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SARS-CoV-2 Infection, Coronavirus disease 2019 (COVID-19)

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.

Key Participants Requirements

Sex

All

Age

60 - N/A

Trial summary

Enrollment Goal
0
Trial Dates
October 2021 - November 2022
Phase
Phase 3
Could I Receive a placebo
Yes
Products
BAY3491699
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Withdrawn
Fundación Cenit para la Investigación en NeurocienciasCABA, C1125 ABD, Argentina
Withdrawn
Sanatorio Parque S.A.Rosario, S2000DSV, Argentina
Withdrawn
Instituto de Investigaciones Clinicas de QuilmesQuilmes, 1878, Argentina
Withdrawn
Centro de Atencion e Investigation Medica S.A.S. - CAIMED CHCundinamarca, Colombia
Withdrawn
Centros de Estudios en Infectologia Pediatrica S.A.S. CEIPCalì, Colombia
Withdrawn
Centro de Investigacion Medico Asistencial S.A.S - CIMEDICALBarranquilla, Colombia
Withdrawn
Istituto de Investigacion NutricionalLima-12, Peru
Withdrawn
Clinica Medica San Martin EIRL - Inv. Metabolicas-CardiologIca, Peru
Withdrawn
Clinica Renal y Oncologica - Centro para Ensayos ClinicosLima, 15011, Peru

Primary Outcome

  • 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 strains
    date_rangeTime Frame:
    28 days after the QIV vaccination

Secondary Outcome

  • Number of participants seroconverting for SARS-CoV- 2 spike protein antibodies
    Measured 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 serum
    Measured 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 antibodies
    Measured by an activity assay.
    date_rangeTime Frame:
    28 days after the second dose of CVnCoV
  • SARS-CoV-2 neutralizing antibody levels in serum
    date_rangeTime Frame:
    28 days after the second dose of CVnCoV
  • Number of participants with seroprotection for serum antibodies against the 4 influenza vaccine strains
    Measured 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 strains
    Measured by hemagglutination inhibition (HI) assay.
    date_rangeTime Frame:
    28 days after the QIV dose
  • Serum antibody titers against the 4 influenza vaccine strains
    Measured 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 vaccine
    date_rangeTime Frame:
    Within 7 days after each study vaccination
  • Number of participants with solicited systemic AEs
    date_rangeTime Frame:
    Within 7 days after each study vaccination
  • Number of participants with unsolicited AEs
    date_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

COVID-19: A Phase 3, randomized, observer-blinded, multicenter clinical study evaluating the immunogenicity, safety, and reactogenicity of the investigational SARS-CoV-2 mRNA Vaccine CVnCoV, when co-administered with a licensed quadrivalent influenza vaccine versus separate administration of the two vaccines in adults 60 years of age and older
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Prevention
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2