More Effective Shingles Vaccine Could Be Coming Soon

About 1 in 3 individuals in the United States will develop shingles in their lifetime.

About 1 in 3 individuals in the United States will develop shingles in their lifetime.

Shingles is caused by the varicella zoster virus (VZV), the same virus that causes chickenpox. Once an individual recovers from chickenpox, the virus stays dormant in the body and can become reactivated years later, causing a very painful rash known as herpes zoster or shingles.

The CDC recommends the zoster vaccine (Zostavax) for those 60 years and older,1 although it’s FDA-approved for those 50 years and older. Even patients who previously had an episode of shingles should receive the vaccine to prevent future occurrences.

Clinical studies demonstrated that Zostavax reduced the overall incidence of shingles by 51% and postherpetic neuralgia (PHN) by 67% among individuals 60 years or older, though the vaccine’s efficacy was only about 38% for those older than 70 years.1

Shingrix is an investigational shingles vaccine from GlaxoSmithKline, which plans to file for the vaccine’s FDA approval sometime this year. Shingrix is a nonlive, adjuvanted, subunit (HZ/su) candidate vaccine that combines glycoprotein E, a protein found on the VZV that causes shingles, with an adjuvant system AS01B, to enhance the immune response to the antigen.2

In phase 3 trials, 2 doses of Shingrix were administered to study participants intramuscularly 2 months. The vaccine was 97% effective against shingles in those 50 years and older, and it was 89.8% effective for those 70 years and older. Additionally, a pooled analysis showed Shingrix was 89% effective in preventing PHN in those 70 years and older and 91% effective in those 50 years and older.3

The risk of serious adverse events was similar between the Shingrix and placebo groups. The most common adverse reactions reported were pain at the injection site and fatigue. Study limitations include that individuals with a history of shingles or those who previously received Zostavax were excluded.3

The results for Shingrix show promise for a more effective shingles vaccine. Patients 70 years and older would also have much greater protection, as Zostavax offers limited efficacy in this population. Additionally, the efficacy for protection against PHN is also higher with Shingrix than Zostavax.

Because Shingrix requires 2 doses, patient compliance may be an issue. Patients who previously received Zostavax and those who experienced episodes of shingles should be included in future studies. However, they should still be candidates for Shingrix, as Zostavax’s efficacy decreases over time.

References

  • CDC. About shingles. cdc.gov/shingles/about/index.html. Accessed September 21, 2016.
  • GlaxoSmithKline. GSK’s candidate shingles vaccine shows high efficacy against shingles and its complications in adults aged 70 years and over in phase III study published in NEJM. gsk.com/en-gb/media/press-releases/2016/gsk-s-candidate-shingles-vaccine-shows-high-efficacy-against-shingles-and-its-complications-in-adults-aged-70-years-and-over-in-phase-iii-study-published-in-nejm/. Accessed September 21, 2016.
  • Cunningham AL, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375:1019-1032.