Currently Enrolling Trials
Shingrix is a recombinant, adjuvanted vaccine against the virus that causes shingles.
Shingrix is specifically indicated for the prevention of herpes zoster (shingles) in adults aged 50 years and older.
Adverse effects associated with the use of Shingrix may include, but are not limited to, the following:
- gastrointestinal symptoms
Shingrix is supplied as a vial of lyophilized recombinant varicella zoster virus surface glycoprotein E (gE) antigen component, which must be reconstituted for intramuscular injection. After reconstitution, administer Shingrix immediately. The recommended dose schedule is two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at month 0 followed by a second dose administered any time between two and six months later.
Clinical Trial Results
The FDA approval of Shingrix was based on a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries. The primary efficacy analysis population (referred to as the modified Total Vaccinated Cohort [mTVC]) included 14,759 subjects aged 50 years and older who received 2 doses (0 and 2 months) of either Shingrix (n = 7,344) or placebo (n = 7,415) and did not develop a confirmed case of HZ within one month after the second dose. Compared with placebo, Shingrix significantly reduced the risk of developing HZ by 97.2 percent (95 percent CI: 93.7, 99.0) in subjects 50 years and older.