Safety and immunogenicity of co-administration of meningococcal type A and measles–rubella vaccines with typhoid conjugate vaccine in children aged 15–23 months in Burkina Faso

Abstract

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Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomized controlled phase 2 trial

“…A single dose of TCV demonstrated a robust antibody response in Burkinabe infants at nine months of age, including day 28 seroconversion in 87Á8% with GMT of 1203Á7 EU/mL. These results are consistent with previous studies of this vaccine (Jin et al, 2017;Kundu et al, 2020;Mohan et al, 2015;Shakya et al, 2019;Sirima et al, 2020) A study in Indian children ages 6 months to 2 years documented day 42 GMT of 1115 EU/mL (Kundu et al, 2020). A separate study in Indian children ages 24 months to 4 years found day 42 seroconversion in 97Á3% with a GMT of 1293 EU/mL (Mohan et al, 2015).…”

“…A separate study in Indian children ages 24 months to 4 years found day 42 seroconversion in 97·3% with a GMT of 1293 EU/mL ( Mohan et al, 2015 ). In 15-month-old Burkinabe children, the day 28 seroconversion of 94–96% was higher than the current study with a GMT of 2757–3707 EU/mL ( Sirima et al, 2020 ). The higher responses in the 15-month-old children may reflect an enhanced immune response in children with more mature immune systems.…”

“…This safety and reactogenicity profile documented in Burkinabe infants is consistent with studies of this TCV from Burkina Faso and -6, 2017-6, , Milligan et al, 2018Mohan et al, 2015;Qamar et al, 2020;Shakya et al, 2019;Sirima et al, 2020) In our study, 4 infants that received TCV (8Á2%) experienced fever and irritability in the seven days after vaccination, which is almost identical to the rate of 8Á1% observed in a study of 15-month-olds in Burkina Faso (Sirima et al, 2020) and less than the observed rate of 18% for IPV recipients in the current study. As IPV is a well-accepted vaccine routinely administered to infants as young as six weeks of age, the current finding that TCV was tolerated as well as, if not better than, IPV bodes well for TCV acceptance among caregivers and healthcare practitioners.…”

“…A recent study in Burkina Faso showed young children vaccinated with TCV at the 15-month visit with both group A meningococcal conjugate vaccines and their second MR vaccine, experienced low reactogenicity and no safety concerns ( Sirima et al, 2020 ). Few (8·1%) experienced mild fever and/or mild irritability seven days after vaccination ( Sirima et al, 2020 ).…”

“…A recent study in Burkina Faso showed young children vaccinated with TCV at the 15-month visit with both group A meningococcal conjugate vaccines and their second MR vaccine, experienced low reactogenicity and no safety concerns ( Sirima et al, 2020 ). Few (8·1%) experienced mild fever and/or mild irritability seven days after vaccination ( Sirima et al, 2020 ). In India, among 360 infants and children 6–23 months of age who received TCV, few experienced fever (2·4%), injection site pain (3·6%), or tenderness (0·6%) after vaccination ( Mohan et al, 2015 ).…”