Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose (CombiVacS)

May 17, 2022 updated by: Instituto de Investigación Hospital Universitario La Paz

A Phase 2, Comparative, Randomised, Adaptive Trial to Evaluate the Safety and Immunogenicity of One Dose of Comirnaty® in Subjects That Had Received One Dose of Vaxzevria®

CombiVacS is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of COMIRNATY after a previous single dose of VAXZEVRIA. A stratification will be made based on the following factors: study site, sex and age. This protocol allows to test the immunogenicity and safety of a heterologous vaccination strategy after a previous single dose of VAXZEVRIA.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, non-blinded, controlled, adaptive, multicenter, Phase II study in subjects aged ≥18 years and in good health or stable clinical situation that have received a previous single dose of VAXZEVRIA. Subjects will be randomized to immediately receive or not a dose of COMIRNATY in a ratio of 2:1. If primary analysis at day 14th confirms the starting hypothesis, subjects randomized to no vaccination will be considered for administration of one dose of COMINARTY at day 28th according to Public Health Department of the Ministry of Health recommendations on heterologous vaccination. In case the primary analysis does not confirm the starting hypothesis, subjects will be followed at the time points defined in the flow-chart without administration of COMIRNATY.

Other heterologous vaccination strategies could be incorporated if deemed necessary for public health reasons. This could include the use of different vaccination strategies including those already marketed vaccines for comparative assessment of their safety and efficacy on SARS-CoV-2 and its variants.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Vall D´Hebron
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
    • Bizkaia
      • Baracaldo, Bizkaia, Spain, 48903
        • Hospital Universitario de Cruces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult subjects (18 years old) having received a prime VAXZEVRIA vaccination between 8 and 12 weeks before the screening visit
  • Participants must provide consent indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study.
  • Subjects in good health or stable clinical situation.
  • Participant is willing and able to adhere to the procedures specified in this protocol.

Exclusion Criteria:

  • Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC within 24 hours prior to the planned dose of study vaccine.
  • Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to COMIRNATY excipients.
  • Subjects with any contraindication to the administration of COMIRNATY, included pregnancy.
  • Subjects with prior documented COVID19 since VAXZEVRIA vaccination.
  • Subjects have symptoms or signs compatible with COVID19.
  • Subjects participating in a clinical trial in the last three months.
  • Any condition or situation precluding or interfering the compliance with the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: VACCINATION
One standard dose of COMIRNATY in adult subjects (18 years old) having received prior VAXZEVRIA vaccination.
Drug: COMIRNATY
One dose of COMIRNATY
Other Names:
  • COVID-19, mRNA vaccine
No Intervention: NO INTERVENTION
No vaccination in adult subjects (18 years old) having received prior VAXZEVRIA vaccination. If primary analysis at day 14th confirms the starting hypothesis, subjects randomized to this arm will be considered for administration of one dose of COMINARTY at day 28th according to Public Health Department of the Ministry of Health recommendations on heterologous vaccination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the humoral immune response against SARS-CoV-2, 14 days after vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA, as compared with no dosing.
Time Frame: 14 days after randomization
Antibodies against SARS-CoV-2 spike protein. Measure: BAU/mL
14 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the humoral immune response against SARS-CoV-2, 28 days after vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA.
Time Frame: 28 days after randomization
Antibodies against SARS-CoV-2 spike protein. Measure: BAU/mL
28 days after randomization
To assess the long-term (up to 1 year) humoral immune response against SARS-CoV-2 of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA.
Time Frame: 3, 6 and 12 months after randomization
Antibodies against SARS-CoV-2 spike protein (BAU/mL)
3, 6 and 12 months after randomization
To assess the occurrence of symptomatic molecularly confirmed COVID-19 and severity of COVID-19 signs and symptoms after the administration of a dose of COMIRNATY in subjects that received a prior single dose of VAXZEVRIA.
Time Frame: Month 1 - 12
Number of participants with molecularly confirmed COVID-19 and presence and severity of COVID-19 signs and symptoms as measured by Symptoms of Infection with Coronavirus-19
Month 1 - 12
To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (solicited adverse events)
Time Frame: Day 1-7
Number of solicited local and systemic adverse events (AEs) for 7 days after vaccine
Day 1-7
To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (unsolicited adverse events)
Time Frame: Day 1-28
Number of unsolicited local and systemic adverse events (AEs) for 28 days after vaccine
Day 1-28
To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (serious adverse events)
Time Frame: Month 1-12
Number of Serious adverse events (SAEs) throughout the study (from randomization until end of the study).
Month 1-12
To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (Medically-attended adverse events)
Time Frame: Month 1-6
Number of Medically-attended adverse events (MAAEs) from the day of vaccination until 6 months after the last vaccination
Month 1-6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the relationship between the immune response measured as NAV (Neutralizing antibodies) and antibodies against SARS-CoV-2 spike protein measured by immunoassay.
Time Frame: Month 1-12
Neutralizing antibodies (BAU/mL) and antibodies against SARS-CoV-2 spike protein (BAU/mL)
Month 1-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborators

Instituto de Salud Carlos III
Spanish Clinical Research Network - SCReN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2021

Primary Completion (Anticipated)

August 22, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5859

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will submit data to European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) and share data result.

IPD Sharing Time Frame

Within one year after study end.

IPD Sharing Access Criteria

Published in EudraCT

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on COMIRNATY

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe