proportions of subjects in each vaccine group with both toxin A- and toxin B-specific neutralizing antibody levels ≥ the specified threshold for toxin A and the specified threshold for toxin B, respectively
timeFrame: Up to 6 months after dose 3
measure: Proportions of subjects in each vaccine group with fold rises in toxin A-specific neutralizing antibody levels
timeFrame: Up to 6 months after dose 3
measure: Proportions of subjects in each vaccine group with fold rises in toxin B-specific neutralizing antibody levels
timeFrame: Up to 6 months after dose 3
measure: Proportions of subjects in each vaccine group with fold rises in both toxin A- and toxin B-specific neutralizing antibody levels
timeFrame: Up to 6 months after dose 3
Other outcomes:
Locations:
city: Sumida-ku
country: Japan
facility: SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)
state: Tokyo
city: Fukuoka
country: Japan
facility: SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic)
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Inoue M, Yonemura T, de Solom R, Yamaji M, Aizawa M, Knirsch C, Pride MW, Jansen KU, Gruber W, Webber C. A phase 1 randomized study assessing safety and immunogenicity of two 3-dose regimens of a Clostridium difficile vaccine in healthy older Japanese adults. Vaccine. 2019 May 1;37(19):2600-2607. doi: 10.1016/j.vaccine.2019.03.014. Epub 2019 Apr 5.