Tuesday, December 3, 2013

Gilead Begins Innovative Antiviral Plus Vaccine Trial Across the U.S.

— 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


  1. Hi Christine

    I am a newbie to hbv, just recently diagnosed.
    Why do you say this is an unique clinical trial? Is the compound being tested a new approach to eradicating hbv?

    1. Great question! To date, the only available treatments for hepatitis B have been interferon (weekly injections that kick-start the immune system to fight infection) and antivirals (daily pills that make it hard for the virus to reproduce). Researchers have tried combining these two drugs, but without much success to date.
      This clinical trial combines an antiviral with a vaccine; but instead of "preventing" hepatitis B infection, this "therapeutic" vaccine contains special proteins to trick the immune system into releasing more killer T cells and antibodies to prime it to attack the hepatitis B infection.
      I believe one of the reasons they want participating patients to be taking antivirals is that the antivirals will have already lowered the amount of HBV in the body (essentially leveling the playing field). This may give the immune system a better opportunity to eradicate the remaining HBV and infected liver cells.
      Bottom line, it's the combining of antivirals with a therapeutic vaccine that makes this clinical trial so unique.

      Thank you, Christine Kukka