A Phase IIb, Randomized, Observer-Blind Study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.

Start Date29 Dec 2021

Sponsor / Collaborator

GSK Plc

NCT05082285 / Active, not recruitingPhase 2

A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants

The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY-2Gen) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.

Start Date29 Nov 2021

Sponsor / Collaborator

GSK Plc

NCT04707391 / CompletedPhase 3

A Phase IIIB, Randomized, Controlled, Observer-blind Study to Evaluate Safety and Immunogenicity of GSK's Meningococcal ABCWY Vaccine When Administered in Healthy Adolescents and Adults, Previously Primed With Meningococcal ACWY Vaccine

The purpose of this study was to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine.

Start Date25 Jan 2021

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with MenABCWY vaccine (GSK)

100 Translational Medicine associated with MenABCWY vaccine (GSK)

100 Patents (Medical) associated with MenABCWY vaccine (GSK)

Literatures (Medical) associated with MenABCWY vaccine (GSK)

01 Sep 2024·Infectious Diseases and Therapy

Quantifying Stated Preferences for Meningococcal Vaccines Among Adolescents/Young Adults and Parents of Adolescents in the United States: A Discrete Choice Experiment

Article

Author: Burman, Cindy ; Shah, Hiral ; Cabrera, Eliazar Sabater ; Kuylen, Elise ; Kocaata, Zeki ; Sohn, Woo-Yun ; Restrepo, Oscar Herrera ; Begum, Shahina

INTRODUCTIONInvasive meningococcal disease (IMD) is a severe and life-threatening disease. In the United States (US), vaccine coverage with MenACWY and MenB meningococcal vaccines is suboptimal among adolescents/young adults aged 16-23 years. A combined meningococcal vaccine (MenABCWY) could increase convenience (e.g., fewer injections) and improve coverage. The objective was to quantify preferences for hypothetical meningococcal vaccine profiles among adolescents/young adults and parents.METHODSAn online discrete choice experiment was conducted among 16- to 23-year-olds, and parents of 16- to 18-year-olds. Attributes (3 × 4) and levels (1 × 2) were based on the literature and focus groups. Participants made ten pair-wise forced trade-off choices, systematically varied using a D-optimal design. Random parameter logit quantified the relative importance of vaccination attributes and estimated the trade-offs. Differences in preferences by subgroups were assessed.RESULTSTotals of 300 adolescents and young adults (median age 20 years) and 300 parents (median age 46 years) completed the survey. Overall, 89.6% of 16- to 23-year-olds and 69.1% of parents preferred a simplified hypothetical meningococcal vaccination profile, e.g., with fewer injections (3 vs. 4) and fewer healthcare provider (HCP) visits (2-3 vs. 4). Having HCP advice and clear Centers for Disease Control and Prevention recommendations impacted vaccination choice, with both groups reporting high trust in HCP information (83.3% among 16- to 23-year-olds; 98.7% among parents). Barriers to vaccination included lack of HCP advice or awareness of meningococcal vaccines, and income level and out-of-pocket costs for parents.CONCLUSIONSAdolescents/young adults and parents demonstrated a significant preference for a meningococcal vaccine that is more convenient (such as combined MenABCWY). Parents' vaccination preferences differed by income level and out-of-pocket costs, suggesting financial barriers to vaccination may exist which could result in IMD prevention inequalities. Findings from this study provide important information to support patient-facing informed policy discussions. A simplified vaccination schedule and strong recommendation could help improve vaccine uptake, schedule compliance, disease prevention, and reduce inequalities in IMD risk and prevention. A graphical abstract is available with this article.

