TY - JOUR
T1 - One-month follow up of a randomized clinical trial-phase II study in 6 to <24 months old Indonesian subjects
T2 - Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine
AU - Medise, Bernie Endyarni
AU - Soedjatmiko, Soedjatmiko
AU - Gunardi, Hartono
AU - Sekartini, Rini
AU - Satari, Hindra Irawan
AU - Hadinegoro, Sri Rezeki
AU - Wirahmadi, Angga
AU - Puspita, Mita
AU - Sari, Rini Mulia
AU - Yang, Jae Seung
AU - Sil, Arijit
AU - Sahastrabuddhe, Sushant
AU - Bachtiar, Novilia Sjafri
N1 - Publisher Copyright:
© 2020 The Authors
PY - 2020/4
Y1 - 2020/4
N2 - Introduction: World Health Organization estimates the annual global incidence of typhoid fever at 11-21 million cases and approximately 128 000 to 161 000 deaths. The currently used Vi-polysaccharides (Vi-PS) vaccines have been proven to be safe and efficacious in children 2 years and above. However, poor immunogenicity of Vi-PS was observed in children below 2 years of age. This Phase II study is the continuation of the previously published Phase I study that aims to evaluate the safety and immunogenicity of a novel Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in subjects 6 to <24 months. Methods: An interventional, blinded, comparative, randomized phase II study was conducted from July 2018 until January 2019. There were 200 healthy subjects divided into two groups: trial and control groups. Inactivated poliovirus vaccine was given to control group. Immediate and delayed local and systemic reactions up to 28 days post vaccination were recorded. Antibody titers were measured prior to vaccination (V1) and 28 days post vaccination (V2). Result: The study showed that the seroconversion of Vi-DT vaccine 98.99%. One dose of Vi-DT vaccine induced higher geometric mean titers (GMT) in all subjects compared to that of baseline. Pain was the most common immediate and delayed local reaction. Immediate and delayed systemic reactions that mostly occurred was fever. There were no serious adverse events reported within 28 days post vaccination. Conclusion: The novel typhoid Vi-DT conjugate vaccine is safe and immunogenic in children 6 to <24 months. Trial registration number: NCT03460405.
AB - Introduction: World Health Organization estimates the annual global incidence of typhoid fever at 11-21 million cases and approximately 128 000 to 161 000 deaths. The currently used Vi-polysaccharides (Vi-PS) vaccines have been proven to be safe and efficacious in children 2 years and above. However, poor immunogenicity of Vi-PS was observed in children below 2 years of age. This Phase II study is the continuation of the previously published Phase I study that aims to evaluate the safety and immunogenicity of a novel Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in subjects 6 to <24 months. Methods: An interventional, blinded, comparative, randomized phase II study was conducted from July 2018 until January 2019. There were 200 healthy subjects divided into two groups: trial and control groups. Inactivated poliovirus vaccine was given to control group. Immediate and delayed local and systemic reactions up to 28 days post vaccination were recorded. Antibody titers were measured prior to vaccination (V1) and 28 days post vaccination (V2). Result: The study showed that the seroconversion of Vi-DT vaccine 98.99%. One dose of Vi-DT vaccine induced higher geometric mean titers (GMT) in all subjects compared to that of baseline. Pain was the most common immediate and delayed local reaction. Immediate and delayed systemic reactions that mostly occurred was fever. There were no serious adverse events reported within 28 days post vaccination. Conclusion: The novel typhoid Vi-DT conjugate vaccine is safe and immunogenic in children 6 to <24 months. Trial registration number: NCT03460405.
KW - Immunogenicity
KW - Safety
KW - Typhoid conjugate vaccine
KW - Vi-DT vaccine Vi-PS vaccine
UR - http://www.scopus.com/inward/record.url?scp=85080099247&partnerID=8YFLogxK
U2 - 10.1016/j.ijid.2020.01.045
DO - 10.1016/j.ijid.2020.01.045
M3 - Article
C2 - 32004693
AN - SCOPUS:85080099247
SN - 1201-9712
VL - 93
SP - 102
EP - 107
JO - International Journal of Infectious Diseases
JF - International Journal of Infectious Diseases
ER -