Meets Big Disappointment in Failed Herpes Vaccine
that began eight years ago to develop a herpes simplex vaccine for women
has ended in failure and uncertainty. After assessing final Phase III trial
results, the GlaxoSmithKline (GSK) vaccine, known as Simplirix, failed to
meet its primary endpoint, which was preventing genital herpes. However,
it remains unclear why the vaccine was not effective. Safety issues were
not cited as a problem.
is a huge disappointment for the drugmaker, which has been attempting to
expand its portfolio of vaccine products, given that an estimated one in
four women in the US alone has genital herpes. In other words, the afflication
is one of the most common infectious diseases and that can translate into
which was a randomized, double-blind trial, was undertaken with the US National
Institute of Allergy and Infectious Diseases, and tested 8,323 women between
18 and 30 years old, who were tested at 50 sites in the United States and
Canada. Participants received either Simplirix or a version of Havrix, an
FDA-approved vaccine for thwarting hepatitis A that is sold by Glaxo (see
the NIAID statement and a question-and-answer from the agency).
studies were encouraging. These involved men and women who did not have
genital herpes but whose sexual partners were known to be infected, and
the vaccine prevented genital herpes disease in more than 70 percent of
the female volunteers although there was no clear effect in men. Moreover,
Simplirix reduced the risk of developing antibodies to herpes, which are
used as an indicator that a person has been infected with HSV, by 40 percent.