NCT04895449

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started Jul 2021

Typical duration for phase_1 covid19

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 16, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

April 24, 2021

Last Update Submit

January 15, 2023

Conditions

Covid19

Keywords

MVASARS-CoV-2vaccinebooster vaccination

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)

  • Number of participants who seroconverted

    during the entire study (up to 6 months)

Study Arms (6)

≥ 1 x 10E7 IU (low dose) in seronegative subjects

EXPERIMENTAL

≥ 1 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 \& 28) in seronegative subjects

Biological: MVA-SARS-2-ST

≥ 5 x 10E7 IU (middle dose) in seronegative subjects

EXPERIMENTAL

≥ 5 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 \& 28) in seronegative subjects

Biological: MVA-SARS-2-ST

≥ 1 x 10E8 IU (high dose)in seronegative subjects

EXPERIMENTAL

≥ 1 x 10E8 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 \& 28) in seronegative subjects

Biological: MVA-SARS-2-ST

≥ 1 x 10E7 IU (low dose)

EXPERIMENTAL

≥ 1 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects

Biological: MVA-SARS-2-ST

≥ 5 x 10E7 IU (middle dose)

EXPERIMENTAL

≥ 5 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects

Biological: MVA-SARS-2-ST

≥ 1 x 10E8 IU (high dose)

EXPERIMENTAL

≥ 1 x 10E8 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects

Biological: MVA-SARS-2-ST

Interventions

MVA-SARS-2-STBIOLOGICAL

i.m. vaccine administration

≥ 1 x 10E7 IU (low dose)≥ 1 x 10E7 IU (low dose) in seronegative subjects≥ 1 x 10E8 IU (high dose)≥ 1 x 10E8 IU (high dose)in seronegative subjects≥ 5 x 10E7 IU (middle dose)≥ 5 x 10E7 IU (middle dose) in seronegative subjects

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

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.
  • Previous immunization with investigational vaccine against COVID-19.
  • Previous immunization with EUA/conditionally licensed vaccine against COVID-19 (not applicable to Part B).
  • Evidence of active SARS-CoV-2 infection
  • 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.
  • Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Uniklinik Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

CTC North

Hamburg, 20251, Germany

Location

Related Publications (1)

  • Grewe I, Friedrich M, Dieck ML, Spohn M, Ly ML, Krahling V, Mayer L, Mellinghoff SC, Rottstegge M, Kraemer R, Volz A, Becker S, Fathi A, Dahlke C, Weskamm LM, Addo MM. MVA-based SARS-CoV-2 vaccine candidates encoding different spike protein conformations induce distinct early transcriptional responses which may impact subsequent adaptive immunity. Front Immunol. 2024 Dec 19;15:1500615. doi: 10.3389/fimmu.2024.1500615. eCollection 2024.

    PMID: 39749328DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marylyn M Addo, MD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2021

First Posted

May 20, 2021

Study Start

July 16, 2021

Primary Completion

November 2, 2022

Study Completion

November 8, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)