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Safety and immunogenicity in North Americans of a single dose of live oral cholera vaccine CVD 103-HgR: results of a randomized, placebo-controlled, double-blind crossover trial. 1992

K L Kotloff, and S S Wasserman, and S O'Donnell, and G A Losonsky, and S J Cryz, and M M Levine
Department of Pediatrics, University of Maryland School of Medicine, Baltimore 21201.

We conducted a double-blind, placebo-controlled, randomized crossover study to evaluate the safety and immunogenicity of a single 5 x 10(8)-CFU dose of live oral recombinant cholera vaccine CVD 103-HgR in 94 North American adults. The vaccine was well tolerated without associated adverse reactions. Despite minimal fecal excretion of vaccine, 97% of subjects exhibited serum vibriocidal antibody and 72% had antitoxin responses.

UI MeSH Term Description Entries
D008297 Male Males
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
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
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
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
D000907 Antibodies, Bacterial Immunoglobulins produced in a response to BACTERIAL ANTIGENS. Bacterial Antibodies
D012449 Safety Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property. Safeties
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

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