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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR MENINGOCOCCAL GROUP B VACCINE


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All Clinical Trials for meningococcal group b vaccine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000820 ↗ A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone. SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines. The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.
NCT00496015 ↗ Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A Completed GlaxoSmithKline Phase 3 2007-07-02 The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically and to assess the impact of pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage compared to control group receiving meningococcal conjugate vaccine (GSK134612). This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00370318).
NCT00935883 ↗ Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD) Completed Alexion Pharmaceuticals Phase 2 2009-07-01 To evaluate the safety and efficacy of eculizumab for the treatment of dry AMD as evaluated by the change in drusen volume and area of geographic atrophy.
NCT00935883 ↗ Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD) Completed Philip J. Rosenfeld, MD, PhD Phase 2 2009-07-01 To evaluate the safety and efficacy of eculizumab for the treatment of dry AMD as evaluated by the change in drusen volume and area of geographic atrophy.
NCT00962624 ↗ Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults Completed Novartis Vaccines Phase 2 2010-07-01 The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). The study will be completed at the Manchester Medical Microbiology Partnership in the UK and will enrol staff who may be at potential occupational exposure to meningococci. Blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.
NCT00962624 ↗ Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults Completed Dr. Elizabeth Miller Phase 2 2010-07-01 The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). The study will be completed at the Manchester Medical Microbiology Partnership in the UK and will enrol staff who may be at potential occupational exposure to meningococci. Blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.
NCT00962624 ↗ Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults Completed Prof. Elizabeth Miller Phase 2 2010-07-01 The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). The study will be completed at the Manchester Medical Microbiology Partnership in the UK and will enrol staff who may be at potential occupational exposure to meningococci. Blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for meningococcal group b vaccine

Condition Name

Condition Name for meningococcal group b vaccine
Intervention Trials
Infections, Meningococcal 3
Meningitis, Meningococcal 2
Atopic Dermatitis 2
HELLP Syndrome 1
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Condition MeSH

Condition MeSH for meningococcal group b vaccine
Intervention Trials
Meningitis 4
Meningococcal Infections 3
Infections 3
Meningitis, Meningococcal 3
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Clinical Trial Locations for meningococcal group b vaccine

Trials by Country

Trials by Country for meningococcal group b vaccine
Location Trials
United States 53
Canada 5
United Kingdom 3
Czech Republic 2
France 2
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Trials by US State

Trials by US State for meningococcal group b vaccine
Location Trials
California 4
Florida 4
North Carolina 4
Ohio 3
New York 3
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Clinical Trial Progress for meningococcal group b vaccine

Clinical Trial Phase

Clinical Trial Phase for meningococcal group b vaccine
Clinical Trial Phase Trials
Phase 4 2
Phase 3 7
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for meningococcal group b vaccine
Clinical Trial Phase Trials
Completed 11
Not yet recruiting 6
Recruiting 3
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Clinical Trial Sponsors for meningococcal group b vaccine

Sponsor Name

Sponsor Name for meningococcal group b vaccine
Sponsor Trials
GlaxoSmithKline 5
Alexion Pharmaceuticals 4
National Institute of Allergy and Infectious Diseases (NIAID) 3
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Sponsor Type

Sponsor Type for meningococcal group b vaccine
Sponsor Trials
Industry 15
Other 13
NIH 3
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Meningococcal Vaccines: Clinical Trials, Market Analysis, and Projections

Introduction to Meningococcal Vaccines

Meningococcal vaccines are crucial in preventing invasive meningococcal disease (IMD), a severe and potentially life-threatening infection caused by the bacterium Neisseria meningitidis. These vaccines target various serogroups of the bacteria, including A, B, C, W, and Y, which are responsible for the majority of IMD cases globally.

Clinical Trials Update: GSK's 5-in-1 MenABCWY Vaccine Candidate

Trial Overview

GSK's 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate has been a significant focus in recent clinical trials. This vaccine combines the antigenic components of GSK's established meningococcal vaccines, BEXSERO (Meningococcal Group B Vaccine) and MENVEO (Meningococcal Groups A, C, Y, and W-135 conjugate vaccine)[1][3][4].

Phase III Trial Results

The phase III trial, initiated in August 2020, involved approximately 3,650 participants aged 10-25 from several countries, including the US, Canada, Czech Republic, Estonia, Finland, Turkey, and Australia. The trial aimed to assess the safety profile, tolerability, and immunogenicity of the MenABCWY vaccine candidate.

Key findings include:

  • All primary endpoints were met, demonstrating immunological non-inferiority to one dose of GSK's Meningococcal Groups A, C, Y, and W Vaccine and non-inferior immune responses against 110 diverse MenB invasive strains compared to two doses of GSK’s Meningococcal Group B Vaccine[1][3][4].
  • The vaccine showed immunological effectiveness against a panel of 110 MenB strains, representing 95% of MenB strains circulating in the US[1][3][4].
  • The vaccine was well tolerated with a safety profile consistent with both BEXSERO and MENVEO[1][3][4].

