You are here: Home Published Research Impact of age on booster responses to the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in children in India: a randomized, open-label study.

Sanjay Lalwani, Sukanta Chatterjee, Jugesh Chhatwal, Anna Simon, Sudheer Ravula, Nancy Francois, Shailesh Mehta, Ana Strezova, and Dorota Borys (2014)

Impact of age on booster responses to the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in children in India: a randomized, open-label study.

Clinical and vaccine immunology : CVI.

In this phase III, open-label, multi-center, descriptive study (NCT01030822) in India, children primed with 3 doses (age: 6-10-14 weeks) of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) (NCT00814710) were randomized (1:1) to receive a booster dose at 9-12 (early booster) or 15-18 months old (late booster), to evaluate impact of age at booster. We also evaluated a 2-dose catch-up vaccination plus experimental booster dose in unprimed children aged 12-18 months. The early booster, late booster, and catch-up vaccination were received by 74, 95, and 87 children respectively; 66, 71, and 81 were included in the immunogenicity according-to-protocol cohort. One month post-booster, for each PHiD-CV serotype, ≥95.2% (early booster) and ≥93.8% (late booster) of children had antibody concentrations ≥0.2 μg/mL; ≥96.7% and ≥93.0% had opsonophagocytic activity (OPA) titers ≥8. Post-booster antibody geometric mean concentrations (GMCs) were in similar ranges for early and late booster; OPA titers appeared lower for most PHiD-CV serotypes (except 6B, 19F) after early booster. Post-dose 2 and post-booster, for each PHiD-CV serotype, ≥88.6% and ≥96.3% of the catch-up immunogenicity according-to-protocol cohort had antibody concentrations ≥0.2 μg/mL; ≥71.4% and ≥90.6% had OPA titers ≥8. At least 1 serious adverse event was reported by 2 children in the early booster (skin infection, gastroenteritis) and 1 child in the catch-up group (febrile convulsion, urinary tract infection); all were resolved, none were considered vaccine-related by investigators. PHiD-CV induced robust immune responses regardless of age at booster. Booster vaccination following 2 catch-up doses induced robust immune responses indicative of effective priming and immunological memory.

 
Document Actions