01 Nov 2022·Journal of Infection

Public health perspective of a pentavalent meningococcal vaccine combining antigens of MenACWY-CRM and 4CMenB

Review

Author: Bekkat-Berkani, Rafik ; Soumahoro, Lamine ; Preiss, Scott ; Sohn, Woo-Yun ; Vadivelu, Kumaran ; Fragapane, Elena ; Rappuoli, Rino

OBJECTIVESInvasive meningococcal disease (IMD) is a life-threatening disease that can rapidly progress to death or leave survivors with severe, life-long sequelae. Five meningococcal serogroups (A, B, C, W and Y) account for nearly all IMD. Meningococcal serogroup distribution fluctuates over time across the world and age groups. Here, we consider the potential public health impact of a pentavalent MenABCWY vaccine developed to help further control meningococcal disease and improve immunisation rates.RESULTSThe GSK MenABCWY vaccine combines the antigenic components of MenACWY-CRM (Menveo®) and 4CMenB (Bexsero®), building on a wide body of clinical experience and real-world evidence. Both approved vaccines have acceptable safety profiles, demonstrate immunogenicity, and are broadly used, including in national immunisation programmes in several countries. Since the advent of quadrivalent vaccines, public health in relation to IMD has improved, with a decline in the overall incidence of IMD and an increase in vaccine coverage.CONCLUSIONA pentavalent MenABCWY has the potential to provide further public health benefits through practical, broad IMD protection programmes encompassing serogroups A, B, C, W and Y, and is currently in late-stage development.

01 Jun 2022·Infectious Diseases and TherapyQ3 · MEDICINE

Rationale for the Development of a Pentavalent Meningococcal Vaccine: A US-Focused Review

Q3 · MEDICINE

ReviewOA

Author: Fergie, Jaime ; Marshall, Gary S ; Peyrani, Paula ; Presa, Jessica

While invasive meningococcal disease (IMD) is uncommon, it can result in serious sequelae and even death. In 2018 in the United States, the incidence of IMD per 100,000 people was 0.03 among adolescents 11-15 years of age, 0.10 among persons 16-23 years of age, and 0.83 among infants < 1 year of age. Serogroup B accounted for 86%, 62%, and 66% of cases, respectively, in those age groups. Currently, routine meningococcal vaccination covering serogroups ACWY (MenACWY) is recommended in the United States for all adolescents at 11-12 years of age, with a booster dose at 16 years of age, whereas a meningococcal serogroup B (MenB) vaccine series is recommended for persons 16-23 years of age under the shared clinical decision-making paradigm. The MenACWY vaccination program in adolescents has been successful in reducing disease burden, but does not prevent disease caused by serogroup B, which accounts for more than half of IMD cases. There are currently no approved vaccines that cover all of the most common disease-causing meningococcal serogroups, which are A, B, C, W, and Y. A pentavalent MenABCWY vaccine that is constituted from 2 licensed meningococcal vaccines-MenB-FHbp and MenACWY-TT-is being investigated in healthy persons ≥ 10-25 years of age. The addition of a MenABCWY vaccine is the next natural step in the incremental meningococcal immunization program in the United States to improve protection against the most common serogroup causing IMD, with no increase in the number of immunizations needed. With high uptake, routine use of MenABCWY could reduce IMD cases and associated mortality, the rate of long-term physical and psychosocial sequelae in survivors, and costs associated with controlling outbreaks, particularly on college campuses. A MenABCWY vaccine would also reduce the number of injections required for adolescents, potentially improving compliance.

News (Medical) associated with MenABCWY vaccine (GSK)

