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Clinical and Diagnostic Laboratory Immunology, November 2001, p. 1115-1119, Vol. 8, No. 6
1071-412X/01/$04.00+0   DOI: 10.1128/CDLI.8.6.1115-1119.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Functional Antibody Activity Elicited by Fractional Doses of Haemophilus influenzae Type b Conjugate Vaccine (Polyribosylribitol Phosphate-Tetanus Toxoid Conjugate)

Sandra Romero-Steiner,1,* Josefina Fernandez,2 Christel Biltoft,1 Melissa E. Wohl,1 Jacqueline Sanchez,2 Jesus Feris,2 Sharon Balter,1 Orin S. Levine,1 and George M. Carlone1

Division of Bacterial and Mycotic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia,1 and Clínica Infantil Robert Reid Cabral, Santo Domingo, Dominican Republic2

Received 7 March 2001/Returned for modification 25 June 2001/Accepted 17 August 2001

We evaluated the functional activities of antibodies, serum bactericidal activity (SBA), and immunoglobulin G (IgG) antibody avidity indices, using sodium thiocyanate (NaSCN) elution, elicited after vaccination with fractional doses of the Haemophilus influenzae type b conjugate (polyribosylribitol phosphate [PRP] conjugated to tetanus toxoid [PRP-T]) vaccine. A cohort of 600 infants from the Dominican Republic were randomized to receive one of three regimens of the PRP-T vaccine at ages 2, 4, and 6 months: full doses (10 µg of PRP antigen), one-half doses (5.0 µg), and one-third doses (3.3 µg) (J. Fernandez et al., Am. J. Trop. Med. Hyg. 62:485-490, 2000). Sixty serum samples, collected at age 7 months, with >= 2.0 µg of anti-PRP IgG per ml were randomly selected for avidity determinations. Geometric mean IgG concentrations were 13, 14, and 17 µg/ml for infants who received the full-dose (n = 19), one-half-dose (n = 19), and one-third-dose (n = 22) regimens, respectively. SBA geometric mean titers (1/dilution) were 85.0, 82.0, and 76.1 in sera from infants receiving the full-, one-half-, and one-third-dose regimens, respectively. Avidity indices (mean ± standard error weighted average of NaSCN molar concentration × serum dilution factor) were 71.9 ± 9.4, 123.6 ± 26.8, and 150.9 ± 24.9 for the full-, one-half-, and one-third-dose regimens, respectively. Upon comparison, the only significant difference (P = 0.024) found was a greater avidity index for sera from infants receiving the one-third-dose regimen than for sera from infants receiving the the full-dose regimen. We conclude that fractional doses elicit similar functional antibody activities in infants with >= 2 µg of anti-PRP IgG per ml, corresponding to 89, 90, and 97% of infants receiving three doses of either the full concentration or one-half or one-third of the labeled concentration, respectively. This approach offers an alternative strategy for the prevention of H. influenzae type b disease in countries with limited resources.

* Corresponding author. Mailing address: MS A-36, Immunology Section, Respiratory Diseases Branch, DBMD, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333. Phone: (404) 639-2473. Fax: (404) 639-3115. E-mail: sxs8{at}cdc.gov.

Clinical and Diagnostic Laboratory Immunology, November 2001, p. 1115-1119, Vol. 8, No. 6
1071-412X/01/$04.00+0   DOI: 10.1128/CDLI.8.6.1115-1119.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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