title: A new DTPw-HBV/Hib vaccine is immunogenic and safe when administered according to the EPI (Expanded Programme for Immunization) schedule and following hepatitis B vaccination at birth.
abstract: New combination vaccines and reliable sources of vaccine components are essential to ensure the success of mass immunisation programmes in the 21st century. We evaluated a new combined diphtheria-tetanus-whole-cell-pertussis-hepatitis B vaccine, extemporaneously mixed with a Haemophilus influenzae type b conjugate vaccine (DTPw-HBV/Hib) containing 2.5 microg PRP in 913 Philippino infants, administered according to the EPI schedule at 6, 10 and 14 weeks of age after a birth dose of hepatitis B vaccine (HBV; trial DTPw-HBV/Hib-001). One month after the third dose of DTPw-HBV/Hib (N = 182), 99.4% and 94.2% of subjects had anti-PRP antibody levels > or =0.15 microg/mL and > or =1.0 microg/mL, respectively. In addition, 95.9%, 100.0% and 87.6% of subjects had seroprotective antibody concentrations against diphtheria, tetanus and hepatitis B, respectively. The seroprotection rate to hepatitis B increased significantly to 94.3% in subjects who received a dose of HBV at birth. The pertussis vaccine response rate was > or =95%. Seroprotection/vaccine response rates to all antigens after DTPw-HBV/Hib were at least as good as those observed after vaccination with GSK Biologicals' licensed Tritanrix HepB/Hiberix (containing 10 microg PRP) which was used as comparator. Although redness >20 mm in diameter and fever > or = 37.5 degrees C (axillary route) occurred more often after the new DTPw-HBV/Hib vaccine (p < 0.05), other Grade 3 adverse events occurred similarly between the groups. The new DTPw-HBV/Hib vaccine was as immunogenic and well tolerated as the licensed control vaccine when administered according to the immunologically challenging EPI schedule. A birth dose of HBV is important to maximize protection against hepatitis B in endemic regions where the EPI schedule is in place.
authors.affiliation: Research Institute for Tropical Medicine, Filinvest Corporate Centre, Alabang, Muntinlupa City, Manila, Philippines.
authors.forename: Salvacion
authors.initials: S
authors.lastname: Gatchalian
authors.forename: Marietta
authors.initials: M
authors.lastname: Reyes
authors.forename: Nancy
authors.initials: N
authors.lastname: Bernal
authors.forename: Inge
authors.initials: I
authors.lastname: Lefevre
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: David
authors.forename: Htay Htay
authors.initials: HH
authors.lastname: Han
authors.forename: Hans L
authors.initials: HL
authors.lastname: Bock
authors.forename: Joanne
authors.initials: J
authors.lastname: Wolter
authors.forename: Lode
authors.initials: L
authors.lastname: Schuerman
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D016667:Bacterial Capsules; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D001068:Feeding and Eating Disorders / Q000139:chemically induced; D005260:Female; D005334:Fever / Q000139:chemically induced; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006514:Hepatitis B Surface Antigens / Q000737:chemistry / Q000235:genetics / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D017589:Immunization Programs / Q000379:methods* / Q000592:standards; D007115:Immunization Schedule; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010146:Pain / Q000139:chemically induced; D010679:Philippines; D011134:Polysaccharides / Q000737:chemistry / Q000276:immunology; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D012894:Sleep Stages / Q000187:drug effects; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011134:Polysaccharides; D011135:Polysaccharides, Bacterial; D017778:Vaccines, Combined; C008984:polyribitol phosphate