Herpes zoster (inactivated) vaccine

Unassigned

New Medicines

Shingrix · Herpes zoster; prevention of shingles in people aged 50 years and older

Information

Shingrix
Vaccine
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Launched

Mar 18: approved in EU [20]


Jan 18: positive 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 17: Approved in US [17].


Sep 17: FDA panellists unanimously voted to approve Shingrix [16].


Nov 16: Filed in EU [14].


Oct 16: Biologics 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 15: GSK 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 14: In Oct 13 the company reported that nine active PIII trials were underway with results anticipated in 2015 [8].


Aug 10: PIII trials started and will enroll more than 30,000 people wordwide [2].


PII study started Feb 07 [1].

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].
Herpes zoster; prevention of shingles in people aged 50 years and older
Intramuscular

Trial or other data

Oct 17: In 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].


Aug 10: A 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].


Aug 10: PIII 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 10: Both PIII studies are observer-blind studies; a pooled analysis of data from both will be conducted contingent on each study achieving its objectives [4].


May 12: NCT01165229 and NCT01165177 are expected to be completed by August 2014 [5].


Jun 12: NCT01610414 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].


Dec 14. GSK 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]


Apr 15: Results 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].


Oct 15: GSK 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].


Oct 16: GSK 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].


Jun 17: GSK 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].

Herpes zoster; prevention of Herpes zoster (shingles) and related complications in immunocompromised individuals (e.g. cancer, AIDS, organ transplant patients)

Information

Vaccine
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Inactivated Varicella-Zoster (shingles) vaccine
The annual incidence of shingles for those aged 70 to 79 years is estimated to be around 790 to 880 cases per 100,000 people in England and Wales. The lifetime risk is estimated at one in four. Incidence and risk are increased in the immunocompromised patient [5].
Herpes zoster; prevention of Herpes zoster (shingles) and related complications in immunocompromised individuals (e.g. cancer, AIDS, organ transplant patients)
Subcutaneous