Feasibility study of the immunogenicity and safety of a novel DTPw/Hib (PRP-T) Brazilian combination compared to a licensed vaccine in healthy children at 2, 4, and 6 months of age

Abstract

Vaccination of infants with conjugated Haemophilus influenzae type b (Hib) vaccines has been proven to reduce Hib meningitis by 95% and pneumoniae by 20%. The routine use of Hib vaccine is facilitated by the introduction of combination vaccines into the EPI (Expanded Plan of Immunization). The objective of this study was to compare the immunogenicity and reactogenicity of an extemporaneously mixed DTPw/Hib (diphtheria-tetanus-whole cell pertussis) combination, using the technology of two Brazilian manufacturers, against a licensed DTPw/Hib European combination in 108 infants vaccinated at 2, 4 and 6 months according to the local national schedule. The Brazilian combination was highly immunogenic with Hib seroprotection rates (anti-PRP > 0.15 mg /ml of 98% after 2 doses and 100% after 3). Also for tetanus and pertussis the new Brazilian combination was as immunogenic as the European counterpart, except the diphtheria seroprotection rates and titers were lower. There was also no clinically relevant difference in reactogenicity. If these feasibility results are confirmed, the Brazilian DTPw/Hib combination should help to boost the uptake of Hib vaccination in Brazil.

Immunogenicity, reactogenicity and consistency of production of a Brazilian combined vaccine against diphtheria, tetanus, pertussis and Haemophilus influenzae type b

“…The proportion of infants seroprotected after the second dose was also high and similar between both vaccines. Immunogenicity was comparable to a previous study with the same reference vaccine, in which 98% and 100% of infants demonstrated anti-PRP antibody titers ≥ 0.15 μg/mL, and GMTs were 4.32 mUI/mL and 9.34 mUI/mL after the second and third doses, respectively (Clemens et al 2003). The proportion of more intense and possibly longlasting responses (titers ≥1 μg) was also high for both vaccines, which was also comparable to the previous study.…”

“…In 1999, Hib vaccine produced by GSK was introduced in the Brazilian National Immunization Program (NIP) and administered at two, four and six months of age, concomitant to the administration at another site of a DTP vaccine produced by Instituto Butantan. Since 2002, these vaccinations have been administered as a single Reports on the quality, immunogenicity and safety of this combination have been demonstrated in a clinical study (Clemens et al 2003).The technology transfer from GSK to Bio-Manguinhos (BM) was a strategic step toward the routine availability of this vaccine by the NIP. This process was concluded in 2005 with the production of the conjugate Hib vaccine by BM.…”

Naturally acquired immunity to Haemophilus influenzae type B in healthy Cuban children

“…This study shows that the Cuban children had high anti-PRP concentrations and provides strong evidence that children in some developing countries acquire natural active immunity to Hib at an early age (Tastan et al 2000, Puliyel et al 2001, Clemens et al 2003. These results support the recommendation of the World Health Organization that the strategy of administering Hib vaccine to all children under 5 years old must be considered only in those countries which can afforded it without to diverting resources from essential infants vaccination programs (WHO 1998).…”

Impaired Humoral Response to Vaccines among HIV-Exposed Uninfected Infants

“…The vaccine is given at birth and at the first and sixth months. DTP/Hib tetravalent vaccine (diphtheriatetanus-pertussis and Haemophilus influenzae type b) contained four protective units of Bordetella pertussis toxin, two units of diphtheria and tetanus toxoids (1.25 mg of aluminum hydroxide and 0.2 mg of thimerosal), and 10 mg H. influenzae type b capsular polysaccharide conjugated to 20 to 40 g tetanus toxoid (7). The vaccine is given at 2, 4, and 6 months of life, and a DTP booster is given at 15 months and 4 to 6 years.…”