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Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults (pVAC)

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ClinicalTrials.gov Identifier: NCT04546841
Recruitment Status : Not yet recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:

Part I:

12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study IMP (CoVac-1). No more than one subject per day will be enrolled. 28 days following vaccination of the 12th volunteer, there will be an interim analysis of safety and a safety review by the data safety monitoring board (DSMB) as well as an amendment to the regulatory authorities (Paul-Ehrlich Institute and Ethics Committee) before proceeding to Part II.

Part II:

12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study investigational medicinal product (IMP) (CoVac-1). 28 days following vaccination of the 12th volunteer, there will be an interim analysis of safety and a safety review by the DSMB whether to proceed to next Part III.

Part III:

12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study IMP (CoVac-1).

The aim of the clinical is to evaluate the safety and immunogenicity of a single use of a SARS-CoV-2-derived multi-peptide vaccine in combination with the toll like receptor (TLR)1/2 ligand XS15 in adults


Condition or disease Intervention/treatment Phase
COVID-19 Vaccine Biological: multipeptide cocktail Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Part I: Adults aged 18-55 years, n=12 Part II: Adults aged 56-74, n=12 Part III: Adults aged ≥ 75, n=12
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: P-pVAC-SARS-CoV-2: Phase I Single-center Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 20, 2021

Arm Intervention/treatment
Experimental: Vaccination

A single vaccination with the IMP CoVac-1 (SARS-CoV-2 HLA-DR peptides, XS15 emulsified in Montanide ISA 51 VG) (500 µl) will be applied subcutaneously (s.c.) to the abdominal skin.

  1. Part I: Age 18-55 at the time of screening, n=12
  2. Part II: Age 56-74 years at the time of screening, n=12
  3. Part III: Age ≥ 75 years at the time of screening, n=12
Biological: multipeptide cocktail

Three groups of participant will be administered the multipeptide cocktail

  1. Part I: Age 18-55 at the time of screening
  2. Part II: Age 56-74 years at the time of screening
  3. Part III: Age ≥ 75 years at the time of screening
Other Name: Vaccination




Primary Outcome Measures :
  1. Safety- Eastern Cooperative Oncology Group (ECOG) Status [ Time Frame: Day 28 ]
    ECOG (Scale 0-5)

  2. Safety -Vital Signs 2 [ Time Frame: Day 28 ]
    temperature (in grade centigrade)

  3. Safety -Vital Signs 3 [ Time Frame: Day 28 ]
    blood pressure/pulse mmHg and bpm Follow-Up Days:Signs/symptoms, as assessed on volunteer's diary and visit

  4. Safety-Blood Chemistry and Coagulation 1 [ Time Frame: Day 28 ]

    Alkaline phosphatase (AP)

    Unit: U/l


  5. Safety-Blood Chemistry and Coagulation 2 [ Time Frame: Day 28 ]

    aspartate transaminase (AST/ SGOT)

    Unit: U/l


  6. Safety-Hematology 1 [ Time Frame: Day 28 ]

    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 Unit: g/dl


  7. Safety-Hematology 2 [ Time Frame: Day 28 ]

    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 Unit: Mio/µl


  8. Safety-Hematology 3 [ Time Frame: Day 28 ]

    platelet count (PLT)

    Unit: 1000/µl

    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


  9. Safety-Hematology 4 [ Time Frame: Day 28 ]

    white blood cells (WBC)

    Unit: 1/µl

    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.



Secondary Outcome Measures :
  1. CoVac-1 specific T-cell response [ Time Frame: Day 28 ]

    60 ml of heparin blood for immunomonitoring and analysis of peptide specific T-cell response will be analyzed by the Walz lab, KKE Translational Immunologie at the Department of Immunology, Tuebingen (central laboratory). Blood will be taken before peptide vaccination on V1, and during vaccination phase and follow-up at each visit.

    Unit:Counts




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. Adult male or non-pregnant, non-lactating female

1. Part I: Age 18-55 at the time of screening 2. Part II: Age 56-74 years at the time of screening 3. Part III: Age ≥ 75 years at the time of screening 2. Pre-existing medical condition

1. Part I and II: Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening 3. Ability to understand and voluntarily sign the informed consent form. 4. Ability to adhere to the study visit schedule and other protocol requirements.

5. female with child bearing potential (FCBP) and male volunteers with partners of childbearing 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 6. Postmenopausal or evidence of non-childbearing status. For women of childbearing potential: negative urine or serum pregnancy test within 7 days prior to study treatment. Postmenopausal or evidence of non-childbearing 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 post menopausal range for women under 50 7. Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination
  • Use of effective barrier prophylaxis, such as latex condoms, during sexual intercourse
  • Avoiding the sharing of needles, razors, or toothbrushes
  • Avoiding open-mouth kissing
  • Refrain from blood donation during the course of the study

Exclusion Criteria:

  1. Pregnant or lactating females.
  2. Participation in any clinical study with intake of any investigational drug interfering with the study primary endpoint
  3. Any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint
  4. Any immunosuppressive treatment except low dose corticosteroids (≤10mg prednisolone/day)
  5. Prior or current infection with SARS-CoV-2 tested serologically or by throat/nose swab (PCR)
  6. History of Guillain-Barré Syndrome
  7. Positive serological HIV, hepatitis B or C test. In case of positive HBsAg, volunteer must provide prove of hepatitis B vaccination, otherwise volunteer must be excluded.
  8. History of relevant central nervous system (CNS) pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child)
  9. Baseline laboratory with lymphocyte count ≤ 1000/µl
  10. Only Part I and II:

    - Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam, and/or laboratory screening test

  11. All parts of the clinical trial

    • Diabetes mellitus Typ II requiring drug treatment
    • Chronic lung disease requiring drug treatment
    • Any chronic liver disease or unknown liver abnormalities defined as:

      • Alanin-aminotransferase (ALT) and Aspartat-aminotransferase (AST) ≤ 2.5 x ULN (upper limit of normal)
      • Gamma-glutamyl-transferase (γ-GT) ≤ 2.5 x ULN
    • Chronic renal failure defined as glomerular filtration rate (GFR) < 40 ml/min/1,73m2
    • Serious pre-existing cardiovascular disease such as New York Heart Association (NYHA) ≥ II, coronary heart disease requiring coronary surgery or known peripheral arterial disease (pAVK) ≥ grade 2
    • Sickle cell anemia
    • Obesity (body mass index ≥ 30kg/m2)
  12. Hospitalization at study inclusion
  13. Administration of immunoglobulins and/or any blood products within 120 days preceding study entry or planned administration during the study period
  14. History of blood donation within 30 days of enrolment or planned donations within the study period
  15. Known hypersensitivity to any of the components included in the CoVac-1 vaccine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546841


Contacts
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Contact: Helmut Salih, Prof. MD +49 7071 29 ext 83275 helmut.salih@med.uni-tuebingen.de
Contact: Juliane Walz, PD MD +49 7071 29 ext 83275 juliane.walz@med.uni-tuebingen.de

Sponsors and Collaborators
University Hospital Tuebingen
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04546841    
Other Study ID Numbers: P-pVAC-SARS-CoV-2
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Tuebingen:
COVID-19 vaccine
COVID-19 infection
preemptive
Additional relevant MeSH terms:
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Infection
Vaccines
Immunologic Factors
Physiological Effects of Drugs