Long-term Persistence of Immunogenicity After Primary Vaccination and Response to Booster Vaccination With Typhoid Conjugate Vaccine: Results of a Phase IV Extension Study
Objective To evaluate the persistence of antibodies three years after primary vaccination with typhoid conjugate vaccine (TCV) of either Cadila Healthcare Ltd. (Cadila-TCV) or Bharat Biotech International Ltd. (Bharat-TCV) administered in a previous phase II/III study, and to study the booster dose...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Kandulna, Ambrose Kumar [verfasserIn] |
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E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2022 |
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| Schlagwörter: |
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| Anmerkung: |
© Indian Academy of Pediatrics 2022 |
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| Übergeordnetes Werk: |
Enthalten in: Indian Pediatrics - Springer-Verlag, 2010, 59(2022), 5 vom: 28. März, Seite 388-392 |
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| Übergeordnetes Werk: |
volume:59 ; year:2022 ; number:5 ; day:28 ; month:03 ; pages:388-392 |
| Links: |
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| DOI / URN: |
10.1007/s13312-022-2520-7 |
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| Katalog-ID: |
SPR047174455 |
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| 520 | |a Objective To evaluate the persistence of antibodies three years after primary vaccination with typhoid conjugate vaccine (TCV) of either Cadila Healthcare Ltd. (Cadila-TCV) or Bharat Biotech International Ltd. (Bharat-TCV) administered in a previous phase II/III study, and to study the booster dose response to Cadila-TCV. Methods This was an open-label, phase IV extension study conducted in tertiary care and multispecialty hospitals in India. 112 subjects (Cadila-TCV-57, Bharat-TCV-55) who had participated in previous study were enrolled. Of these, eligible subjects received a single-dose of Cadila-TCV and were followed-up for 28 days post-booster. Primary outcome was persistence of antibodies 3 years after primary vaccination and seroconversion (≥4-fold rise in antibody titre from baseline) 28 days post-booster. Safety was based on reported adverse events (AEs) post-booster. Results The baseline GMT reported in the current study was significantly higher than pre-vaccination GMT reported in the previous study. 89/112 (79.5%) subjects had antibody titer ≥10 IU/mL at baseline; eligible subjects (n=17) who had baseline antibody titre <10 IU/mL were administered booster dose. All the vaccinated subjects showed seroconversion post-booster. The GMTs reported at 10 days and 28 days post-booster were significantly higher as compared to GMTs reported after primary vaccination in previous study. 4 (23.5%) vaccinated subjects reported 9 AEs; all were solicited and of mild/moderate intensity. Conclusion There was a significant persistence of immunogenicity after primary vaccination with both the TCVs, and robust immune response after booster vaccination with Cadila-TCV. | ||
| 650 | 4 | |a Efficacy |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Protection |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Safety |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Uttam, Kheya Ghosh |4 aut | |
| 700 | 1 | |a Sharma, Shrikant |4 aut | |
| 700 | 1 | |a Kumar, M. Ravi |4 aut | |
| 700 | 1 | |a Prasad, K. Sivaram |4 aut | |
| 700 | 1 | |a Goyal, Vimal Kant |4 aut | |
| 700 | 1 | |a Jangid, Sanjay Kumar |4 aut | |
| 700 | 1 | |a Daultani, Pavankumar |4 aut | |
| 700 | 1 | |a Mittal, Ravindra |4 aut | |
| 700 | 1 | |a Maithal, Kapil |4 aut | |
