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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04860739
Other study ID # 5859
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date April 24, 2021
Est. completion date April 30, 2022

Study information

Verified date April 2021
Source Spanish Clinical Research Network - SCReN
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 676
Est. completion date April 30, 2022
Est. primary completion date May 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
COMIRNATY
One dose of COMIRNATY

Locations

Country Name City State
Spain Hospital Universitario de Cruces Barakaldo Vizkaia
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Vall d´Hebron Barcelona
Spain Hospital Clínico San Carlos Madrid
Spain La Paz University Hospital Madrid

Sponsors (2)

Lead Sponsor Collaborator
Spanish Clinical Research Network - SCReN Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other To evaluate the relationship between the immune response measured as NAV (Neutralizing antibodies) and antibodies against SARSCoV-2 spike protein measured by immunoassay Relationship between neutralizing antibodies and antibodies against SARS-CoV-2 spike protein measured by immunoassay Month 1-12
Primary 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. Serological response to vaccination (antibodies against SARS-CoV-2 spike protein) as measured by immunoassay, 14 days after the boost dose. 14 days after randomization
Secondary 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) Antibodies against SARS-CoV-2 spike protein measured by immunoassay 28 days after randomization
Secondary 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) Virus neutralization assay 14 and 28 days after randomization
Secondary 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 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
Secondary To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (solicited adverse events) Solicited local and systemic adverse events (AEs) for 7 days after vaccine Day 1-7
Secondary To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (unsolicited adverse events) Unsolicited local and systemic adverse events (AEs) for 28 days after vaccine Day 1-28
Secondary To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (serious adverse events) Serious adverse events (SAEs) throughout the study (from randomization until end of the study) Month 1-12
Secondary To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (Medically-attended adverse events) Medically-attended adverse events (MAAEs) from the day of vaccination until 6 months after the last vaccination Month 1-6
Secondary 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 Antibodies against SARS-CoV-2 spike protein measured by immunoassay and SARS-CoV-2 neutralization as measured by virus neutralization assay 3, 6 and 12 months after randomization
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