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Clinical Trials for Meningococcal Infection: Current Research and Vaccine Studies

This article provides information about 8 ongoing clinical trials testing vaccines against meningococcal infection, a serious bacterial disease that can cause meningitis and sepsis. These studies are being conducted across Europe and involve participants ranging from infants to elderly adults, focusing on the safety and effectiveness of various meningococcal vaccines.

Clinical trial locations

Safety and immunogenicity study of Pentavalent Meningococcal ABCYW vaccine (MenPenta SD and MenPenta fHD) compared to licensed meningococcal vaccines in infants, toddlers and children

This trial is testing a new vaccine called MenPenta, which aims to protect against five different types of meningococcal bacteria (groups A, B, C, W, and Y) that can cause serious brain and spinal cord infections. The study involves three age groups: children aged 2 to 9 years, toddlers aged 12 to 15 months, and infants aged 2 months.

Main inclusion criteria: Participants must be within the specified age ranges and in good overall health. For infants and toddlers, birth requirements include either being born at full term (37 weeks or more) with a birth weight of at least 2.5 kg, or being born between 28 and 36 weeks with a birth weight of at least 1.5 kg. Premature infants must be medically stable without serious ongoing health conditions.

Main exclusion criteria: The study excludes anyone with a prior history of meningococcal disease or previous meningococcal vaccination. Other exclusions include known allergies to vaccine components, participation in another clinical trial within the past 30 days, immunosuppressive conditions, chronic medical conditions that could interfere with results, fever within 3 days before vaccination, recent receipt of blood products, and bleeding disorders.

Focus and purpose: The study aims to compare the safety and effectiveness of the new MenPenta vaccine with currently approved meningococcal vaccines. Researchers will monitor how well the immune system responds to the vaccine through blood tests and will carefully track any side effects. Some participants will receive the new vaccine alone, while others will receive it along with standard childhood vaccines such as Prevenar 13, Hexyon, and RotaTeq.

Investigational drug: MenPenta is a pentavalent meningococcal vaccine designed to provide broader protection compared to existing vaccines by targeting all five major serogroups of the bacteria while potentially reducing the number of required injections.

Study on Immune Response Differences to Meningococcal Group B Vaccine in Healthy Transgender and Cisgender Adults Aged 18-40

This trial explores how the immune system responds to Bexsero, a vaccine that protects against Neisseria meningitidis group B bacteria. The study involves healthy transgender and cisgender individuals aged 18 to 40 years, aiming to understand any differences in immune responses between these groups.

Main inclusion criteria: Participants must be aged between 18 and 40 years and in good general health as determined by medical evaluation. They must have a Body Mass Index (BMI) between 18.5 and 35. Participants who could become pregnant must not be pregnant, breastfeeding, or planning to become pregnant during the study, and must have a negative pregnancy test at each vaccination visit. Transgender participants need to be on stable gender-affirming hormone therapy for at least 6 months.

Main exclusion criteria: The study excludes vulnerable populations who may have difficulty making decisions about participation. Participants must not have any significant health issues and should not have received any other vaccine within 30 days prior to the study.

Focus and purpose: The study will assess immune responses by measuring antibody levels and examining how T cells (white blood cells that help protect against infections) respond to the vaccine. Participants will receive two doses of Bexsero given as muscle injections over a 56-day study period.

Investigational drug: 4CMenB (Bexsero) is a vaccine that helps the immune system recognize and fight meningococcal serogroup B bacteria by introducing small, harmless parts of the bacteria to the body.

Study on the Safety and Immune Response of MenACYW Conjugate Vaccine Compared to a Drug Combination in Healthy Infants and Toddlers

This trial compares the effectiveness and safety of two vaccines for preventing meningococcal infection in healthy infants and toddlers: the MenQuadfi vaccine and the Nimenrix vaccine. Both protect against four groups of bacteria (A, C, W, and Y).

Main inclusion criteria: Participants must be aged 6 to 7 months at the time of joining the study and must be healthy as determined by medical evaluation, including medical history, physical examination, and the doctor’s judgment.

Main exclusion criteria: The study excludes participants with serious health conditions that could interfere with the study, history of severe allergic reactions (especially to vaccines), recent receipt of other vaccines, use of medications affecting the immune system (such as steroids), known or suspected immune system disorders, ongoing infections or illnesses, recent participation in another clinical trial, or any conditions that the study doctors believe would make participation unsafe.

