Journal Article

Assessing Efficacy of <i>Haemophilus influenzae</i> Type b Combination Vaccines

Dan M. Granoff

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 33, issue Supplement_4, pages S278-S287
Published in print December 2001 | ISSN: 1058-4838
Published online December 2001 | e-ISSN: 1537-6591 | DOI:
Assessing Efficacy of Haemophilus influenzae Type b Combination Vaccines

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Regulatory approval of diphtheria and tetanus toxoids and acellular pertussis (DTaP)–based combination vaccines containing Haemophilus influenzae type b (Hib) has been delayed in the US because of difficulty in assessing the effect of lower Hib immunogenicity on vaccine efficacy compared with the immunogenicity of the specific Hib component administered separately. Hib conjugate vaccines confer protection by eliciting serum anticapsular antibody and priming for immunologic memory. Therefore, compelling proof of efficacy would be demonstration that a combination vaccine primes for memory and elicits antibody responses that are not inferior to those elicited by other US-licensed Hib conjugate vaccines, not necessarily the specific Hib component used in the combination. Vaccinated infants also can be considered protected if their serum anticapsular antibody concentrations are ⩾0.15 µg/mL immediately before the booster dose given in the second year of life, when antibody concentrations are lowest. These alternative serologic approaches offer a strong scientific and regulatory rationale for licensure of effective DTaP-based Hib combination vaccines.

Journal Article.  8211 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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