Pneumonia Vaccine for People with HIV
(VIVID Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Hennepin Healthcare Research Institute
Must be taking: Antiretrovirals
Disqualifiers: Immunosuppressing conditions, Pregnancy, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345How 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.
12456Eligibility 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
* Age\>=18 years
* HIV Diagnosis
* On Antiretroviral Therapy with HIV Viral Load\<200 within last year
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Pneumococcal VaccinationExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hennepin Healthcare SystemMinneapolis, MN
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Who Is Running the Clinical Trial?
Hennepin Healthcare Research InstituteLead Sponsor
References
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]A 20-valent pneumococcal conjugate vaccine, PCV20, was developed to expand protection against vaccine-preventable pneumococcal disease. PCV20 contains the components of the 13-valent pneumococcal conjugate vaccine, PCV13, and includes capsular polysaccharide conjugates for 7 additional serotypes. Thus, PCV20 may cover those additional serotypes in individuals previously vaccinated with PCV13 or provide benefits of immunization with a conjugate vaccine to individuals previously immunized with a pneumococcal polysaccharide vaccine. This study described the safety and immunogenicity of PCV20 in adults ≥65 years of age with prior pneumococcal vaccination.
20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval. [2023]20‑valent pneumococcal conjugate vaccine (PCV20; Prevnar 20®; Apexxnar®) is a pneumococcal conjugate vaccine (PCV) developed by Pfizer for active immunization for the prevention of pneumococcal infections. PCV20 has a similar structure and formulation to Pfizer's 13-valent PCV (PCV13; Prevnar 13®; Prevenar 13®), with the addition of polysaccharides to target seven further Streptococcus pneumoniae serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F). PCV20 has been approved for active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae in adults since June 2021 in the USA and since February 2022 in the EU. Following further evaluation of its safety, immunogenicity, and effectiveness in pediatric populations, in April 2023 PCV20 received its first pediatric approval, in the USA, for active immunization for the prevention of invasive pneumococcal disease (IPD) caused by S. 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 to 17 years of age and for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks to 5 years of age. This article summarizes the milestones in the development of PCV20 leading to this first pediatric approval for active immunization for the prevention of IPD and otitis media caused by S. pneumoniae.
The evidence for using conjugate vaccines to protect HIV-infected children against pneumococcal disease. [2022]Pneumococcal conjugate vaccines (PCVs) are a potentially useful complement to existing treatment strategies in HIV-infected children, for whom pneumococcal infections are common and serious. This Review summarises available data on the burden of pneumococcal disease and the safety and efficacy of PCVs in HIV-infected children. The data demonstrate that children with HIV have significantly increased risk of pneumococcal disease compared with uninfected children; the serotypes included in currently licensed or near-licensure conjugate vaccines include most serotypes that cause invasive pneumococcal disease (IPD) in HIV-infected children and adults; PCVs provide substantial protection against IPD and clinical pneumonia when given to HIV-infected infants; and HIV-infected adults gain an indirect benefit when children in the community are vaccinated. PCV should be considered as an important intervention for improving the lives of HIV-infected children.
20-Valent Pneumococcal Conjugate Vaccine: A Review of Its Use in Adults. [2022]The introduction of multi-valent pneumococcal vaccines around the world, such as the 13-valent pneumococcal conjugate vaccine (PCV13), has had a significant effect in reducing the burden of disease caused by Streptococcus pneumoniae infection globally. However, S. pneumoniae serotypes not covered by PCV13 still cause significant disease. A 20-valent pneumococcal conjugate vaccine (PCV20; Prevnar20®; Apexxnar®) has recently been licensed for active immunisation for the prevention of invasive disease and pneumonia caused by S. pneumoniae in adults. PCV20 contains all components of PCV13 with the addition of polysaccharide conjugates of seven more serotypes, selected based on their generalised geographic distribution and relative prevalence as a cause of pneumococcal disease. The immunogenicity of PCV20 in adults has been demonstrated in a well-designed program of clinical trials which showed that PCV20 administered as a single dose by intramuscular injection induced robust immune responses to all 20 S. pneumoniae serotypes covered by the vaccine. PCV20 was well tolerated, with a tolerability and safety profile similar to that for PCV13. By expanding the coverage of disease-causing S. pneumoniae serotypes relative to other PCVs, PCV20 presents a valuable new tool with the potential to further reduce the impact of pneumococcal disease.
[Apexxnar®, 20-valent pneumococcal conjugate vaccine]. [2022]Streptococcus pneumoniae infections cause bacteremic and non-bacteremic community-acquired pneumonia and invasive pneumococcal diseases (IPD) such as bacteremia, sepsis and acute meningitis. They are potentially lethal. Although polysaccharide vaccines (PPV23, Pneumovax 23®) have already provided protection in at-risk individuals, they have been imperfect, mainly because the development of anti-polysaccharide antibodies occurs without the help of T cells. The introduction of immunogenic protein conjugate vaccines (ICVs) has overcome this problem and provided better and longer lasting protection. The first available vaccine of this type for adults was Prevenar 13®, targeting 13 polysaccharides of S. pneumoniae (PCV13). A new vaccine, Apexxnar®, targeting 20 polysaccharides (PCV20), the 13 of Prevenar 13®, to which 7 other serotypes considered to be equally responsible for invasive infections have been added, has recently been launched. Clinical studies have demonstrated a good immunogenic response against all 20 serotypes in adult patients who are either vaccine-naive or previously vaccinated with PPV23 and/or PCV13. Furthermore, the tolerance of the PCV20 vaccine was found to be comparable to that of Prevenar 13®. Vaccination with PCV20 involves a single injection. The Belgian Superior Health Council has recently reiterated the importance of vaccinating at-risk individuals against S. pneumoniae (a vaccination that is still under-performed). It now recommends vaccination with PCV20 (Apexxnar®) as the preferred primary vaccination regimen in high-risk adults with co-morbidities or in good health aged between 65 and 85 years.
Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV. [2023]To evaluate safety and immunogenicity of V114 [15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F], followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in adults living with HIV.