Delving into the Latest Updates on Zoster vaccine live(Merck Sharp & Dohme Corp.) with Synapse

The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.

Start Date28 Jul 2020

Sponsor / Collaborator

University of Colorado Denver

[+1]

NCT04016714 / CompletedPhase 3

A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2)

The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one of the currently recommended schedules by the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries.
The primary hypotheses are that V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; that V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™ administered concomitantly with Prevenar 13™ at 30 days following Dose 3 for each antigen included in Vaxelis™.

Start Date28 Aug 2019

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

100 Clinical Results associated with Zoster vaccine live(Merck Sharp & Dohme Corp.)

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100 Translational Medicine associated with Zoster vaccine live(Merck Sharp & Dohme Corp.)

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100 Patents (Medical) associated with Zoster vaccine live(Merck Sharp & Dohme Corp.)

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365

Literatures (Medical) associated with Zoster vaccine live(Merck Sharp & Dohme Corp.)

01 Dec 2023·Journal of drugs in dermatology : JDD

Recombinant Zoster Vaccine Reduces 3-Year Cardiovascular Risk: Insights From a Multi-Centered Database

Article

Author: Raiker, Rahul ; Khoury, Peter A ; Maczuga, Steven ; Helm, Matthew F ; Pakchanian, Haig ; Foulke, Galen T

BACKGROUND:

Herpes zoster increases the risk for stroke and myocardial infarction. Zoster vaccination's impact on this risk is understudied. This retrospective work sought to determine if prophylactic herpes zoster vaccination may reduce the risk of stroke, myocardial infarction, and/or mortality.

METHODS:

A cohort analysis utilized TriNetX, a national, federated database. In one analysis, patients who received 2 doses of recombinant zoster vaccine (RZV) were compared to adults without RZV. A 1:1 propensity-score match analysis was conducted to adjust for demographics and comorbidities in calculating adjusted relative risks (aRR) with 95% confidence intervals. First-time incidences for myocardial infarction, stroke, and mortality were assessed after 3 years. A subgroup analysis between RZV and zoster vaccine live (ZVL) was also assessed.

RESULTS:

Matched cohorts of 7,657 patients revealed that adults who received 2 doses of RZV were at lower risk of MI (aRR [95% CI]) = (0.73 [0.55, 0.96]) and mortality (0.7 [0.57, 0.88]) while having similar risk for stroke (0.97 [0.75, 1.26]). Further subgroup analysis also revealed a reduced risk of 3-year mortality when compared to the ZVL cohort (0.84 [0.74, 0.95]). Sample size and comorbidities included in the analysis were limited by using a large database.

CONCLUSIONS:

RZV reduces the 3-year risk for myocardial infarction and mortality. J Drugs Dermatol. 2023;22(12):1178-1182. doi:10.36849/JDD.7415.

01 Dec 2023·The Journal of clinical investigation

Recruitment of naive CD4+ T cells by the recombinant zoster vaccine correlates with persistent immunity

Article

Author: Levin, Myron J ; Koelle, David M ; Ford, Emily S ; Weinberg, Adriana ; Laing, Kerry J ; Johnson, Michael J

Herpes zoster (HZ) is a substantial problem for people with decreased cell-mediated immunity, including older adults. The first vaccine approved for HZ prevention, the zoster vaccine live (ZVL), which provided limited and short-lived protection, has been supplanted by the superior recombinant zoster vaccine (RZV), which provides robust and durable protection. To understand the mechanisms underlying the differential immunologic characteristics of the 2 vaccines, we used T cell receptor β chain sequencing and peptide-MHC class II tetramer staining to analyze recombinant glycoprotein E-specific (gE-specific) CD4+ T cell clonotypes in RZV and ZVL recipients. Compared with ZVL, RZV expanded more gE-specific CD4+ clonotypes, with greater breadth and higher frequency of public clonotypes. RZV recruited a higher proportion of clonotypes from naive than from memory cells, while ZVL recruited equally from memory and naive compartments. Compared with memory-derived, naive-derived clonotypes were more likely to last 5 or more years after immunization. Moreover, the frequency of tetramer+ persistent clones correlated with the frequency of tetramer+ naive CD4+ prevaccination T cells. We conclude that the ability of RZV to recruit naive CD4+ T cells into the response may contribute to the durability of its effect. The abundance, breadth, and frequency of public clonotypes may further add to its protective effect.

