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Hepatitis E virus (HEV) is widespread and continues to cause large outbreaks in developing countries. One recombinant vaccine was shown to be safe and immunogenic in men in Nepal, where only one of the four HEV genotypes had been isolated (JW Infect Dis Feb 28 2007). Could a vaccine derived from HEV genotype 1 protect against other genotypes in a general adult population? To find out, investigators (2 of whom were employees of the vaccine maker) conducted a double-blind, phase III trial of another candidate vaccine in a region of China where genotypes 1 and 4 circulate.
A total of 112,604 healthy adults (56% women) aged 16 to 65 were randomized to receive three doses of recombinant hepatitis E antigen (vaccine group) or hepatitis B vaccine (…