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10.1007/s13312-022-2520-7 doi (DE-627)SPR047174455 (SPR)s13312-022-2520-7-e DE-627 ger DE-627 rakwb eng Kandulna, Ambrose Kumar verfasserin aut Long-term Persistence of Immunogenicity After Primary Vaccination and Response to Booster Vaccination With Typhoid Conjugate Vaccine: Results of a Phase IV Extension Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Indian Academy of Pediatrics 2022 Objective To evaluate the persistence of antibodies three years after primary vaccination with typhoid conjugate vaccine (TCV) of either Cadila Healthcare Ltd. (Cadila-TCV) or Bharat Biotech International Ltd. (Bharat-TCV) administered in a previous phase II/III study, and to study the booster dose response to Cadila-TCV. Methods This was an open-label, phase IV extension study conducted in tertiary care and multispecialty hospitals in India. 112 subjects (Cadila-TCV-57, Bharat-TCV-55) who had participated in previous study were enrolled. Of these, eligible subjects received a single-dose of Cadila-TCV and were followed-up for 28 days post-booster. Primary outcome was persistence of antibodies 3 years after primary vaccination and seroconversion (≥4-fold rise in antibody titre from baseline) 28 days post-booster. Safety was based on reported adverse events (AEs) post-booster. Results The baseline GMT reported in the current study was significantly higher than pre-vaccination GMT reported in the previous study. 89/112 (79.5%) subjects had antibody titer ≥10 IU/mL at baseline; eligible subjects (n=17) who had baseline antibody titre <10 IU/mL were administered booster dose. All the vaccinated subjects showed seroconversion post-booster. The GMTs reported at 10 days and 28 days post-booster were significantly higher as compared to GMTs reported after primary vaccination in previous study. 4 (23.5%) vaccinated subjects reported 9 AEs; all were solicited and of mild/moderate intensity. Conclusion There was a significant persistence of immunogenicity after primary vaccination with both the TCVs, and robust immune response after booster vaccination with Cadila-TCV. Efficacy (dpeaa)DE-He213 Protection (dpeaa)DE-He213 Safety (dpeaa)DE-He213 Uttam, Kheya Ghosh aut Sharma, Shrikant aut Kumar, M. Ravi aut Prasad, K. Sivaram aut Goyal, Vimal Kant aut Jangid, Sanjay Kumar aut Daultani, Pavankumar aut Mittal, Ravindra aut Maithal, Kapil aut Enthalten in Indian Pediatrics Springer-Verlag, 2010 59(2022), 5 vom: 28. März, Seite 388-392 (DE-627)SPR031274943 nnns volume:59 year:2022 number:5 day:28 month:03 pages:388-392 https://dx.doi.org/10.1007/s13312-022-2520-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_70 GBV_ILN_72 GBV_ILN_110 GBV_ILN_131 GBV_ILN_160 GBV_ILN_376 GBV_ILN_607 AR 59 2022 5 28 03 388-392 |
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10.1007/s13312-022-2520-7 doi (DE-627)SPR047174455 (SPR)s13312-022-2520-7-e DE-627 ger DE-627 rakwb eng Kandulna, Ambrose Kumar verfasserin aut Long-term Persistence of Immunogenicity After Primary Vaccination and Response to Booster Vaccination With Typhoid Conjugate Vaccine: Results of a Phase IV Extension Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Indian Academy of Pediatrics 2022 Objective To evaluate the persistence of antibodies three years after primary vaccination with typhoid conjugate vaccine (TCV) of either Cadila Healthcare Ltd. (Cadila-TCV) or Bharat Biotech International Ltd. (Bharat-TCV) administered in a previous phase II/III study, and to study the booster dose response to Cadila-TCV. Methods This was an open-label, phase IV extension study conducted in tertiary care and multispecialty hospitals in India. 112 subjects (Cadila-TCV-57, Bharat-TCV-55) who had participated in previous study were enrolled. Of these, eligible subjects received a single-dose of Cadila-TCV and were followed-up for 28 days post-booster. Primary outcome was persistence of antibodies 3 years after primary vaccination and seroconversion (≥4-fold rise in antibody titre from baseline) 28 days post-booster. Safety was based on reported adverse events (AEs) post-booster. Results The baseline GMT reported in the current study was significantly higher than pre-vaccination GMT reported in the previous study. 89/112 (79.5%) subjects had antibody titer ≥10 IU/mL at baseline; eligible subjects (n=17) who had baseline antibody titre <10 IU/mL were administered booster dose. All the vaccinated subjects showed seroconversion post-booster. The GMTs reported at 10 days and 28 days post-booster were significantly higher as compared to GMTs reported after primary vaccination in previous study. 