COVID-19 VaccinePhase 1pVACNCT04546841
Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults
A Phase 1 study testing multipeptide cocktail in people with COVID-19 Vaccine, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccine
- What is being tested?
- multipeptide cocktail
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 27 Nov 2020to 2 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
- 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
- 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)
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
About this study
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
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.
Read more
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
Read the detailed description
SARS-CoV-2 peptide vaccine The aim of this study is to investigate the safety and immunogenicity of a peptide vaccine consisting of SARS-CoV-2 specific HLA class II peptides in volunteers without prior or current SARS-CoV-2 infection.
The identification and characterization of T cell epitopes is a long-standing and unparalleled expertise of the Department of Immunology. This unique approach is based on i) the prediction of HLA binding sequences for HLA class I and class II alleles using the world's first prediction tool (www.syfpeithi.de) and newer, more refined methods, all based on SYFPEITHI (database for MHC ligands), ii) the identification of naturally presented HLA class I and class II ligands, iii) the synthesis of synthetic peptides, and iv) the characterization of T-cell epitopes and peptide-specific cluster of differentiation (CD)4+ and CD8+ T cell responses. This strategy has been successfully applied in recent years to define and characterize T-cell epitopes derived from various viruses such as cytomegalovirus (CMV),Epstein-Barr virus (EBV), adenovirus (ADV) and influenza as well as tumor-associated antigens of various solid and hematological malignancies.
Based on this work, the results were translated into therapeutic vaccination and T cell transfer studies in cancer patients (e.g. NCT02802943) and viral infections. This direct translation is made possible by the Wirkstoffpeptidlabor (Prof. Dr. rer. nat. Stefan Stevanović) of the Department of Immunology and the good manufacturing practice (GMP) facility for individualized drugs at the University Hospital Tuebingen as well as our immune monitoring platform equipped with state-of-the-art, validated T-cell assays and methods.
The existing experience and logistics can be directly used for the treatment and prevention of COVID-19 disease. In preliminary work for this study, CD4+ T cell epitopes have already been characterized in a large cohort of SARS-CoV-2 infected donors validating their high relevance in the natural course of COVID-19. The vaccination cocktail in the study will consist of eight promiscuous HLA class II peptides from the different proteins of the SARS-CoV-2 virus, predicted to bind to several HLA class II allotypes. Furthermore, especially those peptides were selected that contain embedded HLA class I sequences in order to induce CD4+ T cell responses and CD8+ T cell responses simultaneously. Furthermore, especially for peptides derived from virus surface proteins, only sequences were selected that do not represent antibody epitopes. This should prevent the formation of antibodies against the vaccinated peptides, which could possibly have a deteriorative effect on COVID-19. Immunogenicity was proven for all HLA class II peptides included in the peptide cocktail in a large cohort of SARS-CoV-2 convalescent donors as well as for single peptides in a first vaccination of a healthy volunteer.
A further prerequisite for successful peptide vaccination, besides selection of optimal antigen targets, is the use of a suitable adjuvant, which is able to induce potent and long-lasting immune responses. Among the most effective approaches tested in humans is the subcutaneous injection of peptides emulsified in Montanide ISA 51 VG, a water-in-oil-emulsion, combined with the TLR9 ligand CpG.However, CpG is not available for clinical trials, and a peptide/antigen vaccine emulsified in Montanide without any additional adjuvant induces no or only weak immune responses. In the P-pVac-SARS-CoV-2 trial, the novel TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG will be employed as adjuvant, applied subcutaneously together with the peptide vaccine. XS15 is a water-soluble derivative of the TLR1/2 ligand Pam3Cys and induced a strong CD8+ and Th1CD4+ T-cell response against free short peptides in Montanide ISA 51 VG after a single s.c. injection in a healthy volunteer as well as in cancer patients.Immune responses could be induced against viral peptides (including SARS-CoV-2 derived peptides), neo-epitopes derived from cancer-specific mutations as well as tumor-associated self-peptides. XS15 results in granuloma formation on the vaccination site, where the vaccinated peptides persist for at least 7 weeks. Peptide-specific T cells were detected at the granuloma site, however, with a lower frequency than in peripheral blood, which rules out the risk of T cell sequestration, dysfunction or deletion at the vaccination site due to the use of XS15 in Montanide ISA 51 VG. Strikingly, the induced immune responses were found to persist for more than 1.5 years.
With regard to the planned study we could also show that this vaccination method is able to induce potent SARS-CoV-2 specific T-cell responses in a human volunteer.
- Conditions
- COVID-19 Vaccine
- Being tested
- multipeptide cocktail
- Keywords
- COVID-19 vaccine, COVID-19 infection, preemptive
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multipeptide cocktailBiological
Also called Vaccination
Three groups of participant will be administered the multipeptide cocktail
- Part I: Age 18-55 at the time of screening
- Part II: Age 56-74 years at the time of screening
- Part III: Age ≥ 75 years at the time of screening
| Study group | Role | What they receive |
|---|---|---|
| Vaccination | Experimental | 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 Receives: Biological: multipeptide cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety- Eastern Cooperative Oncology Group (ECOG) Status
ECOG (Scale 0-5)
Measured: Day 28
Safety -Vital Signs 2
temperature (in grade centigrade)
Measured: Day 28
Safety -Vital Signs 3
blood pressure/pulse mmHg and bpm Follow-Up Days:Signs/symptoms, as assessed on volunteer's diary and visit
Measured: Day 28
Safety-Blood Chemistry and Coagulation 1
Alkaline phosphatase (AP)
Unit: U/l
Measured: Day 28
Safety-Blood Chemistry and Coagulation 2
aspartate transaminase (AST/ SGOT)
Unit: U/l
Measured: Day 28
Safety-Hematology 1
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
Measured: Day 28
Safety-Hematology 2
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
Measured: Day 28
Safety-Hematology 3
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
Measured: Day 28
Safety-Hematology 4
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.
