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Safety and immunogenicity of the oral, whole cell/recombinant B subunit cholera vaccine in North American volunteers. 1993

J L Sanchez, and A F Trofa, and D N Taylor, and R A Kuschner, and R F DeFraites, and S C Craig, and M R Rao, and J D Clemens, and A M Svennerholm, and J C Sadoff
Department of Field Studies, Walter Reed Army Institute of Research, Washington, DC 20307-5100.

A newly formulated, oral, inactivated whole cell plus recombinant B subunit (WC/rBS) cholera vaccine was evaluated in US military personnel. In the first study, 74 subjects were given two doses 14 days apart. In the second study, 186 subjects were randomized into four groups; two groups received vaccine with either full (4 g) or half (2 g) strength bicarbonate buffer, and two groups received either full or half strength buffer without vaccine. Mild gastrointestinal symptoms were associated with full buffer (P = .02) but not with the vaccine. In the first study, 36% of all subjects and 55% with low prevaccination titers (< 1:40) had a > or = 2-fold rise in vibriocidal antibody level; > 80% of subjects developed a 4-fold rise in anti-cholera toxin (CT) titers. Post-vaccination IgA and IgG anti-CT titers were approximately 1.5-fold higher among persons receiving full strength buffer (P = .05). The WC/rBS vaccine is safe and immunogenic in North Americans, although some mild gastrointestinal symptoms occur with the high concentration of buffer necessary to protect the B subunit from gastric acid denaturation. Prior immunity to cholera conferred by parenteral vaccine decreased vibriocidal antibody response.

UI MeSH Term Description Entries
D008297 Male Males
D008889 Military Personnel Persons including soldiers involved with the armed forces. Air Force Personnel,Armed Forces Personnel,Army Personnel,Coast Guard,Marines,Navy Personnel,Sailors,Soldiers,Submariners,Military,Force Personnel, Air,Personnel, Air Force,Personnel, Armed Forces,Personnel, Army,Personnel, Military,Personnel, Navy,Sailor,Soldier,Submariner
D009656 North America The northern continent of the Western Hemisphere, extending northward from the Colombia-Panama border and including CENTRAL AMERICA, MEXICO, Caribbean area, the UNITED STATES, CANADA and GREENLAND. The term often refers more narrowly to MEXICO, continental UNITED STATES, AND CANADA. Northern America
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000284 Administration, Oral The giving of drugs, chemicals, or other substances by mouth. Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D014614 Vaccines, Synthetic Small synthetic peptides that mimic surface antigens of pathogens and are immunogenic, or vaccines manufactured with the aid of recombinant DNA techniques. The latter vaccines may also be whole viruses whose nucleic acids have been modified. Antigens, Synthetic,Chemical Vaccine,Chemical Vaccines,Immunogens, Synthetic,Molecular Vaccine,Molecular Vaccines,Recombinant Vaccine,Semisynthetic Vaccine,Semisynthetic Vaccines,Synthetic Antigen,Synthetic Vaccine,Synthetic Vaccines,Vaccines, Recombinant,Synthetic Antigens,Synthetic Immunogens,Vaccines, Chemical,Vaccines, Molecular,Vaccines, Semisynthetic,Antigen, Synthetic,Recombinant Vaccines,Vaccine, Chemical,Vaccine, Molecular,Vaccine, Recombinant,Vaccine, Semisynthetic,Vaccine, Synthetic
D022121 Cholera Vaccines Vaccines or candidate vaccines used to prevent infection with VIBRIO CHOLERAE. The original cholera vaccine consisted of killed bacteria, but other kinds of vaccines now exist. Cholera Vaccine,Vaccine, Cholera,Vaccines, Cholera

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