PMID- 35348124
OWN - NLM
STAT- MEDLINE
DCOM- 20220517
LR  - 20220531
IS  - 0974-7559 (Electronic)
IS  - 0019-6061 (Linking)
VI  - 59
IP  - 5
DP  - 2022 May 15
TI  - Long-term Persistence of Immunogenicity After Primary Vaccination and Response to 
      Booster Vaccination With Typhoid Conjugate Vaccine: Results of a Phase IV 
      Extension Study.
PG  - 388-392
LID - S097475591600415 [pii]
AB  - 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.
FAU - Kandulna, Ambrose Kumar
AU  - Kandulna AK
AD  - Department of Medicine, GCS Medical College, Hospital and Research Centre, 
      Ahmedabad, Gujarat.
FAU - Uttam, Kheya Ghosh
AU  - Uttam KG
AD  - Department of Pediatrics, Institute of Child Health, Kolkata, West Bengal.
FAU - Sharma, Shrikant
AU  - Sharma S
AD  - Department of Medicine, SMS Medical College and Hospital, Jaipur, Rajasthan.
FAU - Kumar, M Ravi
AU  - Kumar MR
AD  - Department of Medicine, Indo-US Superspeciality Hospital, Ameerpet, Hyderabad, 
      Telangana.
FAU - Prasad, K Sivaram
AU  - Prasad KS
AD  - Department of Pediatrics, Gandhi Medical College and Hospital, Secunderabad, 
      Telangana.
FAU - Goyal, Vimal Kant
AU  - Goyal VK
AD  - Department of Pediatrics, Panchsheel Hospital, Yamuna Vihar, Delhi.
FAU - Jangid, Sanjay Kumar
AU  - Jangid SK
AD  - Department of Medicine, Hi-Tech Medical College and Hospital, Bhubaneswar, 
      Odisha.
FAU - Daultani, Pavankumar
AU  - Daultani P
AD  - Cadila Healthcare Ltd., Ahmedabad, Gujarat. Correspondence to: Dr Pavankumar 
      Daultani, Deputy General Manager, Department of New Product Development, Cadila 
      Healthcare Ltd., Zydus Corporate Park, Near Vaishnodevi Circle, SG Highway, 
      Ahmedabad 382 481, Gujarat. drpavandaultani@gmail.com.
FAU - Mittal, Ravindra
AU  - Mittal R
AD  - Cadila Healthcare Ltd., Ahmedabad, Gujarat.
FAU - Maithal, Kapil
AU  - Maithal K
AD  - Cadila Healthcare Ltd., Ahmedabad, Gujarat.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
DEP - 20220328
PL  - India
TA  - Indian Pediatr
JT  - Indian pediatrics
JID - 2985062R
RN  - 0 (Typhoid-Paratyphoid Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Humans
MH  - Immunization, Secondary
MH  - Seroconversion
MH  - *Typhoid Fever/prevention & control
MH  - *Typhoid-Paratyphoid Vaccines/adverse effects
MH  - Vaccination
MH  - Vaccines, Conjugate/adverse effects
EDAT- 2022/03/30 06:00
MHDA- 2022/05/18 06:00
CRDT- 2022/03/29 09:10
PHST- 2022/03/30 06:00 [pubmed]
PHST- 2022/05/18 06:00 [medline]
PHST- 2022/03/29 09:10 [entrez]
AID - S097475591600415 [pii]
PST - ppublish
SO  - Indian Pediatr. 2022 May 15;59(5):388-392. Epub 2022 Mar 28.