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Pneumococcal infection – Trials in Disease

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Clinical Trials for Pneumococcal Infection

There are currently 8 ongoing clinical trials studying vaccines and immune responses for pneumococcal infection across multiple European countries. These trials involve participants ranging from infants to older adults, testing various pneumococcal conjugate vaccines including new 21-valent formulations and examining their safety and effectiveness in preventing serious bacterial infections.

Clinical trial locations

Study of pneumococcal vaccines in healthy young adults, older adults and people with HIV infection

This trial examines how the immune system responds to pneumococcal vaccines in different populations. It focuses on understanding the formation of germinal centers in lymph nodes, which are special structures crucial for immune system function.

Main inclusion criteria: Participants must be either young adults aged 20-40 years or older adults over 60 years. All participants should be in generally good health. For people living with HIV, additional requirements include being between 20-40 years old, having documented HIV infection, currently taking anti-retroviral therapy, and having a viral load less than 200 copies per milliliter, indicating the virus is well-controlled.

Main exclusion criteria: People cannot participate if they have active infections or fever, previous severe allergic reactions to pneumococcal vaccines, recently received other vaccines, are currently in another clinical trial, are pregnant or breastfeeding, use immunosuppressive medications, have bleeding disorders, have uncontrolled chronic medical conditions, have autoimmune disease, recently received blood products, have substance abuse issues, or have mental conditions that would interfere with following study procedures.

Study focus: The trial compares two types of pneumococcal vaccines—Prevenar 20 and Pneumovax 23—to understand how factors like age and HIV infection influence the body’s response to different vaccine types. Researchers will collect lymph node and blood samples, as well as saliva, to monitor the immune response for up to 6 months after vaccination. The study also examines how lifestyle factors such as diet, exercise, and smoking might affect vaccine response.

Investigational vaccine: Participants receive either Prevenar 20 or Pneumovax 23 pneumococcal vaccine as a single intramuscular injection. These vaccines help protect against Streptococcus pneumoniae bacteria, which can cause serious infections like pneumonia, meningitis, and bloodstream infections.

Study on Pneumococcal Vaccine Response in Healthy Volunteers Using Pneumococcal Polysaccharide Conjugate Vaccine and Drug Combination

This study investigates the body’s immune response to pneumococcal vaccines, specifically examining how lymph nodes react to vaccination. It compares two vaccines: Apexxnar (a 20-valent vaccine) and Prevenar 13 (a 13-valent vaccine). The term “valent” refers to the number of different bacterial strains the vaccine protects against.

Main inclusion criteria: Participants must be healthy adults between 20 and 40 years old. They should not have any auto-immune diseases being actively treated with immune-suppressing medications. People with stable chronic diseases that don’t require immunosuppressive medications may be eligible if their condition has been stable for at least six weeks before joining.

Main exclusion criteria: The study excludes individuals who are not healthy volunteers, those outside the specified age range, and members of vulnerable populations who may need special protection, such as children, pregnant women, or those unable to give consent.

Study focus: The primary goal is to determine the timing of peak germinal center B cell frequency in lymph nodes after vaccination. Researchers will collect lymph node and blood samples at multiple time points to study immune cell changes, T follicular helper cells, and cytokine levels that indicate immune system activity.

Investigational vaccines: Participants receive either Apexxnar or Prevenar 13 via intramuscular injection. These vaccines stimulate the immune system to recognize and fight pneumococcal bacteria, helping prevent serious infections.

Study on the Safety and Immune Response of a 21-Valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

This trial tests a new 21-valent pneumococcal conjugate vaccine (PCV21) in young children, comparing it with the existing 15-valent vaccine called Vaxneuvance. The study aims to determine whether the new vaccine is as effective or better than the existing one in producing a strong immune response.

Main inclusion criteria: Infants aged between 42 to 112 days at enrollment are eligible. They must be healthy as determined by medical evaluation and physical examination. Children must be born at full term (37 weeks or more) with a birth weight of at least 2.5 kg, or born after 28 weeks but before 37 weeks with a birth weight of at least 1.5 kg and be medically stable.

Main exclusion criteria: Children cannot participate if they have received any previous pneumococcal vaccine, have known allergies to vaccine components, have a history of severe allergic reactions like anaphylaxis, have immune system problems, received blood products or immunoglobulins within the last 3 months, have serious chronic illness, are currently in another clinical trial, received other vaccines within 14 days, or have fever or acute illness at vaccination time.

Study focus: The trial monitors immune response by measuring antibody levels and tracks any side effects or reactions to the vaccines. Participants receive multiple doses via intramuscular injection over several months, with follow-up visits to check health and immune response. Researchers will evaluate antibody response and monitor for serious adverse events for up to 6 months after the last injection.