Focus and purpose: The study involves giving two doses of either MenQuadfi or Nimenrix, with the first dose at 6-7 months and the second at 12-13 months. Researchers will monitor antibody levels in the blood to see how well the vaccines work and will track any side effects to ensure safety. The goal is to demonstrate that MenQuadfi is not less effective than Nimenrix in producing an immune response.

Investigational drugs: Both MenACYW conjugate vaccine (MenQuadfi) and Nimenrix are conjugate vaccines that combine pieces of bacteria with proteins to enhance the immune response against meningococcal serogroups A, C, W, and Y.

Study on the Safety and Immune Response of Meningococcal B Vaccine in Adults Without a Spleen

This trial studies the Bexsero vaccine in adults who have had their spleen removed (asplenia), as these individuals are at higher risk for infections. The study aims to determine if the vaccine works as well in people without a spleen as it does in healthy individuals.

Main inclusion criteria: Participants must have asplenia (either from splenectomy or functional asplenia) and be between 18 to 60 years of age. Females must have a negative urine pregnancy test at the start of the study and agree to use adequate birth control during the study. Written informed consent is required.

Main exclusion criteria: The study excludes patients who have had a splenectomy.

Focus and purpose: The study involves two vaccinations given via intramuscular injection. The main focus is to measure the body’s immune response one month after the second vaccination by checking protective antibody levels in the blood. The study will also assess how long these antibodies last and will monitor for any side effects. Blood tests will be conducted at one month and six months after the second vaccination.

Investigational drug: BEXSERO is a vaccine that helps the body build its immune defense system to fight meningococcal serogroup B bacteria. The goal is to ensure it is equally effective in patients without a spleen as in healthy individuals.

Study on Immune Response to Meningococcal Vaccine in Elderly with Invasive Meningococcal Disease Using MenACWY-TT Conjugate Vaccine

This trial investigates how well the Nimenrix vaccine protects older adults against invasive meningococcal disease, which can lead to sepsis and meningitis. The vaccine targets four bacterial groups: A, C, W-135, and Y.

Main inclusion criteria: Participants must be between 65 and 85 years old, in moderate to good general health for their age, and must not have received a MenACWY-TT vaccine before.

Main exclusion criteria: The study excludes anyone with a history of invasive meningococcal disease (including sepsis or meningitis), previous vaccination against MenA, MenC, MenW, or MenY, known allergies to vaccine components, weakened immune system, current participation in another clinical trial, pregnancy or breastfeeding, serious chronic illness, recent blood transfusion, or history of drug or alcohol abuse.

Focus and purpose: The study involves receiving the Nimenrix vaccine and having blood tests to measure protective antibody levels at various time points: one month and one year after vaccination, as well as after a booster dose. Long-term follow-up will continue up to five years after initial vaccination to understand how long the vaccine’s protection lasts.

Investigational drug: The MenACWY-TT conjugate vaccine (Nimenrix) is designed to stimulate the immune system to produce antibodies that fight meningococcal bacteria, potentially improving vaccination strategies for older adults.

Study on the Safety and Immune Response of a Booster Dose of MenACYW Conjugate Vaccine in Children and Adolescents Previously Vaccinated for Meningococcal Infection

This trial evaluates how well the MenQuadfi vaccine works and how safe it is when given as a booster dose to children and adolescents who previously received the vaccine as toddlers. The vaccine protects against four bacterial groups: A, C, W, and Y.

Main inclusion criteria: Participants must have received the MenACYW vaccine in a previous study called MET51 and completed that study by attending all required visits. The participant and their parent or legal representative must be able to attend all scheduled visits and follow trial procedures. Health insurance is required if mandated by local regulations. Signed consent and assent forms are required.

Main exclusion criteria: The study excludes participants who have not received the MenACYW conjugate vaccine approximately 5 or 10 years earlier as toddlers or children, those not part of the MET51 study, those not within the specified age range, those unable to comply with study procedures, or anyone with medical conditions that make participation unsafe.

Focus and purpose: The study aims to understand how long protection from initial vaccination lasts and how the immune system responds to additional booster doses. Participants will receive the vaccine through intramuscular injection and will be monitored for immune responses and side effects over time.

Investigational drug: The MenACYW Conjugate Vaccine (MenQuadfi) helps the body build defense against bacterial groups A, C, W, and Y, reducing the risk of meningitis by encouraging the immune system to create protective antibodies.

Study on the Safety and Immune Response of MenABCWY Vaccine and Drug Combination in Healthy Infants with Meningococcal Infections

This trial tests a new vaccine called MenABCWY, which protects against several groups of bacteria that cause meningococcal infections. The study also involves other vaccines, including MenB and MenACWY-TT, to compare their effectiveness and safety in healthy infants.

