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

  • Clinicaltrials.gov identifier

    NCT04860739

  • Recruitment Status

    Active, not recruiting

  • First Posted

    April 27, 2021

  • Last update posted

    May 4, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:Covid19
  • Intervention/Treatment: Drug: COMIRNATY
  • Phase: Phase 2

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 Design

  • Study Type: Interventional
  • Actual Enrollment: 676 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Subjects will be randomized to immediately receive or not a dose of COMIRNATY in a ratio of 2:1. If primary analysis at 14 days 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.
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: A Phase 2, Comparative, Randomised, Adaptive Trial to Evaluate the Immunogenicity Against SARS-Cov2 and Safety of Boosted Vaccination With COMIRNATY in Subjects Having Received Prime Vaccination With VAXZERIA
  • Actual Study Start Date: April 2021
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: April 2022

Arms and interventions

Arm Intervention/treatment
Experimental: VACCINATION
One standard dose of COMIRNATY in adult subjects (18 years old) having received prior VAXZEVRIA vaccination.
Drug: COMIRNATY
One dose of COMIRNATY

Outcome Measures

  • Primary Outcome Measures: 1. To assess the humoral immune response against SARS-CoV-2, 14 days after a vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA, as compared with no dosing. [ Time Frame: 14 days after randomization ]
    Serological response to vaccination (antibodies against SARS-CoV-2 spike protein) as measured by immunoassay, 14 days after the boost dose.
  • Secondary Outcome Measures: 1. To assess the humoral immune response against SARS-CoV-2, 28 days after a vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (antibodies) [ Time Frame: 28 days after randomization ]
    Antibodies against SARS-CoV-2 spike protein measured by immunoassay
  • 2. To assess the humoral immune response against SARS-CoV-2, 28 days after a vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (Virus neutralization) [ Time Frame: 14 and 28 days after randomization ]
    Virus neutralization assay
  • 3. 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
  • 4. 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 ]
    Solicited local and systemic adverse events (AEs) for 7 days after vaccine
  • 5. 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 ]
    Unsolicited local and systemic adverse events (AEs) for 28 days after vaccine
  • 6. 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 ]
    Serious adverse events (SAEs) throughout the study (from randomization until end of the study)
  • 7. 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 ]
    Medically-attended adverse events (MAAEs) from the day of vaccination until 6 months after the last vaccination
  • 8. To assess the humoral immune response against viral variants of SARS-CoV-2, 14 and 28 days after 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 measured by immunoassay and SARS-CoV-2 neutralization as measured by virus neutralization assay
  • Other Outcome Measures: 1. To evaluate the relationship between the immune response measured as NAV (Neutralizing antibodies) and antibodies against SARSCoV-2 spike protein measured by immunoassay [ Time Frame: Month 1-12 ]
    Relationship between neutralizing antibodies and antibodies against SARS-CoV-2 spike protein measured by immunoassay

Eligibility Criteria

  • Ages Eligible for Study: 18 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Locations

Spain, Vizkaia
Hospital Universitario de Cruces
Barakaldo

Spain
Hospital Vall d´Hebron
Barcelona

Spain
Hospital Clinic de Barcelona
Barcelona

Spain
Hospital Clínico San Carlos
Madrid

Spain
La Paz University Hospital
Madrid

Sponsors and Collaborators

Spanish Clinical Research Network - SCReN

Instituto de Salud Carlos III

Investigators

Study Chair: Cristobal Belda Iniesta, MD, PhD Instituto de Salud Carlos III

Principal Investigator: Jesús Frías Iniesta, MD, PhD Spanish Clinical Research Network - SCReN

Study Director: Jose R Arribas, MD, PhD Hospital Universitario La Paz

More Information