Safety, Reactogenicity and Immunogenicity of a Novel MVA-SARS-2-ST Vaccine Candidate

NCT05226390 | Terminated Phase 1 DMC

• 1 other identifier: MVA-S2-S-R01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a phase I, single-center trial, including a total of 30 participants in two cohorts. Cohort 1 (n=6): Healthy male or female adults aged 18 - ≤ 60 previously primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen. Cohort 2 (n=24): Healthy male or female adults aged 18 - ≤ 60 primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen and subsequently booster immunized with any EU marketed mRNA vaccine Both cohorts will be assigned to inhaled vaccination with MVA-SARS-2-ST

Conditions

COVID-19 Vaccines

Keywords

MVA-SARS-COV-2; MVA-SARS-2-ST

Outcome Measures

Primary Outcomes (23)

• The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST

  Occurrence of solicited local reactogenicity signs and symptoms

  day 0

• The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST

  Occurrence of solicited local reactogenicity signs and symptoms

  day 1

• The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST

  Occurrence of solicited local reactogenicity signs and symptoms

  day 2

• The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST

  Occurrence of solicited local reactogenicity signs and symptoms

  day 3

• The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST

  Occurrence of solicited local reactogenicity signs and symptoms

  day 4

• The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST

  Occurrence of solicited local reactogenicity signs and symptoms

  day 5

• The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST

  Occurrence of solicited local reactogenicity signs and symptoms

  day 6

• The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST

  Occurrence of solicited local reactogenicity signs and symptoms

  day 7

• Change from baseline of pulmonary function associated with MVA-SARS-2-ST

  Change from baseline of pulmonary function measured by spirometry as forced vital capacity (FVC) (%)

  day 0 (2h), day 1, 3, 7, 14, 28, 56, 140

• Change from baseline of pulmonary function associated with MVA-SARS-2-ST

  Change from baseline of pulmonary function measured by spirometry as forced expiratory volume in 1 second (FEV1) (%)

  day 0 (2h), day 1, 3, 7, 14, 28, 56, 140

• Change from baseline of pulmonary function associated with MVA-SARS-2-ST

  Change from baseline of pulmonary function measured by spirometry as FEV1/FVC (%)

  day 0 (2h), day 1, 3, 7, 14, 28, 56, 140

• Change from baseline of pulmonary function associated with MVA-SARS-2-ST

  Change from baseline of pulmonary function measured by peak flow as peak expiratory flow (PEF) frequently

  day 0 and twice daily on days 1, 2, 3, 4, 5, 6, 7

• Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST

  Occurrence of solicited systemic reactogenicity signs and symptoms vaccination

  day 0

• Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST

  Occurrence of solicited systemic reactogenicity signs and symptoms vaccination

  day 1

• Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST

  Occurrence of solicited systemic reactogenicity signs and symptoms vaccination

  day 2

• Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST

  Occurrence of solicited systemic reactogenicity signs and symptoms vaccination

  day 3

• Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST

  Occurrence of solicited systemic reactogenicity signs and symptoms vaccination

  day 4

• Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST

  Occurrence of solicited systemic reactogenicity signs and symptoms vaccination

  day 5

• Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST

  Occurrence of solicited systemic reactogenicity signs and symptoms vaccination

  day 6

• Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST

  Occurrence of solicited systemic reactogenicity signs and symptoms vaccination

  day 7

• Occurrence of unsolicited adverse events (AE) associated with MVA-SARS-2-ST

  Occurrence of unsolicited adverse events (AE)

  from day 0 to day 28 after vaccination

• Change of safety laboratory measures associated with MVA-SARS-2-S

  Change from baseline of safety laboratory measures

  day 1, 3, 7, 14, 28, 56, 140

• Occurrence of serious adverse events (SAE) associated with MVA-SARS-2-ST

  Occurrence of serious adverse events (SAE)

  through study completion, an average of 5 month

Secondary Outcomes (2)

