Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020
A Phase 2 Study Evaluating the Safety, Tolerability, and Immunogenicity of Two 3-Dose Regimens of a Clostridium difficile Vaccine in Healthy US Adults Aged 65 to 85 Years.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02561195 (A PHASE 2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TWO 3-DOSE REGIMENS OF A CLOSTRIDIUM DIFFICILE VACCINE IN HEALTHY ADULTS AGED 65 TO 85 YEARS), which is not on this map. Cited by 30 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 2, placebo-controlled, randomized, observer-blinded study to evaluate the safety, tolerability, and immunogenicity of two 3-dose regimens of a clostridium difficile vaccine in healthy adults aged 65 to 85 years
Who cites it
30 citing papers in PubMed, 52 citations in OpenAlex.
- Safety and Immunogenicity of an Adjuvanted Clostridioides difficile Vaccine Candidate in Healthy Adults: A Randomized Placebo-Controlled Phase 1 Study.The Journal of infectious diseases · 2025Trial
- CLOVER (CLOstridium difficile Vaccine Efficacy tRial) Study: A Phase 3, Randomized Trial Investigating the Efficacy and Safety of a Detoxified Toxin A/B Vaccine in Adults 50 Years and Older at Increased Risk of Clostridioides difficile Infection.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- A Phase 2 Extension Study Evaluating the Immunogenicity, Safety, and Tolerability of 3 or 4 Doses of a Clostridioides difficile Vaccine in Healthy US Adults Aged 65 to 85 Years.The Journal of infectious diseases · 2024Trial
- Microbiome-based therapeutics forGut microbes · 2026Review
- Randomized Phase 3 Comparison of a 2-Dose and 3-Dose Regimen of a Detoxified Toxin A/BOpen forum infectious diseases · 2026Article
- Pooled analyses of Clostridioides difficile vaccine trials identify baseline predictors for vaccine response.Scientific reports · 2026Article
- Comprehensive Evaluation of the Efficacy and Safety of theThe Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2026Article
- AgainstToxins · 2025Review
- The Role ofMicroorganisms · 2025Review
- Mechanisms ofFrontiers in cellular and infection microbiology · 2025Review
- Healthcare as a driver, reservoir and amplifier of antimicrobial resistance: opportunities for interventions.Nature reviews. Microbiology · 2024Review
- Vaccines and monoclonal antibodies to prevent healthcare-associated bacterial infections.Clinical microbiology reviews · 2024Review
- Review
- Advances in Therapeutic Strategies for the Management ofJournal of clinical medicine · 2024Review
- Recent advances in fecal microbiota transplantation forFrontiers in microbiomes · 2024Review
- European Practice for CDI Treatment.Advances in experimental medicine and biology · 2024Article
- Immunization Strategies Against Clostridioides difficile.Advances in experimental medicine and biology · 2024Review
- Host Immune Responses toTropical medicine and infectious disease · 2023Review
- Review
- Microbiome-Related and Infection Control Approaches to Primary and Secondary Prevention ofMicroorganisms · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundClostridium difficile causes toxin-mediated nosocomial diarrhea and community-acquired infections; no preventive vaccine is licensed. In this phase 2 study, we explored safety, tolerability, and immunogenicity in older US adults of an investigational bivalent C. difficile vaccine that contains equal dosages of genetically and chemically detoxified toxins A and B.
methodsConducted from July 2015 through March 2017, 855 healthy adults aged 65-85 years from 15 US centers were randomized 3:3:1 to receive vaccine (100 or 200 μg) or placebo at 0, 1, and 6 months (month regimen) or 1, 8, and 30 days (day regimen). Serum toxin A- and B-specific neutralizing antibodies were measured. Participant-reported local reactions (LRs) and systemic events (SEs), adverse events (AEs), serious AEs, newly diagnosed chronic medical conditions, and immediate AEs were recorded.
resultsThe 200-μg dose level elicited higher immune responses than the 100-µg dose level across regimens. Compared with the day regimen, the month regimen induced stronger and more persistent immune responses that remained elevated 12 months after dose 3. Responses peaked at month 7 (month regimen) and day 37 (day regimen). LRs (primarily injection site pain) were more frequent in vaccine recipients than controls; SE frequency was similar across groups. More related AEs were reported in the day regimen group than the month regimen group.
conclusionsThe C. difficile vaccine was safe, well tolerated, and immunogenic in healthy US adults aged 65-85 years. Immune responses were particularly robust in the 200-μg month regimen group. These results support continued vaccine development. CLINICAL TRIALS REGISTRATION: NCT02561195.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.