stop_circleTerminated/Withdrawn
SARS-CoV-2 Infection, Coronavirus disease 2019 (COVID-19)
Bayer Identifier:infoA unique number for a trial given by Bayer.
21819
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
COVID-19: A trial studying the SARS-CoV-2 mRNA Vaccine CVnCoV to learn about the immune response, the safety, and the degree of typical vaccination reactions when CVnCoV is given at the same time as a flu vaccine compared to when the vaccines are separately given in adults 60 years of age and older
Trial purpose
The most recently discovered coronavirus (SARS-CoV-2) may cause illness in humans ranging from the common cold to serious illness, also referred to as Coronavirus disease 2019 (COVID-19). As of January 2021, there are only few authorized vaccines available for the prevention of COVID-19.
“CVnCoV” is a new SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccine which is currently being developed for the prevention of COVID-19. The vaccine contains a molecule called mRNA which serves as an instruction manual for the cells in the body to produce a piece of protein from SARS-CoV-2 which activates the body´s defense system. The “CVnCoV” vaccine is injected into the muscle. After the injection, the body recognizes the protein as something that does not belong there. In this way the natural infection with the virus is imitated. The body activates immune cells to produce antibodies against the virus and creates specific immune cells called T cells.
“CVnCoV” is given in two doses separated by 28 days.
In this study, the researchers will look at how well “CVnCoV” works when the first of the two doses is given together with a flu vaccine called seasonal quadrivalent influenza vaccine (QIV). They will also look at how well the flu vaccine works under these conditions. The QIV is injected into the muscle and is given as 1 dose. To see how well the participants’ immune systems is activated by “CVnCoV” and QIV, the researches will measure the levels of specific antibodies against the viruses in the blood. Antibodies are proteins that allow the immune system to find and react to bacteria and viruses in the body. The researches will look into how safe the vaccination is and which type and degree of typical vaccination reactions are seen. To give “CVnCoV” and the flu vaccine together in the future when needed, e.g. during the flu season, would reduce the burden on the health system and on the patients.
Participants in this study are adults aged 60 years and older.
In this study, participants are assigned to one of the two parallel groups of the same size. The assignment to either group is done by chance via a computer program. Participants in group 1 (Co-ad group) will receive CVnCoV at the same visit as QIV. Participants in group 2 (control group) will receive QIV and CVnCoV at two different visits. The Co-ad group will receive the first dose of CVnCoV and a dose of QIV in opposite arms at Day 1, the second dose of CVnCoV at Day 29, and a placebo injection, i.e. an injection that looks like a vaccination injection but does not contain vaccine, at Day 57. The control group will receive QIV and placebo in opposite arms at Day 1, the first dose of CVnCoV at day 29 and the second dose of CVnCoV at Day 57.
There will be five visits and four phone calls.
During the study, the study team will take blood samples on four occasions to measure the antibodies against SARS-CoV-2, and nasopharyngeal swabs at 1 occasion. The physicians will do physical examinations at each visit. The participants will be asked how they are feeling and if they have any medical problems. They will, in addition, receive an electronic Diary to report medical problems.
“CVnCoV” is a new SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccine which is currently being developed for the prevention of COVID-19. The vaccine contains a molecule called mRNA which serves as an instruction manual for the cells in the body to produce a piece of protein from SARS-CoV-2 which activates the body´s defense system. The “CVnCoV” vaccine is injected into the muscle. After the injection, the body recognizes the protein as something that does not belong there. In this way the natural infection with the virus is imitated. The body activates immune cells to produce antibodies against the virus and creates specific immune cells called T cells.
“CVnCoV” is given in two doses separated by 28 days.
In this study, the researchers will look at how well “CVnCoV” works when the first of the two doses is given together with a flu vaccine called seasonal quadrivalent influenza vaccine (QIV). They will also look at how well the flu vaccine works under these conditions. The QIV is injected into the muscle and is given as 1 dose. To see how well the participants’ immune systems is activated by “CVnCoV” and QIV, the researches will measure the levels of specific antibodies against the viruses in the blood. Antibodies are proteins that allow the immune system to find and react to bacteria and viruses in the body. The researches will look into how safe the vaccination is and which type and degree of typical vaccination reactions are seen. To give “CVnCoV” and the flu vaccine together in the future when needed, e.g. during the flu season, would reduce the burden on the health system and on the patients.
Participants in this study are adults aged 60 years and older.
