E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy subjects obtaining a potential vaccine for COVID-19 |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084465 |
E.1.2 | Term | COVID-19 vaccination |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and immunogenicity of a single use of a SARS-CoV-2 specific multi-peptide vaccine in combination with the TLR1/2 ligand XS15 in adults
The primary objective of this trial is to evaluate the safety and tolerability of the CoVac-1 vaccine, a single dose SARS-CoV-2 specific multi-peptide vaccine combined with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG in adults. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of this trial are to evaluate the efficacy (immunogenicity), overall safety, SARS-CoV-2 infection rate and course of COVID-19 disease upon application of the CoVac-1 vaccine, a single dose SARS-CoV-2 specific multi-peptide vaccine combinedwith the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 56-80 years at the time of screening 2. Pre-existing medical condition 1. Part I : Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening 2. Part II: With or without pre-existing medical condition, not requiring change in therapy or hospitalization before enrollment 3. Ability to understand and voluntarily sign an informed consent form 4. Ability to adhere to the study visit schedule and other protocol requirements 5. Female volunteers of child bearing potential (FCBP) and male volunteers 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 6. 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: 1. Amenorrhoea for 1 year or more following cessation of exogenous hormonal treatments 2. Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50 7. Be willing to minimize blood and body fluid exposure from others for 7 days after vaccination 1. Use of effective barrier prophylaxis, such as latex condoms, during sexual intercourse 2. Avoiding the sharing of needles, razors, or toothbrushes 3. Avoiding open-mouth kissing 8. Refrain from blood donation during the course of the study |
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E.4 | Principal 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. Serological evidence of prior SARS-CoV-2 infection prior to vaccination 6. Prior or current infection with SARS-CoV-2 tested serologically or by throat/nose swab (PCR) 7. History of Guillain-Barré Syndrome 8. Positive serological HIV, hepatitis B and C test. In case of positive HBsAg volunteer must provide prove of hepatitis B vaccination, otherwise volunteer must be excluded. 9. History of relevant 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) 10. Baseline laboratory with lymphocyte count ≤ 1000/µl 11. Only Part I: 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 12. Hospitalization at study inclusion 13. Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period 14. History of blood donation within 30 days of enrollment or plans to donate within the study period
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E.5 End points |
E.5.1 | Primary end point(s) |
• Incidence of critical events (any (S)AE ≥ 4) associated with administration of CoVac-1 until Visit 4 (V4). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• The nature, frequency, and severity of AEs and/or SAEs associated with administration of CoVac-1 until V5. • Solicited: AEs occurring from the time of injection throughout 28 days following the procedure, facilitated by use of a volunteer diary • Unsolicited: AEs from the time of injection throughout 56 days following injection • SAEs from the time of injection unit the final study visit for each subject • Incidence of AESIs until V5 • Development of a CoVac-1 specific T cell response and IgG antibodies (≥2-fold increase) on Visits 2, 3, 4 and 5 measured by ELISpot and ELISA, respectively as compared to baseline (V1) • Infection rate up to 28 days after vaccination • if applicable: Hospitalization rate after infection Duration of hospitalization Proportion admitted to ICU Proportion requiring invasive ventilation COVID-19 related mortality within 2 month • Quality of life from baseline until end of safety follow-up as assessed by EORTC (QLQ-C30)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The nature, frequency, and severity of AEs and/or SAEs associated with administration of CoVac-1 V1-V5. • Solicited: through out 28 days following the procedure • Unsolicited: throughout 56 days following injection • SAEs from the time of injection unit the final study visit • Incidence of AESIs until V1- V5 • specific T cell response and IgG antibodies on Visits 2, 3, 4 and 5 respectively as compared to baseline (V1) • Infection rate up to 28 days after vaccination • if applicable: Hospitalization rate after infection Duration of hospitalization Proportion admitted to ICU Proportion requiring invasive ventilation COVID-19 related mortality within 2 month • Quality of life from baseline until end of safety follow-up
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 32 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is defined as the last visit of the last volunteer. See Protocol Section Ch.6.6 to 6.10 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |