RSV Vaccine for Blood Cancer Patients
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the RSV vaccine, Abrysvo, can boost the immune system in individuals with blood cancers who have undergone a stem cell transplant or CAR-T cell therapy. The researchers aim to determine if the vaccine increases antibodies to combat RSV, a virus that can cause respiratory issues. They will measure whether antibody levels rise to four times their pre-vaccine levels. Individuals who have received blood cancer treatment and can provide blood samples might be suitable candidates. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have used intravenous immunoglobulin (IVIG) for low antibody levels in the past six months, you cannot participate.
What is the safety track record for the RSV vaccine Abrysvo?
Research has shown that the RSVpreF vaccine is generally safe for adults. In previous studies, most participants experienced only mild reactions, such as pain at the injection site, while serious issues were rare. Among younger adults (ages 18 to under 60), 13.5% reported side effects, and 7.3% experienced serious ones. For older adults (60 and above), these figures were slightly higher, with 22.4% experiencing side effects and 14% having serious ones.
Overall, the vaccine maintains a good safety record, indicating that while some individuals might experience mild side effects, it is generally well-tolerated.12345Why are researchers enthusiastic about this study treatment?
Most treatments for RSV in blood cancer patients are focused on managing symptoms or using antiviral medications like ribavirin. But the RSVpreF vaccine works differently by targeting the virus before it causes illness. This vaccine uses a stabilized version of the RSV protein, which helps the immune system recognize and fight off the virus more effectively. Researchers are excited about RSVpreF because it has the potential to offer direct protection against RSV, reducing the risk of severe infection in a vulnerable population.
What evidence suggests that the RSV vaccine is effective for blood cancer patients?
Research shows that the RSV vaccine, Abrysvo, effectively creates an immune response, particularly in older adults. Studies have found that the vaccine targets a specific protein crucial for building protection against the virus. Early real-world data suggest that this vaccine may lower the risk of infection in people with weakened immune systems, such as those with blood cancers. Additionally, patients with blood-related conditions have responded well to the RSV vaccine, potentially reducing serious outcomes like ICU admissions. Although data for blood cancer patients after a transplant is limited, the vaccine's success in other vulnerable groups is encouraging. Participants in this trial will receive the RSV vaccine to further evaluate its effectiveness in blood cancer patients.678910
Are You a Good Fit for This Trial?
This trial is for blood cancer patients who've had a bone marrow transplant or CAR-T cell therapy. It's testing if they can respond to an RSV vaccine called Abrysvo, which aims to boost immunity against the virus.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Vaccination
Participants receive the RSV vaccine Abrysvo
Primary Follow-up
Measure change in antibody levels against the preF protein four weeks after vaccination
Extended Follow-up
Assess persistence of humoral immune response at six months post-vaccination
What Are the Treatments Tested in This Trial?
Interventions
- Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)
Trial Overview
The study tests the effectiveness of the RSVpreF vaccine in generating an immune response. Researchers will compare antibody levels before and four weeks after vaccination to see if there's a significant increase.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients who will recieve the RSV vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cooper Health System
Lead Sponsor
The Cooper Foundation
Collaborator
Citations
Estimated Vaccine Effectiveness for Respiratory Syncytial ...
To estimate Respiratory Syncytial Virus Prefusion F (RSVpreF) effectiveness in older adults. ... Malignant neoplasm, 1028 (18), 81 (16.1), 119 (18) ...
Estimated Vaccine Effectiveness for Respiratory Syncytial ...
... virus, AIDS, cancers, organ transplant and blood disorders. fCritical outcomes include intensive care unit admission, mechanical ventilation ...
Respiratory Syncytial Virus Exceeded SARS‐CoV‐2 and ...
Respiratory viral infections (RVIs) significantly impact patients with hematologic malignancies (HMs). During the 2023–2024 respiratory viral ( ...
4.
docwirenews.com
docwirenews.com/post/early-real-world-data-suggest-rsv-vaccination-may-reduce-infection-risk-in-older-adultsEarly Real-World Data Suggest RSV Vaccination May ...
Myeloproliferative Neoplasms · PNH · Polycythemia Vera · Pulmonary ... The first real-world study evaluating the effectiveness of newly approved ...
5.
journals.viamedica.pl
journals.viamedica.pl/acta_haematologica_polonica/article/download/105118/83484Vaccination of adult patients with hematological
active treatment of solid tumors and hematopoietic malignancies;. □ hematological malignancies associated with poor re- sponse to COVID-19 ...
Immunogenicity and Safety of the Bivalent Respiratory ...
Adverse event and serious adverse event rates were 13.5% and 7.3% among 18−<60-year-olds and 22.4% and 14.0% among ≥60-year-olds, respectively.
Safety and immunogenicity of adjuvanted respiratory ...
Overall, the vaccine was well tolerated. In the 7 days postvaccination, local AE were the most common, with grade 1 pain occurring at the ...
8.
pharmacytimes.com
pharmacytimes.com/view/rsvpref-vaccine-is-well-tolerated-in-adults-demonstrating-favorable-safety-profileRSVpreF Vaccine Is Well-Tolerated in Adults ...
The RSVpreF vaccine shows a favorable safety profile, with common adverse events being mild localized reactions like injection site pain, ...
Respiratory Syncytial Virus Prefusion F Protein Vaccine in ...
A single dose of the RSVPreF3 OA vaccine had an acceptable safety profile and prevented RSV-related acute respiratory infection and lower respiratory tract ...
NCT05842967 | A Study to Assess the Safety, Tolerability ...
This is a Phase 3 protocol that will assess the safety, tolerability, and immunogenicity of Pfizer's RSVpreF in adults at high risk of severe RSV disease.
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