Antibody persistence in pre-school children after hexavalent vaccine infant primary and booster administration

Abstract

Objective: Antibody persistence evaluation for all antigens of a fully liquid DTaP-IPV-HB-PRP~T vaccine at 3.5 and 4.5 y of age following different primary series and booster schedules in South Africa and Latin America. Methods: Participants had completed one of two previous studies (Study 1-South Africa; Study 2-Latin America). In Study 1, participants who had not received HB vaccine at birth received a 6-10-14 week primary series of DTaP-IPV-HB-PRP~T or DTwP/PRP~T-Hib+HB+OPV and a third group who had received HB vaccine at birth received a 6-10-14 week primary series of DTaP-IPV-HB-PRP~T; all received a booster (15-18 months) of the primary series vaccine(s) except for HB in the DTwP/PRP~T-Hib group. In Study 2, participants received HB vaccine at birth, a 2-4-6 month primary series of DTaP-IPV-HB-PRP~T or DTaP-HB-IPV//PRP~T, and a DTaP-IPV-HB-PRP~T or DTaP-HB-IPV//PRP~T booster (12-24 months). Participants were followed up at 3.5 and 4.5 y of age for antibody persistence.Results: Approximately 80% of eligible participants were assessed. In Study 1, a birth dose of HB increased anti-HBs persistence (≥10 mIU/mL) following DTaP-IPV-HB-PRP~T primary and booster vaccination from 76.3% to 96.1% at 3.5 y of age and from 73.3% to 96.1% at 4.5 y of age; in Study 2, anti-HBs persistence was high and similar in each group. For the other antigens, there were no differences between groups or studies at 3.5 or 4.5 y. Conclusion: Good persistence of antibodies to each antigen in the DTaP-IPV-HB-PRP~T vaccine up to pre-school age, irrespective of the vaccination schedule during the first 2 y of life. ARTICLE HISTORY

DTaP-IPV-HepB-Hib Vaccine (Hexyon®): An Updated Review of its Use in Primary and Booster Vaccination

“…A booster dose of Hexyon ® was evaluated in nearly half of the primary series trials [6, 8–10, 14, 21, 23]. Some studies assessed the long-term persistence of antibodies and immune memory against some of the vaccine antigens [5, 24].…”

“…Persistence of antibodies to Hexyon ® antigens in the longer term are discussed in Sects. 2.2 and 2.4 [5, 24].…”

“…Pre-booster antibody persistence was evaluated in all booster studies (Table 2). In addition, two of the core trials (A3L24 and A3L12) were followed-up to assess the long-term persistence of antibodies [5, 24].…”

“…Infants vaccinated in A3L24 showed good persistence of antibodies to Hexyon ® antigens up to pre-school age [5]. At 4.5 years, in infants primed and boosted with Hexyon ® , seroprotection rates were 92% for anti-HB and 98–100% for anti-D, anti-T, anti-polio types 1–3, and anti-Hib, GMCs were 3.2 and 33.8 EU/mL for anti-PT and anti-FHA, and LTPT rates were 57.2%, 80.8%, 74.0%, and 85.6%, for anti-D, anti-T, anti-HB, and anti-Hib, respectively.…”

“…A review of Hexyon ® was published in Pediatric Drugs in 2013 [4]. Since then, additional data [5–14] have become available. This article provides an updated review of the immunogenicity, reactogenicity and safety of Hexyon ® as primary and booster vaccination against major childhood infectious diseases caused by six pathogens, from a European perspective.…”