Investigational vaccines: The study compares PCV21, which protects against 21 different types of pneumococcal bacteria, with 15vPCV, which protects against 15 types. Both vaccines help the immune system recognize and combat bacteria that cause serious infections like pneumonia, meningitis, and bloodstream infections.

Study on the Safety and Immune Response of a 21-Valent Pneumococcal Vaccine in Healthy Infants, Toddlers, Children, and Adolescents

This trial evaluates the safety and immune response of the new PCV21 vaccine in children and adolescents aged 7 months to 17 years, comparing it with the existing PREVNAR 20® vaccine. The study aims to assess how well the new vaccine works across different age groups and its potential to offer broader protection.

Main inclusion criteria: Participants must be aged 7 months to 17 years and healthy as determined by medical evaluation. For infants and toddlers, specific birth weight and gestational age requirements apply. Adolescent females must not be pregnant or breastfeeding and must use effective contraception or abstinence from 4 weeks before vaccination until 4 weeks after. Both parents/guardians and participants (where applicable) must sign consent/assent forms.

Main exclusion criteria: Exclusions include previous pneumococcal vaccination, serious chronic illnesses, history of severe allergic reactions to vaccines, immune system disorders, medications affecting the immune system, bleeding disorders, neurological disorders, pregnancy or plans to become pregnant, and participation in another clinical trial within the last 30 days.

Study focus: The trial monitors participants through several visits to track health, side effects, and immune response. Blood samples are taken to measure antibody levels. Participants receive one or two doses of vaccine depending on their study group, with monitoring for immediate reactions after each injection.

Investigational vaccines: PCV21 protects against 21 types of pneumococcal bacteria, while 20vPCV protects against 20 types. Both vaccines are administered via intramuscular injection and work by helping the body develop immunity to prevent serious infections caused by these bacteria.

Study on the Safety and Immune Response of PF-07831695 and a Drug Combination for Pneumococcal Infections in Healthy Toddlers Aged 12-15 Months

This study focuses on the safety and immune response of a monovalent pneumococcal conjugate candidate vaccine in healthy toddlers who have already received a primary series of PCV10 vaccine. The vaccine aims to boost protection against bacterial infections that can cause pneumonia, ear infections, and meningitis.

Main inclusion criteria: Children must be between 11 and 15 months old and have received exactly two doses of the PCV10 vaccine as part of their local immunization schedule. They must be healthy based on clinical assessment.

Main exclusion criteria: Children outside the specified age range, those with serious health conditions, previous severe allergic reactions to vaccines, current participation in another clinical trial, recent receipt of other vaccines (within 30 days), weakened immune system, history of seizures or neurological disorders, bleeding disorders, or chronic illnesses requiring regular medication cannot participate.

Study focus: The trial monitors local reactions (redness, swelling, pain) and systemic events (fever, decreased appetite, increased sleepiness, irritability) after vaccination. Researchers measure Immunoglobulin G levels and opsonophagocytic activity to assess the vaccine’s ability to help the immune system fight bacteria. Toddlers receive two doses with monitoring between doses.

Investigational vaccine: The monovalent pneumococcal conjugate candidate (mPnC) is designed to protect against specific pneumococcal bacteria. It is given in two doses to children who have already received PCV10, aiming to strengthen their immune protection.

Study on the Safety and Immune Response of V116 Vaccine for Pneumococcal Disease in Adults Aged 50 and Older

This trial tests a new vaccine called V116 (Pneumococcal 21-valent Conjugate Vaccine) in adults aged 50 years or older who have not previously received a pneumococcal vaccine. The study compares V116 with the existing PPSV23 vaccine to evaluate safety and effectiveness.

Main inclusion criteria: Participants must be aged 18 to 49 years (based on one inclusion criterion set) and can be of any gender. Females must not be pregnant or breastfeeding and must use acceptable contraception or abstain from sexual activity if of childbearing potential. Medical, menstrual, and recent sexual activity history will be reviewed.

Main exclusion criteria: Exclusions include severe allergic reactions to vaccine components or any vaccine, receipt of another vaccine within 30 days, current participation in another clinical trial, weakened immune system, serious illness or infection at enrollment, pregnancy or plans to become pregnant, history of drug or alcohol abuse, receipt of blood products or immunoglobulins within the last 3 months, and any condition making the person unsuitable for the study.

Study focus: The study monitors participants for side effects and measures their immune response to the vaccine by checking antibody levels in blood samples. Participants receive a single intramuscular injection and are followed to observe reactions and measure antibody production.

Investigational vaccines: V116 is a new pneumococcal vaccine designed to protect against 21 types of bacteria, while PPSV23 is an existing vaccine used as a comparison. The study aims to determine if V116 can provide better protection than the current standard vaccine.

