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Effect of aluminum adjuvants on safety and immunogenicity of Haemophilus influenzae type b‐CRM 197 conjugate vaccine
Author(s) -
Kanra Güler,
Viviani Simonetta,
Yurdakök Kadriye,
Özmert Elif,
Anemona Alessandra,
Yalçİn SongüL,
Demiralp Okan,
Bilgili Nihan,
Kara Ates,
Cengiz Ali BüLent,
Mutlu Belgin,
Baldini Alexandra,
Marchetti Elisa,
Podda Audino
Publication year - 2003
Publication title -
pediatrics international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.49
H-Index - 63
eISSN - 1442-200X
pISSN - 1328-8067
DOI - 10.1046/j.1442-200x.2003.01706.x
Subject(s) - medicine , diphtheria , immunogenicity , adjuvant , vaccination , tetanus , immunization , conjugate vaccine , haemophilus influenzae , hib vaccine , pneumococcal conjugate vaccine , adverse effect , pediatrics , immunology , antibody , streptococcus pneumoniae , microbiology and biotechnology , biology , antibiotics
Objective: The present study was carried out to evaluate the safety and immunogenicity of the Haemophilus influenzae type b‐CRM 197 (Hib‐CRM 197 ) conjugate vaccine in relation to the change of adjuvant from aluminum hydroxide to aluminum phosphate (AlPO 4 ).Methods: The present study was a clinical phase II, observer‐blind, randomized, multicenter, controlled study. Subjects were healthy infants aged 6−12 weeks, eligible for expanded program of immunization (EPI) routine vaccination and admitted to Hacettepe University Department of Social Pediatrics and Gülveren Health Center, Ankara. A total of 520 healthy infants were randomized in a 2:2:1 ratio to receive at either Chiron Hib/AlPO 4 vaccine or VaxemHib (aluminum hydroxide adjuvant) vaccine or HibTiter (no adjuvant). Vaccines were administered simultaneously with routine diphtheria, tetanus and pertussis (DTaP) and oral polio vaccine (OPV) vaccines at 2, 4 and 6 months of age. Blood samples for anti‐plain polysaccharide (PRP) antibody measurement were collected before the first vaccination and 1 month after the last vaccination. After each vaccination parents filled out a diary for 7 days.Results: Out of 520 subjects enrolled, 514 received three doses and were included for safety analysis. Local and systemic reactions occurred with low and similar frequencies in all groups. Only erythema was more common in Chiron Hib/AlPO 4 vaccine (19, 10, 11% in Chiron Hib/AlPO 4 , VaxemHib and HibTiter, respectively, P < 0.05). Nine serious adverse events were reported in seven cases of which none were related to vaccines. A total of 504 subjects were included in the immunogenicity analysis. The three vaccines were highly immunogenic and equivalent in terms of percentage of acquisition of long‐term protective levels. The anti‐PRP geometric mean titers were 9.9, 8.3 and 5.14 µg/mL, respectively ( P < 0.05).Conclusions: The use of aluminum compounds adjuvants in Hib‐CRM 197 conjugate vaccines does not impact the safety profile, while it does increase the magnitude of anti‐PRP antibody titers.