Impact Estimate of the 10-Valent Pneumococcal Non-Typeable Haemophilus influenzae Protein D-Conjugate Vaccine (PHiD-CV) on Invasive Pneumococcal Disease (IPD) in Middle East and Asian Countries Academic Article uri icon

abstract

  • Background: This double-blind, controlled study (107007/NCT00344318) evaluated the immune responses of the candidate vaccine, PHiD-CV (GlaxoSmithKline Biologi-cals), designed to protect infants against pneumococcal and non-typeable Haemophilus infiuenzae diseases, following co-administration with DTPw-HBV/Hib + OPV at 6-10-14 weeks of age (EPI schedule) in the Philippines. Methods: 400 healthy Filipino infants 6 to 12 weeks of age were randomized (3:1) to receive either PHiD-CV or licensed 7vCRM vaccine (Prevenar TM /Prevnar TM) co-administered with DTPw-HBV/Hib + OPV. Vaccine immune responses were assessed one month post-dose III (22F-inhibition ELISA, ELISA, micro-neutralization assays). Results: For each of the pneumococcal serotypes common between both vaccines, observed percentages of infants with antibody concentration ≥0.2 g/mL were within the same range for both groups (PHiD-CV group: ≥91.2%; 7vCRM group: ≥86.3%). At least 99.6% of PHiD-CV vaccinees had antibody concentrations ≥0.2 g/mL against pneumococcal serotypes 1, 5 and 7F. Anti-pneumococcal geometric mean antibody concentrations were within the same range for both vaccines except for serotypes 18C and 19F for which higher immune responses were observed in the PHiD-CV group. Moreover, immune responses of all co-administered vaccines were in line with previous observations, with the exception of responses against polio virus types 1 and 3 which seemed lower in the 7vCRM group. Based on these immunogenicity results, PHiD-CV could potentially prevent 79% of IPD in Filipino infants compared to 62% for 7vCRM (abstract# 3.003), reflecting the importance of the additional serotypes (especially 1 and 5) for IPD in the Philippines. Conclusions: PHiD-CV elicited high immune responses for each of the 10 pneumococcal vaccine serotypes in infants vaccinated according to the 6-10-14 week's schedule. No evidence of negative immunological interference beiween PHiD-CV and co-administered vaccines was observed.

publication date

  • January 1, 2008