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November 4, 1998

Recruiting Volunteers for a Typhoid Vaccine—Reply

Author Affiliations

Margaret A.WinkerMD, Senior EditorIndividualAuthorPhil B.FontanarosaMD, Senior EditorIndividualAuthor

JAMA. 1998;280(17):1480-1481. doi:10-1001/pubs.JAMA-ISSN-0098-7484-280-17-jbk1104

In Reply.—Dr Matz raises the question of investigators serving as subjects in their own clinical trials. The path to licensure of vaccines is long (an average of 12 years), highly selective, and expensive. A vaccine candidate must be evaluated in clinical trials that progress from phase 1 (safety and immunogenicity dose response in small numbers of subjects) to phase 2 (safety and immunogenicity in larger numbers, additional age groups, and special-risk populations) and, finally, to large-scale phase 3 efficacy trials.