20 Oct 2023

·www.fiercepharma.com

Pfizer beats out GSK with FDA nod for first 5-in-1 meningitis shot

While Pfizer’s approval has won Penbraya some time to its own on the market, GSK is close behind with its own pentavalent competitor. In the race to secure U.S. approval for the first five-pronged meningitis vaccine, Pfizer has eked out a regulatory win well ahead of its immunization rival GSK. Friday, the U.S. FDA gave a thumbs-up to Penbraya, the commercial moniker for Pfizer’s pentavalent vaccine defending against the most common serogroups behind meningococcal disease. The shot is approved for adolescents and adults between the ages of 10 and 25. Penbraya mixes components from two of the company’s other meningococcal vaccines—Trumenba and Nimenrix—which together tackle serogroups A, B, C, W and Y. Those serogroups account for nearly all invasive meningococcal disease. Prior to Pfizer’s Penbraya approval, protection from all five groups required four injections from two separate vaccines. Chief to Pfizer’s marketing pitch for Penbraya is that the shot needs only be administered twice. The company figures this feature will streamline standard of care and potentially boost the number of people who get vaccinated. The FDA handed Pfizer its regulatory win based on results from the company’s phase 2 and phase 3 trials, which included a late-stage study pitting Pfizer’s pentavalent shot against other meningitis vaccines currently approved in the U.S. Besides Pfizer, GSK’s Bexsero has competed with Trumenba for the meningococcal B vaccine market. GSK also makes Menveo, a vaccine against meningococcal groups A, C, W-135 and Y. Sanofi separately markets its own MenACWY vaccines called Menactra and MenQuadfi. Now, though, Pfizer is poised to disrupt the market with a shot that protects against the serogroups A, B, C, W and Y. Beyond the shot’s approval, the Centers for Disease Control and Prevention’s advisory committee on immunization practices is set to weigh in on how Pfizer’s vaccine should be used on Oct. 25. While Pfizer’s approval has won Penbraya some time to its own on the market, GSK is close behind with its own pentavalent competitor, coded MenABCWY. In May, GSK unveiled study results pitting the investigational MenABCWY vaccine against a combination of Bexsero and Menveo. GSK found its vaccine candidate was noninferior to the Bexsero-Menveo combination in people aged 10 to 25 years across all five of the targeted serotypes.

Drug ApprovalClinical ResultVaccinePhase 2Phase 3

15 May 2023

·www.pmlive.com

GSK’s five-in-one meningococcal vaccine candidate shows promise in phase 3 trial

GSK’s five-in-one meningococcal vaccine candidate has shown promising results in a phase 3 trial involving healthy individuals aged ten to 25 years. Preliminary results for the MenABCWY candidate were presented by the company at the European Society for Paediatric Infectious Diseases congress in Lisbon, Portugal. Invasive meningococcal disease (IMD) is an uncommon but serious illness that can cause life-threatening complications or even death, with the highest incidence occurring in children and adolescents. Five Neisseria meningitides serogroups – A, B, C, W, and Y – account for nearly all IMD cases, but there are currently no approved vaccines that offer simultaneous protection against all of them. In the US, two separate vaccines needing four injections are required to protect against all five serogroups. This regimen, together with low awareness of the disease, can lead to poor immunisation rates. It is hoped that GSK’s MenABCWY, which combines the antigenic components of its approved Bexsero (MenB) and Menveo (MenACWY) meningococcal vaccines, would provide the widest possible protection against the disease and lead to higher vaccine uptake. The phase 3 study evaluating the candidate met all of its primary endpoints, including a non-inferior immune response against all five serogroups in individuals receiving two doses of the MenABCWY vaccine candidate six months apart, compared to those receiving the Bexsero and Menveo regimen. In a separate confirmatory arm of the trial, the candidate showed immunological effectiveness against a panel of 110 diverse MenB invasive strains, which account for 95% of strains circulating in the US. GSK’s chief scientific officer, Tony Wood, said: “This preliminary data further unlocks the potential of our MenABCWY vaccine candidate in providing protection against invasive meningococcal disease caused by serogroups A, B, C, W and Y. "It’s particularly encouraging to see the breadth of coverage against the broadest panel of circulating MenB strains to date, as we know MenB is the most common cause of meningococcal disease in the US with the lowest immunisation rate.” The company said it is now “working closely” with regulatory agencies to review the full phase 3 results and prepare filings. This includes a supplemental application for Bexsero, which has not yet received traditional approval in the US.

