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Infect Immun. 1972 March; 5(3): 295-299
Copyright © 1972 American Society for Microbiology. All Rights Reserved.

Enteric Immunization with Live Adenovirus Type 21 Vaccine I. Tests for Safety, Infectivity, Immunogenicity, and Potency in Volunteers

Department of Virus Diseases, Walter Reed Army Institute of Research, Washington, D.C. 20012
Medical Division, U.S. Army Research Institute of Infectious Diseases, Fort Detrick, Frederick, Maryland 21701

ABSTRACT

Studies were undertaken in volunteers to determine whether living adenovirus type 21 (ADV-21) vaccine could be safely administered orally to susceptible young adults. In the first study, ten volunteers were fed 10^6.4 tissue culture infectious dose₅₀ (TCID₅₀) of ADV-21 vaccine virus, and five received placebo tablets. Nine of ten infected volunteers shed ADV-21 in stools (mean duration, 10.1 days; range, 4 to 17 days). No pharyngeal excretion of ADV-21 was observed in any of these volunteers. Each of the nine developed type-specific neutralizing (N) antibodies to ADV-21. No evidence for person-to-person transmission of vaccine was observed. In a second study, volunteers were immunized with ADV-21 vaccines containing 10^6.8, 10^4.6, and 10^2.4 TCID₅₀. ADV-21 N antibody responses were detected in nine of eleven who received the highest dose, six of twelve who received the middle dose, and two of twelve who were fed the lowest dose. None of twelve susceptible volunteers receiving the placebo capsule developed ADV-21 N antibodies postimmunization. This study established that the human infectious dose₅₀ for these lots of ADV-21 vaccine was approximately 10^4.6 TCID₅₀ and that the dose response to ADV-21 vaccine was lower than those previously reported for live ADV-4 and ADV-7 enteric vaccines.

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