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: 1. To evaluate the efficacy of reimmunization against SARS-CoV-2 in subjects undergoing solid organ transplantation, in terms of incidence of infection and severity of COVID-19 after revaccination in the transplanted patient. 2. To gain insight into the humoral and cellular immune response conferred by the sequential combination of both homologous and heterologous vaccination over one year, as well as its duration in subjects undergoing solid organ transplantation. 3. To evaluate the safety of vaccines against SARS-CoV-2 in subjects undergoing solid organ transplantation. 4. To determine the potential existence of differences in humoral (Anti S Ac) and cellular immune response depending on the immunosuppression regimen. 5. To evaluate the occurrence of side effects, including rejection and anti-HLA and DSA antibodies after revaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
0.5 ml millilitre(s) Intramuscular use
0.5 ml millilitre(s) Intramuscular use
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
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.
Time frame: 28 days
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.
Time frame: 1 year
Changes in the phenotype of effector/memory/virgin B and T cell populations and subtypes of Th and NK cell populations.
T-cell response to SARS-CoV-2 will be analyzed by flow cytometry.
Time frame: 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.
Time frame: 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.
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Time frame: 1 year