Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose

Instituto de Investigación Hospital Universitario La Paz600 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

600

Conditions

Covid19

Interventions

COMIRNATYDRUG

One dose of COMIRNATY

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

Hospital Universitario de Cruces

Barakaldo, Bizkaia, Spain

Hospital Vall d´Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Clínico San Carlos

Madrid, Spain

Outcomes

Primary Outcomes

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.

Antibodies against SARS-CoV-2 spike protein. Measure: BAU/mL

Time frame: 14 days after randomization

Secondary Outcomes

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.

Antibodies against SARS-CoV-2 spike protein. Measure: BAU/mL

Time frame: 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.

Antibodies against SARS-CoV-2 spike protein (BAU/mL)

Time frame: 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.

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

Time frame: 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)

Number of solicited local and systemic adverse events (AEs) for 7 days after vaccine

Time frame: 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)

Data from ClinicalTrials.gov

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