Pneumococcal Vaccine Response and Aging

Overseen By Elsa Bou Ghanem, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: State University of New York at Buffalo

Must not be taking: Immune-modulating drugs

Disqualifiers: Immune deficiency, Malignancies, Chronic infections, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study focuses on the role of neutrophils in shaping the adaptive immune response to the anti-pneumococcal vaccine Prevnar-13 in young and elderly adults.

Will I have to stop taking my current medications?

The trial requires that you do not use immune-modulating or suppressive drugs. If you are taking these types of medications, you may need to stop them to participate.

What data supports the effectiveness of the drug Prevnar 13?

Prevnar 13 has been shown to be effective in preventing pneumococcal disease in children by covering 13 different types of the bacteria, offering broader protection than its predecessor, Prevnar 7. It is also recommended for adults aged 65 and older to prevent pneumonia, based on moderate evidence from a large study involving about 85,000 adults. ^{1 2 3 4 5}

Is the 13-valent pneumococcal conjugate vaccine (PCV13) safe for humans?

The 13-valent pneumococcal conjugate vaccine (PCV13), also known as Prevnar 13, has been shown to have a satisfactory safety profile in both children and adults. It has been licensed by the FDA for use in children and adults over 50, and studies have demonstrated its safety and effectiveness in preventing pneumococcal diseases. ^{2 4 5 6 7}

How is the treatment Prevnar-13 different from other treatments for pneumococcal disease?

Prevnar-13 is unique because it covers 13 different types of pneumococcal bacteria, providing broader protection compared to its predecessor, Prevnar-7, which covered only 7 types. This expanded coverage helps protect against more strains of the bacteria that cause pneumococcal disease. ^{2 4 5 7 8}

Research Team

Elsa N Bou Ghanem, PhD

Principal Investigator

University at Buffalo

Eligibility Criteria

This trial is for adults aged 21-40 and those over 65 who haven't had alcohol in the last day, avoided anti-inflammatory meds in the past week, and have not been vaccinated against pneumococcal diseases. They must be able to consent and free of recent infections.

Inclusion Criteria

Did not ingest alcohol in the last 24 hours

My gender does not affect my eligibility.

I have not had any infections in the past 2 weeks.

Exclusion Criteria

Dementia

Pregnancy

Known hypersensitivity to vaccination and vaccine components

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive an intramuscular vaccination with Prevnar 20

1 day

1 visit (in-person)

Follow-up

Participants are monitored for neutrophil and antibody responses after vaccination

1 month

2 visits (in-person)

Treatment Details

Interventions

• Prevnar-13

Trial Overview The study is examining how neutrophils affect immune responses to Prevnar-13, an anti-pneumococcal vaccine, comparing younger adults with elderly individuals to understand age-related changes.

Participant Groups

Group I: Vaccination with Prevnar. Experimental Treatment 1 Intervention

Intramuscular vaccination with Prevnar 20

Prevnar-13 is already approved in European Union, United States for the following indications:

Approved in European Union as Prevnar 13 for:

• Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in children 6 weeks through 17 years of age and adults 18 years of age and older

Approved in United States as Prevnar 13 for:

• Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in children 6 weeks through 17 years of age and adults 18 years of age and older
• Active immunization for the prevention of otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in children 6 weeks through 5 years of age

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The newly licensed 7-valent pneumococcal conjugate vaccine, Prevnar, has shown a significant impact on preventing pneumococcal pneumonia in children, marking an important advancement in pediatric health.

There is potential for similar saccharide-conjugate vaccines to be effective in preventing pneumococcal pneumonia in adults and the elderly, although there are barriers to their introduction in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing effectiveness of Prevnar [pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein)] and implications for adult immunization. Parijs, BA., Malinoski, FJ.[2015]

PCV13 (Prevnar 13®) is a pneumococcal vaccine that provides comprehensive coverage against over 85% of important pneumococcal serotypes, adding six new serotypes to the previously used PCV7 (Prevnar®).