Phase 3VaccineClinical Result

13 May 2023

·pipelinereview.com

GSK presents pivotal data at ESPID confirming effectiveness of its 5-in-1 meningococcal ABCWY vaccine candidate, with demonstrated coverage against a panel of 110 MenB strains

LONDON, UK I May 12, 2023 I GSK plc (LSE/NYSE: GSK) today presented preliminary positive results from the phase III trial ( NCT04502693 ) evaluating the immunological vaccine effectiveness and safety of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. The preliminary data were disclosed at the 41st Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) in Lisbon, Portugal. The vaccine candidate demonstrated non-inferiority in primary endpoints for five Neisseria meningitidis serogroups (A, B, C, W, and Y) compared to two doses of Bexsero (meningococcal group B vaccine) and one dose of Menveo (meningococcal group A, C, W-135, and Y conjugate vaccine) in 10–25-year-olds. In addition, the vaccine candidate was generally well tolerated, with a safety profile consistent with Bexsero and Menveo . In a separate confirmatory arm of this phase III trial, the MenABCWY vaccine candidate showed immunological effectiveness against a panel of 110 diverse meningococcal serogroup B (MenB) invasive strains, which account for 95% of strains circulating in the US. 1 Tony Wood, Chief Scientific Officer at GSK, said: “These preliminary data further unlock the potential of our MenABCWY vaccine candidate in providing protection against invasive meningococcal disease caused by serogroups A, B, C, W and Y. It’s particularly encouraging to see the breadth of coverage against the broadest panel of circulating MenB strains to date, as we know MenB is the most common cause of meningococcal disease in the US with the lowest immunisation rate.” Five Neisseria meningitidis serogroups (A, B, C, W, and Y) account for nearly all invasive meningococcal disease (IMD) cases in most of the world. 2 Meningitis B is the most common serogroup in the US and accounts for more than half of meningococcal disease cases among 16–20-year-olds. 3, 4 Currently immunisation coverage rates for Men B are estimated at approximately 31% of adolescents in the US. 5 GSK’s MenABCWY vaccine candidate combines the antigenic components of licensed meningococcal vaccines, Bexsero and Menveo . The aim of combining two effective vaccines into one is to help simplify immunisation schedules, which can in turn increase vaccination coverage and help reduce the overall burden of disease. Professor Terry Nolan, principal investigator for the phase III trial, and Head of the Vaccine and Immunisation Research Group at the Peter Doherty Institute for Infection and Immunity at the University of Melbourne, and Murdoch Children’s Research Institute, said: “Meningococcal vaccination can help save lives and these results are significant in moving one step closer to protection against five meningococcal serogroups with a single vaccine. The potential for a simplified immunisation schedule could improve accessibility for the target population susceptible to meningococcal disease.” GSK is working closely with regulatory agencies to review the full phase III data set, including the supplemental Biologics License Application for Bexsero for confirmation of full licensure under the Accelerated Approval pathway. Detailed results will be submitted for publication in a peer-reviewed scientific journal later this year. About the MenABCWY phase III trial The trial conducted by GSK is a phase III randomised, controlled, observer-blind, multi-country trial to evaluate the safety, tolerability, and immunogenicity of GSK’s MenABCWY vaccine candidate. It is part of a comprehensive programme to generate clinical evidence on the benefits of meningococcal immunisation. The trial started in August 2020 , and approximately 3,650 participants aged 10-25 were enrolled in the US, Canada, Czech Republic, Estonia, Finland, Turkey, and Australia. The objective of the trial was to assess the safety profile of the MenABCWY