Six-month follow up of a randomized clinical trial-phase I study in Indonesian adults and children: Safety and immunogenicity of Salmonella typhi polysaccharide-diphtheria toxoid (Vi-DT) conjugate vaccine

• DOI: 10.1371/journal.pone.0211784
• Publication Date: 2019-02-13T18:58:20Z
• Authors: Bernie Endyarni M...; Soedjatmiko Soedj...; Iris Rengganis; Hartono Gunardi; Rini Sekartini; Sukamto Koesno; Hindra Irawan Satari; Sri Rezeki Hadine...; Jae Seung Yang; Jean-Louis Excler; Sushant Sahastrab...; Mita Puspita; Rini Mulia Sari; Novilia Sjafri Ba...
• Keywords: Toxoid; Hepatitis A vaccine; Typhoid vaccine

Introduction There is a high global incidence of typhoid fever, with an annual mortality rate 200,000 deaths. Typhoid fever also affects younger children, particularly in resource-limited settings endemic countries. vaccination important prevention tool against fever. However, the available polysaccharide vaccines are not recommended for children under 2 years age. A new conjugate Vi-diphtheria toxoid (Vi-DT) vaccine has been developed infant immunization. We aimed to define safety and immunogenicity Vi-DT among adults Indonesia. Methods An observational, blinded, comparative, randomized, phase I study two age de-escalating cohorts was conducted East Jakarta, Indonesia, from April 2017 February 2018. enrolled 100 healthy subjects groups: (18–40 2–5 old). These groups were randomized into (Vi-DT vaccine), comparator (Vi-polysaccharide (Vi-PS) another additional vaccine) which administered 4 weeks apart. Subjects followed up six months. Result One hundred completed study. The Vi-PS showed no difference terms intensity any immediate local systemic events within 30 minutes post-vaccination. Overall, pain most common reaction, muscle reaction first 72 hours. No serious adverse deemed related administration. second doses induced seroconversion higher geometric mean titers (GMT) all compared that baseline. GMT, dose did induce booster response. Conclusion safe immunogenic older than years. single able produce GMT individuals.