Shingles Herpes Zoster Vaccine Clinical Trials, Dosage, Indication, Side Effects
Herpes Zoster, known as shingles, is a vaccine-preventable disease caused by the varicella-zoster virus (VZV), which also causes chickenpox, says the U.S. Centers for Disease Control and Prevention (CDC). The U.S. Food and Drug Administration (FDA)-approved shingles vaccines for use in the U.S. according to schedules published for 2023. Immuinize.org publishes updated FAQs regarding shingles vaccines. Various shingles vaccines are approved by the European Medicines Agency in over 30 countries, including Brazil, China (2019), India (2023), Japan, South Korea (2012), and the United Kingdom.
Shingles Vaccines Approved
Shingrix - GSK's Shingrix is a non-live, adjuvanted recombinant shingles vaccine (zoster) consisting of the varicella-zoster virus glycoprotein E antigen and the AS01B adjuvant system, a proprietary adjuvant containing QS-21 and MPL with liposomes.
Zostavax - Merck's Zostavax is a live, attenuated varicella-zoster virus (weakened chickenpox virus) vaccine. According to the U.S. CDC, the zoster vaccine can be administered concurrently with all other live and inactivated vaccines, including those routinely recommended for people 60 or older.
SK bioscience's SKYZoster™ is a live vaccine that attenuates the varicella-zoster virus. SKYZoster was approved in South Korea by the Ministry of Food and Drug Safety in September 2017.
SINOVAC's live attenuated varicella vaccine, a WHO-prequalified Chinese varicella vaccine, was successfully delivered to the Republic of Türkiye in 2023 and is registered in Lebanon and Kenya.
Shingles Vaccine Candidates 2024
Curevo Vaccine's Amezosvatein (CRV-101) is an adjuvanted subunit shingles vaccine candidate designed to maximize CMI protection by combining the gE protein antigen with our proprietary adjuvant. On January 7, 2024, Curevo announced positive data from a Phase 2 trial of Amezosvatein head-to-head versus Shingrix in participants 50 and older.
BioNTech SE initiated a randomized, controlled, dose-selection Phase 1/2 clinical trial of BNT167 in February 2023. The clinical trial evaluates mRNA vaccine candidates' safety, tolerability, and immunogenicity against shingles. The last Update was Posted on March 24, 2023, and a data update is expected in 2023, with an estimated Primary Completion Date of July 5, 2025.
Jiangsu Recbio Technology Co., Ltd. announced on December 29, 2023, that REC610 is equipped with a novel adjuvant BFA01 independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+T cells and antibodies. On December 19, 2022, it received approval from the Philippines FDA to conduct a randomized, observer-blinded, phase I clinical trial. The Interim Analysis results published on December 29, 2023, showed that REC610 demonstrated an overall favorable safety and tolerability profile in healthy participants aged 40 and above after two vaccination doses. REC610 induced strong gE-specific humoral and cellular immune responses, which were evident after the first vaccination and peaked 30 days after the second vaccination.
Immorna announced on January 9. 2023,that the U.S. FDA cleared its investigational new drug application to conduct a Phase 1 multi-center study of JCXH-105, a self-replicating RNA vaccine against Shingles. In addition, on May 30, 2023, it announced that the first subject had been dosed in the Company's First-In-Human (FIH) Phase 1 multi-center study of JCXH-105.
Dynavax's Z-1018 is an investigational vaccine candidate being developed to prevent shingles in adults aged 50 and older. Dynavax expects to submit an Investigational New Drug Application to the FDA to support a Phase 1/2 trial of Z-1018 in the first half of 2024.
Shingles Vaccination and Dementia
The journal BMC Public Health published on October 2, 2023, results from a study that concluded both zoster vaccine for prevention of shingles/herpes zoster and influenza vaccine to prevent influenza were associated with diminished risk of dementia, with the zoster association appearing more pronounced. A non-peer-reviewed study published on May 25, 2023, reported shingles vaccinations were associated with a 19.9% lower risk of dementia.
Shingles Vaccine Price
Most patients pay an out-of-pocket cost of about $50 per dose with insurance. The U.S. CDC Vaccine Price List was last updated in July 2022. As of January 2023, vaccinations covered under MedicaPartart D, approved and recommended by the CDC, will be covered without a co-pay. Vaccine prices and discount information are posted at InstantRx™.
Shingles Vaccine
January 9, 2024 - Original Research published by the Annuals of Internal Medicine found two doses of RZV were highly effective, although less effective than in the previous clinical trials. Two-dose effectiveness waned very little during the four years of follow-up.
January 7, 2024 - Dr. Guy De La Rosa, Curevo's Chief Medical Officer, commented, "Amezosvatein was developed specifically to provide high vaccine effectiveness and best-in-class tolerability. We are very excited by these Phase 2 data."
February 9, 2023 - The journal Nature published a study that concluded that antiviral treatment did not positively affect long-term survival among HZ patients and suggested that HZ is a marker of long-term vascular risk.
January 9, 2023 - Biosciencence announced that the Company had received a biologics license application approval of the SKYZoster™ from the National Pharmaceutical Regulatory Agency in Malaysia.
November 16, 2022 - "Completing this ($26 million) A1 round ahead of data from our Phase 2b trial of CRV-101 head-to-head against Shingrix® is a meaningful demonstration of our investors' confidence in the CRV-101 program," said George Simeon, Curevo's CEO.
September 15, 2022 - Curevo Vaccine announced the completion of enrollment in a Phase 2b trial of their CRV-101 subunit vaccine to prevent the reactivation of the varicella-zoster virus (shingles) in older adults.
March 25, 2022 - Consumer Reports published The Booster Shots You Need As an Adult. The shingles vaccine isn't commonly referred to as a booster, but it does count because it reminds your body how to fight the varicella-zoster virus.
March 14, 2022 - GreenLight Biosciences Holdings PBC announced a licensing agreement with Serum Institute of India, Pvt, Ltd., to accelerate access to messenger RNA products (Shingles) in emerging markets.
February 25, 2022 - GSK wrote the mysterious reactivation (of VZV) that a doctor studied for the first time in Cirencester, England, more than half a century ago. By tracking 1,270 patients from 1947 to 1962, R. Edgar Hope-Simpson demonstrated that shingles were not a new infection from an unknown pathogen but rather a reawakening of the VZV.
September 26, 2019 - Curevo, Inc. announced encouraging preliminary Phase I study results of their Shingles vaccine candidate, CRV-101.
May 23, 2019 - GlaxoSmithKline plc announced that China's National Medical Products Administration approved Shingrix to prevent shingles in adults 50 or older.
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