A Phase I, first-in-human safety and immunogenicity study of a Marburg virus vaccine, ChAdOx1 Marburg, in healthy volunteers aged 18–55 years in the UK

niversity of Oxford0 sites66 target enrollmentMay 1, 2024

ConditionsMarburg virus disease (MVD)Infections and Infestations

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Marburg virus disease (MVD)
Sponsor: niversity of Oxford
Enrollment: 66
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 1, 2024

End Date

November 30, 2025

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity of Oxford

Eligibility Criteria

Inclusion Criteria

•1\. Adults aged between 18 to 55 years (inclusive) at the time of screening.
•2\. Medically healthy, such that according to the investigator's judgement, hospitalisation within the study period is not anticipated, and the participant appears likely to be able to remain a study participant through the end of protocol\-specified follow\-up. Planned elective procedures for pre\-existing conditions are allowable.
•3\. Able to attend the scheduled visits and comply with all study procedures, including internet access for the recording of electronic diary cards.
•4\. Willing and able to give informed consent for participation in the study.
•5\. Willing to allow confirmation of past medical and vaccination history either through provision of or access to a medical record summary or other medical documentation or allowing investigators to obtain a copy of their medical history from their GP practice or via electronic patient records.
•6\. Willing to allow their GP and/or consultant, if appropriate, to be notified of participation in the study.
•7\. Willing to provide their national insurance number or passport number to be registered on The Over\-Volunteering Prevention System (TOPS).
•8\. Agreement to refrain from blood donation during the study.
•9\. For participants of childbearing potential only: willing to use effective contraception for the duration of the study AND to have a pregnancy test on the days of screening and vaccinations. The pregnancy tests taken prior to vaccinations must be negative.

Exclusion Criteria

•1\. Participation in another research study, in which an investigational product has been administered or other procedures performed which could compromise the integrity of this study (such as significant volumes of blood taken) within the 12 weeks prior to enrolment or are planning to do so within the trial period.
•2\. History of previous confirmed or suspected Marburg virus infection.
•3\. Administration of immunoglobulins and/or any blood products within three months preceding the planned administration of the vaccine candidate.
•4\. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; severe infection(s); receipt of immunosuppressive therapy such as anti\-cancer chemotherapy or radiation therapy within the preceding 12 months, or long\-term systemic corticosteroid therapy (including for more than 7 consecutive days within three months preceding the planned administration of the vaccine candidate).
•5\. History of anaphylaxis in relation to vaccination.
•6\. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including hypersensitivity to the active substance or to any of the excipients of the IMP.
•7\. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
•8\. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
•9\. History of any serious psychiatric condition likely to affect participation in the study.
•10\. Participants who are pregnant, breastfeeding or lactating, or are planning pregnancy during the course of the study.