A phase 3, randomized, double-blind, placebo-controlled study of the safety and efficacy of the live, oral adenovirus type 4 and type 7 vaccine, in U.S. military recruits.

Highlights: [•] An efficacy trial of a new adenovirus vaccine was performed in military recruits. [•] 4040 volunteers were randomized in a 3:1 ratio of vaccine to placebo. [•] Efficacy against ADV-4 respiratory disease was >98%. ADV-7 infection did not occur. [•] Vaccine was well tolerated. One placebo-recipient acquired vaccine strain of ADV-4. [•] The new adenovirus vaccine is safe and highly efficacious in the study population. [Copyright &y& Elsevier]