The vaccine has demonstrated a satisfactory safety profile and effective immunologic responses comparable to PCV7, making it a promising option for preventing pneumococcal disease in children worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and clinical evaluation of Prevnar 13, a 13-valent pneumocococcal CRM197 conjugate vaccine. Gruber, WC., Scott, DA., Emini, EA.[2016]

The Advisory Committee on Immunization Practices (ACIP) recommended the routine use of the 13-valent pneumococcal conjugate vaccine (PCV13) for adults aged 65 and older, based on moderate evidence from the CAPiTA trial involving approximately 85,000 participants.

PCV13 should be given in conjunction with the 23-valent pneumococcal polysaccharide vaccine (PPSV23), as both vaccines together enhance protection against community-acquired pneumonia in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). Tomczyk, S., Bennett, NM., Stoecker, C., et al.[2022]

The 13-Valent pneumococcal conjugate vaccine (PCV13) is as effective as the 7-Valent vaccine (PCV7) in generating immune responses against the common serotypes of pneumococcal disease, while also providing additional protection against 6 extra serotypes.

Both vaccines have similar safety profiles, with PCV13 showing mild reactogenicity, indicating it is a safe option for infants receiving routine vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Yeh, SH., Gurtman, A., Hurley, DC., et al.[2015]

The 13-valent pneumococcal conjugate vaccine (PCV13) has been approved for use in children aged 6 weeks to 17 years, showing effective immune responses in those who previously received the 7-valent vaccine (PCV7) and in older children who had not.

PCV13 has a safety profile similar to PCV7 and does not interfere with responses to other routine pediatric vaccines, indicating it can be safely administered alongside them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

13-valent pneumococcal conjugate vaccine: a review of its use in infants, children, and adolescents. Plosker, GL.[2021]

The 13-valent pneumococcal conjugate vaccine (PCV13) is effective in preventing invasive pneumococcal disease in children and was approved for use in adults aged 50 and older to prevent pneumonia and related diseases.

Safety data and immunogenicity studies for PCV13 in adults were summarized to support recommendations for its use, highlighting its importance in protecting older populations from serious infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Licensure of 13-valent pneumococcal conjugate vaccine for adults aged 50 years and older. [2012]

The 13-valent pneumococcal conjugate vaccine (PCV13) was approved by the FDA on February 24, 2010, for preventing invasive pneumococcal disease and otitis media in children aged 6 weeks to 71 months, showing its efficacy against 13 specific serotypes.

The Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination with PCV13 for all children aged 2-59 months and for at-risk children aged 60-71 months, indicating its importance in public health for reducing pneumococcal disease burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children - Advisory Committee on Immunization Practices (ACIP), 2010. [2022]

In a study of 45 children aged 12-23 months, those who received a booster dose of the 7-valent pneumococcal conjugate vaccine (PCV7) showed a strong immune response against serotype 19A, with 100% demonstrating opsonic activity.

Children who received the primary series of 3 doses of PCV7 also had a notable immune response, but the response was significantly enhanced after the booster, indicating that booster vaccinations are important for improving immunity against certain pneumococcal serotypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune response to 19A serotype after immunization of 19F containing pneumococcal conjugate vaccine in Korean children aged 12-23 months. Lee, HJ., Park, SE., Kim, KH.[2021]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Post-marketing effectiveness of Prevnar [pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein)] and implications for adult immunization. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Development and clinical evaluation of Prevnar 13, a 13-valent pneumocococcal CRM197 conjugate vaccine. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

13-valent pneumococcal conjugate vaccine: a review of its use in infants, children, and adolescents. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Licensure of 13-valent pneumococcal conjugate vaccine for adults aged 50 years and older. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children - Advisory Committee on Immunization Practices (ACIP), 2010. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Immune response to 19A serotype after immunization of 19F containing pneumococcal conjugate vaccine in Korean children aged 12-23 months. [2021]