vaccine candidate, to assess the immunological vaccine effectiveness against a panel of 110 MenB strains, and to compare the immune responses of the trial’s participants who received two doses of the MenABCWY vaccine candidate six months apart to the responses of those in the control groups who received GSK’s licensed vaccines, Bexsero (MenB) and one dose of Menveo (MenACWY). There are a total of 11 primary endpoints for the trial, five for MenABCWY and six for Bexsero . Bexsero is used as the comparator for the MenB immune responses induced by the MenABCWY vaccine in the trial, which is both the phase III trial for MenABCWY and confirmatory trial for Bexsero in the US. About Bexsero Bexsero is currently licensed or has received regulatory approval in over 50 countries, including the US and EU, and is used in 13 national immunisation programmes worldwide for the prevention of IMD caused by Neisseria meningitidis serogroup B. Bexsero is the only MenB vaccine with trials that have demonstrated a reduction in IMD, including vaccine effectiveness in real-world settings. Regulatory approvals vary by country. It is approved for individuals two months of age and older in Europe. In the US, Bexsero is licensed under the Accelerated Approval pathway for active immunisation to prevent IMD caused by Neisseria meningitidis serogroup B in individuals from 10 through 25 years. Approval of Bexsero is based on demonstrating an immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the US. The effectiveness of Bexsero against diverse serogroup B strains has not been confirmed. The US Prescribing Information is available here . About Menveo Menveo vaccine for meningococcal groups A, C, Y, and W has received regulatory approval in over 60 countries, including the US, with more than 72 million doses distributed worldwide since 2010. Menveo offers extensive evidence of immunogenicity with a well-characterised safety profile. In the US, Menveo has received regulatory approval for active immunisation to prevent IMD caused by Neisseria meningitidis serogroups A, C, Y, and W in individuals from 2 months through 55 years of age. However, Menveo does not prevent N. meningitidis serogroup B infections. The US Prescribing Information is available here . About Invasive meningococcal disease Invasive meningococcal disease (IMD), a major cause of meningitis and septicaemia, is an uncommon but serious illness that can cause life-threatening complications or even death. 6 Among those contracting meningococcal diseases, one in ten will die, sometimes in as little as 24 hours, despite treatment. 7 One-in-five survivors suffer long-term consequences, such as brain damage, amputations, hearing loss and nervous system problems. 6 About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company . References [1] Muzzi A, Bodini M, Topaz N, et al. Genetic Features of a Representative Panel of 110 Meningococcal B Isolates to Assess the Efficacy of Meningococcal B Vaccines. mSphere. 2022;7(5): e0038522. doi:10.1128/msphere. 00385-22. [2] CDC. Meningococcal Disease Causes and How It Spreads | CDC. Accessed May 2023. [3] CDC. University-Based Outbreaks of Meningococcal Disease Caused by Serogroup B, United States, 2013–2018 - Volume 25, Number 3—March 2019 - Emerging Infectious Diseases journal - CDC. Accessed May 2023. [4] MacNeil JR, Blain AE, Wang X, Cohn AC. Current epidemiology and trends in meningococcal disease—United States, 1996–2015. Clin Infect Dis. 2018; 66:1276–81. [5] Pingali C, Yankey D, Elam-Evans LD, et al. National Vaccination Coverage Among Adolescents Aged 13–17 Years — National Immunization Survey-Teen, United States, 2021. MMWR Morb Mortal Wkly Rep 2022; 71:1101–1108. [6] ECDC, Factsheet about meningococcal diseases. Accessed May 2023. [7] Bing Wang et al., “Case fatality rates of invasive meningococcal disease by serogroup and age: A systematic review and meta-analysis”, in Vaccine, Volume 37, Issue 21, 9 May 2019, Pages 2768-2782. Accessed May 2023. SOURCE: GlaxoSmithKline

