Pneumonia Vaccine for People with HIV

(VIVID Trial)

Overseen By Anne Frosch, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hennepin Healthcare Research Institute

Must be taking: Antiretrovirals

Disqualifiers: Immunosuppressing conditions, Pregnancy, 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

250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must be on antiretroviral therapy, it seems you can continue with those medications.

What data supports the effectiveness of the treatment Conjugate Pneumococcal Vaccine 20 (PCV20) for people with HIV?

PCV20 has been shown to provide strong immune responses against 20 types of bacteria that cause pneumococcal disease, and it is well tolerated in adults. Additionally, similar vaccines have been effective in protecting HIV-infected children from serious pneumococcal infections, suggesting potential benefits for people with HIV. ^{1 2 3 4 5}

How is the drug PCV20 different from other pneumonia vaccines for people with HIV?

PCV20 is unique because it targets 20 different types of the bacteria that cause pneumonia, offering broader protection compared to previous vaccines like PCV13, which only covered 13 types. This expanded coverage is particularly beneficial for people with HIV, who are at higher risk for infections. ^{1 2 4 5 6}

What is the purpose of this trial?

This study will track immune responsiveness to conjugate pneumococcal vaccines over time to help determine how long protection from this vaccine lasts in individuals with chronic medical conditions (in this study - HIV) and with age.

Eligibility Criteria

This trial is for aging individuals living with HIV. It's designed to understand how well and for how long a pneumococcal vaccine (PCV20) can protect them against infections.

Inclusion Criteria

* HIV Diagnosis

* On Antiretroviral Therapy with HIV Viral Load\<200 within last year

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive a pneumococcal vaccine

1 day

1 visit (in-person)

Acute Immune Response Assessment

Evaluate acute immune responses 30 days post-vaccination

30 days

1 visit (in-person)

Long-term Immune Response Assessment

Evaluate long-term immune responses 2 years post-vaccination

2 years

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after vaccination

4 weeks

Treatment Details

Interventions

• Conjugate Pneumococcal Vaccine 20 (PCV20)

Trial Overview The study focuses on the immune response to the PCV20 vaccine in people with HIV as they age, tracking how effective the vaccine is over time in providing protection.

Participant Groups

Group I: Pneumococcal Vaccination Experimental Treatment 1 Intervention

All participants will receive a pneumococcal vaccine.

Conjugate Pneumococcal Vaccine 20 (PCV20) is already approved in United States, European Union for the following indications:

Approved in United States as Prevnar 20 for:

• Invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks through 17 years of age and adults 18 years of age and older

Approved in European Union as APEXXNAR for:

• Invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older

Who Is Running the Clinical Trial?

Hennepin Healthcare Research Institute

Lead Sponsor

Trials

94

Recruited

77,100+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The 20-valent pneumococcal conjugate vaccine (PCV20) was found to be safe and well-tolerated in adults aged 65 and older, with similar rates of local reactions and adverse events compared to the control groups (PCV13 and PPSV23).

PCV20 elicited strong immune responses against all 20 serotypes included in the vaccine, demonstrating its effectiveness in boosting immunity regardless of prior pneumococcal vaccination history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination. Cannon, K., Elder, C., Young, M., et al.[2022]

The 20-valent pneumococcal conjugate vaccine (PCV20) has been approved for use in adults since June 2021 and in pediatric populations since April 2023, targeting a broader range of Streptococcus pneumoniae serotypes compared to the previous 13-valent vaccine.

PCV20 is effective in preventing invasive pneumococcal disease and otitis media in children aged 6 weeks to 17 years, demonstrating its safety and immunogenicity in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval. Shirley, M.[2023]

HIV-infected children are at a significantly higher risk for pneumococcal disease compared to uninfected children, highlighting the need for effective preventive measures.

Pneumococcal conjugate vaccines (PCVs) provide substantial protection against invasive pneumococcal disease and pneumonia in HIV-infected infants, making them a crucial intervention for improving health outcomes in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evidence for using conjugate vaccines to protect HIV-infected children against pneumococcal disease. Bliss, SJ., O'Brien, KL., Janoff, EN., et al.[2022]

The newly licensed 20-valent pneumococcal conjugate vaccine (PCV20) effectively induces strong immune responses against all 20 serotypes of Streptococcus pneumoniae, expanding coverage beyond the 13 serotypes included in PCV13.

PCV20 has a safety and tolerability profile similar to PCV13, making it a promising option for further reducing the incidence of pneumococcal disease in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

20-Valent Pneumococcal Conjugate Vaccine: A Review of Its Use in Adults. Shirley, M.[2022]

The new vaccine Apexxnar® (PCV20) targets 20 serotypes of Streptococcus pneumoniae and has shown a strong immunogenic response in adults, whether they are vaccine-naive or previously vaccinated with other pneumococcal vaccines.

PCV20 is well-tolerated, similar to Prevenar 13®, and is recommended as the preferred vaccination for at-risk adults aged 65 to 85, highlighting its importance in preventing serious infections like pneumonia and meningitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Apexxnar®, 20-valent pneumococcal conjugate vaccine]. Scheen, AJ., Louis, R., Moutschen, M.[2022]

In a phase 3 study involving 302 adults living with HIV, the 15-valent pneumococcal conjugate vaccine (V114) was found to be well tolerated, with most adverse events being mild or moderate in severity.

V114 induced strong immune responses for all 15 pneumococcal serotypes, and when followed by the 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, it effectively broadened serotype coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV. Mohapi, L., Pinedo, Y., Osiyemi, O., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval. [2023]

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

The evidence for using conjugate vaccines to protect HIV-infected children against pneumococcal disease. [2022]

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

20-Valent Pneumococcal Conjugate Vaccine: A Review of Its Use in Adults. [2022]

5. Belgium pubmed.ncbi.nlm.nih.gov

[Apexxnar®, 20-valent pneumococcal conjugate vaccine]. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV. [2023]