Prevnar-13 Vaccine Response in Aging HIV Patients

Overseen By Kelly M Wills, BSN

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: VA Eastern Colorado Health Care System

Must not be taking: Corticosteroids, Chemotherapy, Immunosuppressives, Illicit drugs

Disqualifiers: Spleen removed, Chronic kidney disease, Active liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to learn more about both HIV-1 infection and advancing age, and their association with increased risk of serious infection and impaired response to the Prevnar 13 vaccine.

Will I have to stop taking my current medications?

If you are currently taking corticosteroids, chemotherapy, immunosuppressive medications, or illicit drugs, you will need to stop taking them to participate in this trial.

Is the Prevnar-13 vaccine generally safe for humans?

Prevnar-13 (PCV13) has been shown to have a satisfactory safety profile in both children and adults, including those with certain health conditions. It is recommended for use in various age groups and has been evaluated for safety and effectiveness in preventing pneumococcal disease. ^{1 2 3 4 5}

What makes the Prevnar-13 vaccine unique for aging HIV patients?

Prevnar-13 is unique because it is a 13-valent pneumococcal conjugate vaccine that targets 13 specific strains of the bacteria causing pneumococcal disease, and it is particularly effective in older adults and those with weakened immune systems, such as HIV patients. It is often used in combination with another vaccine, PPSV23, to provide broader protection against pneumococcal infections. ^{2 5 6 7 8}

What data supports the effectiveness of the treatment Prevnar-13 in aging HIV patients?

Research indicates that the 13-valent pneumococcal conjugate vaccine (PCV13) is designed to provide broader protection against pneumococcal disease compared to earlier versions, and studies have explored its immune response in HIV-infected adults, suggesting potential benefits in this population. ^{4 8 9 10 11}

Who Is on the Research Team?

Edward N Janoff, MD

Principal Investigator

University of Colorado Anschutz; Rocky Mountain Regional VAMC

Are You a Good Fit for This Trial?

This trial is for veterans aged 21-45 or 55-75 with HIV but no history of serious infections, who haven't had the Prevnar PCV-13 vaccine. Participants must have an undetectable viral load and be able to attend a few study visits over a month. Those with chronic kidney disease, active liver issues, no spleen, or on certain medications like steroids or immunosuppressants can't join.

Inclusion Criteria

I am between 21-45 or 55-75 years old.

For HIV negative controls: No history or risks for HIV infection

I have not received the Prevnar PCV-13 pneumococcal vaccine.

Exclusion Criteria

My kidney function is impaired (creatinine ≥ 2.0 mg/dL).

I have had my spleen removed.

I have an ongoing liver condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive a one-time administration of the Prevnar-13 vaccine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for mucosal and systemic antibody responses post-vaccination

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Prevnar-13

Trial Overview The study aims to understand how HIV and aging affect the body's response to the Prevnar 13 vaccine, which helps prevent pneumonia and other diseases caused by pneumococcal bacteria.

How Is the Trial Designed?

Group I: HIV+ Active Control 1 Intervention

One time administration of Prevnar-13 vaccine to HIV+ participants

Group II: HIV Negative Controls Active Control 1 Intervention

One time administration of Prevnar-13 vaccine to HIV Negative Control participants

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?

VA Eastern Colorado Health Care System

Lead Sponsor

Trials

55

Recruited

26,200+

Published Research Related to This Trial

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) 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]

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) has been shown to be effective in preventing various forms of pneumococcal disease in a large study of over 84,000 adults aged 65 and older, demonstrating its strong immunogenicity and safety profile.

Based on its effectiveness and changes in disease patterns, health authorities now recommend PCV13 for all adults aged 65 and older, as well as for younger adults with certain health conditions that increase their risk for pneumococcal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

13-Valent Pneumococcal Conjugate Vaccine: A Review of Its Use in Adults. Plosker, GL.[2018]

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. England pubmed.ncbi.nlm.nih.gov

Viro-immunological outcomes after 13-valent pneumococcal vaccination in HIV-1-infected individuals on stable virological suppression. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Long-Term Serological Response to 13-Valent Pneumococcal Conjugate Vaccine Versus 23-Valent Polysaccharide Vaccine in HIV-Infected Adults. [2020]

3. Brazil pubmed.ncbi.nlm.nih.gov

Facilitating access to pneumococcal vaccine for people living with HIV: an experience report. [2023]

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

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

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

A randomized clinical trial comparing revaccination with pneumococcal conjugate vaccine to polysaccharide vaccine among HIV-infected adults. [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

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

8. 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: Updated Recommendations of the Advisory Committee on Immunization Practices. [2020]

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

Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

13-Valent Pneumococcal Conjugate Vaccine: A Review of Its Use in Adults. [2018]

11. 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]