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Safety and immunogenicity of an adjuvanted clostridioides difficile vaccine candidate in healthy adults : a randomized placebo-controlled phase 1 study

Isabel Leroux-Roels (UGent) , Azhar Alhatemi (UGent) , Magalie Caubet, Fien De Boever (UGent) , Bertrand de Wergifosse, Mohamed El Idrissi, Guilherme S Ferreira, Bart Jacobs (UGent) , Axel Lambert, Sandra Morel, et al.
(2025) JOURNAL OF INFECTIOUS DISEASES. 231(3). p.e511-e520
Author
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Abstract
Bacterial infection with Clostridioides difficile can be severe or life threatening. A vaccine candidate to prevent C. difficile infection is being developed, containing a protein (F2 antigen) that stimulates the immune system to neutralize 2 C. difficile toxins. This is the first study investigating this vaccine candidate in people.Healthy people aged 18-45 years were given 2 doses of placebo or F2 antigen. People aged 50-70 years were given 2 doses of placebo, F2 antigen, or F2 antigen with an additional component (adjuvant) that helps stimulate the immune response. Some also received a third dose of F2 antigen or F2 antigen with adjuvant.The vaccine candidate was well tolerated with an acceptable safety profile. Injection site pain, tiredness, and headache were the most common side effects. The effects were mostly mild to moderate and transient, and were more frequently reported in the adjuvanted group, as expected. No serious safety events were considered related to the vaccine candidate.The vaccine candidate induced neutralization activity against both toxins, especially when given with adjuvant. In people with no measurable neutralization activity at the study start, a third dose increased the response. These findings offer potentially valuable insights for C. difficile vaccine development.
Keywords
adjuvant, Clostridioides difficile, immunogenicity, safety, vaccine candidate, TOXOID VACCINE, INFECTION, PREVENTION, GUIDELINES

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MLA
Leroux-Roels, Isabel, et al. “Safety and Immunogenicity of an Adjuvanted Clostridioides Difficile Vaccine Candidate in Healthy Adults : A Randomized Placebo-Controlled Phase 1 Study.” JOURNAL OF INFECTIOUS DISEASES, vol. 231, no. 3, 2025, pp. e511–20, doi:10.1093/infdis/jiae466.
APA
Leroux-Roels, I., Alhatemi, A., Caubet, M., De Boever, F., de Wergifosse, B., El Idrissi, M., … Yarzabal, J. P. (2025). Safety and immunogenicity of an adjuvanted clostridioides difficile vaccine candidate in healthy adults : a randomized placebo-controlled phase 1 study. JOURNAL OF INFECTIOUS DISEASES, 231(3), e511–e520. https://doi.org/10.1093/infdis/jiae466
Chicago author-date
Leroux-Roels, Isabel, Azhar Alhatemi, Magalie Caubet, Fien De Boever, Bertrand de Wergifosse, Mohamed El Idrissi, Guilherme S Ferreira, et al. 2025. “Safety and Immunogenicity of an Adjuvanted Clostridioides Difficile Vaccine Candidate in Healthy Adults : A Randomized Placebo-Controlled Phase 1 Study.” JOURNAL OF INFECTIOUS DISEASES 231 (3): e511–20. https://doi.org/10.1093/infdis/jiae466.
Chicago author-date (all authors)
Leroux-Roels, Isabel, Azhar Alhatemi, Magalie Caubet, Fien De Boever, Bertrand de Wergifosse, Mohamed El Idrissi, Guilherme S Ferreira, Bart Jacobs, Axel Lambert, Sandra Morel, Charlotte Servais, and Juan Pablo Yarzabal. 2025. “Safety and Immunogenicity of an Adjuvanted Clostridioides Difficile Vaccine Candidate in Healthy Adults : A Randomized Placebo-Controlled Phase 1 Study.” JOURNAL OF INFECTIOUS DISEASES 231 (3): e511–e520. doi:10.1093/infdis/jiae466.
Vancouver
1.
Leroux-Roels I, Alhatemi A, Caubet M, De Boever F, de Wergifosse B, El Idrissi M, et al. Safety and immunogenicity of an adjuvanted clostridioides difficile vaccine candidate in healthy adults : a randomized placebo-controlled phase 1 study. JOURNAL OF INFECTIOUS DISEASES. 2025;231(3):e511–20.
IEEE
[1]
I. Leroux-Roels et al., “Safety and immunogenicity of an adjuvanted clostridioides difficile vaccine candidate in healthy adults : a randomized placebo-controlled phase 1 study,” JOURNAL OF INFECTIOUS DISEASES, vol. 231, no. 3, pp. e511–e520, 2025.
@article{01JQ71YGVYJWQ8NJGXNKZRZRBM,
  abstract     = {{Bacterial infection with Clostridioides difficile can be severe or life threatening. A vaccine candidate to prevent C. difficile infection is being developed, containing a protein (F2 antigen) that stimulates the immune system to neutralize 2 C. difficile toxins. This is the first study investigating this vaccine candidate in people.Healthy people aged 18-45 years were given 2 doses of placebo or F2 antigen. People aged 50-70 years were given 2 doses of placebo, F2 antigen, or F2 antigen with an additional component (adjuvant) that helps stimulate the immune response. Some also received a third dose of F2 antigen or F2 antigen with adjuvant.The vaccine candidate was well tolerated with an acceptable safety profile. Injection site pain, tiredness, and headache were the most common side effects. The effects were mostly mild to moderate and transient, and were more frequently reported in the adjuvanted group, as expected. No serious safety events were considered related to the vaccine candidate.The vaccine candidate induced neutralization activity against both toxins, especially when given with adjuvant. In people with no measurable neutralization activity at the study start, a third dose increased the response. These findings offer potentially valuable insights for C. difficile vaccine development.}},
  author       = {{Leroux-Roels, Isabel and Alhatemi, Azhar and Caubet, Magalie and De Boever, Fien and de Wergifosse, Bertrand and El Idrissi, Mohamed and Ferreira, Guilherme S and Jacobs, Bart and Lambert, Axel and Morel, Sandra and Servais, Charlotte and Yarzabal, Juan Pablo}},
  issn         = {{0022-1899}},
  journal      = {{JOURNAL OF INFECTIOUS DISEASES}},
  keywords     = {{adjuvant,Clostridioides difficile,immunogenicity,safety,vaccine candidate,TOXOID VACCINE,INFECTION,PREVENTION,GUIDELINES}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{e511--e520}},
  title        = {{Safety and immunogenicity of an adjuvanted clostridioides difficile vaccine candidate in healthy adults : a randomized placebo-controlled phase 1 study}},
  url          = {{http://doi.org/10.1093/infdis/jiae466}},
  volume       = {{231}},
  year         = {{2025}},
}
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