4 (23.5%) vaccinated subjects reported 9 AEs; all were solicited and of mild/moderate intensity. Conclusion There was a significant persistence of immunogenicity after primary vaccination with both the TCVs, and robust immune response after booster vaccination with Cadila-TCV. Efficacy (dpeaa)DE-He213 Protection (dpeaa)DE-He213 Safety (dpeaa)DE-He213 Uttam, Kheya Ghosh aut Sharma, Shrikant aut Kumar, M. Ravi aut Prasad, K. Sivaram aut Goyal, Vimal Kant aut Jangid, Sanjay Kumar aut Daultani, Pavankumar aut Mittal, Ravindra aut Maithal, Kapil aut Enthalten in Indian Pediatrics Springer-Verlag, 2010 59(2022), 5 vom: 28. März, Seite 388-392 (DE-627)SPR031274943 nnns volume:59 year:2022 number:5 day:28 month:03 pages:388-392 https://dx.doi.org/10.1007/s13312-022-2520-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_70 GBV_ILN_72 GBV_ILN_110 GBV_ILN_131 GBV_ILN_160 GBV_ILN_376 GBV_ILN_607 AR 59 2022 5 28 03 388-392 |
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10.1007/s13312-022-2520-7 doi (DE-627)SPR047174455 (SPR)s13312-022-2520-7-e DE-627 ger DE-627 rakwb eng Kandulna, Ambrose Kumar verfasserin aut Long-term Persistence of Immunogenicity After Primary Vaccination and Response to Booster Vaccination With Typhoid Conjugate Vaccine: Results of a Phase IV Extension Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Indian Academy of Pediatrics 2022 Objective To evaluate the persistence of antibodies three years after primary vaccination with typhoid conjugate vaccine (TCV) of either Cadila Healthcare Ltd. (Cadila-TCV) or Bharat Biotech International Ltd. (Bharat-TCV) administered in a previous phase II/III study, and to study the booster dose response to Cadila-TCV. Methods This was an open-label, phase IV extension study conducted in tertiary care and multispecialty hospitals in India. 112 subjects (Cadila-TCV-57, Bharat-TCV-55) who had participated in previous study were enrolled. Of these, eligible subjects received a single-dose of Cadila-TCV and were followed-up for 28 days post-booster. Primary outcome was persistence of antibodies 3 years after primary vaccination and seroconversion (≥4-fold rise in antibody titre from baseline) 28 days post-booster. Safety was based on reported adverse events (AEs) post-booster. Results The baseline GMT reported in the current study was significantly higher than pre-vaccination GMT reported in the previous study. 89/112 (79.5%) subjects had antibody titer ≥10 IU/mL at baseline; eligible subjects (n=17) who had baseline antibody titre <10 IU/mL were administered booster dose. All the vaccinated subjects showed seroconversion post-booster. The GMTs reported at 10 days and 28 days post-booster were significantly higher as compared to GMTs reported after primary vaccination in previous study. 4 (23.5%) vaccinated subjects reported 9 AEs; all were solicited and of mild/moderate intensity. Conclusion There was a significant persistence of immunogenicity after primary vaccination with both the TCVs, and robust immune response after booster vaccination with Cadila-TCV. Efficacy (dpeaa)DE-He213 Protection (dpeaa)DE-He213 Safety (dpeaa)DE-He213 Uttam, Kheya Ghosh aut Sharma, Shrikant aut Kumar, M. Ravi aut Prasad, K. Sivaram aut Goyal, Vimal Kant aut Jangid, Sanjay Kumar aut Daultani, Pavankumar aut Mittal, Ravindra aut Maithal, Kapil aut Enthalten in Indian Pediatrics Springer-Verlag, 2010 59(2022), 5 vom: 28. März, Seite 388-392 (DE-627)SPR031274943 nnns volume:59 year:2022 number:5 day:28 month:03 pages:388-392 https://dx.doi.org/10.1007/s13312-022-2520-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_70 GBV_ILN_72 GBV_ILN_110 GBV_ILN_131 GBV_ILN_160 GBV_ILN_376 GBV_ILN_607 AR 59 2022 5 28 03 388-392 |
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10.1007/s13312-022-2520-7 doi (DE-627)SPR047174455 (SPR)s13312-022-2520-7-e DE-627 ger DE-627 rakwb eng Kandulna, Ambrose Kumar verfasserin aut Long-term Persistence of Immunogenicity After Primary Vaccination and Response to Booster Vaccination With Typhoid Conjugate Vaccine: Results of a Phase IV Extension Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Indian Academy of Pediatrics 2022 Objective To evaluate the persistence of antibodies three years after primary vaccination with typhoid conjugate vaccine (TCV) of either Cadila Healthcare Ltd. (Cadila-TCV) or Bharat Biotech International Ltd. (Bharat-TCV) administered in a previous phase II/III study, and to study the booster dose response to Cadila-TCV. Methods This was an open-label, phase IV extension study conducted in tertiary care and multispecialty hospitals in India. 