Immunological persistence in 4-6 and 7-9 year olds previously vaccinated in infancy with hexavalent DTPa-HBV-IPV/Hib

Abstract

Combination vaccines induce immunity against multiple diseases in a single injection and thus facilitate delivery of complex vaccination schedules. Use of combination vaccines increases both vaccine coverage and the timeliness of vaccination.1 Infanrix hexa TM , the combined hexavalent diphtheria-tetanus-pertussis-hepatitis B-inactivated poliomyelitis-Haemophilus influenzae type b conjugate vaccine [DTPa-HBV-IPV/Hib, GlaxoSmithKline Biologicals (GSK), Rixensart, Belgium] is the only hexavalent vaccine currently licensed for primary and booster vaccination of infants and provides simultaneous protection against six major diseases of childhood. DTPa-HBV-IPV/Hib contains ≥30 IU diphtheria toxoid, ≥40 IU tetanus toxoid, 25 μg pertussis toxin (PT), 25 μg filamentous haemagglutinin (FHA), 8 μg pertactin (PRN), 10 μg recombinant HBsAg, 40D, 8D and 32D antigen units of poliovirus types 1, 2 and 3 respectively and 10 μg Hib polyribosylribitol-phosphate (PRP) conjugated to tetanus toxoid.Background: the combined diphtheria-tetanus-pertussis-hepatitis B-inactivated poliomyelitis-Haemophilus influenzae conjugate vaccine (Dtpa-HBV-IpV/Hib, Infanrix Hexa tM GlaxoSmithKline Biologicals, rixensart, Belgium) is the only hexavalent vaccine currently licensed for primary and booster vaccination of infants and provides simultaneous protection against six major diseases of childhood. the persistence of the immune response in children aged 4-6 and 7-9 years of age previously vaccinated with four doses of Dtpa-HBV-IpV/Hib vaccine was assessed (www.clinical trials.gov.au 106744 NCt00356564 and 106745 NCt00335881).Methods: A blood sample was collected from 403 children, all of whom had received 3-dose primary vaccination and a booster dose in the second year of life with Dtpa-HBV-IpV/Hib, in previous clinical vaccine trials in Germany.results: Mean time from the fourth Dtpa-HBV-IpV/Hib dose until serological follow-up ranged between 3.6 and 6.4 years. After the 4 th Dtpa-HBV-IpV/Hib dose, in subjects who had not received additional booster doses, seroprotective antibody levels persisted up to 9 years of age in ≥90% of subjects for diphtheria, Hib and poliomyelitis, in 77.2% subjects for Hepatitis B and in 64.7% of subjects for tetanus. Anti-pertussis toxin antibodies remained detectable in no more than 38.2% of subjects.Conclusion: With the exception of pt, the combined Dtpa-HBV-IpV/Hib induces long lasting immune response against all vaccine antigens. Falling seropositivity against pt over time supports the recommended administration of a pertussis booster dose in 5-6 year old children in Germany.

Decennial administration in young adults of a reduced-antigen content diphtheria, tetanus, acellular pertussis vaccine containing two different concentrations of aluminium

“…In our cohort, anti-pertussis antibodies appeared to persist for longer after the first dTpa dose than after Pw-primary vaccination. Furthermore, antibodies to PT, FHA and PRN appeared to be higher 10 years after the first dTpa booster than observed in children after infant vaccination with acellular pertussis vaccines [27,28].…”

Duration of Pertussis Immunity After DTaP Immunization: A Meta-analysis

“…The majority of the 5-dose included studies were conducted in the United States (California, 10,47,59 Minnesota, 9 and Oregon 9 ), with the remaining 5-dose studies conducted in cities across Germany. 60,61 Almost all of the 3-dose studies were conducted in Europe (Italy 38,39,55 and Sweden 41,51 ), although 1 study was conducted in Senegal. 44 The studies included in the analysis differed in terms of defining loss of immunity.…”

Clarification to Long-term anti-HBs antibody persistence and immune memory in children and adolescents who received routine childhood hepatitis B vaccination. Hum Vaccin Immunother 2012; 8:813-8

“…17,18 Therefore, for immunogenicity and the analyses for safety were performed on the Total Vaccinated Cohort (TVC). The TVC included all subjects who received the HBV vaccine challenge dose.…”