NCT04569383

Brief Summary

In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-SARS-2-S. A subgroup will receive a heterologous booster vaccination with a licensed COVID-19 vaccine. The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

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

September 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2021

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

September 21, 2020

Last Update Submit

November 4, 2021

Conditions

Covid19

Keywords

MVAvaccineSARS-CoV-2mRNA vaccineheterologous

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. Number of participants who seroconverted

    during the entire study (up to 6 months)

Study Arms (2)

1x10E7 IU (low dose)

EXPERIMENTAL

1x10E7 IU MVA-SARS-2-S. Subgroup will receive additionally Comirnaty

Biological: MVA-SARS-2-S vaccinations (days 0 & 28)Biological: Comirnaty

1x10E8 IU (high dose)

EXPERIMENTAL

1x10E8 MVA-SARS-2-S. Subgroup will receive additionally Comirnaty

Biological: MVA-SARS-2-S vaccinations (days 0 & 28)Biological: Comirnaty

Interventions

MVA-SARS-2-S vaccinations (days 0 & 28)BIOLOGICAL

Vaccination with MVA-SARS-2-S in two escalating dose regimens

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

Vaccination with Comirnaty (21 day interval)

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

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent
  • Healthy male and female adults aged 18-55 years
  • No clinically significant health problems as determined during medical history and physical examination at screening visit
  • Body mass index 18.5 - 30.0 kg/m2 and weight \> 50 kg at screening
  • Adults male or non-pregnant, non-lactating female with negative pregnancy test
  • Males and females who agree to comply with the applicable contraceptive requirements of the protocol
  • Ability to understand the subject information and to personally name, sign and date the in-formed consent to participate in the study.
  • Provided written informed consent.
  • Continues to be in stable health condition as determined during medical history and physi-cal examination on vaccination visits.
  • Non-pregnant, non-lactating female with a negative pregnancy test at screening and on dosing days (prior to vaccination).
  • Be willing to refrain from blood donation during the course of the study.
  • The subject is co-operative and available for the entire study.
  • Need to have participated in previous part of the MVA-SARS-2-S vaccine study (Eudra-CT No: 2020-002998-10)

You may not qualify if:

  • Prior exposure to SARS-CoV-2
  • 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
  • Known allergy to the components of the SARS-CoV-2 vaccine product
  • Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine
  • Evidence in the subject's medical history or in the medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the investigational product
  • Clinically relevant findings in ECG
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes
  • Any chronic or active neurologic disorder, including seizures, and epilepsy, excluding a single febrile seizure as a child
  • Prior infection with SARS-CoV-2 in medical history (documented by PCR test)
  • Receipt of any vaccine from 2 weeks prior to each trial vaccination (4 weeks for live vac-cines) to 2 weeks after each trial vaccination.
  • Receipt any COVID-19 vaccine (investigational or licensed other than MVA-SARS-2-S be-fore vaccination throughout end of study).
  • Known allergy to the components of t Comirnaty®.
  • Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine.
  • Participation in a clinical trial other than the MVA-SARS-2-S vaccine trial or use of an in-vestigational product other than MVA-SARS-2-S within 30 days or five times the half-life of the investigational product -whichever is longer- prior to receiving the first dose within this study.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CTC North GmbH & Co KG at the University Medical Center Hamburg-Eppendorf

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

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

mRNA VaccinesNucleic Acid-Based VaccinesVaccines, SyntheticRecombinant ProteinsProteinsAmino Acids, Peptides, and ProteinsVaccinesBiological ProductsComplex MixturesCOVID-19 VaccinesViral VaccinesAntigensBiological Factors

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

September 21, 2020

First Posted

September 29, 2020

Study Start

October 5, 2020

Primary Completion

August 24, 2021

Study Completion

August 24, 2021

Last Updated

November 5, 2021

Record last verified: 2021-11

Locations

DE(1)