E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COVID19 vaccine in kidney transplant patients |
Vacuna COVID19 en pacientes trasplantados renales |
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E.1.1.1 | Medical condition in easily understood language |
COVID19 vaccine in kidney transplant patients |
Vacuna COVID19 en pacientes trasplantados renales |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084464 |
E.1.2 | Term | COVID-19 immunization |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084465 |
E.1.2 | Term | COVID-19 vaccination |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective will be to analyze the development of cellular and humoral immunity against SARS-CoV-2 after administration of a third dose of mRNA-1273 (Moderna) vaccine in patients who have remained seronegative after the full standard (two-dose) regimen. |
El objetivo será el de analizar el desarrollo de inmunidad celular y humoral frente a SARS-CoV-2 tras la administración de una tercera dosis de la vacuna mRNA-1273 (Moderna) en pacientes que han permanecido seronegativos tras la pauta estándar completa (dos dosis). |
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E.2.2 | Secondary objectives of the trial |
- To analyse the development of cellular and humoral immunity against SARS-CoV-2 after 4 months of administration of a third dose of mRNA-1273 vaccine (Moderna). - To establish baseline factors associated with biological non-response to vaccination. - To assess the safety and tolerability of the administration of the third dose of mRNA-1273 (Moderna) vaccine. |
•Analizar el desarrollo de inmunidad celular y humoral frente a SARS-CoV-2 tras 4 meses de la administración de una tercera dosis de la vacuna mRNA-1273 (Moderna). •Establecer factores basales asociados a la no respuesta biológica a la vacunación. •Evaluar la seguridad y tolerabilidad de la administración de la tercera dosis de la vacuna mRNA-1273 (Moderna). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age > 18 years; 2. Male or female sex; 3. Renal transplant with stable renal function in the last 2 months prior to study inclusion; 4.Had received a full schedule of vaccination for SARS-CoV-2 with mRNA1273 vaccine (Moderna) and remained seronegative at 2 weeks after the second dose. 5.Patient giving written informed consent. |
1.Edad > 18 años; 2.Sexo masculino o femenino; 3.Trasplante renal con función renal estable en los últimos 2 meses previamente a la inclusión en el estudio; 4.Haber recibido pauta completa de vacunación para SARS-CoV-2 con la vacuna mRNA1273 (Moderna) y haber permanecido seronegativos a las 2 semanas después de la segunda dosis. 5.Paciente que otorgue el consentimiento informado por escrito |
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E.4 | Principal exclusion criteria |
1. Renal transplantation < 3 months; 2. Pregnancy or lactation status; 3. Rejection treated within the last 6 months; 4. Presence of humoral immunity to SARS-CoV-2 defined as the presence of specific IgM/IgG. |
1.Trasplante renal < 3 meses; 2.Estado de embarazo o lactancia; 3.Rechazo tratado en los últimos 6 meses; 4.Presencia de inmunidad humoral frente al SARS-CoV-2 definida como presencia de IgM/IgG específicas. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is to assess biological effectiveness by: - Total antibody and IgG before (day 0) and after administration of the third dose (week +2). - ELISpot of T-cells subjected to SARS-CoV-2 antigenic stimulus before (day 0) and after administration of the third dose (week +2) |
La variable principal del estudio es evaluar la efectividad biológica mediante: •Título anticuerpos totales e IgG antes (día 0) y después de la administración de la tercera dosis (semana +2). •ELISpot de células T sometidas a estímulo antigénicos de SARS-CoV-2 antes (día 0) y después de la administración de la tercera dosis (semana +2); |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
day 0 and week +2 |
Día 0 y semana +2 |
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E.5.2 | Secondary end point(s) |
- Total antibody and IgG at 4 months after the third dose. - ELISpot of T-cells subjected to SARS-CoV-2 antigenic stimulus at 4 months after receiving the third dose. - Analysis of baseline factors associated with biological non-response to vaccination, including demographics, comorbidities, and transplant-associated factors: age, sex, diabetes, type of transplant (kidney-pancreas versus kidney), treatment with anti-thymocyte globulins (ATG) during the last year, lymphopenia defined as < 1000/mm3, time from transplantation < 1 year, eGFR (CKD-EPI), baseline immunosuppression, according to individual drug or the combination received by the patient, type of donor, BMI, ethnicity and blood type. - Percentage of patients with mild and/or severe adverse events after administration of the third dose. |
•Título anticuerpos totales e IgG a los 4 meses tras recibir la tercera dosis. •ELISpot de células T sometidas a estímulo antigénicos de SARS-CoV-2 a los 4 meses tras recibir la tercera dosis. •Análisis de los factores basales asociados a la no respuesta biológica a la vacunación, incluyendo factores demográficos, comorbilidades, y asociados al trasplante: Sexo Tipo de trasplante (renal / renopancreático) Tratamiento con globulinas antitimocíticas durante el último año Limfopenia definida como < 1000/mm3 Tiempo del trasplante < 1 año eGFR (CKD-EPI) inmunosupresion basal de acuerdo al tratamiento recibido por el paciente, tipo de donante, BMI, etnia y grupo sanguineo. •Porcentaje de pacientes que presentan acontecimientos adversos leves y/o graves tras la administración de la tercera dosis |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |