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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how long a new pneumonia vaccine can protect people with HIV. The research focuses on understanding the immune response to this vaccine over time. All participants will receive the same vaccine, called PCV20 (Conjugate Pneumococcal Vaccine 20). Individuals with HIV who are on antiretroviral therapy and have maintained a stable viral load for the past year may be suitable for this trial. As a Phase 4 trial, this research involves an FDA-approved vaccine, ensuring its proven effectiveness, and aims to understand its benefits for more patients.

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 is the safety track record for the Conjugate Pneumococcal Vaccine 20 (PCV20)?

Research has shown that the 20-valent pneumococcal conjugate vaccine (PCV20) is safe and well-tolerated in adults. One study found that PCV20 had safety results similar to an earlier 13-valent vaccine, indicating it did not cause more side effects than vaccines already in use.

Another study demonstrated that PCV20 was effective for people with HIV, even those not receiving antiretroviral therapy (ART). This study identified no major safety concerns.

Overall, evidence suggests that PCV20 is safe for use, even in individuals with chronic conditions like HIV. However, discussing any concerns with a healthcare provider remains important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Conjugate Pneumococcal Vaccine 20 (PCV20) because it offers broader protection against more strains of the bacteria that cause pneumonia. Unlike the current standard treatments that typically cover fewer strains, PCV20 targets 20 different types, potentially reducing the risk of pneumonia more effectively for people with HIV. This broader coverage is particularly important for individuals with weakened immune systems, like those with HIV, who are at higher risk for infections.

What is the effectiveness track record for the Conjugate Pneumococcal Vaccine 20 (PCV20) in people with HIV?

Research has shown that conjugate pneumococcal vaccines, such as PCV20, effectively reduce serious infections caused by pneumococcus bacteria. In adults with HIV, this vaccine lowers the risk of serious bacterial infections by 74%, resulting in fewer cases of severe lung infections, like pneumonia, among vaccinated individuals. Although protection may decrease over time, the initial effectiveness remains strong. PCV20 is approved and widely used to protect against various pneumococcal diseases, proving especially beneficial for people with weakened immune systems, such as those with HIV. All participants in this trial will receive the pneumococcal vaccine. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

Citations

1. cdc.gov cdc.gov/acip/evidence-to-recommendations/pneumo-PCV20-risk-based-etr.html

Evidence to Recommendations for PCV20 use among ... The ACIP Pneumococcal Vaccines Work Group reviewed available data to inform the use of PCV20 in adults and identify policy options.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3367711/

Safety, immunogenicity and efficacy of pneumococcal ... PCV has also been shown to reduce the risk of recurrent IPD by 74% in HIV-infected adults not on ART, albeit, also with subsequent decline in immunity and ...

3. prevnar20adult.pfizerpro.com prevnar20adult.pfizerpro.com/

PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine ... Effectiveness of 13-valent pneumococcal conjugate vaccine against hospitalization for community-acquired pneumonia in older US adults: a test-negative design.

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT00772928?draw=2&rank=1

Study of the Effect of Pneumococcal Conjugate Vaccine ... Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or ...

5. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/immunizations

Immunizations for Preventable Diseases in Adults and ... There are currently no data on clinical effectiveness of PCV21 in people with HIV. Recommendations for PCV and PPSV23 in people with HIV depend ...

6. cdc.gov cdc.gov/acip/grade/pneumo-PCV20-risk-based.html

20-valent pneumococcal conjugate vaccine (PCV20) for ... A systematic literature search was completed to review all available evidence on the immunogenicity and safety of PCV15 and PCV20 among age ...

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

Safety, tolerability, and immunogenicity of an adult-specific ... V116 was well tolerated and immunogenic for all 21 serotypes, supporting the use of this vaccine in adults living with HIV. Adults at high risk ...

8. academic.oup.com academic.oup.com/cid/article/75/3/390/6481672

Pivotal Phase 3 Randomized Clinical Trial of the Safety ... The 20-valent pneumococcal conjugate vaccine (PCV20) was safe and well tolerated, with immunogenicity comparable to that of the 13-valent pneumococcal conj.