Phase 3Clinical ResultDrug ApprovalVaccine

100 Deals associated with MenABCWY vaccine (GSK)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Meningitis, Meningococcal	Phase 3	AR	GSK Plc	25 Jan 2021
Meningitis, Meningococcal	Phase 3	US	GSK Plc	25 Jan 2021
Meningitis, Meningococcal	Phase 3	AU	GSK Plc	25 Jan 2021
Meningitis, Meningococcal	Phase 3	CA	GSK Plc	25 Jan 2021
Meningococcal Infections	Phase 1	US	GSK Plc	01 May 2014

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04707391 (CTgov)	Phase 3	Meningitis, Meningococcal	1,250	Placebo+MenABCWY vaccine (ABCWY Group)	ysotdfhwzl(ffpecgpltz) = nsyvuqgzzb qhzarkcxev (yccfwblvvk, wsqvhwyjam - bljfjajmuj) View more	-	03 Jul 2024
				MenB vaccine+MenACWY vaccine (ACWY Group)	ysotdfhwzl(ffpecgpltz) = exxayfyktl qhzarkcxev (yccfwblvvk, lkjabgzxms - uksykpiipa) View more
NCT04502693 (CTgov)	Phase 3	Meningococcal Infections	3,657	rMenB+OMV NZ vaccine+Y Conjugate Vaccine (MenACWY) (MenB_0_2_6 Group)	ogrfmdrmlf(agkkjywhtn) = ufkhgjchtp cxrihgidkm (xplqgujfjx, wjcvckvwsd - xrkvxiaurj) View more	-	05 Mar 2024
				Placebo+rMenB+OMV NZ vaccine+Y Conjugate Vaccine (MenACWY) (MenB_0_6 Group)	ogrfmdrmlf(agkkjywhtn) = rhkkiyhype cxrihgidkm (xplqgujfjx, xittbbzhyl - mfiwhzbcph) View more
NCT02451514 (CTgov)	Phase 2	Meningococcal Infections	129	MenABCWY+OMV vaccine (MenABCWY+OMV Group)	hulapcvbun(bdqmddttxg) = fapixeizpv khawvgelkq (awwrnzjayv, mfwrrsbuve - eivljulplq) View more	-	09 Jul 2020
				MenABCWY+OMV vaccine (MenACWY Group)	hulapcvbun(bdqmddttxg) = dxavxmlxxl khawvgelkq (awwrnzjayv, mnjiqtpslu - hmwaxuykhn) View more
NCT02946385 (CTgov)	Phase 2	Meningococcal Infections	604	MenABCWY (ABCWY_0_2)	ipexrvjtmm(suejcavtkl) = plfprxkeba udyhqeqmwx (jaiyticopx, gqpbbjpogq - rddzomrvuc) View more	-	20 Aug 2019
				MenABCWY (ABCWY_0_2_6)	ipexrvjtmm(suejcavtkl) = mkqcqqqhht udyhqeqmwx (jaiyticopx, eetalgntzt - badpwblxut) View more
NCT02140762 (Pubmed \| Vaccine)	Phase 2	Invasive Fungal Infections	301	MenABCWY vaccine (MenABCWY)	ppkldyslao(jhvwlmlxzt) = mtrdsffqcf lqkafbuwus (ditvlfufnr, 65 - 69)	-	23 Aug 2018
NCT02140762 (CTgov)	Phase 2	Meningococcal Infections	305	MenABCWY (MenABCWY)	znegkhisrr(zrolkjwpxy) = ebxwtxtwbo csnexiaxcl (gvrevbybkd, wukfauffxm - suzoyodqgf) View more	-	26 Jun 2018
				Placebo+MenACWY (Placebo/MenACWY)	znegkhisrr(zrolkjwpxy) = ucaazjhauz csnexiaxcl (gvrevbybkd, nkhiihxsdv - fjrmdflxpm) View more
NCT02285777 (CTgov)	Phase 2	Meningococcal Infections	189	Meningococcal ABCWY (MenABCWY Group)	agnlqzjled(bkojsanuhn) = ndfvrmfwno azlfkakbza (jpzvbwyavd, nglcjqrlgq - wujreuumjl) View more	-	06 Dec 2017
				Placebo (MenACWY Group)	agnlqzjled(bkojsanuhn) = mwxglympfa azlfkakbza (jpzvbwyavd, pymisjajsz - gaefjcvhke) View more
NCT02212457 (CTgov)	Phase 2	Meningococcal Infections	1,063	Saline Placebo+MenABCWY+Havrix (ABCWY_ 0_2 Group)	tnegqfdzvu(oaxqekdmzu) = cuywqybcbg dmnhcitaot (kyaulssdqe, aonviycjpu - edncddgtcb) View more	-	21 Jul 2017
				Bexsero+Saline Placebo+Havrix (rMenB_0_2 Group)	tnegqfdzvu(oaxqekdmzu) = mcvfwuenqo dmnhcitaot (kyaulssdqe, rudftijnzi - srscngubqf) View more

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