Vaccination is a key strategy for preventing respiratory illnesses. Pneumococcal vaccination is recommended for all adults (age >60 years). Given their wide application, co-administration of pneumococcal and Covid-19 vaccines may support broad population-wide coverage. However, it is unclear whether the co-administration of the new, Omicron-adapted Novavax (NVX XBB.1.5) vaccine and a 20-valent pneumococcal conjugate vaccine results in lower immunogenicity than the administration of either alone.
Conditions
Interventions
Trade Name: Nuvaxovid
Product Name: NVX-CoV2373
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: COVID-19 Vaccine (recombinant, adjuvanted)
Current Sponsor code: Novavax
Other descri
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age: 60 years or older • Males and females • Able and willing (in the investigator's opinion) to comply with all study requirements. • Participants, who already received at least two Covid-19 vaccines, of which the last was an mRNA vaccine (BNT162b2 or mRNA-1273) and at least 12 weeks ago • Only applicable for women: last menstrual bleeding more than one year ago Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 176
Exclusion criteria
Exclusion criteria: • Use of immunosuppressants • Congenital or acquired immunodeficiency (eg, history of HIV infection, hematological disease, current malignancy, or others) • Chronic condition that may significantly interfere with the immune response in the opinion of the investigator • Any unstable medical condition, as assessed by the investigator • History of Covid-19 within 16 weeks before study vaccination • Pneumococcal vaccination within the past 6 months • Contraindication against any ingredient of the NVX XBB.1.5 or the PCV20 vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether the combined administration of NVX XBB.1.5 with a PCV20 is non-inferior to the administration of the NVX vaccine alone in terms of immunogenicity, as determined by anti-RBD antibody levels at day 28.;Secondary Objective: I. To investigate whether the combined administration of new Novavax with a 20-valent pneumococcal vaccine is non-inferior to the administration of the pneumococcal vaccine alone in terms of immunogenicity, as determined by serotype-specific opsonophagocytic antibody titers (OPA titers). II. To compare the local and systemic reactogenicity following combined or separated administration of the two vaccines ;Primary end point(s): •Anti-RBD antibody levels (BAU/mL) at Day 28 ;Timepoint(s) of evaluation of this end point: The primary outcome of this study will be the comparison of anti-RBD antibody titers (BAU/ml) at 28 days after vaccination between the NVX arm and the Combination arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Opsonophagocytic antibody titers (OPA titers) at Day 28 • Relative increase of Anti-RBD antibody levels (GMR) • Relative increase in OPA titers (GMR) • Proportion (%) of participants with serotype-specific OPA response (increase in OPA by =4-times) • Relative increase of serotype-specific opsonophagocytic antibody titers (OPA titers) (GMR) • PCR-confirmed SARS-CoV-2 infection • Microbiologically confirmed Pneumococcal infection ;Timepoint(s) of evaluation of this end point: Day 28 | — |
Countries
Austria
Contacts
Public ContactDepartment of Clinical Pharmacology
Medical University of Vienna
Outcome results
None listed