Covid19Phase 3REIN-TXNCT05048940
Efficacy, Safety, and Immunogenicity of Vaccine Reimmunization With a Third Homologous Versus Heterologous Dose Against COVID-19 in Patients Undergoing Solid Organ Transplantation.
A Phase 3 study testing Janssen vaccine and Spikevax (Moderna) vaccine in people with Covid19, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Janssen vaccine and Spikevax (Moderna) vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to 1 Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
About this study
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.
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Janssen vaccine, Spikevax (Moderna) vaccine
- Keywords
- Vaccine, Covid-19, Liver Trasplant, Lung Trasplant, Heart Trasplant, Kidney Trasplant
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Janssen vaccineBiological
Also called Janssen Biologics B.V., EU/1/20/1525/001 EU/1/20/1525/002
0.5 ml millilitre(s) Intramuscular use
Spikevax (Moderna) vaccineBiological
Also called MODERNA BIOTECH SPAIN, S.L., EU/1/20/1507/001
0.5 ml millilitre(s) Intramuscular use
| Study group | Role | What they receive |
|---|---|---|
| HETEROLOGOUS VACCINE | Experimental | COVID-19 Vaccine Janssen, injectable suspension Receives: Biological: Janssen vaccine |
| HOMOLOGOUS VACCINE | Active comparator | Spikevax (Moderna), injectable dispersion Receives: Biological: Spikevax (Moderna) vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Why it stopped: The health authority indicates that the official vaccination schedule differs from that described in the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Crespo García, Principal investigator, Hospital Universitario Marqués de ValdecillaMarcos López Hoyos, Principal investigator, Hospital Universitario Marqués de Valdecilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048940
- Sponsor's protocol ID
- REIN-TX
- Acronym
- REIN-TX
- Status last verified
- Feb 2023
- First submitted
- 8 Sep 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05048940
- Acronym / sponsor ID
- REIN-TX / REIN-TX
- Conditions
- Covid19
- Keywords
- Vaccine, Covid-19, Liver Trasplant, Lung Trasplant, Heart Trasplant, Kidney Trasplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The health authority indicates that the official vaccination schedule differs from that described in the protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HETEROLOGOUS VACCINE | Experimental | Biological: Janssen vaccineCOVID-19 Vaccine Janssen, injectable suspension |
| HOMOLOGOUS VACCINE | Active comparator | Biological: Spikevax (Moderna) vaccineSpikevax (Moderna), injectable dispersion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Janssen vaccineAlso: Janssen Biologics B.V., EU/1/20/1525/001 EU/1/20/1525/0020.5 ml millilitre(s) Intramuscular use | Biological | HETEROLOGOUS VACCINE |
| Spikevax (Moderna) vaccineAlso: MODERNA BIOTECH SPAIN, S.L., EU/1/20/1507/0010.5 ml millilitre(s) Intramuscular use | Biological | HOMOLOGOUS VACCINE |
Primary outcome
Changes in the production of anti-S1-RBD IgG antibodies.
Time frame: 28 days
Positivity for comparison before and after revaccination and according to homologous or heterologous vaccination will be quantified in the laboratory method units.
4 secondary outcomes
Change in the presence of activated T cells specific for SARS-CoV-2 (Sprotein).
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.
Time frame: 1 year
Incidence of symptomatic/asymptomatic COVID infection after revaccination.
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.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Crespo García principal investigator
Hospital Universitario Marqués de Valdecilla
Marcos López Hoyos principal investigator
Hospital Universitario Marqués de Valdecilla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Janssen vaccine and Spikevax (Moderna) vaccine in people with Covid19, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the production of anti-S1-RBD IgG antibodies. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.