Abstract
No licensed Shigella vaccine is presently available globally. A double-blinded, randomized, placebo-controlled, age descending phase II clinical trial of a bivalent conjugate vaccine was studied in China. The vaccine ZF0901 consisted of O-specific polysaccharides purified and detoxified from lipopolysaccharide (LPS) of S. flexneri 2a and S. sonnei and covalently bonded to tetanus toxoid. A total of 224, 310, and 434 children, consented by parents or guardians, aged 3 to 6 and 6 to 12 months and 1 to 5 years old, respectively, were injected with half or full doses, with or without adjuvant or control Hib vaccine. There were no serious adverse reactions in all recipients of ZF0901 vaccine independent of age, dosage, number of injections, or the adjuvant status. Thirty days after the last injection, ZF0901 induced robust immune responses with significantly higher levels of type-specific serum antibodies (geometric mean concentrations (GMCs) of IgG anti-LPS) against both serotypes in all age groups compared with the pre-immune or the Hib control (p < 0.0001). Here, we demonstrated that ZF0901 bivalent Shigella conjugate vaccine is safe and immunogenic in infants and young children and is likely suitable for routine immunization.
Highlights
A survey in 2016 showed that there were an estimated more than 269 million cases of shigellosis with over 212,000 deaths, of which about 74 million cases of shigellosis were in children younger than 5 years old and caused more than 63,000 deaths [5]
The results demonstrated that ZF0901 was safe in all studied age groups, and permission for further investigation was subsequently granted
This study was undertaken in accordance with the standards of the International Conference on Harmonization guidelines on Good Clinical Practices (ICHGCP), and followed the ethical principles established in the Declaration of Helsinki
Summary
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. Shigellosis remains a common, serious, and increasingly difficult-to-treat disease, especially because of the emergence of antibiotic-resistant strains [1,2,3,4]. The annual morbidity of bacillary dysentery ranked as one of the top five notifiable infectious diseases, according to the Chinese Center for Disease Control and Prevention (CDC) [6,7,8]. The incidence rate of bacillary dysentery has declined markedly due to the improvement of sanitation and hygiene, there were over 80,000 dysentery cases in China in 2020 [9]. Similar to the global trend, the highest incidence of Shigellosis in
Sign-in/Register to view highlights & summary 
Published Version (
Free)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call