Long-term Persistence of Immunogenicity After Primary Vaccination and Response to Booster Vaccination With Typhoid Conjugate Vaccine: Results of a Phase IV Extension Study.
Indian Pediatr
; 59(5): 388-392, 2022 05 15.
Article
em En
| MEDLINE
| ID: mdl-35348124
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.CONCLUSIONS:
There was a significant persistence of immunogenicity after primary vaccination with both the TCVs, and robust immune response after booster vaccination with Cadila-TCV.
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01-internacional
Contexto em Saúde:
1_ASSA2030
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2_ODS3
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4_TD
Base de dados:
MEDLINE
Assunto principal:
Febre Tifoide
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Vacinas Tíficas-Paratíficas
Limite:
Humans
Idioma:
En
Revista:
Indian Pediatr
Ano de publicação:
2022
Tipo de documento:
Article