PENBRAYA or Trumenba for Meningococcal Meningitis

Not yet recruiting at 1 trial location

Overseen By Jessica McCaffery, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Must not be taking: Corticosteroids, Immunosuppressants, others

Disqualifiers: Pregnancy, Neurological disorders, Autoimmune, 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: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two vaccines, PENBRAYA and Trumenba, in protecting young adults against meningitis B (MenB). Researchers aim to determine how many participants are immune to four main types of MenB bacteria before and after vaccination. They also assess the strength of the immune response post-vaccination. Ideal participants are healthy individuals who completed a 2-dose Bexsero vaccine series at least 2.5 years ago. As a Phase 4 trial, this study involves FDA-approved vaccines and seeks to understand their benefits for a broader patient population.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications for chronic conditions that are stable and haven't changed in the last 3 months, you may still be eligible. It's best to discuss your specific medications with the trial team.

What is the safety track record for these treatments?

Research shows that both the PENBRAYA and Trumenba vaccines are generally safe. PENBRAYA, a 5-in-1 vaccine, protects against several types of meningococcal bacteria. Studies indicate it is safe for older teenagers, with common side effects being mild, such as soreness at the injection site or a slight fever.

The FDA approved Trumenba in 2014 for individuals aged 10 to 25 years. It is also generally well-tolerated, with common side effects including pain at the injection site, tiredness, and headache. Serious side effects are rare for both vaccines.

Both vaccines have a strong safety record, supported by research and FDA approval. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about PENBRAYA and Trumenba because they both represent innovative approaches to preventing meningococcal meningitis, a serious bacterial infection. Unlike traditional vaccines that may cover fewer strains, these treatments are designed to target a broader range of meningococcal bacteria, potentially offering enhanced protection. Trumenba, for instance, is known for its ability to target serogroup B, a critical strain, while PENBRAYA is also being explored for its broad efficacy. This wide-ranging coverage is what sets them apart from older vaccines and has the potential to significantly reduce the incidence of this life-threatening disease.

What evidence suggests that this trial's treatments could be effective for meningitis B?

Research has shown that the vaccines PENBRAYA and Trumenba effectively protect against meningococcal meningitis B (MenB). In this trial, participants will join either the PENBRAYA group or the Trumenba group. Studies found that after two doses of PENBRAYA, 75.6% to 96.3% of participants developed protective immune responses against key MenB strains. This vaccine is approved to help reduce cases and long-term effects of meningococcal disease. Trumenba also triggers a strong immune response, with studies confirming its effectiveness against various MenB strains after completing the three-dose series. Both vaccines have proven to enhance the immune system's ability to fight MenB. ^{4 6 7 8 9}

Who Is on the Research Team?

Christina Rostad, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for young adults who have already been vaccinated against meningitis B with a specific vaccine. It's not clear what the exact inclusion or exclusion criteria are, so it's best to contact the study organizers for more details.

Inclusion Criteria

Provides written informed consent before any study procedures are performed

Be able to understand and agree to comply with planned study procedures and be available for all study visits

Subject is in good health as determined by vital signs, medical history, targeted physical examination (if indicated), and the judgment of the investigator

Exclusion Criteria

I have had a fever of 100.4 °F or higher in the last 3 days.

I haven't had a live vaccine recently and don't plan to get one soon.

I have received or plan to receive a flu shot around the time of the study vaccine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of MenB-FHbp (Trumenba) or MenACWY-TT/MenB-FHbp (Penbraya) vaccine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for immunogenicity and safety, with serum samples collected for hSBA assays

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PENBRAYA
• Trumenba

Trial Overview The trial is testing how well new vaccines (PENBRAYA and Trumenba) work in people previously vaccinated against MenB. Researchers want to know if these vaccines can protect against four strains of MenB bacteria and boost immune response.

How Is the Trial Designed?

Group I: Trumenba group Experimental Treatment 1 Intervention

Group II: Penbraya group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7315a4.htm

Use of the Pfizer Pentavalent Meningococcal Vaccine... This report describes recommendations for using Pfizer pentavalent meningococcal vaccines among people ages 10 years and older.

2. fda.gov fda.gov/media/173844/download

Clinical Review Memo - PENBRAYA review of data in an sBLA, or MenABCWY outcomes from Study ... primary safety and effectiveness data supporting licensure of MenABCWY.

3. pfizer.com pfizer.com/news/press-release/press-release-detail/fda-approves-penbrayatm-first-and-only-vaccine-prevention

FDA Approves PENBRAYA™, the First and Only Vaccine ... Routine use of PENBRAYA could also reduce IMD cases and associated mortality, the rate of long-term consequences of infection (sequelae) in ...

4. 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 ...

5. penbraya.pfizerpro.com penbraya.pfizerpro.com/about-penbraya/risks-of-meningococcal-disease

PENBRAYA (Meningococcal A,B,C,W,Y vaccine) Safety Info 1 in 5 survivors of meningococcal disease can have serious long-term consequences such as hearing loss, vision loss, brain damage, or amputation.

6. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_PENBRAYA_MENABCWY_PFS_VACCINE_1X0.5ML_2025.pdf

SAFETY DATA SHEET Use personal protection recommended in Section 8. Page 4. SAFETY DATA SHEET. Product Name Meningococcal Vaccine Pentavalent.

7. penbraya.pfizerpro.com penbraya.pfizerpro.com/efficacy-and-safety/safety-profile

Safety Profile | PENBRAYA (Meningococcal A,B,C,W,Y ... View the safety profile on PENBRAYA (Meningococcal A,B,C,W,Y vaccine) to understand the risks of this 5-in-1 MenABCWY vaccine for older adolescents.

8. fda.gov fda.gov/media/174155/download

PENBRAYA Overall Conclusions from Clinical Studies. The safety and immunogenicity data submitted in this BLA support the use of. MenABCWY, administered ...

9. vaccineadvisor.com vaccineadvisor.com/cch/penbraya-for-protection-against-invasive-meningococcal-disease/

Penbraya for Protection Against Invasive Meningococcal ... Penbraya provides protection against invasive meningococcal disease via complement-mediated antibody-killing of N meningitidis.