Safety, immunogenicity, and lot stability of the whole cell/recombinant B subunit (WC/rCTB) cholera vaccine in peruvian adults and children

David N. Taylor, Vicky Cárdenas, Juan Perez, Romulo Puga, Ann Mari Svennerholm

Research output: Contribution to journalArticle

Abstract

To assess the safety, immunogenicity, and lot stability of the whole cell/recombinant B subunit cholera vaccine, 2 lots manufactured in June 1991 and February 1992 were tested in January 1995. Two oral doses of vaccine or placebo given 2 weeks apart were given with buffer to 216 Peruvian adults and children. Symptoms were elicited for 3 days after each dose. Serum and plasma specimens obtained from each volunteer before vaccination and 1014 days after the second dose were tested for vibriocidal and anti-cholera toxin antibodies. The vaccine was well-tolerated. Nearly half of the 100 vaccinees had pre-vaccination vibriocidal titers ≥ 1:40. Elevated titers were observed in 22% of 37 children 2-5 years of age compared with 66% of 63 vaccinees 6-65 years (P <0.001). A ≥2-fold serum vibriocidal response was observed in 55% of 100 vaccinees and 6% of 32 placebo recipients. An elevated prevaccination titer (≥1:40) did not change the proportion of vaccinees who responded with a ≥2-fold increase in vibriocidal titer (51% versus 59%, difference not significant), but did change the proportion responding with a ≥4-fold increase (41% versus 22%; P <0.05). The vibriocidal seroconversion rate was lowest in children 2-5 years old despite low pre-vaccination titers. Two-fold or greater serum antitoxic responses in IgA find IgG were observed in >90% of the vaccinees; ≥4-fold responses were seen in 65-70% of the vaccinees with a 6-8-fold increase over baseline. Plasma specimens were as good as sera for determining anti-toxic antibodies by ELISA, but were less satisfactory for determining vibriocidal antibody titers.

Original languageEnglish (US)
Pages (from-to)869-873
Number of pages5
JournalAmerican Journal of Tropical Medicine and Hygiene
Volume61
Issue number6
StatePublished - Dec 1999
Externally publishedYes

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Cholera Vaccines
Subunit Vaccines
Vaccination
Vaccines
Safety
Antibodies
Poisons
Cholera Toxin
Serum
Volunteers
Anti-Idiotypic Antibodies
Buffers
Enzyme-Linked Immunosorbent Assay
Placebos

ASJC Scopus subject areas

  • Parasitology
  • Infectious Diseases

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Safety, immunogenicity, and lot stability of the whole cell/recombinant B subunit (WC/rCTB) cholera vaccine in peruvian adults and children. / Taylor, David N.; Cárdenas, Vicky; Perez, Juan; Puga, Romulo; Svennerholm, Ann Mari.

In: American Journal of Tropical Medicine and Hygiene, Vol. 61, No. 6, 12.1999, p. 869-873.

Research output: Contribution to journalArticle

Taylor, David N. ; Cárdenas, Vicky ; Perez, Juan ; Puga, Romulo ; Svennerholm, Ann Mari. / Safety, immunogenicity, and lot stability of the whole cell/recombinant B subunit (WC/rCTB) cholera vaccine in peruvian adults and children. In: American Journal of Tropical Medicine and Hygiene. 1999 ; Vol. 61, No. 6. pp. 869-873.
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