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 :
Completed
First Posted : September 14, 2020
Last Update Posted : March 2, 2022
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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 |
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COVID-19 Vaccine | Biological: multipeptide cocktail | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | N/A |
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 |
Actual Study Start Date : | November 27, 2020 |
Actual Primary Completion Date : | September 30, 2021 |
Actual Study Completion Date : | December 2, 2021 |

Arm | Intervention/treatment |
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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.
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Biological: multipeptide cocktail
Three groups of participant will be administered the multipeptide cocktail
Other Name: Vaccination |
- Safety- Eastern Cooperative Oncology Group (ECOG) Status [ Time Frame: Day 28 ]ECOG (Scale 0-5)
- Safety -Vital Signs 2 [ Time Frame: Day 28 ]temperature (in grade centigrade)
- 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
- Safety-Blood Chemistry and Coagulation 1 [ Time Frame: Day 28 ]
Alkaline phosphatase (AP)
Unit: U/l
- Safety-Blood Chemistry and Coagulation 2 [ Time Frame: Day 28 ]
aspartate transaminase (AST/ SGOT)
Unit: U/l
- 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
- 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
- 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
- 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.
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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:
- Pregnant or lactating females.
- Participation in any clinical study with intake of any investigational drug interfering with the study primary endpoint
- Any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint
- Any immunosuppressive treatment except low dose corticosteroids (≤10mg prednisolone/day)
- Prior or current infection with SARS-CoV-2 tested serologically or by throat/nose swab (PCR)
- History of Guillain-Barré Syndrome
- 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.
- 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)
- Baseline laboratory with lymphocyte count ≤ 1000/µl
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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
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All parts of the clinical trial
- Diabetes mellitus Typ II requiring drug treatment
- Chronic lung disease requiring drug treatment
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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)
- Hospitalization at study inclusion
- Administration of immunoglobulins and/or any blood products within 120 days preceding study entry or planned administration during the study period
- History of blood donation within 30 days of enrolment or planned donations within the study period
- Known hypersensitivity to any of the components included in the CoVac-1 vaccine

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
Germany | |
University Hospital Tuebingen | |
Tuebingen, Baden-Wuerttemberg, Germany, 72076 |
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: | March 2, 2022 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 vaccine COVID-19 infection preemptive |
Infections COVID-19 Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |