OBJECTIVE: The safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in preterm infants were assessed in this study. METHODS: Three parallel groups of infants received 3-dose primary immunization with PHiD-CV at 2, 4, and 6 months of age and a booster dose at 16 to 18 months: preterm I (gestation period ≥ 27 and <31 weeks, N = 50); preterm II (≥31 and <37 weeks, N = 87); and term (≥37 weeks, N = 149). Solicited symptoms and adverse events were recorded. Immune responses to PHiD-CV and coadministered vaccine antigens were measured. RESULTS: The incidence of solicited general symptoms was similar across groups, and the frequency of grade 3 general symptoms was low. Incidences of redness and swelling were generally lower in preterm infants. PHiD-CV was immunogenic for each of the 10 vaccine pneumococcal serotypes (postprimary, ≥92.7% of infants reached enzyme-linked immunosorbent assay antibody concentrations ≥ 0.2 μg/mL and postbooster, ≥97.6%) and for protein D, with a trend for lower postprimary geometric mean antibody concentrations and opsonophagocytic activity (OPA) titers in preterm infants for some pneumococcal serotypes. Postbooster, ≥91.9% of subjects in each group had an OPA titer ≥ 8 for each of the vaccine serotypes. Pneumococcal antibody concentrations and OPA titers after priming and booster vaccination were comparable between the 2 preterm groups. CONCLUSIONS: PHiD-CV was well tolerated and immunogenic in preterm infants when given as a 3-dose primary vaccination, with robust enzyme-linked immunosorbent assay antibody and OPA booster responses in the second year of life.
RCT Entities:
OBJECTIVE: The safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in preterm infants were assessed in this study. METHODS: Three parallel groups of infants received 3-dose primary immunization with PHiD-CV at 2, 4, and 6 months of age and a booster dose at 16 to 18 months: preterm I (gestation period ≥ 27 and <31 weeks, N = 50); preterm II (≥31 and <37 weeks, N = 87); and term (≥37 weeks, N = 149). Solicited symptoms and adverse events were recorded. Immune responses to PHiD-CV and coadministered vaccine antigens were measured. RESULTS: The incidence of solicited general symptoms was similar across groups, and the frequency of grade 3 general symptoms was low. Incidences of redness and swelling were generally lower in preterm infants. PHiD-CV was immunogenic for each of the 10 vaccine pneumococcal serotypes (postprimary, ≥92.7% of infants reached enzyme-linked immunosorbent assay antibody concentrations ≥ 0.2 μg/mL and postbooster, ≥97.6%) and for protein D, with a trend for lower postprimary geometric mean antibody concentrations and opsonophagocytic activity (OPA) titers in preterm infants for some pneumococcal serotypes. Postbooster, ≥91.9% of subjects in each group had an OPA titer ≥ 8 for each of the vaccine serotypes. Pneumococcal antibody concentrations and OPA titers after priming and booster vaccination were comparable between the 2 preterm groups. CONCLUSIONS: PHiD-CV was well tolerated and immunogenic in preterm infants when given as a 3-dose primary vaccination, with robust enzyme-linked immunosorbent assay antibody and OPA booster responses in the second year of life.
Authors: Merryn Voysey; Dominic F Kelly; Thomas R Fanshawe; Manish Sadarangani; Katherine L O'Brien; Rafael Perera; Andrew J Pollard Journal: JAMA Pediatr Date: 2017-07-01 Impact factor: 16.193
Authors: Melinda M Pettigrew; Mark R Alderson; Lauren O Bakaletz; Stephen J Barenkamp; Anders P Hakansson; Kevin M Mason; Johanna Nokso-Koivisto; Janak Patel; Stephen I Pelton; Timothy F Murphy Journal: Otolaryngol Head Neck Surg Date: 2017-04 Impact factor: 3.497
Authors: Alassane Dicko; Olumuyiwa O Odusanya; Abdoulbaki I Diallo; Gaoussou Santara; Amadou Barry; Amagana Dolo; Aminata Diallo; Yetunde A Kuyinu; Omolara A Kehinde; Nancy François; Dorota Borys; Juan P Yarzabal; Marta Moreira; Lode Schuerman Journal: BMC Public Health Date: 2011-11-23 Impact factor: 3.295
Authors: Alienke J Wijmenga-Monsuur; Els van Westen; Mirjam J Knol; Riet M C Jongerius; Marta Zancolli; David Goldblatt; Pieter G M van Gageldonk; Irina Tcherniaeva; Guy A M Berbers; Nynke Y Rots Journal: PLoS One Date: 2015-12-10 Impact factor: 3.240