01 Dec 2023·AJPM focus

Shingles Vaccine Uptake Among Older Adults: Identifying Early, Later, and Nonadopters.

Article

Author: Crimmins, Eileen M ; Kim, Jung Ki ; Kang, Alice H ; Ailshire, Jennifer

Introduction:

There is growing interest in accelerating adoptions of vaccines. This study examined factors that differentiate the acceptance and timing of uptake of the first shingles vaccine, Zostavax, among older adults in the U.S.

Methods:

Data from Health and Retirement Study respondents who were aged ≥62 years in 2008 were analyzed to determine whether they received a shingles vaccination from 2006 to 2016. Multinomial logistic regression was used to examine the characteristics associated with vaccine uptake and timing.

Results:

Of those eligible, 15.2% were vaccinated early (between 2006 and 2010), 20.2% were vaccinated later, and 64.6% remained unvaccinated 10 years after the shingles vaccine was introduced. Respondents more likely to be vaccinated were those who had higher education and income, experience with influenza vaccination, more frequent social interaction with friends, or were residing in an area with higher shingles vaccination rates.

Conclusions:

Shingles vaccination rates vary by social and geographic characteristics. Efforts to improve and expedite vaccination and other new preventive measures should target specific populations and geographic areas.

6

News (Medical) associated with Zoster vaccine live(Merck Sharp & Dohme Corp.)

08 Jan 2024

·www.pharmaceutical-technology.com

Curevo looks to challenge GSK’s Shingrix with positive Phase II data

Shingrix generated £2.5bn ($3.2bn) in sales in the first nine months of 2023, as per GSK’s financials. Image Credit: Stock Footage Inc / Shutterstock. Curevo Vaccine’s varicella-zoster virus vaccine amezosvatein has achieved all primary endpoints, including demonstrating non-inferiority to GSK ’s Shingrix in a Phase II trial. The randomised, observer-blind Phase II trial (NCT05304351) enrolled 876 participants, with 257 participants receiving Shingrix and 619 participants across five arms receiving amezosvatein. The Curevo vaccine achieved the co-primary endpoints of showing humoral immune responses one month after the second vaccine dose. The primary immunogenicity endpoint was met with amezosvatein demonstrating non-inferior participants’ immune responses compared to Shingrix. The vaccine response rate to amezosvatein and Shingrix was 100% and 97.9%, respectively. Amezosvatein also met the co-primary safety endpoint was also by demonstrating lower rates of solicited local and systemic adverse events. Phase II trial investigator Dr William Smith said: “If these data are confirmed in a Phase III trial, amezosvatein holds great promise in meeting the goal of broadening effective vaccination rates against shingles, a serious medical condition capable of causing significant, long-term disruption in adult populations.” In light of positive Phase II data, the US-based company plans to start Phase III trials evaluating the amezosvatein vaccine this year, as per a 7 January press release. As per Curevo, at the chosen dose for amezosvatein for Phase III trials, there were no reported Grade III solicited local or systemic adverse events. The Grade II and III solicited systemic side effects were reported in 19.1% of the participants receiving Shingrix compared to 5.5% of participants reporting Grade II side effects with amezosvatein. Amezosvatein, also known as CRV-101, is a non-messenger ribonucleic acid (mRNA) adjuvanted subunit vaccine. The vaccine’s adjuvant targets toll-like receptor 4 (TLR4) signal pathway to boost the immune response elicited by its subunit protein antigen called glycoprotein E (gE), which in turn elicits a long-term, protective immune response to prevent shingles. Shingles are caused by the reactivation of the varicella-zoster virus. It is characterised by a painful rash on one side of the face or body. Shingrix also has the same mechanism of action as amezosvatein and was first approved by the US Food and Drug Administration (FDA) to prevent shingles in adults aged 50 years and above. In 2017, Shingrix was recommended by the US Centre for Disease Control (CDC) over another approved vaccine, namely MSD’s Zostavax due to higher efficacy despite higher rates of side effects. It generated £2.5bn ($3.2bn) in sales in the first nine months of 2023, as per GSK’s Q3 2023 financials. Another shingles vaccine currently in development includes China-based Jiangsu Recbio Technology’s REC610. The vaccine is currently being evaluated in the Phase I trial (NCT05769049) against Shingrix.

