— Christine M. Kukka, Project Manager, HBV Advocate
One of the most unique hepatitis B clinical
trials to come along in years is currently recruiting hepatitis B
patients to assess the effectiveness of a therapeutic vaccine combined
with antiviral treatment.
Gilead Sciences Inc. is leading
the Phase 2 clinical trial, and is recruiting 175 patients (age 18 and
older, without cirrhosis) who are currently receiving any type of U.S.
Food and Drug Administration-approved antiviral (such as tenofovir
(Viread), entecavir (Baraclude) and others.)
Participants will continue
their antiviral treatment while getting six injections of the GS-4774
Tarmogen vaccine over a 20-week period. The GS-4774 vaccine is composed
of whole, heat-killed, recombinant S. cerevisiae yeast
genetically modified to trigger an immune response to specific proteins
or antigens that make up the hepatitis B virus, including the
hepatitis B X, surface and core antigens. It is also designed to spur
production of the immune system’s fighter T cells, including CD4 and
Clinical trial participants
will either continue to be treated with only antivirals (serving as the
control group), or receive varying GS-4774 vaccine doses (at 2, 10 or
40 yeast units). Patients will get the vaccine by injection every four
weeks over 20 weeks.
Recruitment is taking place at
clinics in Los Angeles, San Francisco, Pasadena, San Diego, San Jose,
Baltimore, Chicago, Richmond, Va., St. Louis, Detroit, Ann Arbor, Mich.,
Boston, and in New Zealand.
Labels: clinical trials, GS-4774, Tarmogen, vaccine