A study of a new vaccine against Nipah virus in adults aged 18 to 55 years
- Conditions
- ipah virusInfections and Infestations
- Registration Number
- ISRCTN87634044
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 51
1. Adults aged between 18 to 55 years (inclusive) at the time of screening.
2. Medically healthy, such that according to investigator 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 to 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 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 accessed 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 course of the study
9. For women of childbearing potential only: willing to use effective contraception from one month prior to receiving the first dose of vaccine and for the duration of the study AND have a negative pregnancy test on the days of screening and vaccination
1. Participation in another research study involving an investigational product or other study which includes procedures that could compromise the integrity of this study (such as significant volumes of blood already taken) within the 12 weeks prior to enrolment, or are planning to do so within the trial period
2. Previous receipt of another adenoviral-vectored vaccine (which includes the Oxford/AstraZeneca and Janssen COVID-19 vaccines) within the preceding year
3. Previous immunisation with an investigational Nipah vaccine
4. History of previous confirmed or suspected Nipah infection
5. Administration of immunoglobulins and/or any blood products within three months preceding the planned administration of the vaccine candidate.
6. 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 3 months preceding the planned administration of the vaccine candidate)
7. History of anaphylaxis in relation to vaccination
8. 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 (EDTA or magnesium chloride)
9. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
10. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
11. History of any serious psychiatric condition likely to affect participation in the study
12. For women only: participants who are pregnant, breastfeeding or lactating, or are planning pregnancy during the course of the study
13. History of a bleeding disorder (e.g. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
14. 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
15. History of capillary leak syndrome
16. 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)
17. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units per week
18. Suspected or known injecting drug use within the 5 years preceding enrolment
19. Detectable circulating hepatitis B surface antigen (HBsAg)
20. Seropositive for hepatitis C virus (antibodies to HCV)
21. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Occurrence of solicited local reactogenicity signs and symptoms at 7 days following each vaccination (D0 to D6; V2 to V2+6)<br>2. Occurrence of solicited systemic reactogenicity signs and symptoms at 7 days following each vaccination (D0 to D6; V2 to V2+6)<br>3. Occurrence of unsolicited adverse events (AEs) at 28 days following each vaccination (D0 to D27; V2 to V2+27)<br>4. Occurence of abnormal safety laboratory measures; Cohort 1: D0, D2, D7, D14, D28, D56, V2, V2+2, V2+7, V2+14, V2+28, V2+56); Cohort 2: D0, D14, D28, V2, V2+14, V2+28<br>5. Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) for the whole duration of the study (D0 to V2+281)
- Secondary Outcome Measures
Name Time Method ipahB glycoprotein G-specific serological response as measured by ELISA; Cohort 1: D0, D14, D28, D56, V2, V2+14, V2+28, V2+56, V2+281; Cohort 2: D0, D14, D28, V2, V2+14, V2+28, V2+281