Clinical ResultVaccineDrug ApprovalPhase 2Phase 1

12 Jul 2023

·www.pmlive.com

NHS extends eligibility for shingles vaccine to almost one million people

The NHS has announced that almost a million more people (900,000) will become eligible for a shingles vaccination with the newly available vaccine, Shingrix, starting in September. The decision was made after the Joint Committee on Vaccination and Immunisation (JCVI) recommended that the Shingrix vaccine be given to a wider cohort of people after trials showed that the vaccine was highly effective and safe for people in those groups. Shingles is an infection that can occur at any age. It causes a rash that can be extremely painful and the pain can remain for many years after the rash has disappeared. Although it cannot be transmitted from other people, it develops in people who have previously been infected with chickenpox over their lifetime. Studies have shown that nine out of ten adults are already infected with the virus that causes shingles, and around one in four people will go on to develop shingles in their lifetime. Dr Mary Ramsay, director of immunisation at the UK Health Security Agency, said: "Shingles is an extremely painful condition, and complications can be long-lasting. Older people and those with weakened immune systems are particularly vulnerable. “Two doses of vaccine are highly effective in reducing your risk of getting shingles, or if you do develop shingles, reduce the severity of your symptoms. I strongly urge all those eligible to protect themselves by taking up the offer of a vaccine when they are contacted by their GP.” The vaccine significantly reduces the risk of people developing shingles and experiencing severe symptoms that can include blindness, hearing loss, nerve pain and even death. Currently, anyone over the age of 70 is eligible to receive the shingles vaccine. However, from 1 September, people will become eligible when they reach the ages of 65 and 70. Those who are severely immunosuppressed and over 50 will get two doses of the Shingrix vaccine. The gap between doses for immunocompromised patients is from eight to six months, and six to 12 months for those that are immunocompetent. Fiona Hazel, chair of the Blood Cancer Alliance and chief executive officer of Leukaemia UK, said: "If you are living with blood cancer, you are likely to have a weakened immune system, which means you are more likely to develop shingles and experience more serious side effects." People who have already been vaccinated against shingles and have received the Zostavax vaccine will not need re-vaccination with Shingrix. Neither will immunocompromised individuals who have already received two doses of Shingrix. Eligibility is set to be expanded to include people aged 60 and older by September 2028.

Vaccine

09 Aug 2022

·www.prnewswire.com

Investigation Report on China's Shingles Vaccine Market 2022-2031: GlaxoSmithKline the Only Shingles Vaccine Manufacturer in the Region

