Safety and immunogenicity of two octavalent pneumococcal conjugate vaccines in American Indian infants.
We evaluated the safety and immunogenicity of two octavalent pneumococcal polysaccharide vaccines (serotypes 3, 4, 6B, 9V, 14, 18C, 19F, and 23F) conjugated to either diphtheria toxoid (PncD) or tetanus protein (PncT) among White Mountain Apache and Gila River Indian Community infants. This was a prospective, non-randomized, open label, comparative pilot study of PncD and PncT. Since this was a pilot study, a small sample size of 60 infants was enrolled. Enrolled healthy infants received either PncD or PncT at 2, 4, and 6 months of age. Antibody concentrations were measured by enzyme-immunoassay (EIA) prior to each dose and 1 month after the last dose. Local reaction rates were similar between PncD and PncT groups. The geometric mean concentrations (GMCs) were significantly higher for PncD than PncT for serotype 3 whereas GMCs were significantly higher for PncT for serotype 4. For this pilot study, both vaccines appeared to be safe and immunogenic in this group of American Indian infants.
Center for American Indian Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health, 621 North Washington Street, Baltimore, MD 21205, USA. aeick@jhsph.edu
Angelia
A
Eick
Janné
J
Croll
Robert
R
Weatherholtz
Larry
L
Croll
Mathuram
M
Santosham
D000276:Adjuvants, Immunologic / Q000494:pharmacology; D000907:Antibodies, Bacterial / Q000032:analysis / Q000096:biosynthesis; D004168:Diphtheria Toxoid / Q000494:pharmacology; D004890:Erythema / Q000209:etiology / Q000473:pathology; D005260:Female; D006801:Humans; D007198:Indians, North American; D007223:Infant; D008297:Male; D010865:Pilot Projects; D011008:Pneumococcal Infections / Q000276:immunology* / Q000517:prevention & control; D022242:Pneumococcal Vaccines / Q000009:adverse effects* / Q000276:immunology*; D012703:Serotyping; D013744:Tetanus Toxin / Q000494:pharmacology; D018074:Vaccines, Conjugate / Q000276:immunology
D000276:Adjuvants, Immunologic; D000907:Antibodies, Bacterial; D004168:Diphtheria Toxoid; D022242:Pneumococcal Vaccines; D013744:Tetanus Toxin; D018074:Vaccines, Conjugate