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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the immune system, particularly neutrophils, responds to the pneumococcal vaccine Prevnar-13 in young and older adults. The goal is to understand how age might affect the body's defense against infections like pneumonia. Participants will receive the vaccine to help researchers learn more about improving immune responses. Suitable candidates include those who have never had a pneumococcal vaccine, are free from recent infections, and haven't recently used anti-inflammatory medicines. As a Phase 4 trial, this study involves an FDA-approved vaccine and aims to understand its benefits for a broader range of patients.

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 is the safety track record for Prevnar-13?

Research shows that Prevnar-13, a vaccine for preventing certain infections, is generally safe. Studies find that the most common side effects are mild, such as swelling, tenderness, and redness at the injection site. Serious side effects are rare. For instance, in babies and young children, serious reactions occurred in about 8.2% of those who received Prevnar-13, slightly higher than the 7.2% with a similar vaccine. Severe allergic reactions are very rare. Overall, evidence suggests Prevnar-13 is well-tolerated. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Prevnar-13 is unique because it targets a broad range of pneumococcal strains, providing extensive protection against pneumonia and related diseases. Unlike older vaccines, Prevnar-13 includes coverage for serotypes that are responsible for a significant number of infections in older adults. Researchers are excited about this treatment as it not only enhances immune response in the elderly but also reduces the risk of antibiotic resistance by preventing infections before they start.

What is the effectiveness track record for Prevnar-13 in young and elderly adults?

Research shows that Prevnar-13, which participants in this trial will receive, is a safe and effective vaccine for preventing certain bacterial infections. Studies have found that it significantly lowers the risk of diseases like pneumonia in older adults. For example, one study found that in people aged 65 and older, the vaccine was 73% effective in preventing specific types of these infections. This greatly helps protect against infections caused by the targeted bacteria. The vaccine is well-known and widely used for its protective benefits in older adults. ^{2 6 7 8 9}

Who Is on the Research Team?

Elsa N Bou Ghanem, PhD

Principal Investigator

University at Buffalo

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6457056/

Efficacy and Safety of the Pneumococcal Conjugate-13 ... This review focuses on the immunogenicity, safety, efficacy and effectiveness data on the use of the 13-valent conjugate pneumococcal vaccine (PCV13) in adults.

2. cdc.gov cdc.gov/mmwr/volumes/68/wr/mm6846a5.htm

Use of 13-Valent Pneumococcal Conjugate Vaccine and ... However, PCV13 is a safe and effective vaccine that can reduce the risk for PCV13-type IPD and noninvasive pneumonia among persons aged ≥65 ...

3. fda.gov fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert------Prevnar-13.pdf

Package Insert - Prevnar 13 The effectiveness of Prevnar 13 in this specific population has not been established. 11. DESCRIPTION. Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine ( ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1408544

Polysaccharide Conjugate Vaccine against Pneumococcal ... Among older adults, PCV13 was effective in preventing vaccine-type pneumococcal, bacteremic, and nonbacteremic community-acquired pneumonia and vaccine-type ...

5. pfizer.com pfizer.com/news/press-release/press-release-detail/a_study_analyzing_observational_data_shows_real_world_effectiveness_of_prevnar_13_in_adults_age_65-0

A Study Analyzing Observational Data Shows Real-World ... “Specifically, based on a 73% vaccine effectiveness observed in this study, we estimate that PCV13 vaccination in adults 65+ might prevent ...

6. cdn.pfizer.com cdn.pfizer.com/pfizercom/products/material_safety_data/PZ01454.pdf

MATERIAL SAFETY DATA SHEET Based on clinical trials in humans, possible adverse effects following exposure to this compound may include: swelling, tenderness, and redness at the injection ...

7. pfizermedical.com pfizermedical.com/prevnar-13/adverse-reactions

PREVNAR 13® (pneumococcal 13-valent conjugate vaccine Serious adverse events reported following vaccination in infants and toddlers occurred in 8.2% among Prevnar 13 recipients and 7.2% among Prevnar recipients.

8. cdc.gov cdc.gov/vaccine-safety/vaccines/pneumococcal.html

Pneumococcal Vaccine Safety Very rarely, severe (anaphylactic) allergic reactions may occur after vaccination. A closer look at the safety data. A 2004 study of VAERS data ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/pneumococcal-13-valent-vaccine-diphtheria-conjugate-intramuscular-route/description/drg-20074043

Pneumococcal 13-valent vaccine, diphtheria conjugate ... Side Effects ; More common · decreased sleep; irritability; red streaks on the skin; swelling, tenderness, or pain at the injection site ; Rare.