GSK’s Shingles Vaccine Effective in Adults 70-Plus Years Old

A randomized Phase III study (ZOE-70) of GlaxoSmithKline’s investigational shingles vaccine, Shingrix, showed 90 percent efficacy in adults aged 70 years and older that is maintained for at least four years. The high efficacy is in line with results of the ZOE-50 trial, a study in people over 50 years old that showed 97 percent efficacy.

In the randomized, observer-blind, placebo-controlled, multicenter trial that started in August 2010 in parallel with the ZOE-50 trial, more than 14,800 adults aged 70 years and older were given two doses of Shingrix intramuscularly two months apart. The primary objective was overall vaccine efficacy against shingles compared to placebo. The risk of serious adverse events, potential immune-mediated diseases or deaths observed was similar in people receiving Shingrix and placebo. The most commonly reported local adverse reaction was pain at the injection site, and the most frequently reported systemic adverse reaction was fatigue. The majority of injection site and systemic reactions occurred within seven days of vaccination, with most lasting one to three days, and generally were mild to moderate in intensity.

A pooled analysis of data from the ZOE-70 and ZOE-50 trials showed that the candidate vaccine effectively reduced the risk of subsequent chronic neuropathic pain, also known as postherpetic neuralgia (PHN), which is the most common, and often severe, complication of shingles. Shingrix was shown to be 89 percent effective in preventing PHN in people aged 70 years and older and 91 percent effective in people aged 50 years and older.