Immunization by selective infection with type 4 adenovirus grown in human diploid tissue cultures. I. Safety and lack of oncogenicity and tests for potency in volunteers

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Abstract
Three type 4 adenovirus strains were administered in enteric-coated capsules to 46 volunteers. Forty of the volunteers received a strain of virus grown in diploid human fibroblast tissue cultures. This virus and the other 2 strains fed to volunteers were shown to be free of adventitious microbial contaminants and of oncogenic activity in newborn hamsters. Virus was not released until the capsule passed beyond the stomach and in this manner the nasopharynx and the respiratory tract, the usual sites of pathology, were bypassed. Infection was shown to be limited to the lower intestinal tract and was not associated with any signs or symptoms of illness. Selective intestinal type 4 adenovirus infection stimulated moderately high levels of neutralizing antibody. Furthermore, type 4 virus did not spread from enterically infected volunteers to susceptible contacts. The results of study suggested that the enteric-capsule technique might be developed into an effective immunoprophylactic procedure for control of adenovirus infection, especially in military recruits.