Regulatory Review

The US FDA has accepted the Biologics License Application (BLA) for GSK's MenABCWY vaccine candidate, with a Prescription Drug User Fee Act (PDUFA) goal date for a decision set for February 14, 2025[1][4].

Market Analysis

Current Market Size and Growth

The global meningococcal vaccines market was valued at USD 3.28 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6.0% from 2023 to 2030[2].

Key Drivers

Several factors are driving the growth of the meningococcal vaccines market:

  • Increasing Prevalence of Meningitis: The rising number of meningitis cases globally, with around 1.2 million cases projected annually, is a significant driver[2][5].
  • Immunization Programs: Growing awareness and implementation of immunization programs are fueling market growth[2][5].
  • R&D Activities: Continuous research and development, including the creation of pentavalent vaccines, are expected to boost the market[2][5].
  • Government Initiatives and Public Awareness: Favorable government initiatives, public awareness campaigns, and educational programs are also contributing to market expansion[5].

Market Segmentation

The serotype B segment dominated the global market with a revenue share of 36.3% in 2022, largely due to the presence of strong vaccines like Trumenba and Bexsero. In North America and Europe, serotype B is the predominant agent causing meningococcal disease, accounting for around half of the total reported cases in these regions[2].

Projections and Future Outlook

Market Size Projections

The meningococcal vaccines market is expected to reach USD 7.2 billion by 2032, exhibiting a CAGR of 7.7% during the forecast period from 2024 to 2032[5].

Innovations and Advancements

The market is anticipated to benefit from:

  • Combination Vaccines: Development of combination vaccines, such as the 5-in-1 MenABCWY vaccine, which simplify immunization schedules and increase compliance[1][3][5].
  • Advanced Technologies: Use of advanced technologies like reverse vaccinology and genomic sequencing to identify new vaccine targets and enhance efficacy[5].
  • Strategic Collaborations: Partnerships with governments and international organizations to ensure wider distribution and access to vaccines in low-income regions[5].

Recent Approvals and Developments

  • Pfizer's PENBRAYA™: Recently approved by the FDA, this pentavalent vaccine provides coverage against meningococcal groups A, B, C, W, and Y for adolescents and young adults aged 10 to 25[5].
  • GSK's MenABCWY: As mentioned, GSK's 5-in-1 MenABCWY vaccine candidate is under regulatory review, with a potential decision by February 14, 2025[1][4].

Key Takeaways

  • Clinical Trials Success: GSK's 5-in-1 MenABCWY vaccine candidate has shown promising results in phase III trials, meeting all primary endpoints and demonstrating broad coverage against the five most common meningococcal serogroups.
  • Market Growth: The global meningococcal vaccines market is expected to grow significantly, driven by increasing disease prevalence, immunization programs, and R&D activities.
  • Future Innovations: The market will benefit from advancements in vaccine technology, combination vaccines, and strategic collaborations to improve accessibility and compliance.

FAQs

What is the current status of GSK's 5-in-1 MenABCWY vaccine candidate?

The US FDA has accepted the Biologics License Application (BLA) for GSK's 5-in-1 MenABCWY vaccine candidate, with a decision expected by February 14, 2025[1][4].

How does the MenABCWY vaccine candidate compare to existing vaccines?

The MenABCWY vaccine candidate has demonstrated non-inferior immune responses compared to two doses of GSK’s Meningococcal Group B Vaccine and one dose of GSK's Meningococcal Groups A, C, Y, and W Vaccine[1][3][4].

What are the key drivers of the meningococcal vaccines market?

The market is driven by the increasing prevalence of meningitis, growing immunization programs, R&D activities, and favorable government initiatives and public awareness campaigns[2][5].

What is the projected market size of the meningococcal vaccines market by 2032?

The market is expected to reach USD 7.2 billion by 2032, exhibiting a CAGR of 7.7% during the forecast period from 2024 to 2032[5].

Which companies are leading in the development of meningococcal vaccines?

Prominent players include GlaxoSmithKline Plc, Pfizer Inc., Novartis AG, Sanofi S.A., and others, who are continuously innovating and expanding their product portfolios[5].

Sources

  1. GSK's 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA - GSK.
  2. Meningococcal Vaccines Market Size & Share Report, 2030 - Grand View Research.
  3. GSK presents pivotal data at ESPID confirming effectiveness of its 5-in-1 meningococcal ABCWY vaccine candidate - GSK.
  4. GSK's 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA - GSK.
  5. Meningococcal Vaccines Market to Reach USD 7.2 Billion by 2032 - BioSpace.

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