A study of a new vaccine against Marburg virus in adults aged 18–55 years
- Conditions
- Marburg virus disease (MVD)Infections and Infestations
- Registration Number
- ISRCTN97679658
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 66
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.
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.
11. History of a bleeding disorder (e.g. clotting factor deficiency, acquired coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
12. History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism); history of antiphospholipid syndrome, or history of heparin-induced thrombocytopenia.
13. History of capillary leak syndrome.
14. History of Guillain-Barre syndrome, transverse myelitis or other neuroinflammatory syndrome
15. Moderate, severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, haematological, immunological, endocrine disorder, or neurological illness (note, mild well-controlled co-morbidities in a healthy participant are acceptable as judged by the Investigator)
16. Suspected or known current alcohol abuse as per investigator’s discretion.
17. Suspected or known injecting drug use within the 5 years preceding enrolment.
18. Acute or chronic hepatitis B or hepatitis C infection.
19. HIV infection.
20. Any clinically significant finding on screening that is either unlikely to resolve or does not resolve (for example on repeat testing at the discretion of an Investigator) within the recruitment timeline of the study.
21. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer if included in the study, affect the ability of the volunteer to participate in the study, or impair interpretation of the study data.
22. Member of the study team. This may include: anyone on the delegation log; anyone who might be anticipated to be placed onto the delegation log in the course of the study; anyone who has access to personal data on study participants (beyond name, contact details, DOB); and anyone who
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following each vaccination (Day 0 and Day 84), as recorded by participants in the electronic diary<br>2. Occurrence of unsolicited adverse events (AEs) for 28 days following each vaccination (Day 0 and Day 84), as recorded by participants in the electronic diary<br>3. Occurrence of abnormal safety laboratory measures for the duration of the study period (Day 0 to Day 365)<br>4. Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) for the duration of the study period (Day 0 to Day 365)
- Secondary Outcome Measures
Name Time Method 1. Serological response assessed using ELISA or other relevant assays before and after vaccination at Day 0 and Day 84