Reduced doses of oral killed enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine is safe and immunogenic in Bangladeshi infants 6-17 months of age: Dosing studies in different age groups

Firdausi Qadri, Tanvir Ahmed, Firoz Ahmed, Yasmin Ara Begum, David A. Sack, Ann Mari Svennerholm

Research output: Contribution to journalArticle

Abstract

The oral-formalin inactivated whole cell enterotoxigenic Escherichia coli (ETEC) vaccine needs to be further tested in developing countries in order to determine the dose at which it will be safe and immunogenic for infants who are the target population for the vaccine. To determine the immunogenicity of reduced doses, studies were first carried out in children, 2-12 years of age (n = 60). The full, half or a quarter doses of the vaccine were comparable in immunogenicity with similar frequency of responses seen to the different antigens (P = NS). Following this result, a pilot study carried out in infants, 6-17 months of age (n = 50), showed that the frequency of episodes of vomiting was lowest when a quarter of the full dose was used. The infants however showed comparable immune responses to the half and quarter dose of vaccine that was tested (P = NS). Based on these results in the infants, a randomized double blind placebo-controlled Phase II study was carried out in 158 children, 6-17 months of age, where a quarter dose of the ETEC vaccine was tested. Adverse events of mild vomiting were seen in only 4% of vaccinees and in 2.5% of placebo recipients. The IgA-antibody secreting cell (ASC) responses to CFA/I (GM: 28.1 ASC/107 PBMC) and BS (GM: 55.7 ASC/107 PBMC) were elevated compared to placebo recipients (CFA/I-2.0; BS-4.8 ASC/107 PBMC) (P = 0.01 to

Original languageEnglish (US)
Pages (from-to)1726-1733
Number of pages8
JournalVaccine
Volume24
Issue number10
DOIs
StatePublished - Mar 6 2006
Externally publishedYes

Fingerprint

Enterotoxigenic Escherichia coli
Antibody-Producing Cells
enterotoxigenic Escherichia coli
Subunit Vaccines
cholera toxin
subunit vaccines
Cholera Toxin
mouth
Escherichia coli Vaccines
Age Groups
Vaccines
vaccines
Placebos
mononuclear leukocytes
dosage
placebos
Vomiting
antibodies
immune response
vomiting

Keywords

  • Dosing
  • Enterotoxigenic Escherichia coli (ETEC) vaccine
  • Immunogenicity
  • Infants and children
  • Safety

ASJC Scopus subject areas

  • Immunology
  • Microbiology
  • Virology
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)

Cite this

Reduced doses of oral killed enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine is safe and immunogenic in Bangladeshi infants 6-17 months of age : Dosing studies in different age groups. / Qadri, Firdausi; Ahmed, Tanvir; Ahmed, Firoz; Begum, Yasmin Ara; Sack, David A.; Svennerholm, Ann Mari.

In: Vaccine, Vol. 24, No. 10, 06.03.2006, p. 1726-1733.

Research output: Contribution to journalArticle

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