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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how older adults with HIV respond to the Prevnar-13 vaccine, which protects against certain infections. Researchers aim to determine whether HIV status or age affects the vaccine's effectiveness. The trial includes two groups: HIV-positive participants and HIV-negative individuals as a control. Veterans who have never received the Prevnar-13 vaccine and can attend a few study visits are suitable candidates for this study. As an Early Phase 1 trial, this research focuses on understanding the vaccine's effects in people, offering participants a chance to contribute to groundbreaking insights.

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 there any evidence suggesting that Prevnar-13 is likely to be safe for humans?

Research has shown that the Prevnar-13 vaccine is generally safe for people living with HIV. One study found that administering this vaccine in three doses was safe for those who had never received a pneumococcal vaccine before. Another study showed that most patients achieved good protection after just one dose. These findings suggest that Prevnar-13 is safe for this group. However, like any vaccine or treatment, some side effects might occur, but they are usually mild. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for HIV patients, which primarily focus on managing viral load with antiretroviral therapy, the Prevnar-13 vaccine is designed to boost the immune response to pneumococcal infections, a common complication in individuals with HIV. Researchers are excited about this vaccine because it potentially offers a new layer of protection by enhancing immunity against specific bacterial infections, thereby reducing the risk of serious illnesses. This approach is particularly promising for aging HIV patients, as their immune systems are often compromised, making them more susceptible to infections.

What evidence suggests that the Prevnar-13 vaccine might be an effective treatment for aging HIV patients?

Research has shown that the Prevnar-13 vaccine works well for adults with HIV. Studies found that 92.1% of patients had a strong immune response one month after receiving the vaccine, indicating improved readiness to fight infections. In this trial, one group will receive the Prevnar-13 vaccine among HIV-positive participants, while another group will administer it to HIV-negative control participants. Other pneumococcal vaccines have not worked as well for people with HIV. Overall, Prevnar-13 is considered safe and helps protect HIV-positive individuals from infections. ^{1 3 6 7 8}

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

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 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 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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4521829/

Immunogenicity and safety of the 13-valent pneumococcal ... Pneumococcal conjugate vaccines have demonstrated efficacy in HIV-infected adults [17,18], whereas pneumococcal polysaccharide vaccines have failed to do so [9] ...

2. academic.oup.com academic.oup.com/ofid/article/12/Supplement_1/ofae631.219/7986750

P-8. Assessment of 13-valent pneumococcal conjugate ... Assessment of 13-valent pneumococcal conjugate vaccine effectiveness among people living with HIV in the United States Open Access. Amanda C ...

3. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2021.791147/full

Single-Dose 13-Valent Conjugate Pneumococcal Vaccine ... One month after PCV13 vaccination, we found that thirty-five (92.1%) and thirty (78.9%) patients were globally protected according to ELISA and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7012181/

Immunogenicity and safety of 13-valent pneumococcal ... PCV13 was safe and well tolerated in HIV-infected patients irrespective of immune status. In conclusion, PCV13 showed significantly inferior immunogenicity ...

5. academic.oup.com academic.oup.com/jid/advance-article-abstract/doi/10.1093/infdis/jiaf405/8221349

Effectiveness of 13-Valent Pneumococcal Conjugate Vaccine ... Vaccine effectiveness of PCV13 only against all-cause pneumonia hospitalization was 3.8% (95% CI 2.4%–5.2%) overall: 5.6% (3.9%–7.2%) for LTC ...

6. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf438/8222751

Long-term Immunogenicity and Boostability of the 13-valent ... Only a minority of PLWH and patients on immunosuppressive therapy and under half of controls remained seroprotected 3 years after vaccination.

7. thelancet.com thelancet.com/journals/lanhiv/article/PIIS2352-3018(25)00165-1/abstract

Safety, tolerability, and immunogenicity of an adult-specific ... Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination. AIDS.

8. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7401a1.htm

Expanded Recommendations for Use of Pneumococcal ... This report describes CDC's updated pneumococcal conjugate vaccine recommendation for all adults aged ≥50 years who are PCV-naïve or who ...