Main inclusion criteria: The participant’s parent or legal representative must be able and willing to follow study requirements. Written or witnessed informed consent must be obtained before any study procedures. Participants must be healthy, as determined by medical history and physical examination, and must be male or female between 55 and 89 days old (about 2 months old) at the time of first vaccination. They must have been born after at least 37 weeks of pregnancy with a birth weight of at least 2.5 kg.

Main exclusion criteria: The study excludes patients with any current or past meningococcal infections, those who have received any meningococcal vaccines previously, anyone with known allergies to vaccine components, those with immune system disorders, current participation in another clinical trial, pregnancy or breastfeeding, serious chronic illnesses, or recent receipt of blood products.

Focus and purpose: The study aims to evaluate the safety and effectiveness of the vaccines in producing an immune response. Participants will receive vaccines as injections and will be monitored over several months for any reactions and to measure immune response. The trial includes comparisons with placebo to ensure accurate results.

Investigational drugs: The study tests several vaccines: MenABCWY-2nd Gen and MenABCWY-1st Gen (targeting serogroups A, B, C, W, and Y), MenB (specifically for serogroup B), and MenACWY-TT (for serogroups A, C, W, and Y). All work by training the immune system to recognize and fight the bacteria.

Study on the Safety and Immune Response of MenABCWY Vaccine in Healthy Adolescents Aged 11-14 with Meningococcal Meningitis

This trial tests the MenABCWY vaccine in healthy adolescents aged 11 to 14 years to understand how the immune system responds to two doses given on different schedules (at 0 and 24 months, or at 0 and 48 months).

Main inclusion criteria: The participant or their parent/legal representative must be able to follow study rules, including filling out electronic diaries and attending follow-up visits. Written informed consent and assent must be obtained. Participants must be male or female between 11 and 14 years old at first vaccination and must be healthy as determined by medical history and physical examination. Females of childbearing potential must have used effective birth control for 30 days before first vaccination, have a negative pregnancy test on vaccination day, and agree to use effective birth control for 30 days before and after each of the two subsequent vaccinations.

Main exclusion criteria: The study excludes anyone with a history of severe allergic reactions to vaccine components, current or past diagnosis of meningococcal meningitis, recent receipt of other vaccines (within 30 days), weakened immune system, pregnancy or breastfeeding, serious chronic illness, current participation in another clinical trial, history of drug or alcohol abuse within the past year, or recent blood transfusion.

Focus and purpose: The study monitors participants for side effects and measures immune responses through blood tests to determine the vaccine’s effectiveness. The goal is to ensure the vaccine is safe and well-tolerated while providing protection against meningococcal disease caused by Neisseria meningitidis.

Investigational drug: MenABCWY is a vaccine that targets multiple strains of bacteria, including serogroup B, one of the most common causes of meningococcal disease. It stimulates the immune system to recognize and fight the bacteria if exposed in the future.

Summary

The eight ongoing clinical trials for meningococcal infection demonstrate a strong focus on developing and testing vaccines that provide broad protection across multiple bacterial serogroups. A notable trend is the testing of pentavalent vaccines like MenPenta and MenABCWY, which aim to protect against five different bacterial groups (A, B, C, W, and Y) in a single vaccine formulation, potentially reducing the number of injections required.

Germany stands out as the most active location for these trials, hosting five of the eight studies, followed by Finland, Poland, and Spain. The research spans a wide age range, from infants as young as 2 months to elderly adults up to 85 years, with particular emphasis on pediatric populations who are at higher risk for meningococcal disease.

Several trials focus on special populations with specific needs: one study examines immune responses in adults without a spleen who are at higher risk for infections, another explores potential differences in vaccine responses between transgender and cisgender individuals, and one investigates long-term protection in elderly adults. Multiple studies are examining booster doses to determine optimal vaccination schedules and the duration of protection.

The vaccines being tested include both established products like Bexsero and Nimenrix, as well as new formulations like MenPenta and MenABCWY. These studies collectively aim to improve protection strategies against this serious bacterial infection that can rapidly progress to life-threatening conditions such as meningitis and sepsis.

Ongoing Clinical Trials on Meningococcal infection

  • Study of rMenB+OMV NZ meningococcal group B vaccine immune response and safety in previously vaccinated healthy participants aged 10 to 20 years

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland Italy Spain

  • Study on the Safety and Immune Response of MenACYW Conjugate Vaccine Compared to a Drug Combination in Healthy Infants and Toddlers

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Finland Germany Poland Romania

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