Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants

摘要

Objective: To evaluate the immunogenicity and safety of a pentavalent rotavirus vaccine (PRV) in Indian infants.Study Design:Open-label, single-arm multicentric study.Setting:Hospital facilities (out patients)Subjects:One hundred and ten (110) healthy Indian infants were enrolled between the ages of 6 weeks and 12 weeks.Intervention:Three doses of oral pentavalent rotavirus vaccine (PRV) were administered with an interval of 4 to 10 weeks (28 to 70 days).Main Outcome Measures:Immunogenicity of PRV was based on the proportion of infants exhibiting a >3-fold rise in serum anti rotavirus IgA antibodies (from pre dose 1 to 14 days post dose 3).   Safety was evaluated for 14 days after each dose. Results:Of the 110 infants enrolled, 83% exhibited at least a 3-fold rise (seroconversion) in serum anti rotavirus IgA antibodies.  There were no clinically significant adverse events reported.Conclusions:A 3-dose regimen of PRV was found to be immunogenic and well tolerated in healthy Indian infants. id="__p17">Clinical trials registration: id="__p18" class="p p-last">ClinicalTrials.gov;