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

Abstract

Hexyon ® is a fully-liquid, ready-to-use, hexavalent vaccine approved in the EU since 2013 for primary and booster vaccination in infants and toddlers from age 6 weeks against diphtheria, tetanus, pertussis, hepatitis B (HB), poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b (Hib). While the source of HB antigen in Hexyon ® is different from other vaccines, the rest of its valences have been extensively used in other approved vaccines. Hexyon ® is highly immunogenic for all its component toxoids/antigens when used as primary and booster vaccine in infants and toddlers, irrespective of vaccination schedule. It provides durable protection against hepatitis B. Hexyon ® can be used for a mixed primary series of hexavalent-pentavalent-hexavalent vaccines or as a booster in infants primed with Infanrix hexa™ or pentavalent (whole-cell or acellular pertussis) vaccines. Coadministration of Hexyon ® with other common childhood vaccines did not affect immune response to any vaccines. Hexyon ® has a good reactogenicity/safety profile. The immunogenicity and safety profile of Hexyon ® was similar to that of several approved vaccines, including Infanrix hexa™. However, Hexyon ® offers the convenience of full-liquid, ready-to-use formulation, which may minimize vaccination errors and preparation time. Thus, Hexyon ® is a convenient, useful option for vaccination against childhood diseases caused by six major pathogens.

Peptides, Antibodies, Peptide Antibodies and More

“…Rhesus-D Ig/rhesus syndrome prophylaxis PAb (Sp IVIG) [69] Anti-toxins/botulism PAb (Sp IVIG) [70,71] Rituximab/lymphoma, Ocrelizumab/multiple sclerosis MAb (recombinant), chimeric [72,73] Infliximab/rheumatoid arthritis MAb (recombinant), chimeric [74] Nivolumab/malignant melanoma MAb (recombinant), human [75] Panitumumab/EGFR metastatic colorectal carcinoma MAb (recombinant), human [76] Daclizumab/allograft rejection Mab (recombinant), humanized [77] HpHbR Ab-PBD conjugate/African trypanosomiasis treatment (mouse model) MAb-drug conjugate [78] Vaccines MMR live attenuated viruses vaccine/measles, mumps, rubella prophylaxis PAb in vivo [79] DiTePePolHiB SU vaccine/diphtheria-tetanus-pertussis-polio-hemophilus prophylaxis PAb in vivo [80][81][82] HPV SU vaccine/cervix cancer prophylaxis PAb in vivo [83,84] CD: cluster of differentiation. DiTePePolHiB SU: Diphteria-Tetanus-Pertussis-Polio-Hemophilus influenzae B subunit vaccine.…”

Immunogenicity and safety of a hexavalent pediatric vaccine in HIV-exposed infected and uninfected infants in Republic of South Africa

“…13,15 The incidence of AEs was generally lower following the booster vaccination than for the primary series (with the exception of solicited injection site reactions), which is expected based on similar findings in previous studies with the DTaP-IPV-HB-PRP~T vaccine in non-HIV infected infants. 4,13,15 The main limitation of the present study is the lower than expected recruitment of HIV-exposed infected infants in Group A, which precludes a robust interpretation of the study results. However, a strength of the study is to have evaluated the immunogenicity and safety of the DTaP-IPV-HB-PRP~T vaccine in at least a small group of these infants and toddlers, and to be able to make a comparison (albeit with caution, due to the small number of participants) not only to a group of HIV-exposed uninfected participants but also to historical data from a comparable cohort of healthy infants.…”

“…18 The oral poliovirus, BCG, pneumococcal, and rotavirus vaccines would not be expected to have any effect on the safety or immunogenicity of the DTaP-IPV-HB-PRP~T vaccine, and coadministration with pneumococcal and rotavirus vaccines has been evaluated during the clinical development program . 4 …”

“…18 The oral poliovirus, BCG, pneumococcal, and rotavirus vaccines would not be expected to have any effect on the safety or immunogenicity of the DTaP-IPV-HB-PRP~T vaccine, and coadministration with pneumococcal and rotavirus vaccines has been evaluated during the clinical development program . 4 The main exclusion criteria were the prior receipt of any vaccine containing D, T, P, poliovirus (except for a birth dose of oral poliovirus vaccine, which is routinely recommended in RSA), HB (except for a birth dose of standalone HB vaccine, which is recommended for infants born to HB surface antigen positive mothers in RSA), or Hib antigens, or history of infection with any of these diseases; previous (in the 4 weeks before enrollment) or planned (during the study period) participation in another clinical study; any chronic condition (except HIV infection in Group A); receipt of blood or blood-derived products; thrombocytopenia or bleeding disorder; history of seizures or uncontrolled neurological disorder; known hypersensitivity or contraindication to any vaccine component; acute illness or febrile illness (axillary temperature ≥38.0°C) on the day of vaccination. Additional contraindications to subsequent vaccination included receipt of immunosuppressive therapy, systemic corticosteroids (for more than 2 consecutive weeks), immunoglobulins, blood or blood-derived products, or any non-study vaccine containing D, T, P, IPV, HB, or Hib antigens since the preceding visit, any acute or severe chronic illness that could have interfered with the conduct of the study or any known contraindication to pertussis vaccination since the preceding visit.…”

“…2,3 Hexaxim is a fully liquid hexavalent vaccine containing D, T, acellular pertussis (aP), inactivated poliovirus, HB, and Hib polysaccharide conjugated to tetanus protein (PRP~T) antigens (DTaP-IPV-HB-PRP~T) that was first licensed in 2012 after demonstrating strong immunogenicity and good safety during a thorough clinical development program in a wide range of schedules, on four continents, with or without a birth dose of HB, alone and in co-administration with other common pediatric vaccines. 4 Over 100 million doses of this DTaP-IPV-HB-PRP~T vaccine have been distributed in more than 100 countries worldwide and the vaccine is pre-qualified by the World Health Organization. 5 This vaccine was the first to be evaluated via the European Medicines Agency Article 58 procedure.…”