NCT05048940

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

Same day

First QC Date

September 8, 2021

Last Update Submit

February 28, 2023

Conditions

Covid19

Keywords

VaccineCovid-19Liver TrasplantLung TrasplantHeart TrasplantKidney Trasplant

Outcome Measures

Primary Outcomes (1)

  • 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.

    28 days

Secondary Outcomes (4)

  • Change in the presence of activated T cells specific for SARS-CoV-2 (Sprotein).

    1 year

  • Changes in the phenotype of effector/memory/virgin B and T cell populations and subtypes of Th and NK cell populations.

    1 year

  • Incidence of symptomatic/asymptomatic COVID infection after revaccination.

    1 year

  • Number of patients with hospital admissions and/or visits to the emergency department for severe symptoms related to COVID-19 infection.

    1 year

Study Arms (2)

HETEROLOGOUS VACCINE

EXPERIMENTAL

COVID-19 Vaccine Janssen, injectable suspension

Biological: Janssen vaccine

HOMOLOGOUS VACCINE

ACTIVE COMPARATOR

Spikevax (Moderna), injectable dispersion

Biological: Spikevax (Moderna) vaccine

Interventions

Janssen vaccineBIOLOGICAL

0.5 ml millilitre(s) Intramuscular use

Also known as: Janssen Biologics B.V., EU/1/20/1525/001 EU/1/20/1525/002
HETEROLOGOUS VACCINE
Spikevax (Moderna) vaccineBIOLOGICAL

0.5 ml millilitre(s) Intramuscular use

Also known as: MODERNA BIOTECH SPAIN, S.L., EU/1/20/1507/001
HOMOLOGOUS VACCINE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA VaccinesNucleic Acid-Based VaccinesVaccines, SyntheticRecombinant ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological ProductsComplex MixturesCOVID-19 VaccinesViral VaccinesAntigensBiological Factors

Study Officials

  • Javier Crespo García

    Hospital Universitario Marqués de Valdecilla

    PRINCIPAL INVESTIGATOR

  • Marcos López Hoyos

    Hospital Universitario Marqués de Valdecilla

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 17, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

March 2, 2023

Record last verified: 2023-02

Locations

ES(1)