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20142211000001104

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Herpes zoster (live, attenuated) vaccine

30 October 2014Recombinant vaccine to varicella zoster virus glycoprotein E antigen, containing Antigenics QS-21 (Stimulon) adjuvant
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New Medicines

ShingrixPrevention of herpes zoster and post-herpetic neuralgia in people aged 50 years and older

Information

Shingrix
Vaccine
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

Launched
Licensed but not launched
Launched
August 2021
Aug 21Shingrix powder and suspension for injection available in the UK. Price for 1 vial = £160.00 [24].
Oct 20UK launch not expected imminently as company is focussed on launches in other countries [23].
Jan 19Has been available in the US since Q4 2017 [22].
Dec 18No UK launch date currently available [21].
Mar 18Approved in EU [20].
Jan 18Positive opinion from the CHMP, indicated for "prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in adults 50 years of age or older"; it also states that "The use of Shingrix should be in accordance with official recommendations" [19].
Oct 17Approved in US [17].
Sep 17FDA panellists unanimously voted to approve Shingrix [16].
Nov 16Filed in EU [14].
Oct 16Biologics License Application filed in US. Regulatory submissions in the EU and Canada are on track for 2016 and planned for Japan in 2017 [12].
Oct 15GSK intends to submit a regulatory application for Shingrix for prevention of shingles in people 50 years of age and over in North America, Japan and EU during H2 16 [11].
Apr 14In Oct 13 the company reported that nine active PIII trials were underway with results anticipated in 2015 [8].
Aug 10PII study started Feb 07 [1].
Aug 10PIII trials started and will enroll more than 30,000 people wordwide [2].

Category

Recombinant vaccine to varicella zoster virus glycoprotein E antigen, containing Antigenics QS-21 (Stimulon) adjuvant
Incidence of shingles increases with age. Under 20 years - 0.4 to 1.6 cases per 1,000 persons; 20 to 50 years - 2.0 to 3.0 cases per 1,000 persons; over 80 years - 4.5 to 11.0 cases per 1,000 persons. About 20% of people will have shingles at some stage in their lives [7].
Prevention of herpes zoster and post-herpetic neuralgia in people aged 50 years and older
Intramuscular

