MenABCWY Vaccine for Meningococcal Meningitis

Recruiting at 37 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Must not be taking: Corticosteroids, Antineoplastics, Immunomodulators, others

Disqualifiers: Neuroinflammatory, Autoimmune, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 48 months

302 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine designed to protect against meningococcal meningitis, a serious infection affecting the brain and spinal cord. The study evaluates the safety of the MenABCWY vaccine, its tolerability, and its ability to trigger an immune response. Participants receive doses of the vaccine and a placebo (an inactive substance) at different times to assess its effectiveness. The trial seeks healthy children aged 11 to 14 who have not had previous meningococcal infections or vaccines (except for one specific type at a very young age). As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on certain immune-modifying drugs or investigational products, you may need to stop them before joining the study. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that the MenABCWY vaccine is likely to be safe for humans?

Research has shown that the MenABCWY vaccine is generally well-tolerated. In previous studies, many participants exhibited strong immune responses after receiving two doses. Most found the vaccine easy to handle. Another study found that most participants developed protective levels of antibodies, which are proteins that help fight infections.

Although specific side effects weren't detailed, consistent findings across studies suggest the vaccine is safe. Since this trial is in Phase 2, the researchers are focusing on confirming its safety and effectiveness. This indicates the vaccine has already passed initial safety tests, further supporting its well-tolerated nature. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for meningitis?

Unlike the standard vaccines for meningococcal meningitis, which typically target specific strains such as A, C, W, and Y or B separately, the MenABCWY vaccine combines protection against all five major strains in a single formulation. Researchers are excited because this could simplify vaccination schedules and broaden protection with fewer doses. Additionally, this vaccine is designed to be administered over a longer timeframe, which might enhance long-term immunity, providing lasting protection against this potentially deadly disease.

What evidence suggests that the MenABCWY vaccine could be effective for meningococcal meningitis?

Research has shown that the MenABCWY vaccine could help protect against serious meningococcal disease. In this trial, participants will receive the MenABCWY vaccine in different dosing schedules. A study from Chile found that a similar vaccine, MenACWY, led to a 92% drop in cases of this disease caused by a specific type of bacteria in young children. Additionally, the MenABCWY vaccine has demonstrated strong immune responses against different strains of meningococcal bacteria in lab tests. This suggests the vaccine might protect against several types of bacteria that cause meningococcal disease. These findings indicate that the MenABCWY vaccine may offer broad protection against this disease. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy boys and girls aged 11 to 14 who haven't started their periods, had certain surgeries or are not pregnant. They must be willing to use birth control around the time of vaccination and follow the study rules. Consent from them or a guardian is needed.

Inclusion Criteria

I am between 11 and 14 years old.

You or your legal guardian have given written or thumbprint consent before any study procedure is performed.

Before any study-specific procedures are done, you must give written permission to participate (if you're able to do so).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MenABCWY vaccine on different dosing schedules

48 months

3 visits (in-person) at Day 1, Day 721, and Day 1441

Follow-up

Participants are monitored for safety and effectiveness after each vaccination

6 months after first vaccination

Long-term follow-up

Antibody persistence is evaluated 25 months after the second dose

25 months after second dose

What Are the Treatments Tested in This Trial?

Interventions

• MenABCWY vaccine

Trial Overview The MenABCWY vaccine, designed to protect against five types of meningococcal disease, is being tested for safety and immune response in adolescents. Participants will either receive this vaccine or a placebo according to different dosing schedules.

How Is the Trial Designed?

Group I: ABCWY-48 Group Experimental Treatment 2 Interventions

Participants receive 2 doses of the MenABCWY vaccine at Day 1 and Day 1441, 1 dose of Placebo at Day 721.

Group II: ABCWY-24 Group Experimental Treatment 2 Interventions

Participants receive 2 doses of the MenABCWY vaccine at Day 1 and Day 721, 1 dose of Placebo at Day 1441.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9258937/

Vaccine Impact and Effectiveness of Meningococcal ... A study from Chile showed a 92% reduction in IMD-W cases in the first 4 years after a mass campaign in the MenACWY vaccinated cohort that consisted of infants ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02140762

NCT02140762 | Effectiveness, Immunogenicity and Safety ... Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine. Official Title. A Phase 2b, Randomized ...

3. cdc.gov cdc.gov/acip/downloads/slides-2024-10-23-24/02-Mening-Dong-508.pdf

National Center for Immunization & Respiratory Diseases Costs and health outcomes of meningococcal cases are assessed from age 11 ... Q=Quadrivalent (MenACWY) vaccine; P=Pentavalent (MenABCWY) vaccine; ...

4. gsk.com gsk.com/en-gb/media/press-releases/gsk-presents-pivotal-data-at-espid/

GSK presents pivotal data at ESPID confirming ... The MenABCWY vaccine candidate showed immunological effectiveness against a panel of 110 diverse meningococcal serogroup B (MenB) invasive strains.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10486281/

Real-world impact and effectiveness of MenACWY-TT Recent real-world data have confirmed the public health impact and effectiveness of a single dose of MenACWY-TT in toddlers, adolescents and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39722560/

A Phase 3, Randomized Controlled Clinical Study Conclusions: Immune responses against serogroups ACWY following 1 and 2 doses of investigational MenABCWY vaccine are noninferior to those following MenACWY-CRM ...

7. academic.oup.com academic.oup.com/cid/article/80/4/752/7932666

Immunogenicity, Reactogenicity, and Safety of a Pentavalent ... After 2 MenABCWY doses, 75.6%–96.3% of participants had hSBA titers ≥LLOQ against MenB indicator strains. The MenABCWY vaccine was well ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11853628/

A phase 2b randomized clinical trial Safety, tolerability, and immunogenicity of pentavalent meningococcal MenABCWY vaccine in healthy infants: A phase 2b randomized clinical trial