Attenuated, Streptomycin-Dependent Salmonella typhi Oral Vaccine: Potential Deleterious Effects of Lyophilization

Four studies were done with streptomycin-dependent Salmonella typhi as an oral, attenuated vaccine. Studies 1 and 3 employed freshly harvested vaccine, whereas studies 2 and 4 involved lyophilized vaccine. Five to eight doses (3 × 1010–1011 organisms/dose) were given; oral streptomycin (1.0 g) was a...

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Bibliographic Details
Published in:The Journal of infectious diseases 1976-04, Vol.133 (4), p.424-429
Main Authors: Levine, Myron M., DuPont, Herbert L., Hornick, Richard B., Snyder, Merrill J., Woodward, William, Gilman, Robert H., Libonati, Joseph P.
Format: Article
Language:English
Subjects:
Administered dose
Administration, Oral
Adult
Antibodies, Bacterial - analysis
Antibody Formation - drug effects
Dosage
Dose-Response Relationship, Drug
Excretion
Experimentation
Feces - analysis
Feces - microbiology
Freeze Drying
Humans
Immunity
Immunization Schedule
Major Articles
Male
Salmonella typhi
Salmonella typhi - drug effects
Salmonella typhi - immunology
Salmonella typhi - isolation & purification
Streptomycin - administration & dosage
Streptomycin - pharmacology
Typhoid
Typhoid fever
Typhoid Fever - immunology
Vaccination
Vaccines, Attenuated - administration & dosage
Vaccines, Attenuated - isolation & purification
Vaccines, Attenuated - pharmacology
Volunteerism
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Summary:Four studies were done with streptomycin-dependent Salmonella typhi as an oral, attenuated vaccine. Studies 1 and 3 employed freshly harvested vaccine, whereas studies 2 and 4 involved lyophilized vaccine. Five to eight doses (3 × 1010–1011 organisms/dose) were given; oral streptomycin (1.0 g) was administered concomitantly in studies 2 and 3, with only two of the doses of vaccine in study 1, and was not given in study 4. No adverse reactions were encountered in 179 vaccinated men, and 94% of the men excreted the vaccine. In challenge studies (which included the control groups) with 105 virulent S. typhi organisms (Quailes strain), the fresh vaccine was highly protective (66%–78% efficacy), while lyophilized vaccine gave no clinical protection. Fresh vaccine also interfered significantly with intestinal proliferation of virulent S. typhi; only 17% of the vaccinees excreted organisms as compared with 75% of the controls. Studies of protection in mice showed no difference between immunogen content of the fresh and the lyophilized vaccines. Field trials with streptomycin-dependent, oral typhoid vaccine must await development of a lyophilized product that will retain the protective properties of the vaccine.
ISSN:0022-1899
1537-6613
DOI:10.1093/infdis/133.4.424