Trial reportInfection and immunity2001
Safety and immunogenicity of increasing doses of a Clostridium difficile toxoid vaccine administered to healthy adults.
Trial report in Infection and immunity, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
50 citing papers in PubMed, 1 synthesis or guideline pooled it, 155 citations in OpenAlex.
- Pooled it
- Adenosine deaminase co-immunization reverses age-associated immunosenescence by restoring germinal center T follicular helper cell function.bioRxiv : the preprint server for biology · 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
- Immunization Strategies Against Clostridioides difficile.Advances in experimental medicine and biology · 2024Review
- European Practice for CDI Treatment.Advances in experimental medicine and biology · 2024Article
- Mucosal Vaccination Strategies againstVaccines · 2023Review
- Major pathogenicIranian journal of basic medical sciences · 2022Review
- In Vitro and In Vivo Anti-Journal of microbiology and biotechnology · 2022Article
- Immune response againstTherapeutic advances in gastroenterology · 2021Review
- A probiotic yeast-based immunotherapy againstScience translational medicine · 2020Article
- A Bayesian design for phase I cancer therapeutic vaccine trials.Statistics in medicine · 2019Article
- Management of adult Clostridium difficile digestive contaminations: a literature review.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2019Review
- [Treatment of acute and recurrent Clostridium difficile infections : What is new?]Der Internist · 2018Review
- A Review of the Safety and Efficacy of Vaccines as Prophylaxis for Clostridium difficile Infections.Vaccines · 2017Review
- Article
- Intravenous adenovirus expressing a multi-specific, single-domain antibody neutralizing TcdA and TcdB protects mice from Clostridium difficile infection.Pathogens and disease · 2016Article
- Vaccines for Healthcare-associated Infections: Promise and Challenge.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Article
- Clostridium difficile Infection.Microbiology spectrum · 2016Review
- Review
- A chimeric protein comprising the glucosyltransferase and cysteine proteinase domains of toxin B and the receptor binding domain of toxin A induces protective immunity against Clostridium difficile infection in mice and hamsters.Human vaccines & immunotherapeutics · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
Abstract
Clostridium difficile is a major cause of nosocomial diarrhea in industrialized countries. Although most illnesses respond to available therapy, infection can increase morbidity, prolong hospitalization, and produce life-threatening colitis. Vaccines are being explored as an alternative means for protecting high-risk individuals. We assessed the safety, immunogenicity, and dose response of a parenteral vaccine containing C. difficile toxoids A and B. Thirty healthy adults were assigned to receive four spaced inoculations on days 1, 8, 30, and 60 with one of three doses of vaccine (6.25, 25, or 100 microg). At each dose level, subjects were randomized, in a double-blind fashion, to receive either the soluble toxoids (n = 5) or toxoids adsorbed to alum (n = 5). Subjects were monitored for clinical and immunologic responses to vaccination. Vaccination was generally well tolerated, with occasional, usually mild, systemic reactions (abdominal pain, arthralgia, and diarrhea). The most common local reaction, mild arm pain, was reported by all recipients of the toxoid-alum formulation. Nearly all subjects (> or = 90%) developed vigorous serum antibody responses to both toxins, as measured by immunoglobulin G (IgG) enzyme-linked immunosorbent assay and neutralization of cytotoxicity, whereas fecal IgA increases occurred in approximately 50%. Statistically significant effects of dose and formulation on immunogenicity were not seen, although antibody levels tended to be higher with the alum-adjuvanted formulations and with increasing doses of soluble toxoid. Serum antibody responses among the toxoid-alum group appeared to plateau at 25 microg. We concluded that the C. difficile toxoid vaccine is safe and immunogenic in healthy volunteers. Further development as a prophylactic vaccine or for producing C. difficile hyperimmune globulin is justified.
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What OpenQuestion holds
Registered trials
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.