Clinical, metabolic, and antibody responses of adult volunteers to an investigational vaccine composed of pertussis toxin inactivated by hydrogen peroxide

Ronald D. Sekura, Yan ling Zhang, Robin Roberson, Brett Acton, Birger Trollfors, Nathaniel Tolson, Joseph Shiloach, Dolores Bryla, Joann Muir-Nash, David Koeller, Rachel Schneerson, John B. Robbins

Research output: Contribution to journalArticle

51 Scopus citations

Abstract

A toxoid vaccine, composed of purified pertussis toxin inactivated with H2O2 (NICHD-Ptxd), was developed on the basis of evidence that serum neutralizing antibodies (antitoxin) would confer immunity to pertussis. In vivo and in vitro assays of NICHD-Ptxd showed only trace or nondetectable levels of pyrogenic, adenosine diphosphate-ribosyltransferase, binding and pharmacologic activities. Nevertheless, about 40% of the antigencicity of pertussis toxin was retained. Adult volunteers were injected, two times 6 weeks apart, with either 10 (n=21), 50 (n=25), or 75 (n=30) μg/dose of one lot, Ptx-06, adsorbed onto Al(OH)3. Neither fever nor changes in the levels of leukocytes, lymphocytes, fasting blood glucose, or insulin were observed in the volunteers. The optimal immunizing dose, 50 μg, induced levels of antitoxin (geometric mean (GM) 302 U) comparable to those found in eight adults convalescent from pertussis (GM 269 U) and greater than those found in 18-month-old children after their fourth dose of diphtheria and fetanus toxoids and pertussis vaccine (GM 20.0 U, p<0.001). These data indicate that NICHD-Ptxd is safe and immunogenic in adults, and they justify its evaluation in infants and children.

Original languageEnglish (US)
Pages (from-to)806-813
Number of pages8
JournalThe Journal of pediatrics
Volume113
Issue number5
DOIs
StatePublished - Nov 1988

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Fingerprint Dive into the research topics of 'Clinical, metabolic, and antibody responses of adult volunteers to an investigational vaccine composed of pertussis toxin inactivated by hydrogen peroxide'. Together they form a unique fingerprint.

  • Cite this

    Sekura, R. D., Zhang, Y. L., Roberson, R., Acton, B., Trollfors, B., Tolson, N., Shiloach, J., Bryla, D., Muir-Nash, J., Koeller, D., Schneerson, R., & Robbins, J. B. (1988). Clinical, metabolic, and antibody responses of adult volunteers to an investigational vaccine composed of pertussis toxin inactivated by hydrogen peroxide. The Journal of pediatrics, 113(5), 806-813. https://doi.org/10.1016/S0022-3476(88)80005-2