Safety and immunogenicity of a combined Tetanus, Diphtheria, recombinant acellular Pertussis vaccine (TdaP) in healthy Thai adults
Background: An acellular Pertussis (aP) vaccine containing recombinant genetically detoxified Pertussis Toxin (PTgen), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) has been developed by BioNet-Asia (BioNet). We present here the results of the first clinical study of this recombinant aP vaccin...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2017-01-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2016.1234555 |
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| author | Chukiat Sirivichayakul Pornthep Chanthavanich Kriengsak Limkittikul Claire-Anne Siegrist Wassana Wijagkanalan Pailinrut Chinwangso Jean Petre Pham Hong Thai Mukesh Chauhan Simonetta Viviani |
| author_facet | Chukiat Sirivichayakul Pornthep Chanthavanich Kriengsak Limkittikul Claire-Anne Siegrist Wassana Wijagkanalan Pailinrut Chinwangso Jean Petre Pham Hong Thai Mukesh Chauhan Simonetta Viviani |
| author_sort | Chukiat Sirivichayakul |
| collection | DOAJ |
| description | Background: An acellular Pertussis (aP) vaccine containing recombinant genetically detoxified Pertussis Toxin (PTgen), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) has been developed by BioNet-Asia (BioNet). We present here the results of the first clinical study of this recombinant aP vaccine formulated alone or in combination with tetanus and diphtheria toxoids (TdaP). Methods: A phase I/II, observer-blind, randomized controlled trial was conducted at Mahidol University in Bangkok, Thailand in healthy adult volunteers aged 18–35 y. The eligible volunteers were randomized to receive one dose of either BioNet's aP or Tetanus toxoid-reduced Diphtheria toxoid-acellular Pertussis (TdaP) vaccine, or the Tdap Adacel® vaccine in a 1:1:1 ratio. Safety follow-up was performed for one month. Immunogenicity was assessed at baseline, at 7 and 28 d after vaccination. Anti-PT, anti-FHA, anti-PRN, anti-tetanus and anti-diphtheria IgG antibodies were assessed by ELISA. Anti-PT neutralizing antibodies were assessed also by CHO cell assay. Results: A total of 60 subjects (20 per each vaccine group) were enrolled and included in the safety analysis. Safety laboratory parameters, incidence of local and systemic post-immunization reactions during 7 d after vaccination and incidence of adverse events during one month after vaccination were similar in the 3 vaccine groups. One month after vaccination, seroresponse rates of anti-PT, anti-FHA and anti-PRN IgG antibodies exceeded 78% in all vaccine groups. The anti-PT IgG, anti-FHA IgG, and anti-PT neutralizing antibody geometric mean titers (GMTs) were significantly higher following immunization with BioNet's aP and BioNet's TdaP than Adacel® (P< 0.05). The anti-PRN IgG, anti-tetanus and anti-diphtheria GMTs at one month after immunization were comparable in all vaccine groups. All subjects had seroprotective titers of anti-tetanus and anti-diphtheria antibodies at baseline. Conclusion: In this first clinical study, PTgen-based BioNet's aP and TdaP vaccines showed a similar tolerability and safety profile to Adacel® and elicited significantly higher immune responses to PT and FHA. |
| first_indexed | 2024-03-11T22:01:42Z |
| format | Article |
| id | doaj.art-6a54544991a24c4597d8ba54f9454172 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:01:42Z |
| publishDate | 2017-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-6a54544991a24c4597d8ba54f94541722023-09-25T11:00:54ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2017-01-0113113614310.1080/21645515.2016.12345551234555Safety and immunogenicity of a combined Tetanus, Diphtheria, recombinant acellular Pertussis vaccine (TdaP) in healthy Thai adultsChukiat Sirivichayakul0Pornthep Chanthavanich1Kriengsak Limkittikul2Claire-Anne Siegrist3Wassana Wijagkanalan4Pailinrut Chinwangso5Jean Petre6Pham Hong Thai7Mukesh Chauhan8Simonetta Viviani9Faculty of Tropical Medicine, Mahidol UniversityFaculty of Tropical Medicine, Mahidol UniversityFaculty of Tropical Medicine, Mahidol