Measured: Day 28
Secondary outcomes (1)
CoVac-1 specific T-cell response
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
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start27 Nov 2020
- Primary completion30 Sep 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccineStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546841
- Sponsor's protocol ID
- P-pVAC-SARS-CoV-2
- Acronym
- pVAC
- Status last verified
- Aug 2021
- First submitted
- 26 Aug 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04546841
- Acronym / sponsor ID
- pVAC / P-pVAC-SARS-CoV-2
- Conditions
- COVID-19 Vaccine
- Keywords
- COVID-19 vaccine, COVID-19 infection, preemptive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
SARS-CoV-2 peptide vaccine The aim of this study is to investigate the safety and immunogenicity of a peptide vaccine consisting of SARS-CoV-2 specific HLA class II peptides in volunteers without prior or current SARS-CoV-2 infection.
The identification and characterization of T cell epitopes is a long-standing and unparalleled expertise of the Department of Immunology. This unique approach is based on i) the prediction of HLA binding sequences for HLA class I and class II alleles using the world's first prediction tool (www.syfpeithi.de) and newer, more refined methods, all based on SYFPEITHI (database for MHC ligands), ii) the identification of naturally presented HLA class I and class II ligands, iii) the synthesis of synthetic peptides, and iv) the characterization of T-cell epitopes and peptide-specific cluster of differentiation (CD)4+ and CD8+ T cell responses. This strategy has been successfully applied in recent years to define and characterize T-cell epitopes derived from various viruses such as cytomegalovirus (CMV),Epstein-Barr virus (EBV), adenovirus (ADV) and influenza as well as tumor-associated antigens of various solid and hematological malignancies.
Based on this work, the results were translated into therapeutic vaccination and T cell transfer studies in cancer patients (e.g. NCT02802943) and viral infections. This direct translation is made possible by the Wirkstoffpeptidlabor (Prof. Dr. rer. nat. Stefan Stevanović) of the Department of Immunology and the good manufacturing practice (GMP) facility for individualized drugs at the University Hospital Tuebingen as well as our immune monitoring platform equipped with state-of-the-art, validated T-cell assays and methods.
The existing experience and logistics can be directly used for the treatment and prevention of COVID-19 disease. In preliminary work for this study, CD4+ T cell epitopes have already been characterized in a large cohort of SARS-CoV-2 infected donors validating their high relevance in the natural course of COVID-19. The vaccination cocktail in the study will consist of eight promiscuous HLA class II peptides from the different proteins of the SARS-CoV-2 virus, predicted to bind to several HLA class II allotypes. Furthermore, especially those peptides were selected that contain embedded HLA class I sequences in order to induce CD4+ T cell responses and CD8+ T cell responses simultaneously. Furthermore, especially for peptides derived from virus surface proteins, only sequences were selected that do not represent antibody epitopes. This should prevent the formation of antibodies against the vaccinated peptides, which could possibly have a deteriorative effect on COVID-19. Immunogenicity was proven for all HLA class II peptides included in the peptide cocktail in a large cohort of SARS-CoV-2 convalescent donors as well as for single peptides in a first vaccination of a healthy volunteer.
A further prerequisite for successful peptide vaccination, besides selection of optimal antigen targets, is the use of a suitable adjuvant, which is able to induce potent and long-lasting immune responses. Among the most effective approaches tested in humans is the subcutaneous injection of peptides emulsified in Montanide ISA 51 VG, a water-in-oil-emulsion, combined with the TLR9 ligand CpG.However, CpG is not available for clinical trials, and a peptide/antigen vaccine emulsified in Montanide without any additional adjuvant induces no or only weak immune responses. In the P-pVac-SARS-CoV-2 trial, the novel TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG will be employed as adjuvant, applied subcutaneously together with the peptide vaccine. XS15 is a water-soluble derivative of the TLR1/2 ligand Pam3Cys and induced a strong CD8+ and Th1CD4+ T-cell response against free short peptides in Montanide ISA 51 VG after a single s.c. injection in a healthy volunteer as well as in cancer patients.Immune responses could be induced against viral peptides (including SARS-CoV-2 derived peptides), neo-epitopes derived from cancer-specific mutations as well as tumor-associated self-peptides. XS15 results in granuloma formation on the vaccination site, where the vaccinated peptides persist for at least 7 weeks. Peptide-specific T cells were detected at the granuloma site, however, with a lower frequency than in peripheral blood, which rules out the risk of T cell sequestration, dysfunction or deletion at the vaccination site due to the use of XS15 in Montanide ISA 51 VG. Strikingly, the induced immune responses were found to persist for more than 1.5 years.
With regard to the planned study we could also show that this vaccination method is able to induce potent SARS-CoV-2 specific T-cell responses in a human volunteer.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Vaccination | Experimental | Biological: multipeptide cocktailA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multipeptide cocktailAlso: VaccinationThree 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 | Biological | Vaccination |
Primary outcome
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.
1 secondary outcome
CoVac-1 specific T-cell response
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- COVID-19 peptide vaccine for the induction of SARS-CoV-2 T cell immunity; Nature \| Vol 601 \| 27 January 2022Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing multipeptide cocktail in people with COVID-19 Vaccine, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety- Eastern Cooperative Oncology Group (ECOG) Status (time frame: Day 28). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.