title: Maternal immunization with pneumococcal 9-valent conjugate vaccine and early infant otitis media.
abstract: A randomized trial of an investigational 9-valent pneumococcal conjugate vaccine (PCV-9) or placebo given to pregnant women during the last trimester to prevent early infant otitis media (OM) was conducted. All infants received Prevnar(®) at 2, 4, 6, and 12 months. Clinic and adverse event records were reviewed to identify OM. Variables significantly related to acute OM by age 6 months (p<0.05) were: vaccine group (9 valent or placebo), sibling history of tympanostomy tubes, upper respiratory infection, and number of clinic visits by 6 months. Infant OM rates were similar between 6 and 12 months (58% and 56%). Results suggested that immunizing pregnant women with PCV-9 increased infants' risk of acute OM in the first 6 months of life, and this correlated with decreased infant antibody responses to their infant Streptococcus pneumoniae vaccine serotypes, but did not influence antibody responses to 3 other serotypes two of which were in maternal vaccine (types 1 and 5) and one was a control (type 7F). Explanations for these results include dampening of infant antibody production by high levels of passively acquired maternal pneumococcal antibodies and/or altered B lymphocyte immune responses in infants exposed to these specific polysaccharide antigens in utero.
authors.affiliation: Department of Otolaryngology, University of Minnesota Medical School, Minneapolis, MN, USA.
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Daly
authors.affiliation: Department of Otolaryngology, University of Minnesota Medical School, Minneapolis, MN, USA; Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.
authors.forename: G
authors.initials: G
authors.lastname: Scott Giebink
authors.affiliation: Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Lindgren
authors.affiliation: Department of Otolaryngology, University of Minnesota Medical School, Minneapolis, MN, USA.
authors.forename: JoAnn
authors.initials: J
authors.lastname: Knox
authors.affiliation: HealthPartners Research Foundation, Minneapolis, MN, USA.
authors.forename: Betty Jo
authors.initials: BJ
authors.lastname: Haggerty
authors.affiliation: HealthPartners Research Foundation, Minneapolis, MN, USA.
authors.forename: James
authors.initials: J
authors.lastname: Nordin
authors.affiliation: Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Goetz
authors.affiliation: Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA; Department of Laboratory Medicine and Pathology, University of Minnesota Medical School, Minneapolis, MN, USA. Electronic address: ferri002@umn.edu.
authors.forename: Patricia
authors.initials: P
authors.lastname: Ferrieri
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007112:Immunity, Maternally-Acquired; D007114:Immunization / Q000379:methods*; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010033:Otitis Media / Q000453:epidemiology* / Q000517:prevention & control*; D010919:Placebos / Q000008:administration & dosage; D011008:Pneumococcal Infections / Q000453:epidemiology* / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000276:immunology*; D011247:Pregnancy; D016896:Treatment Outcome; D018074:Vaccines, Conjugate
chemical_list: D010919:Placebos; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate
keywords: Maternal immunization; Otitis media; Pneumococcal antibodies; Pneumococcus