Abstract
Background. Yellow fever (YF) is still a major public health problem in endemic regions of Africa and South America. In Africa, one of the main control strategies is routine vaccination within the Expanded Programme on Immunization (EPI). A new meningococcal A conjugate vaccine (PsA-TT) is about to be introduced in the EPI of countries in the African meningitis belt, and this study reports on the immunogenicity of the YF-17D vaccines in infants when administered concomitantly with measles vaccine and PsA-TT.Methods. Two clinical studies were conducted in Ghana and in Mali among infants who received PsA-TT concomitantly with measles and YF vaccines at 9 months of age. YF neutralizing antibody titers were measured using a microneutralization assay.Results. In both studies, the PsA-TT did not adversely affect the immune response to the concomitantly administered YF vaccine at the age of 9 months. The magnitude of the immune response was different between the 2 studies, with higher seroconversion and seroprotection rates found in Mali vs Ghana.Conclusions. Immunogenicity to YF vaccine is unaffected when coadministered with PsA-TT at 9 months of age. Further studies are warranted to better understand the determinants of the immune response to YF vaccine in infancy.Clinical Trials Registration. ISRCTN82484612 (PsA-TT-004); PACTR201110000328305 (PsA-TT-007).
Highlights
Yellow fever (YF) is still a major public health problem in endemic regions of Africa and South America
The magnitude of the immune response was different between the 2 studies, with higher seroconversion and seroprotection rates found in Mali vs Ghana
We report here the immune response to YF vaccine following coadministration with group A meningococcal conjugate vaccine (PsA-TT) in 2 infant clinical trials conducted in Ghana and in Mali
Summary
Two clinical studies were conducted in Ghana and in Mali among infants who received PsA-TT concomitantly with measles and YF vaccines at 9 months of age. The studies were designed and conducted in accordance with the Good Clinical Practice guidelines established by the International Conference on Harmonisation, and with the Declaration of Helsinki, and approved by the competent ethics committees and regulatory authorities. Both studies were coordinated by MVP, a partnership between the World Health Organization (WHO) and PATH, aiming to develop an affordable, monovalent, group A meningococcal conjugate vaccine through a public–private partnership with the vaccine manufacturer Serum Institute of India, Ltd. Study A The first study (PsA-TT-004) was a phase 2, double-blind, randomized, controlled, dose-ranging study to evaluate the safety, immunogenicity, dose response, and schedule response of PsA-. Group 4 was the control group for this vaccine period (no blood draw was performed in group 3 at this time point)
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