— 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 CD8.
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.
More information is available at: http://clinicaltrials.gov/show/NCT01943799