Impact of maternal diphtheria-tetanus-acellular pertussis vaccination on pertussis booster immune responses in toddlers: Follow-up of a randomized trial

Q3 · MEDICINE

Article

Author: Nolan, Terry ; Tapiéro, Bruce ; Marchisio, Paola Giovanna ; Novas, Begoña Arias ; Palomino, Esperanza Escribano ; Vanderkooi, Otto G ; Kostanyan, Lusine ; Halperin, Scott A ; Janota, Jan ; García-Sicilia, José ; Amador, Jose Tomas Ramos ; Miranda-Valdivieso, Mariano ; Baca, Manuel ; Kosina, Pavel ; Bozensky, Jan ; Zuccotti, Gian Vincenzo ; Meyer, Nadia ; Cheuvart, Brigitte ; Ortega, María José Cilleruelo ; Stranak, Zbynek ; Mesaros, Narcisa ; de la Cueva, Ignacio Salamanca ; Arribas, Jose M Merino ; Perrett, Kirsten P ; Ceregido, Maria Angeles ; Virta, Miia ; Kuriyakose, Sherine O ; Rumlarova, Sarka ; Martinón-Torres, Federico

BACKGROUNDTransplacentally transferred antibodies induced by maternal pertussis vaccination interfere with infant immune responses to pertussis primary vaccination. We evaluated whether this interference remains in toddlers after booster vaccination.METHODSIn a prior phase IV, observer-blind, placebo-controlled, randomized study (NCT02377349), pregnant women in Australia, Canada and Europe received intramuscular tetanus-reduced-antigen-content diphtheria-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) at 27^0/7-36^6/7 weeks' gestation, with crossover immunization postpartum. Their infants were primed (study NCT02422264) and boosted (at 11-18 months; current study NCT02853929) with diphtheria-tetanus-three-component acellular pertussis-hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b vaccine (DTaP-HepB-IPV/Hib) and 13-valent pneumococcal conjugate vaccine. Immunogenicity before and after booster vaccination, and reactogenicity and safety of the booster were evaluated descriptively.RESULTS263 (Tdap group) and 277 (control group) toddlers received a DTaP-HepB-IPV/Hib booster. Pre-booster vaccination, observed geometric mean concentrations (GMCs) for the three pertussis antigens and diphtheria were 1.4-1.5-fold higher in controls than in the Tdap group. No differences were observed for the other DTaP-HepB-IPV/Hib antigens. One month post-booster vaccination, booster response rates for pertussis antigens were ≥ 92.1% and seroprotection rates for the other DTaP-HepB-IPV/Hib antigens were ≥ 99.2% in both groups (primary objective). Higher post-booster GMCs were observed in controls versus the Tdap group for anti-filamentous hemagglutinin (1.2-fold), anti-pertussis toxoid (1.5-fold) and anti-diphtheria (1.4-fold). GMCs for the other DTaP-HepB-IPV/Hib antigens were similar between groups. Serious adverse events were reported for three toddlers (controls, not vaccination-related). One death occurred pre-booster (Tdap group, not vaccination-related).CONCLUSIONSAs a consequence of interference of maternal pertussis antibodies with infant immune responses to pertussis primary vaccination, pertussis antibody concentrations were still lower in toddlers from Tdap-vaccinated mothers before DTaP-HepB-IPV/Hib booster vaccination. After the booster, antibody concentrations were lower for filamentous hemagglutinin and pertussis toxoid but not for pertactin. The clinical significance of this interference requires further evaluation.CLINICAL TRIAL REGISTRATIONClinicalTrials.gov: NCT02853929.

02 Aug 2020·Expert Review of VaccinesQ2 · MEDICINE

Safety profile of Infanrix hexa – 17 years of GSK’s passive post-marketing surveillance

Q2 · MEDICINE

Article

Author: Puente Gómez, Ivonne ; Verheust, Céline ; Dolhain, Jan ; Hanssens, Linda

INTRODUCTIONThis paper reports 17 years of passive safety surveillance of routine use of the pediatric hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b-conjugate vaccine (DTPa-HBV-IPV/Hib, Infanrix hexa, GSK).METHODSGlobal post-licensure passive surveillance data collected in GSK's central safety database since DTPa-HBV-IPV/Hib's launch (2000) are described.RESULTSThe most common spontaneously reported adverse events (AEs) after DTPa-HBV-IPV/Hib vaccination in children were fever (reporting rate: 7.74/100,000 doses distributed), crying (2.62/100,000), injection site erythema (1.87/100,000) and swelling (1.28/100,000). A review of extensive limb swelling did not reveal any safety concerns. An observed-to-expected analysis did not show an increased risk of sudden death after DTPa-HBV-IPV/Hib vaccination, in line with previous observations. The analyses confirmed that increases in spontaneous reporting proportions of convulsions with/without fever and hypotonic-hyporesponsive episodes after co-administration of DTPa-HBV-IPV/Hib and 13-valent pneumococcal conjugate vaccine remained small and their clinical significance unknown. The most common vaccination errors were mistakes in the vaccination schedule. Reporting of preparation errors (mostly reconstitution) was low and did not impact the vaccine's benefit-risk profile.CONCLUSIONSSeventeen years of post-licensure experience confirm confidence in the safety profile of DTPa-HBV-IPV/Hib in routine use, with a favorable benefit-risk profile in infants and toddlers.PLAIN LANGUAGE SUMMARYWhat is the context? The cornerstone of childhood vaccination in many countries worldwide is a vaccine that protects against several diseases: diphtheria, tetanus, whooping cough, hepatitis B, polio and Haemophilus influenzae type b infections (such as meningitis). One of these vaccines (the longest on the market) is called Infanrix hexa; it has been available for infants and toddlers since 2000. After a vaccine is included in a country's routine vaccination program, its safety is constantly checked; this is done in clinical trials and through spontaneous reporting of adverse events after vaccination. It is important to share up-to-date information on the safety of vaccines, particularly since concerns about vaccine safety in parents may lead to lower vaccination rates an disease outbreaks. Here we summarize 17 years of safety data for the Infanrix hexa vaccine. What is new? We analyzed spontaneously reported adverse events after Infanrix hexa vaccinations between 2000 and 2017 The most commonly reported adverse events were fever, crying and injection site redness and swelling An in-depth review of extensive limb swelling after Infanrix hexa vaccination revealed no safety concerns. There was no increased risk of sudden death after Infanrix hexa vaccination, consistent with what was shown in several other studies. As shown previously, seizures were more common when Infanrix hexa was given together with the pneumococcal conjugate vaccine, Prevnar 13, than when it was given alone. What is the take-home message? The large amount of safety data gathered from clinical trials and from spontaneous adverse event reporting during 17 years of routine vaccination with Infanrix hexa supports its continued use in young children.

01 Jul 2019·Vaccine

Immunization of preterms with hexavalent combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine: The position of the Italian Pediatric Society

Letter

Author: Russo, Rocco ; Bozzola, Elena ; Villani, Alberto

100 Deals associated with Hib-DTP-hepatitis B-poliovirus vaccine(Panacea Biotec Ltd.)

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Indication	Country/Location	Organization	Date
Diphtheria	IN	Panacea Biotec Ltd.	01 Jan 2017
Haemophilus Infections	IN	Panacea Biotec Ltd.	01 Jan 2017
Hepatitis B	IN	Panacea Biotec Ltd.	01 Jan 2017
Poliomyelitis	IN	Panacea Biotec Ltd.	01 Jan 2017
Tetanus	IN	Panacea Biotec Ltd.	01 Jan 2017
Whooping Cough	IN	Panacea Biotec Ltd.	01 Jan 2017

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