CLINICAL TRIALS PROFILE FOR MENINGOCOCCAL GROUP B VACCINE

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.

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
Risk-Taking	1

Condition MeSH

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

Clinical Trial Locations for meningococcal group b vaccine

Trials by Country

Trials by Country for meningococcal group b vaccine
Location	Trials
United States	53
Poland	6
Canada	5
United Kingdom	5
Spain	2

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

Clinical Trial Progress for meningococcal group b vaccine

Clinical Trial Phase

Clinical Trial Phase for meningococcal group b vaccine
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	2
Phase 3	7

Clinical Trial Status

Clinical Trial Status for meningococcal group b vaccine
Clinical Trial Phase	Trials
Completed	11
Not yet recruiting	6
Recruiting	4

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

Sponsor Type

Sponsor Type for meningococcal group b vaccine
Sponsor	Trials
Industry	16
Other	13
NIH	3

Meningococcal Group B Vaccine: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 2, 2025

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Introduction

Meningococcal disease, caused by Neisseria meningitidis, poses a significant global health threat, particularly in infants, adolescents, and immunocompromised populations. Among its serogroups, B remains the most difficult to target due to its unique polysaccharide capsule mimicry of human neural tissue, complicating vaccine development. Accordingly, the meningococcal group B (MenB) vaccine landscape has evolved with innovative platforms, clinical trial advancements, and market dynamics aimed at reducing meningococcal disease burden worldwide. This report offers a comprehensive update on ongoing clinical trials, analyzes current market trends, and projects future growth for MenB vaccines.

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Clinical Trials Update

1. Latest Developments in MenB Vaccine Trials

Over the past year, several pivotal clinical trials have yielded promising data for MenB vaccines, notably Bexsero® (Novartis/GSK), Trumenba® (Pfizer), and the emerging 4CMenB (routine maintenance and immunogenicity in various age groups).

• Bexsero® (4CMenB):
  The vaccine has completed phase IV post-marketing surveillance in multiple countries, confirming its safety and immunogenicity profile. Recent studies in infants and adolescents demonstrated robust immune responses with high seroconversion rates (>90%) against strain panels representative of circulating MenB strains. Notably, an observational study published in 2022 indicated a 70% reduction in invasive MenB disease incidence in countries with high vaccine uptake, such as the UK [1].

• Trumenba® (Pfizer):
  Undergoing multiple ongoing phase III trials focusing on adolescents and young adults, recent interim analyses revealed sustained antibody titers over five years. An ongoing phase IV trial in Africa aims to establish efficacy in meningitis-endemic regions with diverse strain coverage. The vaccine demonstrated a favorable safety profile, with mild injection site reactions and transient fever being the most common adverse events.

• Next-Generation Vaccines:
  Several candidates are entering clinical evaluation. For instance, Novavax's nanoparticle-based MenB vaccine entered phase I/II trials in 2022, aiming for broader strain coverage and improved immunogenicity. Similarly, the University of Oxford's RHEPBAC project explores conserved surface protein antigens to circumvent strain variability issues.

2. Innovations and Challenges in Trials

• Vaccine Strain Coverage:
  Because N. meningitidis exhibits significant antigenic variability, clinical trials increasingly incorporate geographically diverse strain panels to evaluate vaccine breadth comprehensively. For instance, recent studies have included strains from Africa’s “meningitis belt,” where disease burden remains high despite vaccination efforts.

• Immunogenicity in Special Populations:
  Trials are expanding into immunocompromised groups, infants under six months, and pregnant women to establish safety and efficacy across vulnerable demographics. Preliminary data indicates promising immune responses with acceptable safety profiles.

• Emerging Variants & Molecular Surveillance:
  The incorporation of genome sequencing in trial designs has facilitated real-time tracking of circulating strains, enabling adaptive trial methodologies that align immunogenicity with prevalent variants.

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Market Analysis

1. Current Market Landscape

• Global Market Size:
  The meningococcal vaccine market, valued at approximately USD 1.2 billion in 2022, is projected to grow at a CAGR of 7% over the next five years, driven by rising disease awareness, immunization initiatives, and expanding indications.

• Key Players & Market Share:
  GSK's Bexsero maintains a dominant presence in Europe and North America, supported by robust distribution networks and high immunization coverage. Pfizer’s Trumenba is gaining traction, especially in the U.S. and emerging markets. Novartis' prior portfolio has transitioned under GSK, with new entrants like Novavax and other biotech firms vying to capture niche segments.

• Geographic Trends:
  Africa’s meningitis belt remains a critical focus, with Gavi, the Vaccine Alliance, actively subsidizing MenB vaccine deployment in endemic regions. Asia-Pacific markets are witnessing increased adoption due to rising awareness and government vaccination programs.

2. Challenges Facing Market Expansion

• Cost & Reimbursement:
  The high price point (ranging from USD 60-140 per dose) impacts accessibility in low-income settings. Reimbursement policies vary, influencing vaccine uptake.

• Strain Coverage Limitations:
  Antigenic variability may necessitate vaccine updates or multivalent formulations, adding to development costs and complexity.

• Public Perception & Awareness:
  Vaccine hesitancy and low disease awareness remain hurdles, particularly in regions where MenB disease incidence appears sporadic.

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Future Market Projections

1. Growth Drivers

• Expanding Indications & Age Groups:
  Approval for use in infants <2 months, adolescents, and high-risk groups will broaden market penetration. Recent trial data suggest strong immunogenicity supports these extensions.

• Innovative Platforms & Vaccination Programs:
  Next-generation vaccines employing protein-based or nanoparticle platforms promise broader strain coverage, higher efficacy, and improved thermostability, appealing to resource-limited settings.

• Government & International Initiatives:
  Increased funding from WHO, GAVI, and national governments for meningococcal immunization will sustain market growth, especially in endemic regions.

2. Market Revenue Forecasts

• The combined global MenB vaccine market is anticipated to reach USD 2.3 billion by 2028, with a CAGR of approximately 8%. Factors influencing this include new vaccine approvals, expanded indications, and heightened disease surveillance.

• Key Emerging Markets such as China, India, and Brazil represent significant growth opportunities, driven by rising health expenditure and increasing capacity for vaccine manufacturing and procurement.

3. Competitive Landscape & Innovation Outlook

• Pipeline & R&D:
  The ongoing development of broad-spectrum, strain-cross-reactive vaccines suggests that market incumbents will face competition from novel biotech entrants, potentially disrupting current dynamics.

• Vaccine Delivery Models:
  Innovations such as microarray patches and portable thermostable formulations could lower logistical costs and improve coverage, catalyzing future market expansion.

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Key Takeaways

• Clinical trials for MenB vaccines are increasingly emphasizing strain coverage breadth, safety in vulnerable populations, and regional efficacy, with promising results indicating sustained immunogenicity and disease reduction potential.

• The current global MenB vaccine market is on an upward trajectory, driven by rising disease awareness, expanding indications, and international immunization programs, yet faces hurdles such as cost, strain variation, and vaccine hesitancy.

• Future projections indicate robust growth, with innovations in vaccine technology and strategic collaborations poised to enhance coverage, reduce costs, and reach underserved populations.

• Policymakers and manufacturers should prioritize broad strain coverage, thermostability, and affordability to maximize public health impact and capitalize on emerging market opportunities.

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FAQs

1. What are the main differences between Bexsero® and Trumenba®?
Bexsero® (4CMenB, GSK) is a multicomponent vaccine combining multiple protein antigens, providing broad coverage against diverse MenB strains. Trumenba® (Pfizer) employs two lipidated outer membrane vesicle (OMV) proteins targeting specific MenB strains, with a focus on adolescents and young adults. Their immunogenicity profiles and efficacy vary slightly based on strain prevalence and age group.

2. How effective are current MenB vaccines against circulating strains?
Clinical data demonstrates high immunogenicity (>90% seroconversion) against tested strains, with real-world studies reporting significant reductions in invasive disease incidence post-vaccination. However, effectiveness varies by region due to antigenic diversity, emphasizing the importance of regional strain surveillance.

3. What challenges do vaccine developers face with MenB vaccine technologic innovation?
Developers confront challenges such as antigenic variability of N. meningitidis, safety concerns in immunocompromised populations, and creating vaccines with broad strain coverage without increasing complexity or cost. Overcoming these requires advanced molecular biology techniques and adaptive clinical trial designs.

4. Are MenB vaccines included in routine immunization schedules globally?
Routine inclusion varies by country. High-income nations like the UK, Canada, and parts of Europe have incorporated MenB vaccines into adolescent and infant schedules, driven by national disease burden assessments. Lower-income countries often depend on international assistance and targeted campaigns.

5. What is the outlook for MenB vaccine development in the next decade?
The outlook is optimistic, with ongoing innovations aiming for universal coverage, longer-lasting immunity, and lower costs. Novel platforms such as protein nanoparticle vaccines and mRNA technology could revolutionize meningococcal disease prevention, expanding global access.

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References

[1] Public health reports and recent peer-reviewed studies evaluating MenB vaccine effectiveness and epidemiology trends.