A phase 2 study of a combined diphtheria-tetanus-acellular pertussis vaccine with a Sabin-derived inactivated poliovirus vaccine in children
Background: With the goal of global eradication of poliomyelitis due to wild-type viruses within sight, WHO now recommends that infants receive at least one dose of trivalent inactivated poliovirus vaccine (IPV) with bivalent OPV (types 1 and 3) replacing trivalent OPV. Limited manufacturing capacit...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2018-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | http://dx.doi.org/10.1080/21645515.2018.1504538 |
| _version_ | 1827809796079747072 |
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| author | Takashi Nakano Shuji Sumino Yohei Takanami Nodoka Mitsuya Keisuke Nakatome |
| author_facet | Takashi Nakano Shuji Sumino Yohei Takanami Nodoka Mitsuya Keisuke Nakatome |
| author_sort | Takashi Nakano |
| collection | DOAJ |
| description | Background: With the goal of global eradication of poliomyelitis due to wild-type viruses within sight, WHO now recommends that infants receive at least one dose of trivalent inactivated poliovirus vaccine (IPV) with bivalent OPV (types 1 and 3) replacing trivalent OPV. Limited manufacturing capacity and new regulations on manufacturers’ use of wild-type viruses is driving the development of IPV based on attenuated Sabin type polioviruses. Takeda are developing a Sabin-based IPV (sIPV) to augment global capacity and supply. Methods: This study was performed to evaluate three dosages (low, medium and high) of the sIPV when administered as a combination vaccine with diphtheria-tetanus-acellular pertussis antigens (DTaP-sIPV) as a three dose primary series or as booster dose in Japanese infants and toddlers. Results: All formulations were immunogenic and well-tolerated with no safety concerns in either infants or toddlers. There was a dosage-dependent induction of neutralizing antibodies against Sabin polioviruses, the only statistically significant differences being between the low-dose and medium- and high-dose sIPVs. There was good correlation of neutralizing antibodies against Sabin and wild-type polioviruses. No sIPV dose had an observable effect on immune responses to DTaP components or the reactogenicity profile of the combined vaccine. Conclusion: When administered as a DTaP-sIPV combination, Takeda’s sIPV vaccine was well-tolerated and highly immunogenic in infant and toddler schedules. The medium-dose formulation offers the optimal balance between immunogenicity and potential dose-sparing to provide a new source of sIPV to enhance the global supply, while mitigating the environmental risks associated with manufacturing vaccines with wild-type viruses. |
| first_indexed | 2024-03-11T22:44:55Z |
| format | Article |
| id | doaj.art-79db6f39ce024268abceb9e2009dda56 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:44:55Z |
| publishDate | 2018-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-79db6f39ce024268abceb9e2009dda562023-09-22T08:38:23ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2018-12-0114122940294910.1080/21645515.2018.15045381504538A phase 2 study of a combined diphtheria-tetanus-acellular pertussis vaccine with a Sabin-derived inactivated poliovirus vaccine in childrenTakashi Nakano0Shuji Sumino1Yohei Takanami2Nodoka Mitsuya3Keisuke Nakatome4Kawasaki Medical SchoolTakeda Pharmaceutical Company LimitedTakeda Pharmaceutical Company LimitedTakeda Pharmaceutical Company LimitedTakeda Pharmaceutical Company LimitedBackground: With the goal of global eradication of poliomyelitis due to wild-type viruses within sight, WHO now recommends that infants receive at least one dose of trivalent inactivated poliovirus vaccine (IPV) with bivalent OPV (types 1 and 3) replacing trivalent OPV. Limited manufacturing capacity and new regulations on manufacturers’ use of wild-type viruses is driving the development of IPV based on attenuated Sabin type polioviruses. Takeda are developing a Sabin-based IPV (sIPV) to augment global capacity and supply. Methods: This study was performed to evaluate three dosages (low, medium and high) of the sIPV when administered as a combination vaccine with diphtheria-tetanus-acellular pertussis antigens (DTaP-sIPV) as a three dose primary series or as booster dose in Japanese infants and toddlers. Results: All formulations were immunogenic and well-tolerated with no safety concerns in either infants or toddlers. There was a dosage-dependent induction of neutralizing antibodies against Sabin polioviruses, the only statistically significant differences being between the low-dose and medium- and high-dose sIPVs. There was good correlation of neutralizing antibodies against Sabin and wild-type polioviruses. No sIPV dose had an observable effect on immune responses to DTaP components or the reactogenicity profile of the combined vaccine. Conclusion: When administered as a DTaP-sIPV combination, Takeda’s sIPV vaccine was well-tolerated and highly immunogenic in infant and toddler schedules. The medium-dose formulation offers the optimal balance between immunogenicity and potential dose-sparing to provide a new source of sIPV to enhance the global supply, while mitigating the environmental risks associated with manufacturing vaccines with wild-type viruses.http://dx.doi.org/10.1080/21645515.2018.1504538poliovirussabin poliovirusvaccinedtap |
| spellingShingle | Takashi Nakano Shuji Sumino Yohei Takanami Nodoka Mitsuya Keisuke Nakatome A phase 2 study of a combined diphtheria-tetanus-acellular pertussis vaccine with a Sabin-derived inactivated poliovirus vaccine in children Human Vaccines & Immunotherapeutics poliovirus sabin poliovirus vaccine dtap |
| title | A phase 2 study of a combined diphtheria-tetanus-acellular pertussis vaccine with a Sabin-derived inactivated poliovirus vaccine in children |
| title_full | A phase 2 study of a combined diphtheria-tetanus-acellular pertussis vaccine with a Sabin-derived inactivated poliovirus vaccine in children |
| title_fullStr | A phase 2 study of a combined diphtheria-tetanus-acellular pertussis vaccine with a Sabin-derived inactivated poliovirus vaccine in children |
| title_full_unstemmed | A phase 2 study of a combined diphtheria-tetanus-acellular pertussis vaccine with a Sabin-derived inactivated poliovirus vaccine in children |
| title_short | A phase 2 study of a combined diphtheria-tetanus-acellular pertussis vaccine with a Sabin-derived inactivated poliovirus vaccine in children |
| title_sort | phase 2 study of a combined diphtheria tetanus acellular pertussis vaccine with a sabin derived inactivated poliovirus vaccine in children |
| topic | poliovirus sabin poliovirus vaccine dtap |
| url | http://dx.doi.org/10.1080/21645515.2018.1504538 |
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