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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Christopher
Chiu
+44 (0)20 8383 2301
c.chiu@imperial.ac.uk
Ms
Polly
Fox
-
polly.fox@imperial.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
COVID-19
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
COVHIC002 is a human infection challenge study in which healthy adults aged 18-30 previously vaccinated with an approved COVID-19 vaccine will be administered a SARS-CoV-2 Delta variant virus. The aim is to achieve upper respiratory infection in the majority of challenged individuals with mild or no illness, providing information on the course of SARS-CoV-2 infection and the immune response in vaccinated people. This study will establish an optimised dose and study design that will then be used to evaluate the efficacy of new treatments and vaccine candidates in follow-on trials.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. History or evidence of any clinically significant or currently active cardiovascular, (including thromboembolic events), respiratory, dermatological, gastrointestinal, endocrine, haematological, hepatic, immunological, rheumatological, metabolic, urological, renal, neurological, psychiatric illness.2. Any significant abnormality altering the anatomy or function of the nose or nasopharynx in a substantial way (including loss of or alterations in smell or taste), a clinically significant history of epistaxis within the last 3 months, nasal or sinus surgery within 6 months of inoculation.3. Clinically active rhinitis (including hay fever) or history of moderate to severe rhinitis, or history of seasonal allergic rhinitis likely to be active at the time of inclusion and/or requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of admission to quarantine.4. History of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the PI.5. History or presence of alcohol addiction, or excessive use of alcohol or use of drugs of abuse6. Psychiatric illness including subjects with a history of depression and/or anxiety with associated severe psychiatric comorbidities, for example psychosis. Specifically, (a) Subjects with history of anxiety-related symptoms of any severity within the last 2 years if the Generalized Anxiety Disorder-7 score is > = 4; (b)Subjects with a history of depression of any severity within the last 2 years if the Patient Health Questionnaire-9 score is > = 47. Subjects who have smoked > = 5 pack years at any time.8. Family history of 1st degree relative aged 50 years or less with sudden cardiac or unexplained death9. Family History of Severe COVID or response to any other viral disease e.g. Guillain–Barré10. A total body weight of < = 50kg and a BMI < = 18 kg/m2 and > = 28 kg/m2. The upper limit of BMI may be increased to < = 30kg/m2 at the PI’s discretion, in the case of physically fit muscular individual11. Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.12. Any clinically significant abnormal finding on screening biochemistry, haematology and microbiology blood tests or urinalysis i.e. grade 1 lab abnormalities or above apart from minor deviations which are clinically acceptable and approved by the Principal Investigator13. A forced expiratory volume in 1 second (FEV1) and a forced vital capacity (FVC) < 80% of predicted value calculated using ATS/ERS guidance14. Twelve-lead ECG recording with clinically relevant abnormalities as judged by the study physician/PI.15. History of, or currently active symptoms suggestive of upper or lower respiratory tract infection (including reduced sense of taste and smell, raised body temperature and/or persistent cough) within 6 weeks prior to viral challenge.16. Presence of cold-like symptoms and/or fever (defined as subject presenting with a temperature reading of > 37.9ºC) on Day -2, Day -1 and/or pre-challenge on Day 0.17. Evidence of any respiratory viruses (on nasopharyngeal swab analysis) prior to challenge virus inoculation on admission to the quarantine unit.18. Evidence of a live vaccine within 60 days prior to the planned date of viral challenge, a non-live vaccine within 30 days prior to the planned date of viral challenge or intention to receive any vaccination(s) before the day 28 follow-up visit.19. Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned date of viral challenge or planned during the 3 months after the final visit.20. Use of certain medications (listed in more detail in the protocol)21. Prior participation in another human viral challenge study in the preceding 12 months22. Previous participation in a SARS-CoV-2 vaccine trial of a currently unapproved/unlicensed vaccine in the UK23. Any nasal sampling procedure in the 6 months before date of expected viral challenge in this study (excluding study tolerance test or routine tests for COVID-19)24. Subject is mentally or legally incapacitated in the opinion of the Investigator.25. Females who: Are breastfeeding within 6 months of study commencement, or Had been pregnant within 6 months prior to the study, or Had a positive pregnancy test at any point during screening or prior to inoculation with challenge virus26. Those in close domestic contact with children under 2 years, the elderly (> 65 years), immunosuppressed persons, or those with chronic respiratory disease27. Subjects who are currently employed or a first-degree relative of someone employed by the Sponsor or participating site, or any CRO involved in this study.28. Any other reason that the Investigator considered made the subject unsuitable to participate.29. Participants with no knowledge of their family history
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Christopher
Chiu
+44 (0)20 8383 2301
c.chiu@imperial.ac.uk
Ms
Polly
Fox
-
polly.fox@imperial.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Imperial College London and funded by Wellcome Trust.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 53784
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
