A phase I study to assess the safety and immunogenicity of an MVA-based vaccine for Crimean-Congo Haemorrhagic Fever (MVA-CCHF)

niversity Hospital Southampton NHS Foundation Trust0 sites18 target enrollmentNovember 10, 2021

Overview

No summary available.

Registry

who.int

Start Date

November 10, 2021

End Date

June 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity Hospital Southampton NHS Foundation Trust

•1\. Healthy adults aged 18 to 45 years
•2\. Able and willing (in the Investigator’s opinion) to comply with all study requirements
•3\. Willing to allow the Investigators to discuss the volunteer’s medical history with their General Practitioner (GP)
•4\. Willingness to practice continuous effective contraception (see below) during the study and (for females only) a negative pregnancy test on the day(s) of screening and vaccination
•5\. Agreement to refrain from blood donation during the course of the study
•6\. Provide written informed consent
•7\. Female volunteers of childbearing potential are required to use an effective form of contraception for the duration of their participation in the study. Acceptable forms of contraception for female volunteers are as follows:
•7\.1\.Established use of oral, injected or implanted hormonal methods of contraception
•7\.2\. Placement of an intrauterine device or intrauterine system
•7\.3\. Total abdominal hysterectomy or surgical sterilisation

•Current exclusion criteria as of 06/04/2023:
•1\. Participation in another research study involving receipt of an investigational product in the 30 days preceding receipt of MVA\-CCHF, or planned use during the study period
•2\. Prior receipt of an MVA based vaccine or other investigational vaccine likely to impact on interpretation of the trial data, as assessed by the investigator
•3\. Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe
•4\. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
•5\. Confirmed or under investigation for immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 20 mg/day (for adult subjects), or equivalent. Inhaled and topical steroids are allowed
•6\. Administration of long\-acting immune\-modifying drugs at any time during the study period (e.g. infliximab)
•7\. History of CCHF anti\-viral treatment within 60 days prior to vaccination
•8\. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
•9\. Any history of anaphylaxis in relation to vaccination