NCT05378191

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Apr 2021

Longer than P75 for phase_2 covid19

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

1.3 years

First QC Date

September 21, 2021

Last Update Submit

May 17, 2022

Conditions

Covid19

Keywords

heterologous vaccination

Outcome Measures

Primary Outcomes (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.

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

    14 days after randomization

Secondary Outcomes (7)

  • 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.

    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.

    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.

    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)

    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)

    Day 1-28

  • +2 more secondary outcomes

Other Outcomes (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.

    Month 1-12

Study Arms (2)

VACCINATION

ACTIVE COMPARATOR

One standard dose of COMIRNATY in adult subjects (18 years old) having received prior VAXZEVRIA vaccination.

Drug: COMIRNATY

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.

Interventions

COMIRNATYDRUG

One dose of COMIRNATY

Also known as: COVID-19, mRNA vaccine
VACCINATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Universitario de Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

Hospital Vall d´Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (3)

  • Garcia-Perez J, Borobia AM, Perez-Olmeda M, Portoles A, Castano L, Campins-Arti M, Bertran MJ, Bermejo M, Arribas JR, Lopez A, Ascaso-Del-Rio A, Arana-Arri E, Fuentes Camps I, Vilella A, Cascajero A, Garcia-Morales MT, Castillo de la Osa M, Perez Ingidua C, Lora D, Jimenez-Santana P, Pino-Rosa S, Gomez de la Camara A, De La Torre-Tarazona E, Calonge E, Cruces R, Belda-Iniesta C, Alcami J, Frias J, Carcas AJ, Diez-Fuertes F; CombiVacS Study Group. Immunogenicity of a third dose with mRNA-vaccines in the ChAdOx1-S/BNT162b2 vaccination regimen against SARS-CoV-2 variants. iScience. 2024 Aug 14;27(9):110728. doi: 10.1016/j.isci.2024.110728. eCollection 2024 Sep 20.

    PMID: 39286494DERIVED

  • Garcia-Perez J, Gonzalez-Perez M, Castillo de la Osa M, Borobia AM, Castano L, Bertran MJ, Campins M, Portoles A, Lora D, Bermejo M, Conde P, Hernandez-Gutierrez L, Carcas A, Arana-Arri E, Tortajada M, Fuentes I, Ascaso A, Garcia-Morales MT, Erick de la Torre-Tarazona H, Arribas JR, Imaz-Ayo N, Mellado-Pau E, Agusti A, Perez-Ingidua C, Gomez de la Camara A, Ochando J, Belda-Iniesta C, Frias J, Alcami J, Perez-Olmeda M; CombiVacS study Group. Immunogenic dynamics and SARS-CoV-2 variant neutralisation of the heterologous ChAdOx1-S/BNT162b2 vaccination: Secondary analysis of the randomised CombiVacS study. EClinicalMedicine. 2022 Jul 1;50:101529. doi: 10.1016/j.eclinm.2022.101529. eCollection 2022 Aug.

    PMID: 35795713DERIVED

  • Borobia AM, Carcas AJ, Perez-Olmeda M, Castano L, Bertran MJ, Garcia-Perez J, Campins M, Portoles A, Gonzalez-Perez M, Garcia Morales MT, Arana-Arri E, Aldea M, Diez-Fuertes F, Fuentes I, Ascaso A, Lora D, Imaz-Ayo N, Baron-Mira LE, Agusti A, Perez-Ingidua C, Gomez de la Camara A, Arribas JR, Ochando J, Alcami J, Belda-Iniesta C, Frias J; CombiVacS Study Group. Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet. 2021 Jul 10;398(10295):121-130. doi: 10.1016/S0140-6736(21)01420-3. Epub 2021 Jun 25.

    PMID: 34181880DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 VaccineCVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA VaccinesNucleic Acid-Based VaccinesVaccines, SyntheticRecombinant ProteinsProteinsAmino Acids, Peptides, and ProteinsVaccinesBiological ProductsComplex MixturesCOVID-19 VaccinesViral VaccinesAntigensBiological Factors

Study Officials

  • Cristobal Belda Iniesta, MD, PhD

    Instituto de Salud Carlos III

    STUDY CHAIR

  • Jesús Frías Iniesta, MD, PhD

    Spanish Clinical Research Network - SCReN

    PRINCIPAL INVESTIGATOR

  • Jose R Arribas, MD, PhD

    Hospital Universitario La Paz

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2021

First Posted

May 18, 2022

Study Start

April 22, 2021

Primary Completion

August 22, 2022

Study Completion

December 30, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Within one year after study end.
Access Criteria
Published in EudraCT
More information

Locations

ES(5)