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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Spanish Clinical Research Network - SCReN | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VACCINATION | Active Comparator | One standard dose of COMIRNATY in adult subjects (18 years old) having received prior VAXZEVRIA vaccination. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMIRNATY | Drug | One dose of COMIRNATY |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the relationship between the immune response measured as NAV (Neutralizing antibodies) and antibodies against SARS-CoV-2 spike protein measured by immunoassay. | Neutralizing antibodies (BAU/mL) and antibodies against SARS-CoV-2 spike protein (BAU/mL) | Month 1-12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristobal Belda Iniesta, MD, PhD | Instituto de Salud Carlos III | Study Chair |
| JesĂşs FrĂas Iniesta, MD, PhD | Spanish Clinical Research Network - SCReN | Principal Investigator |
| Jose R Arribas, MD, PhD | Hospital Universitario La Paz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Cruces | Barakaldo | Bizkaia | 48903 | Spain | ||
| Hospital Vall d´Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39286494 | Derived | 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. | |
| 35795713 |
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Will submit data to European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) and share data result.
Within one year after study end.
Published in EudraCT
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Not provided
| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| C000722934 | CVnCoV COVID-19 vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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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.
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Antibodies against SARS-CoV-2 spike protein (BAU/mL) |
| 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 | 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 | 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) | Number of unsolicited local and systemic adverse events (AEs) for 28 days after vaccine | Day 1-28 |
| To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (serious adverse events) | Number of Serious adverse events (SAEs) throughout the study (from randomization until end of the study). | Month 1-12 |
| To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (Medically-attended adverse events) | Number of Medically-attended adverse events (MAAEs) from the day of vaccination until 6 months after the last vaccination | Month 1-6 |
| Barcelona |
| 08035 |
| Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital ClĂnico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Derived |
| 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. |
| 34181880 | Derived | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |