A Phase 3, Multicenter, Randomized, Controlled Trial to Evaluate Immune Equivalence and Safety of Multidose and Single-dose Formulations of Vi-DT Typhoid Conjugate Vaccine in Healthy Filipino Individuals 6 Months to 45 Years of Age

• DOI: 10.1016/j.lanwpc.2022.100484
• Publication Date: 2022-05-30T16:19:21Z
• Authors: Josefina Cadorna ...; Birkneh Tilahun T...; Charissa Borja-Ta...; Edison Alberto; Michelle C. Ylade; Arijit Sil; Deok Ryun Kim; Hyeon Seon Ahn; Jae Seung Yang; Ji Yeon Lee; Min Soo Kim; Jiwook Park; Soo-Young Kwon; Hun Kim; Seon-Young Yang; Ji-hwa Ryu; Hokeun Park; Jong-hoon Shin; Yoonyeong Lee; Jerome H. Kim; Zenaida Reynoso M...; T. Anh Wartel; Sushant Sahastrab...
• Keywords: Seroconversion; Meningococcal vaccine

Phase 3, randomized, controlled, multicenter, equivalence trial.Recruitment of participants occurred between 04Februray2020 and 15July2020 at four centers in the Philippines: University East - Ramon Magsaysay Memorial Medical Center Inc., Quezon City; Philippines Manila National Institute Health, Ermita Manila; Asian Hospital Center, Metro Manila, Study; Research Unit, Tropical Disease Foundation, Makati City, Philippines.1800 adults children 6-months to 45-years age.Participants received a single injection multidose (MD) or dose (SD) Vi-DT as test vaccines meningococcal conjugate vaccine comparator.To evaluate immune SD MD formulations Vi-DT, assess safety both compared with comparator vaccine.Blood draw for immunogenicity was performed baseline prior receipt weeks after vaccination subset determine anti-Vi IgG geometric mean titers (GMT) seroconversion rates. The primary outcome comparison anti Vi-IgG GMT two 4 following administration. Immune confirmed when two-tailed 95% confidence interval (CI) ratio is within [0.67, 1.5] two-sided significance level 0.05. All were followed events six months administration.Participants randomized receive 2.5:2.5:1 allocation ratio.Study observers blinded treatment assignment.Immune (n=252) (n=247) by 1.14 (95%CI: 0.91, 1.43) respective GMTs groups 640.62 IU/mL 546.39, 751.11) 562.57 478.80, 661.00) (p=0.259). Similarly, rate difference ‒0.43% -4.42, 3.56) corresponding rates 98.38% 95.91, 99.37) 98.81% 96.56, 99.59) formulations, respectively (p=0.722). Both had satisfactory profile all five serious adverse reported during study unrelated investigational product.The elicited robust equivalent responses one vaccination, demonstrated favorable profile.ClinicalTrials.gov: NCT04204096.This funded Bill & Melinda Gates Foundation (OPP 1115556).