A multi-center phase Ib trial to assess the safety, tolerability and immunogenicity of the candidate vaccine MVA-SARS-2-ST in adults

Phase 1

• Conditions: This study is designed to evaluate the safety, tolerability and reactogenicity of intramuscular dose administrations of:-3 dose levels of the MVA-SARS-2-ST vaccine in healthy SARS-CoV-2 seronegative adults (2 administrations) (Part A). -1 dose level of the MVA-SARS-2-ST vaccine in healthy adults with previous mRNA vaccination against COVID-19 (1 administration) (Part B).; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000548-23-DE
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-18
• Last Update Posted: 3 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Written informed consent.
2.Healthy male and female adults aged 18 – 64 at time of informed consent.
3.Body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screening.
4.Female participants: non-pregnant, non-lactating with negative pregnancy test.
5.Females who agree to comply with the applicable contraceptive requirements of the protocol.
6. = 6 months fully vaccinated with a (conditionally) licensed mRNA vaccine against COVID-19 (Part B only).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1.Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live vaccines) to 6 weeks after each trial vaccination.
2.Previous rMVA immunization.
3.Previous immunization with investigational vaccine against COVID-19.
4.Previous immunization with EUA/conditionally licensed vaccine against COVID-19 (not applicable to part B).
5.Evidence of active SARS-CoV-2 infection (positive SARS-CoV-2 antigen test followed by a confirmatory positive PCR test).
6.Known allergy to the components of the MVA-SARS-2-ST vaccine product or history of life-threatening reactions to vaccine containing the same substances.
7.Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
8.Evidence in the participant's medical history or in the medical examination that might influence either the safety of the participant or the absorption, distribution, metabolism or excretion of the investigational product.
9.Clinically relevant findings in ECG or significant thromboembolic events in medical history.
10.Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c = 7.0).
12.Any known chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified