Persistence of Antibodies in Children Primed with Two Different Hexavalent Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae Type b Vaccines and Evaluation of Booster Vaccination

Abstract

This study assessed the persistence of antibodies following primary vaccination with two commercially available, hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccines (Infanrix hexa and Hexavac). The immunogenicity and reactogenicity of booster vaccination with Infanrix hexa were also evaluated. A total of 329 children primed at 2, 4, and 6 months with Infanrix hexa (n=166) or Hexavac (n=163) received booster vaccination with Infanrix hexa at 12-19 months of age. Antibody concentrations were measured immediately before and 1 month after booster vaccination. Prebooster persistence of antibodies to HBs, PRP and poliovirus types was significantly higher in children primed with Infanrix hexa than with Hexavac, both in terms of seroprotection rate and GMCs/GMTs (p < 0.05). Boosting with Infanrix hexa elicited strong immune responses to all antigens irrespective of the primary vaccine used, with post-booster seroprotection rates comparable between the two primary vaccine groups (ranging from 98.1 to 100%). The incidence of clinically relevant solicited symptoms did not differ significantly between primary vaccine groups, even if the incidence of local symptoms appeared to be more frequent in subjects primed with Infanrix hexa than in those primed with Hexavac. In summary, booster vaccination with Infanrix hexa during the second year of life is immunogenic and well tolerated, offering protection irrespective of the primary combination vaccine used.

Pertussis vaccination during pregnancy in Belgium: Follow-up of infants until 1 month after the fourth infant pertussis vaccination at 15 months of age

“…Therefore, blunting might not necessarily be a sign of a less effective immunization. In comparison with available literature on humoral responses to Infanrix hexa ® at the age of 15 months [29,30], the pertussis specific antibody titers were lower in our study, at both time points in both study groups. Gimenez-Sanchez et al [29] collected blood samples after a fourth dose of Infanrix hexa ® at 11-15 months of age, concomitantly administered with PCV 7 or PCV 13.…”

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

“…3 We report two serological follow up studies conducted in Germany in healthy children between 4 and 9 years of age who had been previously primed and boosted with four doses of combined DTPa-HBV-IPV/Hib vaccine in previous GSK-sponsored clinical trials. 3,[5][6][7][8][9] The immune response to a challenge dose of hepatitis B vaccine in these subjects was also assessed and has been reported elsewhere.…”

Unterschiedliche Impfschemata in Europa

“…Nur in einer Publikation fanden sich häufiger lokale Reaktionen nach Anwendung des Infanrix hexa®-Impfstoffes [11,23]. Allerdings konnte bei einer Untersuchung desselben bei Frühgeborenen und Kindern mit geringem Geburtsgewicht eine durchwegs gute Verträglichkeit dokumentiert werden [28].…”

“…Impfstoff [23] wurden beim 2+1-vs. 3+1-Schema nach Boosterimmunisierung Seroprotektionsraten von jeweils 99% beobachtet, vor der Boosterimpfung aber nur 79% nach 2 Dosen gegenüber 92% nach 3 Dosen; diese Resultate ergaben sich unter Berücksichtigung eines Grenzwertes von PRP-Antikörperspiegeln >15 µg/ml. Allerdings waren in ursprünglichen Wirksamkeitsprüfungen ("efficacy trials") protektive Serumantikörperkonzentrationen von 0,4-0,15 µg ermittelt worden, welche die Schutzraten nach 2 Immunisierungen (vor der Boosterimmunisierung) in einem deutlich höheren protektiven Bereich ansiedeln lassen [9].…”