ISRCTN17936606
Active, Not Recruiting
Phase 1
A Phase I study to determine the safety and immunogenicity of a new vaccine against the Middle East Respiratory Syndrome Coronavirus in Adults aged 50 to 70 years
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection
- Sponsor
- niversity of Oxford
- Enrollment
- 84
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults aged between 50 to 70 years (inclusive) at the time of screening
- •2\. Medically stable, 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. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 90 days prior to enrolment.
- •3\. Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diary cards
- •4\. Willing to allow confirmation of their past medical history either through: provision of or access to medical record summary, allowing investigators to obtain a copy of their medical history from their GP practice or accessed via the electronic patient record or other medical documentation provided by the participant
- •5\. Agreement to refrain from blood donation during the course of the study
- •6\. Willing and able to give informed consent for participation in the study
- •7\. For women of childbearing potential only (As defined by protocol section 8\.4\): Willing to use effective contraception as defined from one month prior to receiving the first vaccine and for the duration of the study AND a negative pregnancy test on the days of screening and vaccination.
- •8\. Willing to provide their national insurance number or passport number to be registered on The Over\-Volunteering Prevention System (TOPS)
- •9\. Willing to allow his or her General Practitioner and/or Consultant, if appropriate, to be notified of participation in the study
- •10\. Group 1 specific inclusion criteria: a confirmed history of receiving at least TWO doses of the ChAdOx1 nCov\-19 (Oxford/AZ COVID\-19\) vaccine prior to enrolment
Exclusion Criteria
- •1\. Participation in another research study involving an investigational product or that which may compromise the integrity of the study (e.g. significant volumes of blood already taken in previous study) in the past 12 weeks, or are planning to do so within the trial period
- •2\. Planned receipt of another adenoviral vectored vaccine (e.g. Oxford/AstraZeneca or Janssen COVID\-19 vaccines) within 90 days of any study vaccine.
- •3\. Previous immunisation with an investigational MERS vaccine
- •4\. History of prior confirmed or suspected MERS infection
- •5\. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- •6\. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; severe infections or 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 days consecutively within the previous 3 months)
- •7\. 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 or Vaxzevria (i.e. the Oxford/AstraZeneca COVID\-19 vaccine)
- •8\. History of allergic reaction to aminoglycoside antibiotics
- •9\. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
- •10\. History of anaphylaxis in relation to vaccination
Outcomes
Primary Outcomes
Not specified
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