MVA-S2-S-R01

Overview
Related items

Safety, reactogenicity and immunogenicity of a novel MVA-SARS-2-ST vaccine candidate administered as inhalation boost in SARS-CoV-2 immunized adults – phase I Study

SEEK ID: https://ldh.zks-mhh.imise.uni-leipzig.de/projects/7

Public web page: Not specified

NFDI4Health PALs: No PALs for this Project

Project start date: 24th Feb 2022

Project end date: 21st Nov 2023

Extended Metadata (Nfdi4Health MDS 3.3)

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Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : Safety, reactogenicity and immunogenicity of a novel MVA-SARS-2-ST vaccine candidate administered as inhalation boost in SARS-CoV-2 immunized adults – phase I Study
Language of the title/name : English

Acronym(s) of the Project

Acronym : MVA-S2-S-R01
Language of the acronym : English

Description(s) of the Project

Description : This will be a phase I, single-center trial, including a total of 30 participants in two cohorts. Cohort 1 (n=6): Healthy male or female adults aged 18 - ≤ 60 previously primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen. Cohort 2 (n=24): Healthy male or female adults aged 18 - ≤ 60 primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen and subsequently booster immunized with any EU marketed mRNA vaccine Both cohorts will be assigned to inhaled vaccination with MVA-SARS-2-ST
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : MVA-SARS-COV-2

Keyword(*) : MVA-SARS-2-ST

Language(s) of the project : English

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Jens
Family name(s)(*) : Hohlfeld
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : jens.hohlfeld@item.fraunhofer.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Hannover Medical School, Department of Respiratory Medicine
Address : Carl-Neuberg-Str. 1 30625 Hannover, Germany
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Fraunhofer ITEM, Divison of Clinical Airway Research
Address : Feodor-Lynen-Straße 15, 30625 Hannover
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Sponsor (primary)
Given name(*) : Daniel
Family name(s)(*) : Breuer
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Breuer.Daniel@mh-hannover.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Hannover Medical School Department
Address : Carl-Neuberg-Str. 1 30625 Hannover, Germany
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : EudraCT
Identifier(*) : 2020-004010-35

