Covid19 Clinical Trial
— MVA-SARS2-STOfficial title:
A Multi-center Phase Ib Trial to Assess the Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST in Adults
Verified date | January 2023 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Multi-center phase Ib study to evaluate the Modified Vaccinia Virus Ankara (MVA) vaccine against SARS-CoV-2 in seronegative (Part A) and previously SARS-CoV-2-vaccinated individuals (Part B).
Status | Completed |
Enrollment | 43 |
Est. completion date | November 8, 2022 |
Est. primary completion date | November 2, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | 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) 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 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). 11. Any known chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child. |
Country | Name | City | State |
---|---|---|---|
Germany | Uniklinik Köln | Cologne | NRW |
Germany | CTC North | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf | Clinical Trial Center North (CTC North GmbH & Co. KG), German Center for Infection Research, IDT Biologika, Ludwig-Maximilians - University of Munich, Philipps University Marburg Medical Center |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol | Safety and reactogenicity will be assessed by observation, questionaire and diary. Occurence of Serious Adverse Events (SAE) will be collected throughout the entire study duration. | during the entire study (up to 6 months) | |
Secondary | Number of participants who seroconverted | Magnitude of SARS-CoV-2-S specific antibody responses will be measured by ELISA and neutralization assays | during the entire study (up to 6 months) |
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