Adults with congenital or acquired B cell/antibody deficiency MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004865
Conditions
Interventions
Product Name: Multipeptide vaccine + XS15
Pharmaceutical Form: Injection
Sponsors
University Hospital Tuebingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult (=18 years) male or non-pregnant, non-lactating female 2. Primary antibody deficiency syndrome or Secondary antibody deficiency syndrome, defined by one of the following: - IgG =65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females 2. Participation in any clinical trial with intake of any investigational or non-registered vaccine product 3. Any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint: - Active infection - Psychiatric disorders - Known systemic anaphylaxis 4. Prior or current infection with SARS-CoV-2 as assessed by medical history, or by throat/nose swab (PCR) or serologically documented immunization against SARS-CoV-2 (after infection or vaccination) 5. persisting symptoms developed after vaccination against SARS-CoV-2 with one of the approved vaccines-products 6. HIV infection, chronic or active hepatitis B or C 7. History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/haemorrhage, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child) 8. Baseline laboratory CD4+ T cell count < 100 µl 9. The following pre-existing medical conditions: - Chronic liver failure defined as Child-Pugh Score =B - Chronic renal failure defined as GFR <40 ml/min/1,73m2 - Serious pre-existing cardiovascular disease such as NYHA = III - Sickle cell anemia 10. Known hypersensitivity to any of the components included in the CoVac-1 vaccine 11. Pre-existing auto-immune disease except for Hashimoto thyroiditis and mild (not requiring immunosuppressive treatment) psoriasis 12. Patient receiving active treatment with Proteosome- Inhibitors (e.g. Bortezomib), Phosphoinositid-3-Kinase-Inhibors (e.g. Idelalisib) 13. Patient receiving active treatment with small molecules, including Tyrosine Kinases-Inhibitors (e.g. Ibrutinib), Proteosome-Inhibitors (e.g. Bortezomib), Bcl-2-Inhibitors (Venetoclax) or Phosphoinositid-3-Kinase-Inhibors (e.g. Idelalisib) 14. Intention of receiving one dose of an already approved vaccine against SARS-CoV-2 before day 56
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: The primary objective of phase I of this trial is to evaluate the safety and tolerability of CoVac-1 in adults with congenital or acquired B cell/antibody deficiency. Phase II: The primary objective of phase II of this trial is to evaluate the efficacy of the CoVac-1 vaccine in terms of induction of SARS-CoV-2 specific T cells. ;Secondary Objective: Phase I: The secondary objective of phase I of this trial is to evaluate the efficacy of the CoVac-1 vaccine. In addition, humoral immune responses will be assessed. Phase II: The secondary objectives of phase II of this trial are to evaluate the safety and tolerability of CoVac-1. In addition, humoral immune responses will be assessed. ;Primary end point(s): Phase I Based on the primary objective the primary endpoint is defined as: • The nature, frequency, and severity of AEs and/or SAEs associated with CoVAC-1: - Solicited: ADRs/AEs occurring from the time of each injection throughout V4 days following the procedure, facilitated by use of a patient diary - Unsolicited: AEs from the time of injection throughout V5 following injection - SAEs from the time of injection until the final study visit for each subject - Incidence of AESIs until the final study visit for each subject Phase II: Based on the primary objective the primary endpoint is defined as: • Development of a CoVac-1 specific T cell response to at least one of the single SARS-CoV-2 T cell epitopes included in the CoVac-1 vaccine in > 80% of the patients until V4 measured by IFN-? ELISpot ex vivo and after in vitro T cell amplification (compared to Visit 1) ;Timepoint(s) of evaluation of this end point: Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 98, Month 5 and 8 after peptide vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I ? Cellular immunity: Development of a CoVac-1 specific T cell response to at least one of the single SARS-CoV-2 T cell epitopes included in the CoVac-1 vaccine on Visits 2, 3, 4, 5, 6 measured by IFN-? ELISpot ex vivo and after in vitro T cell amplification (compared to Visit 1), this includes: ? Cellular conversion rate (CCR) at Visits 2, 3, 4, 5, 6 after immunization ? Assessment of humoral immune response: Development of SARS-CoV-2 specific antibodies at Visits 2, 3, 4, 5, 6 after immunization (measured by Siemens sCOVG Assay at the Central Laboratory of the University Hospital Tubingen). Phase II - Solicited: ADRs/AEs occurring from the time of each injection throughout V4 following the procedure, facilitated by use of a patient diary - Unsolicited: AEs from the time of injection throughout V5 following injection - SAEs from the time of injection until the final study visit for each subject - Incidence of AESIs until the final study visit for each subject ? Assessment of humoral immune response: Development of SARS-CoV-2 specific antibodies at Visits 2, 3, 4, 5, 6 after immunization (measured by Siemens sCOVG Assay at the Central Laboratory of the University Hospital Tubingen).;Timepoint(s) of evaluation of this end point: Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 98, Month 5 and 8 after peptide vaccination | — |
Countries
Germany
Contacts
Public ContactZentrum fuer Klinische Studien
Zentrum fuer Klinische Studien
Outcome results
None listed