A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months
This first in human study was designed as an open label clinical trial to assess the safety and immunogenicity of SIIPL DTwP-HepB-IPV-Hib (Hexavalent) combination vaccine in healthy toddlers, aged 16–24 months. A total of 24 healthy toddlers were administered a 0.5 ml single dose of SIIPL DTwP-HepB-...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2022-11-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2022.2146435 |
| _version_ | 1827806363413118976 |
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| author | Hitt Sharma Sanjay Lalwani Sameer Parekh Pramod Pujari Sunil Shewale Sonali Palkar Neeta Hanumante Shilpa Gokhale Jaganathan Ks Rakesh Kumar Inderjit Sharma Sunil Gairola |
| author_facet | Hitt Sharma Sanjay Lalwani Sameer Parekh Pramod Pujari Sunil Shewale Sonali Palkar Neeta Hanumante Shilpa Gokhale Jaganathan Ks Rakesh Kumar Inderjit Sharma Sunil Gairola |
| author_sort | Hitt Sharma |
| collection | DOAJ |
| description | This first in human study was designed as an open label clinical trial to assess the safety and immunogenicity of SIIPL DTwP-HepB-IPV-Hib (Hexavalent) combination vaccine in healthy toddlers, aged 16–24 months. A total of 24 healthy toddlers were administered a 0.5 ml single dose of SIIPL DTwP-HepB-IPV-Hib vaccine intramuscularly, and followed for 28 days for safety outcomes viz. immediate, solicited, unsolicited and serious adverse events. Blood samples were collected immediately prior to and 28 days after vaccination to assess the immunogenicity. Twenty four completed the study in compliance with the study protocol. None of the participants experienced any immediate or any serious adverse event. In terms of the frequency and intensity, the adverse events were comparable to DTwP-based combination vaccines. The vaccine elicited a strong booster response as demonstrated by a large increase in antibodies against all vaccine antigens. One month post booster vaccination seroprotection for diphtheria, tetanus, Hepatitis B, Haemophilus influenzae type b and polio virus type 1 and 3 was 100%. The percentage sero-response for pertussis was 75%. Four-fold increase in antibody concentration for pertussis was achieved in 87.5% subjects. Indigenously developed DTwP-HepB-IPV-Hib vaccine by Serum Institute of India Pvt. Ltd. was found to be safe, well tolerated and showed a robust immune response in toddlers. It was concluded that this vaccine should be assessed in the next phases of clinical development in the target population. Clinical Trial Registration – CTRI/2018/10/015875. |
| first_indexed | 2024-03-11T21:40:07Z |
| format | Article |
| id | doaj.art-cdd376e1788d4b8c9561126652699c3f |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:40:07Z |
| publishDate | 2022-11-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-cdd376e1788d4b8c9561126652699c3f2023-09-26T13:25:46ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2022-11-0118610.1080/21645515.2022.21464352146435A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 monthsHitt Sharma0Sanjay Lalwani1Sameer Parekh2Pramod Pujari3Sunil Shewale4Sonali Palkar5Neeta Hanumante6Shilpa Gokhale7Jaganathan Ks8Rakesh Kumar9Inderjit Sharma10Sunil Gairola11Serum Institute of India Pvt. LtdBharati Vidyapeeth (Deemed to be University) Medical college & HospitalSerum Institute of India Pvt. LtdSerum Institute of India Pvt. LtdSerum Institute of India Pvt. LtdBharati Vidyapeeth (Deemed to be University) Medical college & HospitalBharati Vidyapeeth (Deemed to be University) Medical college & HospitalBharati Vidyapeeth (Deemed to be University) Medical college & HospitalSerum Institute of India Pvt. LtdSerum Institute of India Pvt. LtdSerum Institute of India Pvt. LtdSerum Institute of India Pvt. LtdThis first in human study was designed as an open label clinical trial to assess the safety and immunogenicity of SIIPL DTwP-HepB-IPV-Hib (Hexavalent) combination vaccine in healthy toddlers, aged 16–24 months. A total of 24 healthy toddlers were administered a 0.5 ml single dose of SIIPL DTwP-HepB-IPV-Hib vaccine intramuscularly, and followed for 28 days for safety outcomes viz. immediate, solicited, unsolicited and serious adverse events. Blood samples were collected immediately prior to and 28 days after vaccination to assess the immunogenicity. Twenty four completed the study in compliance with the study protocol. None of the participants experienced any immediate or any serious adverse event. In terms of the frequency and intensity, the adverse events were comparable to DTwP-based combination vaccines. The vaccine elicited a strong booster response as demonstrated by a large increase in antibodies against all vaccine antigens. One month post booster vaccination seroprotection for diphtheria, tetanus, Hepatitis B, Haemophilus influenzae type b and polio virus type 1 and 3 was 100%. The percentage sero-response for pertussis was 75%. Four-fold increase in antibody concentration for pertussis was achieved in 87.5% subjects. Indigenously developed DTwP-HepB-IPV-Hib vaccine by Serum Institute of India Pvt. Ltd. was found to be safe, well tolerated and showed a robust immune response in toddlers. It was concluded that this vaccine should be assessed in the next phases of clinical development in the target population. Clinical Trial Registration – CTRI/2018/10/015875.http://dx.doi.org/10.1080/21645515.2022.2146435hexavalenttoddlerphase ivaccinesafety |
| spellingShingle | Hitt Sharma Sanjay Lalwani Sameer Parekh Pramod Pujari Sunil Shewale Sonali Palkar Neeta Hanumante Shilpa Gokhale Jaganathan Ks Rakesh Kumar Inderjit Sharma Sunil Gairola A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months Human Vaccines & Immunotherapeutics hexavalent toddler phase i vaccine safety |
| title | A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months |
| title_full | A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months |
| title_fullStr | A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months |
| title_full_unstemmed | A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months |
| title_short | A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months |
| title_sort | phase i open label clinical study to assess the safety and immunogenicity of indigenously developed liquid dtwp hepb ipv hib hexavalent combination vaccine in healthy toddlers aged 16 24 months |
| topic | hexavalent toddler phase i vaccine safety |
| url | http://dx.doi.org/10.1080/21645515.2022.2146435 |
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