title: Comparison of alternative buffers for use with a new live oral cholera vaccine, Peru-15, in outpatient volunteers.
abstract: During development of Peru-15, a new live oral vaccine for cholera, the role of buffer needed to be evaluated. Generally, oral bacterial vaccines are acid labile and need to be administered by using a formulation which protects them from gastric acid. We compared three different buffers for use with Peru-15, including a standard bicarbonate-ascorbic acid buffer, Alka-Seltzer, and a new electrolyte-rice buffer, CeraVacx. Saline served as the control. Thirty-nine healthy adult volunteers received Peru-15 (10(8) CFU) with one of the three buffers or saline in a double-masked study. The volunteers were monitored for symptoms for 7 days after the dose, serum was tested for antibody responses by vibriocidal antibody and immunoglobulin G antitoxin enzyme-linked immunosorbent assays, and stool samples were tested for excretion of the vaccine strain. Side effects were minimal in all groups. All 30 volunteers who took Peru-15 with a buffer showed significant rises in vibriocidal antibody titer. The magnitude of the rises was higher in the CeraVacx group than in the other two buffer groups. Four of nine volunteers who took the vaccine with saline also showed increased titers, but they were lower than those in any of the three buffer groups. Excretion of the vaccine strain was similar in the buffer groups, but excretion was not associated with the magnitude of the vibriocidal responses. Excretion of Peru-15 was not detected in the saline group. We conclude that buffer does amplify the serological response to Peru-15 and that CeraVacx may provide benefits not provided by other buffers.
authors.affiliation: Department of International Health, The Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland 21205, USA. dsack@phnet.sph.jhu.edu
authors.forename: D A
authors.initials: DA
authors.lastname: Sack
authors.forename: J
authors.initials: J
authors.lastname: Shimko
authors.forename: R B
authors.initials: RB
authors.lastname: Sack
authors.forename: J G
authors.initials: JG
authors.lastname: Gomes
authors.forename: K
authors.initials: K
authors.lastname: MacLeod
authors.forename: D
authors.initials: D
authors.lastname: O'Sullivan
authors.forename: D
authors.initials: D
authors.lastname: Spriggs
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000992:Antitoxins / Q000097:blood; D002021:Buffers; D022121:Cholera Vaccines / Q000008:administration & dosage* / Q000276:immunology; D005243:Feces / Q000382:microbiology; D006801:Humans; D008875:Middle Aged; D010045:Outpatients
chemical_list: D000992:Antitoxins; D002021:Buffers; D022121:Cholera Vaccines