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

NCT05950776 | Withdrawn Phase 2 DMC

• 1 other identifier: UKE-SARS-COV-2-II
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19

Keywords

MVA; vaccine; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immunogenicity

  during the entire study (up to 6 months)

Study Arms (3)

1x10E7 IU (low dose)

EXPERIMENTAL

1x10E7 IU MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 \& 28)

Biological: MVA-SARS-2-S

1x10E8 IU (high dose)

EXPERIMENTAL

1x10E8 MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 \& 28)

Biological: MVA-SARS-2-S

Placebo

PLACEBO COMPARATOR

Days 0 \& 28

Other: Placebo

Interventions

MVA-SARS-2-S BIOLOGICAL

Vaccination with MVA-SARS-2-S

1x10E7 IU (low dose); 1x10E8 IU (high dose)

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Written informed consent.
• 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.
• 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.
• Body mass index 18.5 - 32.0 kg/m2 and weight \> 50 kg at screening.
• Non-pregnant, non-lactating female with negative pregnancy test.
• Females who agree to comply with the applicable contraceptive requirements of the protocol.

You may not qualify if:

• Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live vaccines) to 6 weeks after each trial vaccination.
• Previous rMVA immunization.
• Evidence of an active SARS-CoV-2 infection.
• 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.
• Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine.
• 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.
• Clinically relevant findings in ECG or significant thromboembolic events in medical history.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c \> 7.0).
• Any known chronic or active neurologic disorder, including seizures, and epilepsy, excluding a single febrile seizure as a child.

Sponsors & Collaborators

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

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Marylyn M Addo, MD

  CTC-NORTH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind: two or more parties are unaware of the intervention assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 * Placebo

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: July 18, 2023
• Study Start: January 15, 2021
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-06