112 subjects (Cadila-TCV-57, Bharat-TCV-55) who had participated in previous study were enrolled. Of these, eligible subjects received a single-dose of Cadila-TCV and were followed-up for 28 days post-booster. Primary outcome was persistence of antibodies 3 years after primary vaccination and seroconversion (≥4-fold rise in antibody titre from baseline) 28 days post-booster. Safety was based on reported adverse events (AEs) post-booster. Results The baseline GMT reported in the current study was significantly higher than pre-vaccination GMT reported in the previous study. 89/112 (79.5%) subjects had antibody titer ≥10 IU/mL at baseline; eligible subjects (n=17) who had baseline antibody titre <10 IU/mL were administered booster dose. All the vaccinated subjects showed seroconversion post-booster. The GMTs reported at 10 days and 28 days post-booster were significantly higher as compared to GMTs reported after primary vaccination in previous study. 4 (23.5%) vaccinated subjects reported 9 AEs; all were solicited and of mild/moderate intensity. Conclusion There was a significant persistence of immunogenicity after primary vaccination with both the TCVs, and robust immune response after booster vaccination with Cadila-TCV. Efficacy (dpeaa)DE-He213 Protection (dpeaa)DE-He213 Safety (dpeaa)DE-He213 Uttam, Kheya Ghosh aut Sharma, Shrikant aut Kumar, M. Ravi aut Prasad, K. Sivaram aut Goyal, Vimal Kant aut Jangid, Sanjay Kumar aut Daultani, Pavankumar aut Mittal, Ravindra aut Maithal, Kapil aut Enthalten in Indian Pediatrics Springer-Verlag, 2010 59(2022), 5 vom: 28. März, Seite 388-392 (DE-627)SPR031274943 nnns volume:59 year:2022 number:5 day:28 month:03 pages:388-392 https://dx.doi.org/10.1007/s13312-022-2520-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_70 GBV_ILN_72 GBV_ILN_110 GBV_ILN_131 GBV_ILN_160 GBV_ILN_376 GBV_ILN_607 AR 59 2022 5 28 03 388-392 |
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10.1007/s13312-022-2520-7 doi (DE-627)SPR047174455 (SPR)s13312-022-2520-7-e DE-627 ger DE-627 rakwb eng Kandulna, Ambrose Kumar verfasserin aut Long-term Persistence of Immunogenicity After Primary Vaccination and Response to Booster Vaccination With Typhoid Conjugate Vaccine: Results of a Phase IV Extension Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Indian Academy of Pediatrics 2022 Objective To evaluate the persistence of antibodies three years after primary vaccination with typhoid conjugate vaccine (TCV) of either Cadila Healthcare Ltd. (Cadila-TCV) or Bharat Biotech International Ltd. (Bharat-TCV) administered in a previous phase II/III study, and to study the booster dose response to Cadila-TCV. Methods This was an open-label, phase IV extension study conducted in tertiary care and multispecialty hospitals in India. 112 subjects (Cadila-TCV-57, Bharat-TCV-55) who had participated in previous study were enrolled. Of these, eligible subjects received a single-dose of Cadila-TCV and were followed-up for 28 days post-booster. Primary outcome was persistence of antibodies 3 years after primary vaccination and seroconversion (≥4-fold rise in antibody titre from baseline) 28 days post-booster. Safety was based on reported adverse events (AEs) post-booster. Results The baseline GMT reported in the current study was significantly higher than pre-vaccination GMT reported in the previous study. 89/112 (79.5%) subjects had antibody titer ≥10 IU/mL at baseline; eligible subjects (n=17) who had baseline antibody titre <10 IU/mL were administered booster dose. All the vaccinated subjects showed seroconversion post-booster. The GMTs reported at 10 days and 28 days post-booster were significantly higher as compared to GMTs reported after primary vaccination in previous study. 4 (23.5%) vaccinated subjects reported 9 AEs; all were solicited and of mild/moderate intensity. Conclusion There was a significant persistence of immunogenicity after primary vaccination with both the TCVs, and robust immune response after booster vaccination with Cadila-TCV. Efficacy (dpeaa)DE-He213 Protection (dpeaa)DE-He213 Safety (dpeaa)DE-He213 Uttam, Kheya Ghosh aut Sharma, Shrikant aut Kumar, M. Ravi aut Prasad, K. Sivaram aut Goyal, Vimal Kant aut Jangid, Sanjay Kumar aut Daultani, Pavankumar aut Mittal, Ravindra aut Maithal, Kapil aut Enthalten in Indian Pediatrics Springer-Verlag, 2010 59(2022), 5 vom: 28. März, Seite 388-392 (DE-627)SPR031274943 nnns volume:59 year:2022 number:5 day:28 month:03 pages:388-392 https://dx.doi.org/10.1007/s13312-022-2520-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_70 GBV_ILN_72 GBV_ILN_110 GBV_ILN_131 GBV_ILN_160 GBV_ILN_376 GBV_ILN_607 AR 59 2022 5 28 03 388-392 |
