Two studies (29,311 participants for safety evaluation and 22,022 participants for efficacy evaluation) compared RZV (two doses intramuscularly, two months apart) versus placebo. These data came from four studies with 6980 participants aged 60 years or over. The vaccinated group had a higher incidence of one or more adverse events (RR 1.71, 95% CI 1.38 to 2.11 RD 23% number needed to treat for an additional harmful outcome (NNTH) 4.3) and injection site adverse events (RR 3.73, 95% CI 1.93 to 7.21 RD 28% NNTH 3.6) of mild to moderate intensity (moderate‐quality evidence). There were no differences between the vaccinated and placebo groups for serious adverse events (RR 1.08, 95% CI 0.95 to 1.21) or deaths (RR 1.01, 95% CI 0.92 to 1.11 moderate‐quality evidence).
The incidence of herpes zoster at up to three years follow‐up was lower in participants who received the LZV (one dose subcutaneously) than in those who received placebo (risk ratio (RR) 0.49, 95% confidence interval (CI) 0.43 to 0.56 risk difference (RD) 2% number needed to treat for an additional beneficial outcome (NNTB) 50 moderate‐quality evidence) in the largest study, which included 38,546 participants. Most data for the primary outcome (incidence of herpes zoster) and secondary outcomes (adverse events and dropouts) came from studies that had a low risk of bias and included a large number of participants. The overall quality of the evidence was moderate. Most studies were conducted in high‐income countries in Europe and North America and included healthy Caucasians (understood to be white participants) aged 60 years or over with no immunosuppressive comorbidities. Only three studies assessed the incidence of herpes zoster in groups that received vaccines versus placebo. The review now includes a total of 24 studies involving 88,531 participants. We included 11 new studies involving 18,615 participants in this update.
#Cid new episode 2016 episode 1346 update
This is an update of a Cochrane Review last updated in 2016. It consists of recombinant VZV glycoprotein E and a liposome‐based AS01B adjuvant system. A new adjuvanted recombinant VZV subunit zoster vaccine, recombinant zoster vaccine (RZV), has also been approved. The USA Food and Drug Administration has approved a herpes zoster vaccine with an attenuated active virus, live zoster vaccine (LZV), for clinical use amongst older adults, which has been tested in large populations. Vaccination with an attenuated form of the VZV activates specific T‐cell production avoiding viral reactivation. The natural process of aging is associated with a reduction in cellular immunity, and this predisposes older people to herpes zoster.
Years later, with declining immunity, the varicella zoster virus (VZV) can reactivate and cause herpes zoster, an extremely painful condition that can last many weeks or months and significantly compromise the quality of life of the affected person. After resolution of the varicella episode, the virus can remain latent in the sensitive dorsal ganglia of the spine.
Herpes zoster, commonly known as shingles, is a neurocutaneous disease caused by the reactivation of the virus that causes varicella (chickenpox).