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Infection and Immunity, November 2001, p. 6696-6701, Vol. 69, No. 11
0019-9567/01/$04.00+0   DOI: 10.1128/IAI.69.11.6696-6701.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Effects of Alum Adjuvant or a Booster Dose on Immunogenicity during Clinical Trials of Group B Streptococcal Type III Conjugate Vaccines

L. C. Paoletti,1,* M. A. Rench,2 D. L. Kasper,1 D. Molrine,3,dagger D. Ambrosino,3,dagger and C. J. Baker2

Channing Laboratory, Brigham and Women's Hospital,1 and Children's Hospital Medical Center,3 Harvard Medical School, Boston, Massachusetts 02115, and Baylor College of Medicine, Houston, Texas 770302

Received 18 April 2001/Returned for modification 3 July 2001/Accepted 1 August 2001

Phase 1 and 2 clinical trials of group B streptococcal (GBS) capsular polysaccharide (CPS)-protein conjugate vaccines in healthy adults have demonstrated their safety and improved immunogenicity compared with uncoupled CPSs. Two recent trials sought to determine (i) whether adsorption of conjugate vaccine to aluminum hydroxide would improve immunogenicity and (ii) whether the CPS-specific immunoglobulin G (IgG) response could be boosted by administration of a second dose. Adsorption of GBS type III CPS-tetanus toxoid (III-TT) conjugate vaccine to alum did not improve the immune response to a 12.5-µg dose in healthy adult recipients. Four weeks after vaccination, the geometric mean antibody concentrations (GMCs) for the 15 recipients of III-TT with or without alum were 3.3 and 3.6 µg/ml, respectively. In the second trial, 36 healthy adults vaccinated previously with GBS III-TT conjugate were given a second 12.5-µg dose 21 months later. At 4 weeks after the second dose, the GMCs of type III CPS-specific IgG were similar to those measured 4 weeks after the primary vaccination, suggesting a lack of a booster response. However, 8 (22%) of the 36 participants who had undetectable III CPS-specific IgG (<0.05 µg/ml) before the first dose of III-TT conjugate exhibited a booster response to the second dose, with a fourfold-greater GMC of type III CPS-specific IgG than after the initial immunization. These results suggest that prior natural exposure to type III GBS or a related antigen may be responsible for the brisk IgG response to CPS noted in most adults after vaccination. However, a second dose of GBS III-TT conjugate vaccine may be required for adults whose initial CPS-specific IgG concentrations are very low and would also restore the initial peak-specific III CPS-IgG in responders to previous vaccination.

* Corresponding author. Mailing address: Channing Laboratory, 181 Longwood Ave., Boston, MA 02115. Phone: (617) 525-2678. Fax: (617) 525-2682. E-mail: lpaoletti{at}channing.harvard.edu.

dagger Present address: Massachusetts Biologic Laboratories, University of Massachusetts Medical School, Jamaica Plains, MA 02130.

Infection and Immunity, November 2001, p. 6696-6701, Vol. 69, No. 11
0019-9567/01/$04.00+0   DOI: 10.1128/IAI.69.11.6696-6701.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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