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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05378191
Recruitment Status : Active, not recruiting
First Posted : May 18, 2022
Last Update Posted : May 18, 2022
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Spanish Clinical Research Network - SCReN
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

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 Intervention/treatment Phase
Covid19 Drug: COMIRNATY 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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 Safety and Immunogenicity of One Dose of Comirnaty® in Subjects That Had Received One Dose of Vaxzevria®
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : August 22, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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. 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 ]
    Number of 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 ]
    Number of 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 ]
    Number of 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 ]
    Number of Medically-attended adverse events (MAAEs) from the day of vaccination until 6 months after the last vaccination


Other Outcome Measures:
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05378191


Locations
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Spain
Hospital Universitario de Cruces
Baracaldo, Bizkaia, Spain, 48903
Hospital Vall d´Hebron
Barcelona, Spain, 08035
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Instituto de Salud Carlos III
Spanish Clinical Research Network - SCReN
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT05378191    
Obsolete Identifiers: NCT04860739
Other Study ID Numbers: 5859
First Posted: May 18, 2022    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will submit data to European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) and share data result.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Within one year after study end.
Access Criteria: Published in EudraCT
URL: https://eudract.ema.europa.eu/index.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
heterologous vaccination
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs