Efficacy, Safety, and Immunogenicity of Vaccine Reimmunization With a Third Homologous Versus Heterologous Dose Against COVID-19 in Patients Undergoing Solid Organ Transplantation.

NCT ID: NCT05048940

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2021-09-01

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:

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HETEROLOGOUS VACCINE

COVID-19 Vaccine Janssen, injectable suspension

Group Type: EXPERIMENTAL

Janssen vaccine

Intervention Type: BIOLOGICAL

0.5 ml millilitre(s) Intramuscular use

HOMOLOGOUS VACCINE

Spikevax (Moderna), injectable dispersion

Group Type: ACTIVE_COMPARATOR

Spikevax (Moderna) vaccine

Intervention Type: BIOLOGICAL

0.5 ml millilitre(s) Intramuscular use

Interventions

Janssen vaccine

0.5 ml millilitre(s) Intramuscular use

Intervention Type: BIOLOGICAL

Spikevax (Moderna) vaccine

0.5 ml millilitre(s) Intramuscular use

Intervention Type: BIOLOGICAL

Other Intervention Names

Janssen Biologics B.V.; EU/1/20/1525/001 EU/1/20/1525/002; MODERNA BIOTECH SPAIN, S.L.; EU/1/20/1507/001

Eligibility Criteria

Inclusion Criteria

1. Patients who underwent solid organ transplantation prior to revaccination against COVID-19.

2. 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.

3. Age > 18 years.

4. All participants must have previously agreed to participate in the study by signing the informed consent form.

Exclusion Criteria

1. Having suffered SARS-CoV-2 infection at any time prior to inclusion in the study.

2. 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.

3. Age < 18 years

4. Temperature of at least 38°C in the 24 hours prior to immunization or other clinically relevant acute symptomatology.

5. Clinical manifestations compatible with COVID-19 infection at the time of evaccination.

6. Known allergy or history of anaphylaxis or other serious adverse events to the administration of vaccines or their excipients.

7. Any other condition that contraindicates vaccination against SARSCov2, including pregnancy.

8. Having presented graft rejection in the 15 days prior to the start of the study.

9. Any condition or situation that may interfere with the ability to maintain adherence to study procedures and visits.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Marqués de Valdecilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Crespo García

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Marqués de Valdecilla

Marcos López Hoyos

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Marqués de Valdecilla

Locations

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Countries

Spain

Other Identifiers

REIN-TX

Identifier Type: -

Identifier Source: org_study_id