Type of the registry(*) : NCT (ClinicalTrials.gov)
Identifier(*) : NCT05226390

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Single group
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : COVID-19 Vaccines
Terminology/classification(*) : Not specified
Code of the health condition or disease : Not specified
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : []
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : Not specified
Start date : 24 February 2022
End date : 21 November 2023
Mono- or multicentric? : Monocentric
Number of centers : Not specified
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : 60
Unit of age(*) : Years
Eligible gender : Male, Female
Inclusion criteria : The subject must not be enrolled before all inclusion criteria (including test results) are confirmed. Subjects meeting all of the criteria listed below will be included in the study. Signed written informed consent from subject prior to any study-related procedure and willingness to comply with treatment and follow-up procedures Healthy men or women, aged ≥ 18 ≤ 60 at day of inclusion having received either primary immunization (cohort 1) with any regimen using any EU marketed SARS- CoV-2 vaccine or subsequently booster immunization (cohort 2) with any EU marketed mRNA vaccine at least 3 months prior to enrollment Adults with SARS-CoV-2 specific IgG concentration between 10 RU/ml and 1200 RU/ml determined by Anti-SARS-CoV-2-QuantiVac-ELISA (IgG) Males or non-pregnant, non-lactating females of child-bearing potential with negative pregnancy test at screening who agree to comply with the applicable contraceptive requirements of the protocol (Section 3.4) from at least 14 days prior to vaccination and during the entire duration of the study. or Females without child-bearing potential defined as follows: at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or hysterectomy or uterine agenesis or ≥ 50 years and in postmenopausal state > 1 year or < 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening Normal pulmonary function: FEV1 predicted ≥ 80% and FEV1/FVC > 70% Body mass index 18.5 - 30.0 kg/m2 and weight > 50 kg at screening Subject is capable of understanding the investigational nature, potential risks and benefits of the clinical trial
Exclusion criteria : Subjects are excluded from the study if any of the following criteria are met at screening or on dosing day. Previous MVA or rMVA vaccination Known allergy to the components of the SARS-CoV-2 vaccine product 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 Any laboratory value outside the reference range that the investigator considers to be of clinical relevance; safety laboratory screening evaluation can be repeated a maximum of two times Any finding in the medical history and physical examination deviating from normal and assessed as clinically relevant by the investigator Evidence in the subject's medical history or in the medical examination that might influence the absorption, distribution, metabolism or excretion of the investigational medicinal product Current smoking/ vaping or smoking /vaping in the previous year. Clinically relevant findings in ECG Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes Asthma, chronic obstructive pulmonary disease or other lung disease Respiratory tract infection in the 4 weeks prior to study treatment Any chronic or active neurologic disorder, including seizures, and epilepsy, excluding a single febrile seizure as a child Known intolerance to medication used during bronchoscopy, i.e. midazolam and lidocaine. Treatment with ß-adrenoceptor antagonists Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males) Drug abuse or positive drug screening Any positive result for HIV1/2, HCV antibody or HBs antigen testing Moderate or severe illness and/or fever >38 °C within 1 week prior to vaccination History of blood donation within 60 days of enrollment or plans to donate within the treatment phase Participation in a clinical trial or use of an investigational product 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 Investigator or employee of the study site or Sponsor with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, natural or adopted child) of the investigator or employee with direct involvement in the proposed study
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : MVA-SARS-2-ST
Type of the intervention : Biological/Vaccine
Additional information about the intervention : All Participants will receive a single booster dose of 1 x 107 IU MVA-SARS-2-ST in 0.5 mL as inhalation (total inhaled volume 0.5 mL)
Name(s) of the arm(s) associated with the given intervention : Experimental
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited local reactogenicity signs and symptoms
Type of the outcome measure : Primary
Time point(s) of assessment : day 0
Name of the outcome measure(*) : The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited local reactogenicity signs and symptoms
Type of the outcome measure : Primary
Time point(s) of assessment : day 1
Name of the outcome measure(*) : The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited local reactogenicity signs and symptoms
Type of the outcome measure : Primary
Time point(s) of assessment : day 2
Name of the outcome measure(*) : The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited local reactogenicity signs and symptoms
Type of the outcome measure : Primary
Time point(s) of assessment : day 3
Name of the outcome measure(*) : The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited local reactogenicity signs and symptoms
Type of the outcome measure : Primary
Time point(s) of assessment : day 4
Name of the outcome measure(*) : The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited local reactogenicity signs and symptoms
Type of the outcome measure : Primary
Time point(s) of assessment : day 5
Name of the outcome measure(*) : The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited local reactogenicity signs and symptoms
Type of the outcome measure : Primary
Time point(s) of assessment : day 6
Name of the outcome measure(*) : The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited local reactogenicity signs and symptoms
Type of the outcome measure : Primary
Time point(s) of assessment : day 7
Name of the outcome measure(*) : Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Description of the outcome measure : Change from baseline of pulmonary function measured by peak flow as peak expiratory flow (PEF) frequently
Type of the outcome measure : Primary
Time point(s) of assessment : day 0 (2h), day 1, 3, 7, 14, 28, 56, 140
Name of the outcome measure(*) : Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Description of the outcome measure : Change from baseline of pulmonary function measured by spirometry as forced expiratory volume in 1 second (FEV1) (%)
Type of the outcome measure : Primary
Time point(s) of assessment : day 0 (2h), day 1, 3, 7, 14, 28, 56, 140
Name of the outcome measure(*) : Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Description of the outcome measure : Change from baseline of pulmonary function measured by spirometry as FEV1/FVC (%)
Type of the outcome measure : Primary
Time point(s) of assessment : day 0 (2h), day 1, 3, 7, 14, 28, 56, 140
Name of the outcome measure(*) : Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Type of the outcome measure : Primary
Time point(s) of assessment : day 0
Name of the outcome measure(*) : Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Type of the outcome measure : Primary
Time point(s) of assessment : day 1
Name of the outcome measure(*) : Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Type of the outcome measure : Primary
Time point(s) of assessment : day 2
Name of the outcome measure(*) : Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Type of the outcome measure : Primary
Time point(s) of assessment : day 3
Name of the outcome measure(*) : Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Type of the outcome measure : Primary
Time point(s) of assessment : day 4
Name of the outcome measure(*) : Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Type of the outcome measure : Primary
Time point(s) of assessment : day 5
Name of the outcome measure(*) : Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Type of the outcome measure : Primary
Time point(s) of assessment : day 6
Name of the outcome measure(*) : Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Type of the outcome measure : Primary
Time point(s) of assessment : day 7
Name of the outcome measure(*) : Occurrence of unsolicited adverse events (AE) associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of unsolicited adverse events (AE)
Type of the outcome measure : Primary
Time point(s) of assessment : from day 0 to day 28 after vaccination
Name of the outcome measure(*) : Change of safety laboratory measures associated with MVA-SARS-2-S
Description of the outcome measure : Change from baseline of safety laboratory measures
Type of the outcome measure : Primary
Time point(s) of assessment : day 1, 3, 7, 14, 28, 56, 140
Name of the outcome measure(*) : Occurrence of serious adverse events (SAE) associated with MVA-SARS-2-ST
Description of the outcome measure : Occurrence of serious adverse events (SAE)
Type of the outcome measure : Primary
Time point(s) of assessment : through study completion, an average of 5 month
Name of the outcome measure(*) : To evaluate immunogenicity of the candidate MVA-SARS-2-ST
Description of the outcome measure : Change from baseline of levels of binding antibodies against SARS-CoV-2 spike S1 protein measured by ELISA in blood
Type of the outcome measure : Secondary
Time point(s) of assessment : day 7, 14, 28, 56 and 140
Name of the outcome measure(*) : To evaluate immunogenicity of the candidate MVA-SARS-2-ST
Description of the outcome measure : Change from baseline of levels of binding antibodies against SARS-CoV-2 spike S1 protein measured by ELISA in (bronchial alveolar lavage) BAL on day 14
Type of the outcome measure : Secondary
Time point(s) of assessment : day 14
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : No, there is no plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Phase-1
Masking of intervention(s) assignment
Masking implemented? : false
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

MVA-S2-S-R01

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