DUBLIN, Aug. 9, 2022 /PRNewswire/ -- The "Investigation Report on China's Shingles Vaccine Market 2022-2031" report has been added to ResearchAndMarkets.com's offering. The trade name of shingles vaccine (recombinant zoster vaccine) is SHINGRIX, which was developed by GlaxoSmithKline. Its product was firstly approved in China in 2020. The Shingles vaccine is suitable for adults aged 50 years and over to protect against shingles (herpes zoster). The recombinant zoster vaccine has been listed in the Chinese market. By July 2022, GlaxoSmithKline Biologicals is the only manufacturer in the Chinese Shingles Vaccine market. According to this market research, since the Shingles Vaccine entered the Chinese market in 2020, its annual sales value reached CNY19 million(US$2.85 million), and its annual sales volume reached nearly 12,000 doses. Therefore, the development prospects are quite good. According to the analysis, from 2022 to 2031, as Shingles Vaccine market expands, its sales will continue to grow. Compared with Merck's Zostavax, SHINGRIX has better preventive effects and faster replacement velocity. Therefore, as the market share of Shingles Vaccine will gradually increase, and sales and sales volume will also increase. Topics Covered: The impact of COVID-19 on China's Shingles Vaccine market Sales volume and value of China's Shingles Vaccine 2020-2021 Sales volume and value of Shingles Vaccine by regions in China 2020-2021 Competitive landscape of China's Shingles Vaccine market Prices of Shingles Vaccine in China Prices of Shingles Vaccine in China by regions in China Analysis on factors affecting the development of China's Shingles Vaccine market Prospect of China's Shingles Vaccine market from 2022 to 2031 Key Topics Covered: 1 Relevant Concepts of Shingles Vaccine 1.1 Indications for Shingles Vaccine 1.2 Development of Shingles Vaccine in China 1.3 Governmental Approval of Shingles Vaccine in China 1.4 The Impact of COVID-19 on Shingles Vaccine sales in China 2 Sales of Shingles Vaccine in China in 2020-2021 2.1 Sales Value of Shingles Vaccine 2.1.1 Overall Sales Value 2.1.2 Sales Value by Regions 2.2 Sales Volume of Shingles Vaccine 2.2.1 Overall Sales Volume 2.2.2 Sales Volume by Regions 2.3 Sales of Shingles Vaccine by Dosage Form in China in 2020-2021 2.3.1 Injection 2.3.2 Analysis of Other Dosage Forms 3 Analysis of Major Shingles Vaccine Manufacturers in China in 2020-2021 3.1 Analysis of Market Share of Major Shingles Vaccine Manufacturers 3.1.1 Investigation on Market Share by Sales Value 3.1.2 Investigation on Market Share by Sales volume 3.2 GlaxoSmithKline Biologicals 3.2.1 Enterprise Profile 3.2.2 Sales of SHINGRIX (GlaxoSmithKline Biologicals' Shingles Vaccine) in China 4 Prices of Shingles Vaccine for Different Manufacturers in China, 2021-2022 4.1 GlaxoSmithKline Biologicals (SHINGRIX) 4.2 Others 5 Prospect of Chinese Shingles Vaccine Market, 2022-2026 5.1 Influential Factors of Chinese Shingles Vaccine Market Development 5.1.1 The Impact of COVID-19 on Chinese Shingles Vaccine Market 5.1.2 Market Drivers and Opportunities 5.1.3 Market Threats and Challenges 5.2 Forecast on Market Size 5.3 Forecast on Market Trend Companies Mentioned GlaxoSmithKline Biologicals (SHINGRIX) For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Vaccine

100 Deals associated with Zoster vaccine live(Merck Sharp & Dohme Corp.)

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KEGG	Wiki	ATC	Drug Bank
-	Zoster vaccine live(Merck Sharp & Dohme Corp.)	J07BK02	DB10318

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Herpes Zoster	EU	Merck Sharp & Dohme BV	19 May 2006
Herpes Zoster	IS	Merck Sharp & Dohme BV	19 May 2006
Herpes Zoster	LI	Merck Sharp & Dohme BV	19 May 2006
Herpes Zoster	NO	Merck Sharp & Dohme BV	19 May 2006
Neuralgia, Postherpetic	EU	Merck Sharp & Dohme BV	19 May 2006
Neuralgia, Postherpetic	IS	Merck Sharp & Dohme BV	19 May 2006
Neuralgia, Postherpetic	LI	Merck Sharp & Dohme BV	19 May 2006
Neuralgia, Postherpetic	NO	Merck Sharp & Dohme BV	19 May 2006

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Chickenpox	Phase 3	-	Merck Sharp & Dohme LLC	01 Sep 2005
Influenza, Human	Phase 3	-	Merck Sharp & Dohme LLC	01 Sep 2005
HIV Infections	Phase 2	US	Merck Sharp & Dohme Corp.	29 Apr 2009

