COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
The study has three components:
1. Open-label, non-randomised dose escalation: 15 participants age 18-45 will be in the dose-escalation component. This will be carried out in a single centre.
1.1. Th
and a sentinel at 1.0 µg will follow if there are none of the safety concerns outlined above at 48 hours post-vaccination of the participants at 0.3 µg
1.5. Participants will be followed up for 52 wee
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults from the following age ranges: 1.1. For the dose escalation and evaluation, aged 18- 45 years on the day of screening 1.2. For the expanded safety evaluation, aged 18-75 years on the day of screening 2. At a similar risk of acquiring SARS-CoV2 infection to the general population 3. Willing and able to provide written informed consent 4. If female and of childbearing potential and not sterilised, willing to use a highly effective method of contraception from screening until 18 weeks after the last injection 5. If male and not sterilised, willing to avoid impregnating female partners from screening until 18 weeks after last injection 6. Willing to avoid all other vaccines 4 weeks after the first injection through to 4 weeks after the second injection 7. Willing and able to comply with visit schedule, complete online diaries and provide samples 8. Willing to grant authorised persons access to his/her trial-related medical record and GP records either directly or indirectly
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating 2. Presence of active systemic disease or pre-exisiting conditions that require investigation or a change to treatment that in the opinion of the investigator may compromise the volunteer’s safety, preclude vaccination or compromise interpretation of the immune response to vaccine 3. History of COVID-19 infection 4. History of severe or multiple allergies to drugs or pharmaceutical agents 5. History of severe local or general reaction to vaccination defined as: 5.1. Local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours 5.2. General: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours 6. Ever received an experimental vaccine against COVID-19 7. Receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical 8. Detection of antibodies to hepatitis C 9. Detection of antibodies to HIV 10. Grade 1 and above abnormalities in routine laboratory parameters (see Table 4) using the FDA toxicity table Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download) 11. Participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days of screening 12. Has received an immunisation within 28 days of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Solicited local injection site reactions (pain, tenderness, erythema, swelling), collected via symptom diaries and immunisation eCRFs, within 7 days of administration of each vaccine 2. Solicited systemic and laboratory reactions (pyrexia, fatigue, myalgia, headache, chills, arthralgia) collected via symptom diaries and immunisation eCRFs, within 7 days of administration of each vaccine 3. Unsolicited adverse reactions (ARs, including serious ARs) collected via the eDC system throughout the study period (52 weeks) 4. Serious Adverse Events collected via the eDC system throughout the study period (52 weeks) 5. Unsolicited adverse events collected via the eDC system throughout the study period (52 weeks) 6. The titre of serum neutralising antibodies measured using SARS-CoV-2 pseudovirus-based neutralization assay, data received by statisticians directly from the laboratory, at 2 weeks after the second vaccination 7. The titre of vaccine-induced serum IgG binding antibody responses to the SARS-CoV-2 S glycoprotein, data received by statisticians directly from the laboratory, at 2 weeks after the first and second vaccinations | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactJames Fletcher
Outcome results
None listed