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| Name | Class |
|---|---|
| The Cooper Foundation | UNKNOWN |
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This study evaluates whether the RSV vaccine Abrysvo can produce an antibody response in patients with blood cancers who have previously received a hematopoietic stem cell transplant (HSCT) or CAR-T cell therapy. The vaccine targets the prefusion F (preF) protein of RSV, which is an important component of protective immunity against the virus.
The main goal of the study is to measure the change in antibody levels against the preF protein four weeks after vaccination compared with levels before vaccination. The study will also assess whether participants develop a meaningful immune response, defined as at least a four-fold increase in RSV neutralizing antibody levels four weeks after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine Recipients | Experimental | Patients who will recieve the RSV vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF) | Biological | Patients will receive a single dose of the Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF) starting at three months post-HSCT or CAR-T therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Fold Rise in Antibody Titers and Seroconversion | The primary endpoint is the fold rise in antibody titers against the preF protein at four weeks post-vaccination compared to pre-vaccination (baseline) levels. An additional related objective is to assess whether patients are able to achieve seroconversion. The endpoint for this objective is the proportion of patients with at least a four-fold increase in neutralizing titers from the pre-vaccination baseline at four weeks post-vaccination. | From the time the patient receives the vaccine to four weeks post-vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence of Humoral Immune Response | The secondary objective is to assess whether patients who achieve seroconversion at four weeks post-vaccination retain high levels of neutralizing antibodies at six months post-vaccination. The endpoint for this objective is the fold change in antibody titers against the preF protein at six months post-vaccination compared to four weeks post-vaccination. | From four weeks post-vaccination to six months post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anil K Rengan, MD | Contact | 855-632-2667 | rengan-anil@cooperhealth.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
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| COVID-19 and Influenza Immunity | Although vaccination against these pathogens is not part of the study protocol, neutralizing antibody titers for influenza and COVID-19 will be obtained alongside RSV titers as part of a broader titer analysis. | From the collection of baseline antibody titers to the collection of antibody titers at six months post-vaccination against RSV. |