UniversityWHO Collaborating Center for Vaccine Immunology, Faculty of Medicine, University of GenevaBioNet-Asia Co., Ltd., PrakanongBioNet-Asia Co., Ltd., PrakanongBioNet-Asia Co., Ltd., PrakanongBioNet-Asia Co., Ltd., PrakanongBioNet-Asia Co., Ltd., PrakanongBioNet-Asia Co., Ltd., PrakanongBackground: An acellular Pertussis (aP) vaccine containing recombinant genetically detoxified Pertussis Toxin (PTgen), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) has been developed by BioNet-Asia (BioNet). We present here the results of the first clinical study of this recombinant aP vaccine formulated alone or in combination with tetanus and diphtheria toxoids (TdaP). Methods: A phase I/II, observer-blind, randomized controlled trial was conducted at Mahidol University in Bangkok, Thailand in healthy adult volunteers aged 18–35 y. The eligible volunteers were randomized to receive one dose of either BioNet's aP or Tetanus toxoid-reduced Diphtheria toxoid-acellular Pertussis (TdaP) vaccine, or the Tdap Adacel® vaccine in a 1:1:1 ratio. Safety follow-up was performed for one month. Immunogenicity was assessed at baseline, at 7 and 28 d after vaccination. Anti-PT, anti-FHA, anti-PRN, anti-tetanus and anti-diphtheria IgG antibodies were assessed by ELISA. Anti-PT neutralizing antibodies were assessed also by CHO cell assay. Results: A total of 60 subjects (20 per each vaccine group) were enrolled and included in the safety analysis. Safety laboratory parameters, incidence of local and systemic post-immunization reactions during 7 d after vaccination and incidence of adverse events during one month after vaccination were similar in the 3 vaccine groups. One month after vaccination, seroresponse rates of anti-PT, anti-FHA and anti-PRN IgG antibodies exceeded 78% in all vaccine groups. The anti-PT IgG, anti-FHA IgG, and anti-PT neutralizing antibody geometric mean titers (GMTs) were significantly higher following immunization with BioNet's aP and BioNet's TdaP than Adacel® (P< 0.05). The anti-PRN IgG, anti-tetanus and anti-diphtheria GMTs at one month after immunization were comparable in all vaccine groups. All subjects had seroprotective titers of anti-tetanus and anti-diphtheria antibodies at baseline. Conclusion: In this first clinical study, PTgen-based BioNet's aP and TdaP vaccines showed a similar tolerability and safety profile to Adacel® and elicited significantly higher immune responses to PT and FHA.http://dx.doi.org/10.1080/21645515.2016.1234555clinical trialphase i/iithailandrecombinant acellular pertussis vaccinetdap |
| spellingShingle | Chukiat Sirivichayakul Pornthep Chanthavanich Kriengsak Limkittikul Claire-Anne Siegrist Wassana Wijagkanalan Pailinrut Chinwangso Jean Petre Pham Hong Thai Mukesh Chauhan Simonetta Viviani Safety and immunogenicity of a combined Tetanus, Diphtheria, recombinant acellular Pertussis vaccine (TdaP) in healthy Thai adults Human Vaccines & Immunotherapeutics clinical trial phase i/ii thailand recombinant acellular pertussis vaccine tdap |
| title | Safety and immunogenicity of a combined Tetanus, Diphtheria, recombinant acellular Pertussis vaccine (TdaP) in healthy Thai adults |
| title_full | Safety and immunogenicity of a combined Tetanus, Diphtheria, recombinant acellular Pertussis vaccine (TdaP) in healthy Thai adults |
| title_fullStr | Safety and immunogenicity of a combined Tetanus, Diphtheria, recombinant acellular Pertussis vaccine (TdaP) in healthy Thai adults |
| title_full_unstemmed | Safety and immunogenicity of a combined Tetanus, Diphtheria, recombinant acellular Pertussis vaccine (TdaP) in healthy Thai adults |
| title_short | Safety and immunogenicity of a combined Tetanus, Diphtheria, recombinant acellular Pertussis vaccine (TdaP) in healthy Thai adults |
| title_sort | safety and immunogenicity of a combined tetanus diphtheria recombinant acellular pertussis vaccine tdap in healthy thai adults |
| topic | clinical trial phase i/ii thailand recombinant acellular pertussis vaccine tdap |
| url | http://dx.doi.org/10.1080/21645515.2016.1234555 |
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