Back to resultsEfficacy, Safety, and Immunogenicity of Vaccine Reimmunization With a Third Homologous Versus Heterologous Dose Against COVID-19 in Patients Undergoing Solid Organ Transplantation. (REIN-TX)
Primary Purpose
Covid19
Status
Withdrawn
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Janssen vaccine
Spikevax (Moderna) vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring Vaccine, Covid-19, Liver Trasplant, Lung Trasplant, Heart Trasplant, Kidney Trasplant
Eligibility Criteria
Inclusion Criteria:
- Patients who underwent solid organ transplantation prior to revaccination against COVID-19.
- Patients who have received the full COVID-19 vaccination regimen with Spikevax (Moderna) vaccine, with a minimum of 8 weeks having elapsed from the second dose to the time of trial initiation.
- Age > 18 years.
- All participants must have previously agreed to participate in the study by signing the informed consent form.
Exclusion Criteria:
- Having suffered SARS-CoV-2 infection at any time prior to inclusion in the study.
- Subjects without solid organ transplantation or with a different solid organ (e.g. pancreas transplantation) and without any type of immunosuppression (immunocompetent non-transplanted) from the general population.
- Age < 18 years
- Temperature of at least 38°C in the 24 hours prior to immunization or other clinically relevant acute symptomatology.
- Clinical manifestations compatible with COVID-19 infection at the time of evaccination.
- Known allergy or history of anaphylaxis or other serious adverse events to the administration of vaccines or their excipients.
- Any other condition that contraindicates vaccination against SARSCov2, including pregnancy.
- Having presented graft rejection in the 15 days prior to the start of the study.
- Any condition or situation that may interfere with the ability to maintain adherence to study procedures and visits.
Sites / Locations
- Hospital Universitario Marqués de Valdecilla
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HETEROLOGOUS VACCINE
HOMOLOGOUS VACCINE
Arm Description
COVID-19 Vaccine Janssen, injectable suspension
Spikevax (Moderna), injectable dispersion
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05048940
First Posted
September 8, 2021
Last Updated
February 28, 2023
Sponsor
Instituto de Investigación Marqués de Valdecilla
1. Study Identification
Unique Protocol Identification Number
NCT05048940
Brief Title
Efficacy, Safety, and Immunogenicity of Vaccine Reimmunization With a Third Homologous Versus Heterologous Dose Against COVID-19 in Patients Undergoing Solid Organ Transplantation.
Acronym
REIN-TX
Official Title
Randomized, Open-label, Adaptive, Controlled, Phase III Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Reimmunization With Third Dose of Homologous vs. Heterologous Vaccine Against COVID-19 in Patients Undergoing Solid Organ Transplantation: Liver, Heart, Kidney and Lung.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The health authority indicates that the official vaccination schedule differs from that described in the protocol.
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Marqués de Valdecilla
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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:
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.
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.
To evaluate the safety of vaccines against SARS-CoV-2 in subjects undergoing solid organ transplantation.
To determine the potential existence of differences in humoral (Anti S Ac) and cellular immune response depending on the immunosuppression regimen.
To evaluate the occurrence of side effects, including rejection and anti-HLA and DSA antibodies after revaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Vaccine, Covid-19, Liver Trasplant, Lung Trasplant, Heart Trasplant, Kidney Trasplant
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HETEROLOGOUS VACCINE
Arm Type
Experimental
Arm Description
COVID-19 Vaccine Janssen, injectable suspension
Arm Title
HOMOLOGOUS VACCINE
Arm Type
Active Comparator
Arm Description
Spikevax (Moderna), injectable dispersion
Intervention Type
Biological
Intervention Name(s)
Janssen vaccine
Other Intervention Name(s)
Janssen Biologics B.V., EU/1/20/1525/001 EU/1/20/1525/002
Intervention Description
0.5 ml millilitre(s) Intramuscular use
Intervention Type
Biological
Intervention Name(s)
Spikevax (Moderna) vaccine
Other Intervention Name(s)
MODERNA BIOTECH SPAIN, S.L., EU/1/20/1507/001
Intervention Description
0.5 ml millilitre(s) Intramuscular use
Primary Outcome Measure Information:
Title
Changes in the production of anti-S1-RBD IgG antibodies.
Description
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
Secondary Outcome Measure Information:
Title
Change in the presence of activated T cells specific for SARS-CoV-2 (Sprotein).
Description
T-cell response to SARS-CoV-2 will be analyzed by flow cytometry.
Time Frame
1 year
Title
Changes in the phenotype of effector/memory/virgin B and T cell populations and subtypes of Th and NK cell populations.
Description
T-cell response to SARS-CoV-2 will be analyzed by flow cytometry.
Time Frame
1 year
Title
Incidence of symptomatic/asymptomatic COVID infection after revaccination.
Description
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
Title
Number of patients with hospital admissions and/or visits to the emergency department for severe symptoms related to COVID-19 infection.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who underwent solid organ transplantation prior to revaccination against COVID-19.
Patients who have received the full COVID-19 vaccination regimen with Spikevax (Moderna) vaccine, with a minimum of 8 weeks having elapsed from the second dose to the time of trial initiation.
Age > 18 years.
All participants must have previously agreed to participate in the study by signing the informed consent form.
Exclusion Criteria:
Having suffered SARS-CoV-2 infection at any time prior to inclusion in the study.
Subjects without solid organ transplantation or with a different solid organ (e.g. pancreas transplantation) and without any type of immunosuppression (immunocompetent non-transplanted) from the general population.
Age < 18 years
Temperature of at least 38°C in the 24 hours prior to immunization or other clinically relevant acute symptomatology.
Clinical manifestations compatible with COVID-19 infection at the time of evaccination.
Known allergy or history of anaphylaxis or other serious adverse events to the administration of vaccines or their excipients.
Any other condition that contraindicates vaccination against SARSCov2, including pregnancy.
Having presented graft rejection in the 15 days prior to the start of the study.
Any condition or situation that may interfere with the ability to maintain adherence to study procedures and visits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Crespo García
Organizational Affiliation
Hospital Universitario Marqués de Valdecilla
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcos López Hoyos
Organizational Affiliation
Hospital Universitario Marqués de Valdecilla
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Safety, and Immunogenicity of Vaccine Reimmunization With a Third Homologous Versus Heterologous Dose Against COVID-19 in Patients Undergoing Solid Organ Transplantation.
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