In this study, participants are assigned to one of the two parallel groups of the same size. The assignment to either group is done by chance via a computer program. Participants in group 1 (Co-ad group) will receive CVnCoV at the same visit as QIV. Participants in group 2 (control group) will receive QIV and CVnCoV at two different visits. The Co-ad group will receive the first dose of CVnCoV and a dose of QIV in opposite arms at Day 1, the second dose of CVnCoV at Day 29, and a placebo injection, i.e. an injection that looks like a vaccination injection but does not contain vaccine, at Day 57. The control group will receive QIV and placebo in opposite arms at Day 1, the first dose of CVnCoV at day 29 and the second dose of CVnCoV at Day 57.
There will be five visits and four phone calls.
During the study, the study team will take blood samples on four occasions to measure the antibodies against SARS-CoV-2, and nasopharyngeal swabs at 1 occasion. The physicians will do physical examinations at each visit. The participants will be asked how they are feeling and if they have any medical problems. They will, in addition, receive an electronic Diary to report medical problems.
Key Participants Requirements
Sex
AllAge
60 - N/ATrial summary
Enrollment Goal info
0The overall number of participants needed for a trial.
Trial Dates info
October 2021 - November 2022Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 3A phase is a step in the research of a new treatment.
Could I Receive a placebo info
YesA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
BAY3491699A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
YesA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Fundación Cenit para la Investigación en Neurociencias | CABA, C1125 ABD, Argentina |
Withdrawn | Sanatorio Parque S.A. | Rosario, S2000DSV, Argentina |
Withdrawn | Instituto de Investigaciones Clinicas de Quilmes | Quilmes, 1878, Argentina |
Withdrawn | Centro de Atencion e Investigation Medica S.A.S. - CAIMED CH | Cundinamarca, Colombia |
Withdrawn | Centros de Estudios en Infectologia Pediatrica S.A.S. CEIP | Calì, Colombia |
Withdrawn | Centro de Investigacion Medico Asistencial S.A.S - CIMEDICAL | Barranquilla, Colombia |
Withdrawn | Istituto de Investigacion Nutricional | Lima-12, Peru |
Withdrawn | Clinica Medica San Martin EIRL - Inv. Metabolicas-Cardiolog | Ica, Peru |
Withdrawn | Clinica Renal y Oncologica - Centro para Ensayos Clinicos | Lima, 15011, Peru |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Antibody titers for SARS-CoV-2 receptor binding domain (RBD)date_rangeTime Frame:28 days after the second dose of CVnCoV
- Hemagglutination inhibition (HI) titers for each of the 4 strainsdate_rangeTime Frame:28 days after the QIV vaccination
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Number of participants seroconverting for SARS-CoV- 2 spike protein antibodiesMeasured by enzyme-linked immunosorbent assay (ELISA).date_rangeTime Frame:28 days after the second dose of CVnCoV
- SARS-CoV-2 spike protein-specific antibody levels in serumMeasured by enzyme-linked immunosorbent assay (ELISA).date_rangeTime Frame:28 days after the second dose of CVnCoV
- Number of participants seroconverting for SARS-CoV- 2 neutralizing antibodiesMeasured by an activity assay.date_rangeTime Frame:28 days after the second dose of CVnCoV
- SARS-CoV-2 neutralizing antibody levels in serumdate_rangeTime Frame:28 days after the second dose of CVnCoV
- Number of participants with seroprotection for serum antibodies against the 4 influenza vaccine strainsMeasured by hemagglutination inhibition (HI) assay.date_rangeTime Frame:28 days after the QIV dose
- Number of participants seroconverting for serum antibodies against the 4 influenza vaccine strainsMeasured by hemagglutination inhibition (HI) assay.date_rangeTime Frame:28 days after the QIV dose
- Serum antibody titers against the 4 influenza vaccine strainsMeasured by hemagglutination inhibition (HI) assay.date_rangeTime Frame:28 days after the QIV dose
- Number of participants with solicited local adverse events (AEs) of CVnCoV vaccinedate_rangeTime Frame:Within 7 days after each study vaccination
- Number of participants with solicited systemic AEsdate_rangeTime Frame:Within 7 days after each study vaccination
- Number of participants with unsolicited AEsdate_rangeTime Frame:Within 28 days after each study vaccination
- Number of participants with serious adverse event (SAEs)date_rangeTime Frame:Approximately 60 weeks
- Number of participants with adverse event of special interest (AESIs)date_rangeTime Frame:Approximately 60 weeks
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
Biological/VaccineAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
PreventionThe main reason the clinical trial is being done.
Allocation info
RandomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Parallel AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
2A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.