What is the mechanism of action of this treatment?

Meningococcal vaccines, such as the MenABCWY vaccine, work by introducing inactivated or subunit components of Neisseria meningitidis groups A, B, C, W, and Y to the immune system. These components stimulate the body to produce specific antibodies against these bacterial groups without causing disease. This immune response prepares the body to recognize and fight off actual infections if exposed in the future. For patients, this is crucial as it provides broad protection against multiple strains of meningococcal bacteria, significantly reducing the risk of severe infections like meningitis and septicemia.

What side effects are associated with this type of intervention?

Common treatments for Meningococcal Vaccines, such as MenABCWY, which target Neisseria meningitidis groups A, B, C, W, and Y, generally induce a good immune response. Known side effects include pain at the injection site, which is more common compared to other vaccines like the trivalent inactivated influenza vaccine. Other adverse events may include mild to moderate reactions such as redness, swelling, and fever. Serious side effects are rare but can include severe allergic reactions. Overall, these vaccines are considered safe with a favorable risk-benefit profile.

What prior FDA approvals exist?

The FDA has approved several meningococcal vaccines targeting different groups of Neisseria meningitidis. Menveo and Menactra are quadrivalent vaccines that protect against groups A, C, W, and Y. Bexsero and Trumenba are vaccines specifically targeting group B. These vaccines have been approved to provide broad protection against the most common serogroups causing meningococcal disease. The MenABCWY vaccine under study aims to combine these protections into a single formulation, inducing an immune response against groups A, B, C, W, and Y.

What other types of research exist?

As of now, there are no specific novel alternatives to the MenABCWY vaccine mentioned in the provided context. The MenABCWY vaccine remains a comprehensive option for inducing an immune response against Neisseria meningitidis groups A, B, C, W, and Y. Patients should consult with their healthcare provider for the most current and personalized recommendations.

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Vaccine

MenABCWY Vaccine for Meningococcal Disease Prevention

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization

Male or female participants 11 through <15 years of age at the time of randomization

Must not have

Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection

Significant neurological disorder or history of seizure (excluding simple febrile seizure)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 minutes after vaccination 2

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a vaccine for meningitis in adolescents. The vaccine helps the body build defenses against five types of bacteria that cause meningitis.

Who is the study for?

This trial is for healthy boys and girls aged 11 to less than 15 who haven't had a meningococcal vaccine before. They must be available for the whole study, reachable by phone, and not pregnant. They can't join if they have bleeding issues, unstable allergies, are on certain immune system drugs or antibiotics, have had meningitis or similar diseases, neurological disorders or seizures (except simple febrile seizure), received blood products recently, had severe reactions to vaccines before, or have autoimmune conditions.

What is being tested?

The trial tests two schedules of the MenABCWY vaccine against meningitis: one group gets two doses with a gap of either 12 months or another with a gap of 36 months. The safety and body's defense response right after vaccination and up to 24 months later are being studied.

What are the potential side effects?

Possible side effects from the MenABCWY vaccine may include pain at injection site, fever, fatigue, headache and muscle pain. These are common responses to vaccines as the body builds immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never received a meningococcal vaccine.

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I am between 11 and 14 years old.

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I am not pregnant, as confirmed by a urine test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding condition that makes injections unsafe for me.

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I do not have a significant neurological disorder or history of seizures, except for simple febrile seizures.

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I have a condition like MS or inflammation of the optic nerve.

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I have not received blood products or immunoglobulin in the last 6 months.

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I am not on long-term antibiotics.

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I have had an infection caused by Neisseria bacteria.

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I am on an experimental allergy treatment or not on a stable dose of a licensed allergy treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 minutes after vaccination 3 in group 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 minutes after vaccination 3 in group 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 minutes after vaccination 3 in group 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains

Percentage of participants achieving an hSBA titer >= LLOQ for 4 primary MenB test strains

Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 vaccination phase

+16 more

Secondary study objectives

Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains

Complement System Proteins

Percentage of participants in Group 2 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain

Side effects data

From 2022 Phase 3 trial • 1610 Patients • NCT03135834

68%

Injection site pain (PAIN AT INJECTION SITE)

51%

Fatigue

42%

Headache

19%

Erythema (REDNESS)

18%

Myalgia (MUSCLE PAIN)

14%

Swelling

12%

Arthralgia (JOINT PAIN)

11%

Chills

10%

Diarrhoea (DIARRHEA)

SARS-CoV-2 test positive

COVID-19

Abortion spontaneous

Oropharyngeal pain

Vomiting

Eye injury

Psychophysiologic insomnia

Pyrexia (FEVER)

Skin laceration

Scoliosis

Haematoma

Psychotic disorder

Abdominal pain

Pain

Upper respiratory tract infection

Urinary tract infection

Depression

Dysmenorrhoea

100%

80%

60%

40%

20%

Study treatment Arm

Stage 2: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)

Stage 1: Group 1: MenABCWY + Saline (ACWY-Naive)

Stage 1: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)

Stage 1: Group 3: MenABCWY + Saline (ACWY-Experienced)

Stage 1: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)

Stage 2: Group 1: MenABCWY + Saline (ACWY-Naive)

Stage 2: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)

Stage 2: Group 3: MenABCWY + Saline (ACWY-Experienced)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2 (MenABCWY 0-, 36-months)Experimental Treatment2 Interventions

MenABCWY administered at Month 0 and Month 36

Group II: Group 1 (MenABCWY 0-, 12-months)Experimental Treatment1 Intervention

MenABCWY administered at Month 0 and Month 12

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MenABCWY

2017

Completed Phase 3

~5720

Saline

2013

Completed Phase 4

~2130

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Meningococcal vaccines, such as the MenABCWY vaccine, work by introducing inactivated or subunit components of Neisseria meningitidis groups A, B, C, W, and Y to the immune system. These components stimulate the body to produce specific antibodies against these bacterial groups without causing disease. This immune response prepares the body to recognize and fight off actual infections if exposed in the future. For patients, this is crucial as it provides broad protection against multiple strains of meningococcal bacteria, significantly reducing the risk of severe infections like meningitis and septicemia.

Seasonal upsurge of pneumococcal meningitis in the Central African Republic.