Trial or other data

Oct 17In the US, the Centers for Disease Control and prevention (CDC) advisory committee has endorsed Shingrix over Zostavax. By an 8-7 vote the committee recommended Shingrix for herpes zoster prevention in patients aged 50 and over (previously guidelines recommended in patients aged 60 and over), and for people who have previously received Zostavax. The new recommendations mean up to 62 million more adults in the US should be immunised using Shingrix. Some panel members expressed concern about lack of real world data with the new vaccine, and potential for supply problems with expanded use. The recommendations now go to CDC officials for final approval [18].
Jun 17GSK present new data from PIII Zoster-048 (NCT02581410) trial. Study showed that Shingrix, induces a strong immune response in older adults (≥65 years) who have previously been vaccinated against shingles with live-attenuated zoster vaccine (Zostavax) [15].
Oct 16GSK present new data for co-administration of Shringrix with flu vaccine; a flexible dosing schedule; and vaccine´s impact on QoL. Some of these data are included in recent regulatory submission to FDA and will also be part of submissions in other parts of world later this year [13].
Oct 15GSK announce that the second pivotal PIII study of its candidate vaccine Shingrix™ in adults aged 70 years and over (known as ZOE-70) successfully met its primary objective, demonstrating 90% (95% confidence interval: 84–94) efficacy against shingles compared to placebo. The high efficacy seen in ZOE-70 is in line with the efficacy shown in the first pivotal PIII study in adults aged 50 years and over (ZOE-50) presented earlier this year. In addition, a pre-specified pooled analysis of ZOE-70 and ZOE-50 data demonstrated that the candidate vaccine effectively prevents subsequent chronic neuropathic pain, also known as postherpetic neuralgia (PHN) which is the most common severe complication of shingles. Shingrix was demonstrated to be 89% (95% confidence interval: 69– 97) efficacious in preventing PHN in people aged 70 years and over and 91% (95% confidence interval: 76– 98) efficacious in people aged 50 years and over [11].
Apr 15Results of PIII study have been published in the Lancet. Use of an investigational herpes zoster (HZ) vaccine in adults ≥50 years of age was associated with an overall efficacy of 97.2% (95% CI 93.7 to 99.0; P<0.001), with a HZ incidence rate (vs control) of 0.3 vs. 9.1 per 1000 person-years, respectively [10].
Dec 14GSK reported that the randomised, placebo-controlled PIII trial (ZOE-50) met its primary endpoint of overall vaccine efficacy in adults aged 50 years or above. The study which enrolled 16,160 subjects showed that HZ/su reduced the risk of shingles by 97.2 per cent compared to placebo [7].
Jun 12NCT01610414 An observer-blind PIII study to evaluate GSK1437173A (2-dose schedule) vs placebo in the prevention of Herpes zoster in 1474 autologous haematopoietic cell transplant recipients (≥18 years of age). The study will start Jun 12 and is due to complete May 16 [6].
May 12NCT01165229 and NCT01165177 are expected to be completed by August 2014 [5].
Oct 10Both PIII studies are observer-blind studies; a pooled analysis of data from both will be conducted contingent on each study achieving its objectives [4].
Aug 10PIII clinical trials programme began. Two PIII trials in adults aged ≥ 70 years (NCT01165229; 113077) and ≥ 50 years (NCT01165177; 110390) will investigate efficacy, safety and immunogenicity of the vaccine in more than 30,000 pts globally [3].
Aug 10A PII study to evaluate the safety and immune response of the zoster vaccine, GSK1437173A, and to compare 3 in 715 healthy elderly subjects, aged ≥60 years started in Feb 07 and is expected to complete Jul 10. It comprises a primary study (108494) and three extension studies (108516, 108518 & 108520). The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A and evaluate the persistence of the immune response induced by the vaccine [1].

Evidence based evaluations

ShingrixHerpes zoster prophylaxis in patients from the age of 18 years at increased risk of herpes zoster

Information

Shingrix
Vaccine
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

Launched
Licensed but not launched
Licensed but not launched
August 2021
Aug 21Shingrix powder and suspension for injection available in the UK. Price for 1 vial = £160.00 [7].
Jul 21Licence extension approved in the US for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has begun discussions to consider recommendations for use of Shingrix in immunocompromised adults [6].
Aug 20Licence extension approved in EU [5].
Jul 20EU positive opinion for a licence extension to include use in adults 18 years of age or older at increased risk of herpes zoster (previously only from the age of 50 years). The new licence will be prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in adults 50 years of age or older, and adults 18 years of age or older at increased risk of HZ [4].
Dec 19Filed in the EU [2].

Category

Recombinant vaccine to varicella zoster virus glycoprotein E antigen, containing Antigenics QS-21 (Stimulon) adjuvant
Shingles is caused by the human herpesvirus-3 (HHV-3). Primary infection usually occurs in childhood, producing chickenpox (varicella). Reactivation of the virus is thought to be associated with immunosuppression as a result of a decline in cell-mediated immunity. Shingles is seen as a disease of older people but it can affect all ages, including children. The incidence and severity increase with age [3].
Herpes zoster prophylaxis in patients from the age of 18 years at increased risk of herpes zoster
Intramuscular

Trial or other data

Mar 20PII ZOSTER-047 study is recruiting [1].
Jun 19PII ZOSTER-047 trial to evaluate the reactogenicity, safety and immunogenicity of GSK 1437173A for the prevention of herpes zoster in immunocompromised paediatric patients with renal transplant aged 1-17 years starts ( NCT04006808). The randomised, open-label trial is designed to enrol 184 patients in Spain, France and the UK [1].

Evidence based evaluations