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(Cadila-TCV) or Bharat Biotech International Ltd. (Bharat-TCV) administered in a previous phase II/III study, and to study the booster dose response to Cadila-TCV. Methods This was an open-label, phase IV extension study conducted in tertiary care and multispecialty hospitals in India. 112 subjects (Cadila-TCV-57, Bharat-TCV-55) who had participated in previous study were enrolled. Of these, eligible subjects received a single-dose of Cadila-TCV and were followed-up for 28 days post-booster. Primary outcome was persistence of antibodies 3 years after primary vaccination and seroconversion (≥4-fold rise in antibody titre from baseline) 28 days post-booster. Safety was based on reported adverse events (AEs) post-booster. Results The baseline GMT reported in the current study was significantly higher than pre-vaccination GMT reported in the previous study. 89/112 (79.5%) subjects had antibody titer ≥10 IU/mL at baseline; eligible subjects (n=17) who had baseline antibody titre <10 IU/mL were administered booster dose. All the vaccinated subjects showed seroconversion post-booster. The GMTs reported at 10 days and 28 days post-booster were significantly higher as compared to GMTs reported after primary vaccination in previous study. 4 (23.5%) vaccinated subjects reported 9 AEs; all were solicited and of mild/moderate intensity. 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Long-term Persistence of Immunogenicity After Primary Vaccination and Response to Booster Vaccination With Typhoid Conjugate Vaccine: Results of a Phase IV Extension Study Efficacy (dpeaa)DE-He213 Protection (dpeaa)DE-He213 Safety (dpeaa)DE-He213 |
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Kandulna, Ambrose Kumar Uttam, Kheya Ghosh Sharma, Shrikant Kumar, M. Ravi Prasad, K. Sivaram Goyal, Vimal Kant Jangid, Sanjay Kumar Daultani, Pavankumar Mittal, Ravindra Maithal, Kapil |
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long-term persistence of immunogenicity after primary vaccination and response to booster vaccination with typhoid conjugate vaccine: results of a phase iv extension study |
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Long-term Persistence of Immunogenicity After Primary Vaccination and Response to Booster Vaccination With Typhoid Conjugate Vaccine: Results of a Phase IV Extension Study |
| abstract |
Objective To evaluate the persistence of antibodies three years after primary vaccination with typhoid conjugate vaccine (TCV) of either Cadila Healthcare Ltd. (Cadila-TCV) or Bharat Biotech International Ltd. (Bharat-TCV) administered in a previous phase II/III study, and to study the booster dose response to Cadila-TCV. Methods This was an open-label, phase IV extension study conducted in tertiary care and multispecialty hospitals in India. 112 subjects (Cadila-TCV-57, Bharat-TCV-55) who had participated in previous study were enrolled. Of these, eligible subjects received a single-dose of Cadila-TCV and were followed-up for 28 days post-booster. Primary outcome was persistence of antibodies 3 years after primary vaccination and seroconversion (≥4-fold rise in antibody titre from baseline) 28 days post-booster. Safety was based on reported adverse events (AEs) post-booster. Results The baseline GMT reported in the current study was significantly higher than pre-vaccination GMT reported in the previous study. 89/112 (79.5%) subjects had antibody titer ≥10 IU/mL at baseline; eligible subjects (n=17) who had baseline antibody titre <10 IU/mL were administered booster dose. All the vaccinated subjects showed seroconversion post-booster. The GMTs reported at 10 days and 28 days post-booster were significantly higher as compared to GMTs reported after primary vaccination in previous study. 4 (23.5%) vaccinated subjects reported 9 AEs; all were solicited and of mild/moderate intensity. Conclusion There was a significant persistence of immunogenicity after primary vaccination with both the TCVs, and robust immune response after booster vaccination with Cadila-TCV. © Indian Academy of Pediatrics 2022 |
