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Booster shot study aims to strengthen meningitis b protection in young adults

NCT ID NCT07197762

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a single booster dose of a meningitis B vaccine can protect young adults who got a different meningitis B vaccine at least 2.5 years ago. Researchers will measure immune responses in 125 healthy participants before and after the booster. The goal is to see how many people maintain or regain protection against four key strains of the bacteria.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 25 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * Vaccinated with 2-dose Bexsero primary series at least 2.5 years before vaccination. Must confirm vaccination status and dates of administration through GRITS, healthcare provider, or other official documentation * Women of childbearing potential must agree to use or have practiced true abstinence2 or use at least one acceptable primary form of contraception from 28 days prior through 28 days after vaccination. * Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours before vaccination Exclusion Criteria: * Subject has an acute illness with fever (temperature ≥100.4 °F) within 72 hours before vaccine administration. * Subject is currently pregnant or breastfeeding an infant/child. * Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation. (Including acute, subacute, intermittent,t or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. Chronic medical conditions that are stable, with no escalation in medication doses or new medications administered in the preceding 3 months, will not be considered exclusionary.) * Presence of self-reported or medically documented significant medical or psychiatric condition(s) as determined by the investigator. * Received or plans to receive a licensed, live vaccine within 4 weeks before or after the study vaccination. * Received or plans to receive a licensed, inactivated vaccine within 2 weeks before through 4 weeks after the study vaccination. * Any previous severe hypersensitivity or anaphylactic reaction to any vaccine or vaccine-related component * Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. * Received any MenB vaccine within the last 2.5 years before vaccination. * Received more than 2 doses of Bexsero or any other MenB vaccine(s) (e.g. Trumenba or Penbraya) * Any known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy \>20 mg per day for ≥14 days, or those receiving immunosuppressive therapy. Participants with terminal complement deficiency are excluded from participation in this study. * Significant neurological disorder or history of seizure (excluding simple febrile seizure). * Any neuroinflammatory condition or autoimmune condition requiring immunomodulatory treatment, including, but not limited to, Guillain-Barré syndrome, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory Children's Center-Vaccine Research Clinic

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Hope Clinic

    RECRUITING

    Atlanta, Georgia, 30329, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.