• To evaluate immunogenicity of the candidate MVA-SARS-2-ST

  day 7, 14, 28, 56 and 140

• To evaluate immunogenicity of the candidate MVA-SARS-2-ST

  day 14

Study Arms (1)

1 x 107 IU/dose MVA-SARS-2-ST

EXPERIMENTAL

All Participants will receive a single booster dose of 1 x 107 IU MVA-SARS-2-ST in 0.5 mL as inhalation (total inhaled volume 0.5 mL)

Biological: MVA-SARS-2-ST

Interventions

MVA-SARS-2-ST BIOLOGICAL

In this trial MVA-SARS-2-ST will be used. Each vial contains 1 x 107 IU/dose MVA-SARS-2-ST in 0.5 mL as active ingredient. The solution will be used for nebulization and direct administration to the respiratory tract.

1 x 107 IU/dose MVA-SARS-2-ST

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed written informed consent from subject prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
• primary immunization (cohort 1) with any regimen using any EU marketed SARS- CoV-2 vaccine or
• subsequently booster immunization (cohort 2) with any EU marketed mRNA vaccine
• at least 3 months prior to enrollment
• Adults with SARS-CoV-2 specific IgG concentration between 10 RU/ml and 1200 RU/ml determined by Anti-SARS-CoV-2-QuantiVac-ELISA (IgG)
• Males or non-pregnant, non-lactating females of child-bearing potential with negative pregnancy test at screening who agree to comply with the applicable contraceptive requirements of the protocol (Section 3.4) from at least 14 days prior to vaccination and during the entire duration of the study.
• Females without child-bearing potential defined as follows:
• at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
• hysterectomy or uterine agenesis or
• ≥ 50 years and in postmenopausal state \> 1 year or
• \< 50 years and in postmenopausal state \> 1 year with serum FSH \> 40 IU/l and serum estrogen \< 30 ng/l or a negative estrogen test, both at screening
• Normal pulmonary function: FEV1 predicted ≥ 80% and FEV1/FVC \> 70%
• Body mass index 18.5 - 30.0 kg/m2 and weight \> 50 kg at screening
• Subject is capable of understanding the investigational nature, potential risks and benefits of the clinical trial

You may not qualify if:

• Subjects are excluded from the study if any of the following criteria are met at screening or on dosing day.
• Previous MVA or rMVA vaccination
• Known allergy to the components of the SARS-CoV-2 vaccine product as chicken proteins or history of life-threatening reactions to vaccine containing the same substances
• Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance; safety laboratory screening evaluation can be repeated a maximum of two times
• Any finding in the medical history and physical examination deviating from normal and assessed as clinically relevant by the investigator
• Evidence in the subject's medical history or in the medical examination that might influence the absorption, distribution, metabolism or excretion of the investigational medicinal product
• Current smoking/ vaping or smoking /vaping in the previous year.
• Clinically relevant findings in ECG
• Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes
• Asthma, chronic obstructive pulmonary disease or other lung disease
• Respiratory tract infection in the 4 weeks prior to study treatment
• Any chronic or active neurologic disorder, including seizures, and epilepsy, excluding a single febrile seizure as a child
• Known intolerance to medication used during bronchoscopy, i.e. midazolam and lidocaine.
• Treatment with ß-adrenoceptor antagonists

Sponsors & Collaborators

• Hannover Medical School: lead
• German Center for Infection Research: collaborator
• IDT Biologika: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

Hannover Medical School ZKS - Early Clinical Trial Unit at CRC Hannover

Hanover, 30625, Germany

Location

Study Officials

• Jens Hohlfeld, Prof.

  Hannover Medical School, Department of Respiratory Medicine and Fraunhofer ITEM, Division of Clinical Airway Research

  PRINCIPAL INVESTIGATOR

• Reinhold Förster, Prof.

  Hannover Medical School Institute of Immunology

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 7, 2022
• Study Start: February 24, 2022
• Primary Completion: November 21, 2023
• Study Completion: November 21, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)