A new DTPw-HB/Hib combination vaccine for primary and booster vaccination of infants in Latin America.
OBJECTIVE
In 1998 the World Health Organization (WHO) recommended the inclusion of Haemophilus influenza type B (Hib) conjugate vaccines in infant immunization programs, whenever in accordance with national priorities. GlaxoSmithKline Biologicals has developed a new pentavalent combined diphtheria-tetanus-whole cell pertussis-hepatitis B/Hib (DTPw-HB/Hib) vaccine containing 5 microg of polyribosylribitol phosphate (PRP), and we assessed the immunogenicity and reactogenicity of primary and booster vaccination of healthy children with this new vaccine compared with a reference regimen consisting of the licensed DTPw-HB (Tritanrix) and Hib (Hiberix) vaccines given as simultaneous concomitant injections.


METHODS
We performed a randomized, double-blind study from September 1998 to August 1999 to establish the immunogenicity and reactogenicity of primary and booster vaccination of healthy children with the new pentavalent combined DTPw-HB/Hib vaccine given as a single injection, compared with the reference regimen.


RESULTS
Both vaccination regimens elicited excellent immune responses, with all subjects in both groups achieving seroprotective anti-PRP antibody concentrations of > or = 0.15 microg/mL one month after primary vaccination. The combined DTPw-HB/Hib vaccine was non-inferior to the licensed vaccines in terms of seroprotection/seropositivity/vaccine response rates for all antigen components. Persistence of antibodies against all study vaccine antigens up to the time of booster vaccination was comparable between groups, and a marked increase of all antibody concentrations was observed after the booster dose. Both vaccine regimens were similar in terms of their overall reactogenicity profiles.


CONCLUSIONS
Our results indicate that the new DTPw-HB/Hib pentavalent combination vaccine provides an efficient and reliable way of implementing WHO recommendations for controlling hepatitis B and Hib infections on a worldwide basis.
Tregnaghi
Miguel
M
Centro de Desarrollo de Proyectos Avanzados, Córdoba, Argentina.
López
Pio
P
Rocha
Crisanta
C
Rivera
Luis
L
David
Marie-Pierre
MP
Rüttimann
Ricardo
R
Schuerman
Lode
L
D002675:Child, Preschool; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000276:immunology; D004311:Double-Blind Method; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000276:immunology; D019741:Haemophilus influenzae type b / Q000276:immunology; D006509:Hepatitis B / Q000517:prevention & control; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007223:Infant; D007843:Latin America; D013997:Time Factors; D014611:Vaccination; D017778:Vaccines, Combined / Q000008:administration & dosage*; D014944:World Health Organization
D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined; C080881:diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine