Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults
This was a randomized, placebo-controlled, Phase I/II study conducted in a Japanese cohort to assess the safety and immunogenicity of Clostridium difficile vaccine (the same formulation as that used in the ongoing global Phase III study). Healthy Japanese adults aged 40–75 years were randomized to r...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2018-02-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2017.1395538 |
| _version_ | 1827809957859295232 |
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| author | Osamu Matsuoka Dhaval M. Patel Shin Sasaki Hayato Oka Toru Sasaki Patricia J. Pietrobon Thelma Laot Alain Bouckenooghe Josemund Menezes Guy de Bruyn |
| author_facet | Osamu Matsuoka Dhaval M. Patel Shin Sasaki Hayato Oka Toru Sasaki Patricia J. Pietrobon Thelma Laot Alain Bouckenooghe Josemund Menezes Guy de Bruyn |
| author_sort | Osamu Matsuoka |
| collection | DOAJ |
| description | This was a randomized, placebo-controlled, Phase I/II study conducted in a Japanese cohort to assess the safety and immunogenicity of Clostridium difficile vaccine (the same formulation as that used in the ongoing global Phase III study). Healthy Japanese adults aged 40–75 years were randomized to receive either C. difficile vaccine (N = 67) or placebo (N = 34) by intramuscular injection on Days 0, 7, and 30. Serum IgG specific for toxins A and B was measured by enzyme-linked immunosorbent assay (ELISA) and in vitro functional activity by toxin neutralizing assay (TNA). The seroconversion rate (percentage of participants with a ≥4-fold rise in antibody levels from baseline) was high for both toxin A (ELISA and TNA) and toxin B (ELISA), approaching 100% for each by Day 60. For toxin B assessed by TNA, however, the response was lower, with the seroconversion rate not rising significantly beyond the value of 42.9% seen on Day 14 (44.4% at Day 60). Although the response in the participants who were seronegative at baseline was slower than that in those who were seropositive, seroconversion was seen in nearly all (100%) subjects by Day 60, with the exception of the response to toxin B evaluated using TNA (16–18% on Days 14–60). The proportion of participants with solicited local reactions, solicited systemic reactions, and vaccine-related unsolicited reactions were 67.6%, 19.1%, and 20.6%, respectively. Most of the adverse reactions were mild to moderate in intensity, occurring within 3 days post-vaccination, and resolving by 3–6 days post-vaccination. There were no withdrawals due to adverse events and no serious adverse events. These data confirm the safety and immunogenicity of C. difficile vaccine in Japanese adults. |
| first_indexed | 2024-03-11T22:47:05Z |
| format | Article |
| id | doaj.art-9c3dc09bf2ee47019249f073ede3f0c2 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:47:05Z |
| publishDate | 2018-02-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-9c3dc09bf2ee47019249f073ede3f0c22023-09-22T08:17:53ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2018-02-0114232232810.1080/21645515.2017.13955381395538Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adultsOsamu Matsuoka0Dhaval M. Patel1Shin Sasaki2Hayato Oka3Toru Sasaki4Patricia J. Pietrobon5Thelma Laot6Alain Bouckenooghe7Josemund Menezes8Guy de Bruyn9ToCROM ClinicSanofi Pasteur, Research and DevelopmentSanofi K.K., Sanofi Pasteur MedicalSanofi K.K., Sanofi Pasteur MedicalSanofi K.K., Medical OperationSanofi Pasteur, Research and DevelopmentSanofi Pasteur, Global Clinical ScienceSanofi Pasteur, Global Clinical ScienceSanofi Pasteur, Global Clinical ScienceSanofi Pasteur, Research and DevelopmentThis was a randomized, placebo-controlled, Phase I/II study conducted in a Japanese cohort to assess the safety and immunogenicity of Clostridium difficile vaccine (the same formulation as that used in the ongoing global Phase III study). Healthy Japanese adults aged 40–75 years were randomized to receive either C. difficile vaccine (N = 67) or placebo (N = 34) by intramuscular injection on Days 0, 7, and 30. Serum IgG specific for toxins A and B was measured by enzyme-linked immunosorbent assay (ELISA) and in vitro functional activity by toxin neutralizing assay (TNA). The seroconversion rate (percentage of participants with a ≥4-fold rise in antibody levels from baseline) was high for both toxin A (ELISA and TNA) and toxin B (ELISA), approaching 100% for each by Day 60. For toxin B assessed by TNA, however, the response was lower, with the seroconversion rate not rising significantly beyond the value of 42.9% seen on Day 14 (44.4% at Day 60). Although the response in the participants who were seronegative at baseline was slower than that in those who were seropositive, seroconversion was seen in nearly all (100%) subjects by Day 60, with the exception of the response to toxin B evaluated using TNA (16–18% on Days 14–60). The proportion of participants with solicited local reactions, solicited systemic reactions, and vaccine-related unsolicited reactions were 67.6%, 19.1%, and 20.6%, respectively. Most of the adverse reactions were mild to moderate in intensity, occurring within 3 days post-vaccination, and resolving by 3–6 days post-vaccination. There were no withdrawals due to adverse events and no serious adverse events. These data confirm the safety and immunogenicity of C. difficile vaccine in Japanese adults.http://dx.doi.org/10.1080/21645515.2017.1395538clostridium difficileimmunogenicitysafetyvaccine |
| spellingShingle | Osamu Matsuoka Dhaval M. Patel Shin Sasaki Hayato Oka Toru Sasaki Patricia J. Pietrobon Thelma Laot Alain Bouckenooghe Josemund Menezes Guy de Bruyn Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults Human Vaccines & Immunotherapeutics clostridium difficile immunogenicity safety vaccine |
| title | Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults |
| title_full | Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults |
| title_fullStr | Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults |
| title_full_unstemmed | Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults |
| title_short | Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults |
| title_sort | safety and immunogenicity of clostridium difficile toxoid vaccine in japanese adults |
| topic | clostridium difficile immunogenicity safety vaccine |
| url | http://dx.doi.org/10.1080/21645515.2017.1395538 |
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