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The health authority indicates that the official vaccination schedule differs from that described in the protocol.
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Patients undergoing solid organ transplantation randomly selected from those who have received two doses of Spikevax (Moderna) vaccine, provided that a minimum of 8 weeks have elapsed from the second dose to the time of the start of the trial. It is planned to include 386 patients.
The main objective of this trial is to evaluate the immunogenicity of reimmunization against SARS-CoV-2 in patients undergoing solid organ transplantation with heterologous revaccination, testing whether in patients who received two doses of Spikevax Moderna vaccine there is a significant increase at 28 days in their antibody titers against SARS-CoV-2 after receiving a dose of Janssen.
The secondary objectives of this trial are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HETEROLOGOUS VACCINE | Experimental | COVID-19 Vaccine Janssen, injectable suspension |
|
| HOMOLOGOUS VACCINE | Active Comparator | Spikevax (Moderna), injectable dispersion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Janssen vaccine | Biological | 0.5 ml millilitre(s) Intramuscular use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the production of anti-S1-RBD IgG antibodies. | Positivity for comparison before and after revaccination and according to homologous or heterologous vaccination will be quantified in the laboratory method units. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the presence of activated T cells specific for SARS-CoV-2 (Sprotein). | T-cell response to SARS-CoV-2 will be analyzed by flow cytometry. | 1 year |
| Changes in the phenotype of effector/memory/virgin B and T cell populations and subtypes of Th and NK cell populations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Crespo GarcÃa | Hospital Universitario Marqués de Valdecilla | Principal Investigator |
| Marcos López Hoyos | Hospital Universitario Marqués de Valdecilla | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
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| Spikevax (Moderna) vaccine | Biological | 0.5 ml millilitre(s) Intramuscular use |
|
|
T-cell response to SARS-CoV-2 will be analyzed by flow cytometry. |
| 1 year |
| Incidence of symptomatic/asymptomatic COVID infection after revaccination. | Confirmed COVID-19 is defined as the presence of at least one of the following symptoms: fever, new onset or increased cough, new onset or increased shortness of breath, chills, new onset or increased muscle pain, loss of taste or smell, sore throat, diarrhea or vomiting, combined with a respiratory specimen, obtained during the symptomatic period, positive for SARS-CoV-2 by nucleic acid amplification (PCR)-based testing or antigen testing. | 1 year |
| Number of patients with hospital admissions and/or visits to the emergency department for severe symptoms related to COVID-19 infection. | Confirmed COVID-19 is defined as the presence of at least one of the following symptoms: fever, new onset or increased cough, new onset or increased shortness of breath, chills, new onset or increased muscle pain, loss of taste or smell, sore throat, diarrhea or vomiting, combined with a respiratory specimen, obtained during the symptomatic period, positive for SARS-CoV-2 by nucleic acid amplification (PCR)-based testing or antigen testing. | 1 year |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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