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02590068 (CTgov)	Not Applicable	Chronic viral hepatitis \| Hepatitis C	14	Zoster vaccine live (Hepatitis C Infected Volunteers)	dpckafghxl(grbnuijyig) = hiuanjsxop zimpabyppv (uslclzrvhj, jihpfvmrxs - xohvvdvkcj) View more	-	18 Dec 2019
				Zoster vaccine live (Healthy Volunteers)	dpckafghxl(grbnuijyig) = jmqttlgsak zimpabyppv (uslclzrvhj, pnjvnibtrx - mdsrrrotgh) View more
NCT02624375 (CTgov)	Phase 4	Herpes Zoster	10	Zostavax	inglvojwnn(acigoviehy) = qgjoqqfrkm gcpkmixkqh (idpeeivgss, qdcejvwfti - cgsqttekzw) View more	-	05 Dec 2019
NCT02704572 (Pubmed)	Not Applicable	Herpes Zoster	60	Live Zoster Vaccine (6-12 months group)	qvbqtgapmx(malxevdnuw) = yqxsmyssfc olptlgaafq (weylevlexv )	-	01 Dec 2018
				Live Zoster Vaccine (1-5 years group)	qvbqtgapmx(malxevdnuw) = mysuuhzhpe olptlgaafq (weylevlexv )
NCT00851786 (Pubmed)	Phase 2	HIV Infections	395	Zoster Vaccine Live	thtrayjpyb(dpvhzjxtvv) = npxxcggfjo ocnymateiq (ajjdiyhyng ) View more	-	13 Nov 2018
				Placebo	thtrayjpyb(dpvhzjxtvv) = wkuviiixsk ocnymateiq (ajjdiyhyng ) View more
NCT01600079 (Pubmed \| Am J Epidemiol)	Not Applicable	Herpes Zoster	1,505,647	Zoster vaccine	yxfwfrhjes(waarcrhrfy) = wjbabmlhif ianjfylmxb (hpcvbybscc, 47.5, 50.6) View more	-	01 Jan 2018
NCT00561080 (V211-043, CTgov)	Phase 3	Herpes Zoster	759	Zostavax (Group 2: Zostavax - Day 0 and Month 1)	hogkdjmhyg(hxvexeluvp) = aerpbmqocl aaajuggxkx (pqupkxniej, pdmdkchtvq - ueizpmfkfl) View more	-	22 Dec 2017
				Zostavax (Group 3: Zostavax - Day 0 and Month 3)	hogkdjmhyg(hxvexeluvp) = bmpycgjrbc aaajuggxkx (pqupkxniej, ryzqdpcoad - pndhwakvge) View more
NCT01391546 (V211-045, CTgov)	Phase 3	Herpes Zoster	354	ZOSTAVAX (ZOSTAVAX Intramuscular (IM) Route)	dlueocfwoc(oxkrsjrtap) = spbdphduzl eyomktachk (zrxzeiiyab, mcyfaqemui - gcaqbytcwy) View more	-	20 Nov 2017
				ZOSTAVAX (ZOSTAVAX Subcutaneous (SC) Route)	dlueocfwoc(oxkrsjrtap) = ytqehyrrbd eyomktachk (zrxzeiiyab, mstdpwxzxe - zbnlbuqzew) View more
NCT02958345 (CTgov)	Phase 4	Fibrosis \| Herpes Zoster	28	Zostavax (Zostavax)	ewwlxdgzuw(kvxgxvwuwy) = fjzongedjk ywxbaytffr (rvnkngrsfc, gnohtnqgsq - lujlnfxrdd) View more	-	19 Jul 2017
				Placebo (Placebo)	ewwlxdgzuw(kvxgxvwuwy) = nnyrdknjoh ywxbaytffr (rvnkngrsfc, oaksnnfbew - njzrghwjtw) View more
NCT02519855 (V211-062, CTgov)	Phase 3	Herpes Zoster \| Influenza, Human	882	Placebo to ZOSTAVAX™+ZOSTAVAX™ (Concomitant Vaccination)	jjfrxcnrwz(phwlwzfqet) = qzwtkovycc xqufldqnzo (dfphbqigyt, btworxynhx - gjgumbghlw) View more	-	14 Feb 2017
				Placebo to ZOSTAVAX™+ZOSTAVAX™ (Nonconcomitant Vaccination)	jjfrxcnrwz(phwlwzfqet) = qbflknwvvn xqufldqnzo (dfphbqigyt, hlnwfkrfaq - pxnxdygcdo) View more
NCT01556451 (V211-034, Pubmed \| J Korean Med Sci)	Phase 4	-	180	ZOSTAVAXTM	fjarhyiydk(lakvkyezab) = hhorwmxnog sefgjnzyws (ksyunqzcrj ) View more	-	01 Jan 2016