B-pVAC-SARS-CoV-2: Study to Prevent COVID-19 Infection in Adults With Bcell/ Antibody Deficiency

NCT04954469 | Completed Phase 1 DMC

• 1 other identifier: B-pVAC-SARS-CoV-2
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

Brief Summary

The indication of this study is To evaluate the safety and immunogenicity of a SARSCoV- 2-derived multi-peptide vaccine in combination with the TLR1/2 ligand XS15 in adults with congenital or acquired B-cell/antibody deficiency

Conditions

Immune Deficiency Disease

Outcome Measures

Primary Outcomes (8)

• Safety-Vital Signs 1 (Body Temperature)

  Body temperature will be measured \[temperature in centigrade\]

  Day 28

• Safety-Vital Signs 2 (Blood Pressure and Pulse)

  blood pressure \[mmHg\] pulse \[bpm\]

  Day 28

• Safety-Eastern Cooperative Oncology Group (ECOG) Status

  Scale 0-5, the lower the scale value, the better

  Day 28

• Safety-Hematology 1 (Hemoglobin)

  hemoglobin (Hb). Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing. Hemoglobin \[g/dl \]

  day 28

• Safety-Hematology 2 (White Blood Cells)

  white blood cells (WBC). Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing. White Blood Cells \[1/µl\]

  day 28

• Safety-Hematology 3 (Platelet Count)

  platelet count (PLT) . Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing. Platelet Count \[1000/µl\]

  day 28

• Safety-Hematology 4 (Red Blood Cells)

  red blood cells (RBC). Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing. Red Blood Cells \[Mio/µl\]

  day 28

• T cell response

  Blood will be taken before peptide vaccination on V1, and during vaccination phase and follow-up at each visit. IFN-gamma ELISPOT Counts

  Day 28

Study Arms (1)

CoVAC-1 Vaccine

EXPERIMENTAL

Peptide vaccination should be started as soon as possible after the screening visit. Or in case of two vaccinations: Peptide vaccination should be started as soon as possible after the screening visit (V1) and on day 42 (V5)

Biological: CoVAC-1

Interventions

CoVAC-1 BIOLOGICAL

Peptide vaccination should be started as soon as possible after the screening visit.

CoVAC-1 Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years) male or non-pregnant, non-lactating female
• Primary antibody deficiency syndrome or Secondary antibody deficiency syndrome, defined by one of the following:
• IgG \< 4 g/l
• Ongoing substitution of immunoglobline for hypogammaglobinemia
• Anti-CD20 antibody (monospecific) therapy for malignant disease:
• after combined Anti-CD20 antibody therapy with chemotherapy (e.g. fludarabin, cyclophosphamid, bendamustin, anthracycline, vincristin) or BTK-inhibitors or BCL2-inhibitors (within 1-6 months post therapy)
• ongoing single agent Anti-CD20 antibody therapy
• Anti-CD20 antibody maintenance therapy
• Ability to understand and voluntarily sign an informed consent form
• Ability to adhere to the study visit schedule and other protocol requirements
• Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception. This should be started from the signing of the informed consent and continue until three months after vaccination. Furthermore, contraception must be carried on by patients receiving B-cell depleting therapies for the whole duration of the treatment.
• Postmenopausal or evidence of non-child-bearing status. For women of childbearing potential: negative urine or serum pregnancy test within 7 days prior to study treatment. Postmenopausal or evidence of nonchildbearing status is defined as:
• Amenorrhoea for 1 year or more following cessation of exogenous hormonal treatments
• Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50

You may not qualify if:

• Pregnant or lactating females
• Participation in any clinical trial with intake of any nonregistered vaccine product
• Any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint:
• Active infection
• Psychiatric disorders
• Known systemic anaphylaxis
• Prior or current infection with SARS-CoV-2 as assessed by medical history and/or by throat/nose swab (PCR) or serologically documented immunization against SARSCoV- 2 (after infection or vaccination)
• History of Guillain-Barré syndrome
• HIV infection, chronic or active hepatitis B or C
• 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)
• Baseline laboratory CD4+ T cell count \< 100 μl
• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (3)

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische Forschung (IKF)

Frankfurt am Main, Frankfurt, 60488, Germany

Location

Charité - Universitätsmedizin Berlin Medizinische Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie Charité Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Related Publications (1)

• Heitmann JS, Tandler C, Marconato M, Nelde A, Habibzada T, Rittig SM, Tegeler CM, Maringer Y, Jaeger SU, Denk M, Richter M, Oezbek MT, Wiesmuller KH, Bauer J, Rieth J, Wacker M, Schroeder SM, Hoenisch Gravel N, Scheid J, Marklin M, Henrich A, Klimovich B, Clar KL, Lutz M, Holzmayer S, Horber S, Peter A, Meisner C, Fischer I, Loffler MW, Peuker CA, Habringer S, Goetze TO, Jager E, Rammensee HG, Salih HR, Walz JS. Phase I/II trial of a peptide-based COVID-19 T-cell activator in patients with B-cell deficiency. Nat Commun. 2023 Aug 18;14(1):5032. doi: 10.1038/s41467-023-40758-0.

  PMID: 37596280 DERIVED

MeSH Terms

Conditions

Immune Deficiency Disease

Interventions

COVAC-1 COVID-19 vaccine

Study Officials

• Helmut Salih, Prof. MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase I: Part I: 14 patients not infected with SARS-CoV-2 will receive an open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVAC-1). Part II (optional): If there is an insufficient immune response measured by IFN-γ ELISpot in Part I of Phase I on day 28, an additional Part (Part II) of Phase I will start enrollment of 14 subjects receiving two open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVac-1) on d1 and d42. Phase II (after an amendment to the protocol): 40 subjects will receive an open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVac-1) on d1 and, depending on the data collected in Phase I, a econd vaccination on d42 if necessary.

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 8, 2021
• Study Start: June 30, 2021
• Primary Completion: August 18, 2022
• Study Completion: April 30, 2023
• Last Updated: August 4, 2023

Record last verified: 2022-11

Locations

DE (3)