title: Safety and immunogenicity of Haemophilus influenzae type B-Neisseria meningitidis group B outer membrane protein complex conjugate vaccine mixed in the syringe with diphtheria-tetanus-pertussis vaccine in young Gambian infants.
abstract: To ensure compliance and to reduce costs it is important, especially in less developed countries, that programs of child immunization should require as few clinic attendances and as few injections as possible. Therefore we have investigated whether a Haemophilus influenzae type b conjugate vaccine could be given safely and effectively with diphtheria-tetanus-pertussis vaccine (DTP). One hundred twenty-six Gambian infants were given both polyribosylribitol phosphate (PRP)-outer membrane protein complex (PedvaxHIB) and DTP on the same day at 8, 12 and 16 weeks of age; 60 were given the vaccines mixed in the syringe and 66 were given the vaccines separately. To minimize the injection volume the dose of PRP-OMPC used in both groups was 7.5 micrograms, which is half the usual dose. There were no significant differences in anti-PRP antibody titers between the groups after 1, 2 or 3 doses. The geometric mean titers of antibody for the two groups combined were 0.29 micrograms/ml 1 month after the first dose, 1.03 micrograms/ml after the second dose and 1.11 micrograms/ml after the third dose. Concentrations of antibodies to diphtheria, tetanus and pertussis 1 month after the third dose were not significantly different between the two groups. Systemic side effects were reported with equal frequency in the two groups and were similar to those reported elsewhere for DTP. Tenderness at the injection site was more common where the combined injection (0.75 ml) had been given than where DTP alone (0.5 ml) had been given. The main drawback to the use of these 2 vaccines together is the complexity of the mixing procedure used in this clinical trial.
authors.affiliation: Medical Research Council Laboratories, Banjul, The Gambia.
authors.forename: E K
authors.initials: EK
authors.lastname: Mulholland
authors.forename: V I
authors.initials: VI
authors.lastname: Ahonkhai
authors.forename: A M
authors.initials: AM
authors.lastname: Greenwood
authors.forename: L C
authors.initials: LC
authors.lastname: Jonas
authors.forename: L J
authors.initials: LJ
authors.lastname: Lukacs
authors.forename: C M
authors.initials: CM
authors.lastname: Mink
authors.forename: J M
authors.initials: JM
authors.lastname: Staub
authors.forename: J
authors.initials: J
authors.lastname: Todd
authors.forename: P P
authors.initials: PP
authors.lastname: Vella
authors.forename: B M
authors.initials: BM
authors.lastname: Greenwood
mesh_terms: D000907:Antibodies, Bacterial / Q000096:biosynthesis* / Q000097:blood; D001425:Bacterial Outer Membrane Proteins / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D004165:Diphtheria / Q000276:immunology / Q000517:prevention & control; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D005714:Gambia; D006192:Haemophilus Infections / Q000276:immunology* / Q000517:prevention & control; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007223:Infant; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D013742:Tetanus / Q000276:immunology / Q000517:prevention & control; D018074:Vaccines, Conjugate; D014917:Whooping Cough / Q000276:immunology / Q000517:prevention & control
chemical_list: D000907:Antibodies, Bacterial; D001425:Bacterial Outer Membrane Proteins; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C061964:Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine; D011135:Polysaccharides, Bacterial; D018074:Vaccines, Conjugate