PEDIATRICS Vol. 85 No. 3 March 1990, pp. 331-337
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Safety and Immunologic Response to Haemophilus Influenzae Type b Oligosaccharide-CRM197 Conjugate Vaccine in 1- to 6-Month-Old Infants

Dace Viceps Madore PhD1, Cynthia L. Johnson 1, Donna C. Phipps MS1, Lou A. Popejoy MC, USA1, Ronald Eby PhD1, David H. Smith MD1, and Pennridge Pediatric Associates

1 From Praxis Biologics, Inc, Rochester, New York; Pennridge Pediatrics, Sellersville, Pennsylvania; Temple University School of Medicine and St Christophers Hospital for Children, Philadelphia, Pennsylvania; and William Beaumont Army Medical Center, El Paso, Texas

A Haemophilus influenzae type b oligosaccharide-CRM197 conjugate (HbOC) vaccine was evaluated for safety and immunogenicity in 432 infants 1 to 6 months of age. In a multicenter study involving 10 sites in six states, infants were vaccinated with three 10-µg doses of HbOC at 2-month intervals. Side effects associated with vaccination were mild, transient, and occurred in fewer than 2% of the subjects. More than 90% of infants of all ages responded after two doses, and more than 98% had anti-H influenzae type b capsular polysaccharide (HbPs) antibody levels ge1 µg/mL after three doses. One month after the third vaccination, the geometric mean anti-HbPs antibody levels were 16.84, 26.23, and 29.11 in infants initially vaccinated at 1 to 2, 3 to 4, and 5 to 6 months of age, respectively. A long-term antibody response was observed; more than 80% of these infants had anti-HbPs levels ge1 µg/mL at 2 years of age. The HbOC generated an immune response characteristic of a protein antigen; IgG anti-HbPs antibodies of IgG1 subclass predominated and the response could be boosted. The immune sera killed H influenzae type b when evaluated in an in vitro bactericidal assay. The data indicate that HbOC safely primed and boosted the immune system of young infants, providing long-lasting protective levels of anti-HbPs antibodies.

Key Words: Haemophilus influenzae type b • immunogenicity • immunization • oligosaccharide conjugate vaccine • vaccination

Submitted on March 27, 1989
Accepted on May 9, 1989




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