Study on the Safety and Immune Response of V116 Vaccine in Children and Adolescents at Higher Risk for Pneumococcal Disease

This study evaluates the V116 vaccine in children and adolescents who are at increased risk of developing serious infections due to conditions like diabetes, chronic lung disease, heart disease, liver disease, or kidney disease. The vaccine is compared with the existing Pneumovax® 23 vaccine and a placebo.

Main inclusion criteria: Participants must have at least one risk condition such as diabetes mellitus (receiving diabetes medication), compensated chronic liver disease, chronic obstructive pulmonary disease, mild or moderate persistent asthma, chronic heart disease, or chronic kidney disease. These conditions must be stably managed for at least 3 months. Participants should not have received more than one dose of the 23-valent pneumococcal vaccine in the last five years.

Main exclusion criteria: Individuals with known allergies to vaccine components, history of severe allergic reactions to pneumococcal vaccines, weakened immune system, current immunosuppressive treatment, certain blood disorders, pregnancy, recent receipt of another vaccine, current illness with fever, or recent participation in another clinical trial cannot join.

Study focus: The trial monitors participants for adverse events and measures immune response through blood tests checking antibody levels. Follow-up assessments evaluate the effectiveness of the vaccine in producing an immune response and compare it with the previously used 23-valent vaccine.

Investigational vaccine: V116 is administered as an intramuscular injection to help prevent pneumococcal disease in vulnerable populations. The study aims to understand its safety and ability to generate protective antibodies in children and adolescents at higher risk.

Study on the V116 Vaccine for Adults Aged 18-64 at Increased Risk of Pneumococcal Infection

This trial tests the V116 vaccine in adults aged 18 to 64 who are at increased risk for pneumococcal disease due to conditions like diabetes, chronic liver disease, COPD, asthma, chronic heart disease, or chronic kidney disease. The study compares V116 with PCV15 and PPSV23 vaccines, as well as a placebo.

Main inclusion criteria: Participants must have at least one risk condition for pneumococcal disease. For diabetes, all blood sugar tests must be 9% or lower in the last 6 months. Other qualifying conditions include compensated chronic liver disease, COPD, mild or moderate persistent asthma, chronic heart disease, or chronic kidney disease lasting more than 3 months. All conditions must be stably managed for at least 3 months with no major treatment changes expected and no more than one hospital stay related to the condition. Females of childbearing potential must use acceptable birth control or choose abstinence.

Main exclusion criteria: Exclusions include severe allergic reactions to vaccines, weakened immune system, current immunosuppressive treatment, receipt of other vaccines within 30 days, bleeding disorders, pregnancy or breastfeeding, participation in another trial within 30 days, and history of drug or alcohol abuse within the past year.

Study focus: The study evaluates safety and immune response by monitoring side effects for five days after vaccination and measuring antibody levels through blood tests. Participants receive two doses: the first dose of V116 and approximately 12 weeks later, a second dose which may be PCV15 + PPSV23.

Investigational vaccines: V116 is a new vaccine being tested, while PCV15 and PPSV23 are existing pneumococcal vaccines used for comparison. The study aims to determine if V116 provides better protection for adults at increased risk of pneumococcal infections.

Summary

The eight ongoing clinical trials for pneumococcal infection represent a comprehensive effort to develop and evaluate new vaccines across all age groups. The trials show a strong geographic concentration in Poland, which hosts five studies, followed by Finland with three trials and Estonia with two. Other participating countries include Spain, Germany, the Netherlands, Belgium, Czechia, Italy, Greece, France, and Sweden.

A notable pattern is the focus on testing newer, broader-spectrum vaccines. Multiple trials are evaluating 21-valent pneumococcal conjugate vaccines (PCV21 or V116) that offer protection against more bacterial strains than currently available vaccines. These are being compared with existing vaccines like PPSV23, PCV15, and Vaxneuvance across different populations.

The trials target diverse participant groups, from young infants as young as 42 days old to older adults over 60 years. Several studies specifically focus on vulnerable populations, including people living with HIV, children and adults with chronic conditions like diabetes, heart disease, lung disease, or kidney disease, and individuals who have not previously received pneumococcal vaccination.

All trials share common goals of evaluating vaccine safety, monitoring for adverse events, and measuring immune response through antibody levels. The research aims to provide evidence for improved vaccination strategies that could better protect against serious pneumococcal infections like pneumonia, meningitis, and bloodstream infections across different age groups and risk categories.

Ongoing Clinical Trials on Pneumococcal infection

  • Study on the Safety and Immune Response of PF-07831695 and a Drug Combination for Pneumococcal Infections in Healthy Toddlers Aged 12-15 Months

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland Poland

  • Study on the Safety and Immune Response of V116 Vaccine in Children and Adolescents at Higher Risk for Pneumococcal Disease

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland France Poland Spain Sweden

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