A new DTPw-HBV/Hib vaccine: Immune memory after primary vaccination and booster dosing in the second year of life

Salvacion Gatchalian, Marietta Reyes, Nancy Bermal, Vijayalakshmi Chandrasekaran, Htay Htay Han, Hans L. Bock and Inge Lefevre

volume 4 | issue 1

january/february 2008
Pages: 60 - 66

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The response to booster vaccination at 15-18 months of age and the presence of immune memory in 10-month old children, primed with a new combined diphtheria-tetanus-hepatitis B- whole cell pertussis vaccine extemporaneously mixed with Haemophilus influenzae type b-tetanus toxoid conjugate (DTPw-HBV/Hib) from new antigen sources and containing 2.5µg polyribosyl-ribitol-phosphate (PRP) was assessed. Primary vaccination with the new DTPw-HBV/Hib vaccine was immunogenic and of comparable tolerability to commercially available Tritanrix™ HepB/Hiberix™. Children were boosted with DTPw-HBV, DTPw-HBV/Hib or separate DTPw-HBV+Hiberix™. Immune memory was assessed through administration of 10µg PRP polysaccharide. Anti-PRP antibody GMCs increased substantially after the challenge in DTPw-HBV/Hib-primed subjects indicating the presence of immune memory. One month after the booster dose, 100% of subjects had seroprotective antibody concentrations against PRP, diphtheria and tetanus, >95% were seroprotected against hepatitis B, ≥94.0% had a pertussis booster response. Substantial increases in antibody GMCs against all antigens were observed. Swelling >20 mm was the most common Grade 3 solicited symptom reported (up to 26.0% of subjects). Fever >39.5ºC was uncommon (<2.5%). Eleven large swelling reactions were reported; none involved an adjacent joint. One serious adverse event occurred that was considered unrelated to vaccination. This new DTPw-HBV/Hib vaccine with new vaccine components and 2.5µg PRP induced effective priming against Hib evidenced by a vigorous anamnestic response on exposure to PRP polysaccharide. The booster dose was immunogenic and the safety profile was acceptable. Combined DTPw-HBV and DTPw-HBV/Hib vaccines using new vaccine antigen sources will promote continued supply of combined DTPw-based vaccines to global mass vaccination campaigns.

Authors

Salvacion Gatchalian

Research Institute for Tropical Medicine; Filinvest Corporate Centre; Alabang; Muntinlupa City, Manila, Philippines

Marietta Reyes

Quirino Memorial Medical Centre; Quezon City, Manila, Philippine

Nancy Bermal

San Juan de Dios Educational Foundation, Inc. (Hospital); Pasay City, Manila, Philippines

Vijayalakshmi Chandrasekaran

GlaxoSmithKline Biologicals; Rixensart, Belgium

Htay Htay Han

GlaxoSmithKline Biologicals, Gateway West, Singapore

Hans L. Bock