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

NCT04546841 | Completed Phase 1 DMC

• 1 other identifier: P-pVAC-SARS-CoV-2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19 Vaccine

Keywords

COVID-19 vaccine; COVID-19 infection; preemptive

Outcome Measures

Primary Outcomes (9)

• Safety- Eastern Cooperative Oncology Group (ECOG) Status

  ECOG (Scale 0-5)

  Day 28

• Safety -Vital Signs 2

  temperature (in grade centigrade)

  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

  Day 28

• Safety-Blood Chemistry and Coagulation 1

  Alkaline phosphatase (AP) Unit: U/l

  Day 28

• Safety-Blood Chemistry and Coagulation 2

  aspartate transaminase (AST/ SGOT) Unit: U/l

  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

  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

  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

  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.

  Day 28

Secondary Outcomes (1)

• CoVac-1 specific T-cell response

  Day 28

Study Arms (1)

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

Biological: multipeptide cocktail

Interventions

multipeptide cocktail BIOLOGICAL

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

Also known as: Vaccination

Vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adult male or non-pregnant, non-lactating female
• \. 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
• \. 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.
• \. 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

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Links

• COVID-19 peptide vaccine for the induction of SARS-CoV-2 T cell immunity; Nature \| Vol 601 \| 27 January 2022

MeSH Terms

Conditions

COVID-19

Interventions

COVAC-1 COVID-19 vaccine; Vaccination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Design

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

Model Details: Part I: Adults aged 18-55 years, n=12 Part II: Adults aged 56-74, n=12 Part III: Adults aged ≥ 75, n=12

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 14, 2020
• Study Start: November 27, 2020
• Primary Completion: September 30, 2021
• Study Completion: December 2, 2021
• Last Updated: March 2, 2022

Record last verified: 2021-08

Locations

DE (1)