COVID-19 Trial of the Candidate Vaccine MVA-SARS-2-S in Adults

• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT05950776
• Collaborator: German Center for Infection Research (Other), Philipps University Marburg Medical Center (Other), Ludwig-Maximilians - University of Munich (Other), University Hospital Tuebingen (Other), CTC-NORTH (Other)
• Enrollment: 0
• Arms: 3
• Anticipated Duration (Months): 21.6

Study Details

Study Description

Brief Summary

In this multi-center phase II clinical trial, adults in stable health conditions will be vaccinated twice with either a low dose or high dose of the candidate vaccine MVA-SARS-2-S, or placebo.

The aim of the study is to assess the safety and immunogenicity of the candidate vaccine.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Biological: MVA-SARS-2-S; Other: Placebo	Phase 2

Detailed Description

The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the SARS-CoV-2 spike protein (S).

This will be a combined Phase II, multi-center trial in a total of 580 participants.

The dose finding study will be conducted randomized-controlled, in adults in stable health conditions, including health care workers, COVID-19 risk populations, individuals with advanced age and seropositive individuals.

Male and female individuals in stable health conditions will be stratified for age (18-64 years and 65 and older).

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Male and female individuals in stable health conditions (group I and II, see below) will be stratified for age and included to the following groups with a random allocation to one of the two dose groups or the placebo in a 4:4:1 ratio: 1 x 107 ± 0.5 log IU MVA-SARS-2-S 1 x 108 ± 0.5 log IU MVA-SARS-2-S Placebo Male and female individuals in stable health conditions will be stratified for age and randomized to low dose, hogh dose of MVA SARS-2-S or the placebo in a 4:4:1 ratio: 1 x 107 ± 0.5 log IU MVA-SARS-2-S 1 x 108 ± 0.5 log IU MVA-SARS-2-S PlaceboMale and female individuals in stable health conditions (group I and II, see below) will be stratified for age and included to the following groups with a random allocation to one of the two dose groups or the placebo in a 4:4:1 ratio:1 x 107 ± 0.5 log IU MVA-SARS-2-S 1 x 108 ± 0.5 log IU MVA-SARS-2-S PlaceboMale and female individuals in stable health conditions will be stratified for age and randomized to low dose, hogh dose of MVA SARS-2-S or the placebo in a 4:4:1 ratio:1 x 107 ± 0.5 log IU MVA-SARS-2-S 1 x 108 ± 0.5 log IU MVA-SARS-2-S Placebo
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Double-blind: two or more parties are unaware of the intervention assignment.
• Primary Purpose: Prevention
• Official Title: A Multi-center, Randomized Placebo-controlled Phase II Trial to Assess the Safety, Tolerability and Immunogenicity of Two Doses of the Candidate Vaccine MVA-SARS-2-S in Adults Aged 18 to 64 and 65 and Older
• Actual Study Start Date: Jan 15, 2021
• Anticipated Primary Completion Date: Nov 2, 2022
• Anticipated Study Completion Date: Nov 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1x10E7 IU (low dose) 1x10E7 IU MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 & 28)	Biological: MVA-SARS-2-S; Vaccination with MVA-SARS-2-S
Experimental: 1x10E8 IU (high dose) 1x10E8 MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 & 28)	Biological: MVA-SARS-2-S; Vaccination with MVA-SARS-2-S
Placebo Comparator: Placebo Days 0 & 28	Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol [during the entire study (up to 6 months)]

   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.

Secondary Outcome Measures

1. Immunogenicity [during the entire study (up to 6 months)]

   Number of participants who seroconverted. Magnitude of SARS-CoV-2 specific antibody responses (ELISA and neutralization assay)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Written informed consent.

2. Male and female adults in stable health conditions aged 18 - 64 at time of informed consent (participation of health care workers and risk groups will be prioritized) and male or female in stable health conditions aged ≥ 65 at time of informed consent.

3. Either in good or stable health in the opinion of the investigator. Participants may have underlying illness as long as their symptoms are medically controlled, and they are on a stable medication for the respective underlying illness for at least 8 weeks before screening and no changes are expected during the study.

4. Body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screening.

5. Non-pregnant, non-lactating female with negative pregnancy test.

6. Females who agree to comply with the applicable contraceptive requirements of the protocol.

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. Evidence of an active SARS-CoV-2 infection.

4. Known allergy to the components of the MVA-SARS-2-S vaccine product such as chicken proteins, or history of life-threatening reactions to vaccine containing the same substances.

5. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine.

6. 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 under investigation.

7. Clinically relevant findings in ECG or significant thromboembolic events in medical history.

8. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c > 7.0).

9. Any known chronic or active neurologic disorder, including seizures, and epilepsy, excluding a single febrile seizure as a child.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universitätsklinikum Hamburg-Eppendorf
• German Center for Infection Research
• Philipps University Marburg Medical Center
• Ludwig-Maximilians - University of Munich
• University Hospital Tuebingen
• CTC-NORTH

Investigators

• Principal Investigator: Marylyn M Addo, MD, CTC-NORTH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT05950776
• Other Study ID Numbers: UKE-SARS-COV-2-II
• First Posted: Jul 18, 2023
• Last Update Posted: Jul 18, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Universitätsklinikum Hamburg-Eppendorf: MVA; vaccine; SARS-CoV-2
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Jul 18, 2023