| abstractGer |
Objective To evaluate the persistence of antibodies three years after primary vaccination with typhoid conjugate vaccine (TCV) of either Cadila Healthcare Ltd. (Cadila-TCV) or Bharat Biotech International Ltd. (Bharat-TCV) administered in a previous phase II/III study, and to study the booster dose response to Cadila-TCV. Methods This was an open-label, phase IV extension study conducted in tertiary care and multispecialty hospitals in India. 112 subjects (Cadila-TCV-57, Bharat-TCV-55) who had participated in previous study were enrolled. Of these, eligible subjects received a single-dose of Cadila-TCV and were followed-up for 28 days post-booster. Primary outcome was persistence of antibodies 3 years after primary vaccination and seroconversion (≥4-fold rise in antibody titre from baseline) 28 days post-booster. Safety was based on reported adverse events (AEs) post-booster. Results The baseline GMT reported in the current study was significantly higher than pre-vaccination GMT reported in the previous study. 89/112 (79.5%) subjects had antibody titer ≥10 IU/mL at baseline; eligible subjects (n=17) who had baseline antibody titre <10 IU/mL were administered booster dose. All the vaccinated subjects showed seroconversion post-booster. The GMTs reported at 10 days and 28 days post-booster were significantly higher as compared to GMTs reported after primary vaccination in previous study. 4 (23.5%) vaccinated subjects reported 9 AEs; all were solicited and of mild/moderate intensity. Conclusion There was a significant persistence of immunogenicity after primary vaccination with both the TCVs, and robust immune response after booster vaccination with Cadila-TCV. © Indian Academy of Pediatrics 2022 |
| abstract_unstemmed |
Objective To evaluate the persistence of antibodies three years after primary vaccination with typhoid conjugate vaccine (TCV) of either Cadila Healthcare Ltd. (Cadila-TCV) or Bharat Biotech International Ltd. (Bharat-TCV) administered in a previous phase II/III study, and to study the booster dose response to Cadila-TCV. Methods This was an open-label, phase IV extension study conducted in tertiary care and multispecialty hospitals in India. 112 subjects (Cadila-TCV-57, Bharat-TCV-55) who had participated in previous study were enrolled. Of these, eligible subjects received a single-dose of Cadila-TCV and were followed-up for 28 days post-booster. Primary outcome was persistence of antibodies 3 years after primary vaccination and seroconversion (≥4-fold rise in antibody titre from baseline) 28 days post-booster. Safety was based on reported adverse events (AEs) post-booster. Results The baseline GMT reported in the current study was significantly higher than pre-vaccination GMT reported in the previous study. 89/112 (79.5%) subjects had antibody titer ≥10 IU/mL at baseline; eligible subjects (n=17) who had baseline antibody titre <10 IU/mL were administered booster dose. All the vaccinated subjects showed seroconversion post-booster. The GMTs reported at 10 days and 28 days post-booster were significantly higher as compared to GMTs reported after primary vaccination in previous study. 4 (23.5%) vaccinated subjects reported 9 AEs; all were solicited and of mild/moderate intensity. Conclusion There was a significant persistence of immunogenicity after primary vaccination with both the TCVs, and robust immune response after booster vaccination with Cadila-TCV. © Indian Academy of Pediatrics 2022 |
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Long-term Persistence of Immunogenicity After Primary Vaccination and Response to Booster Vaccination With Typhoid Conjugate Vaccine: Results of a Phase IV Extension Study |
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Uttam, Kheya Ghosh Sharma, Shrikant Kumar, M. Ravi Prasad, K. Sivaram Goyal, Vimal Kant Jangid, Sanjay Kumar Daultani, Pavankumar Mittal, Ravindra Maithal, Kapil |
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