Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Cohort 1:0.5ml, once by Intramuscular
Cohort 2:0.5ml, once by Intramuscular
Cohort 3:0.5ml, once by Intramuscular
Cohort 4:0.5ml, once by Intramuscular
Sponsors
Canadian Center for Vaccinology Dalhousie University/IWK Health Centre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults of 18 years of age, and older; 2. Able and willing (in the Investigators opinion) to comply with all study requirements; 3. Willing to allow the investigators to discuss the volunteers medical history with their General; 4. Practitioner/personal doctor and access all medical records when relevant to study procedures; 5. Healthy adults, or stable-healthy adults who may have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment [4]; 6. For females of childbearing potential only, willingness to practice continuous effective contraception (see glossary) for 30 days prior to enrollment in the study, for 90 days after receiving vaccination during the study, and have a negative pregnancy test on the day(s) of screening/ vaccination (Day 0); 7. Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (see glossary) and refrain from donating sperm for 90 days after receiving the study vaccination; 8. Agreement to refrain from blood donation during the study; 9. Provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Participation in any other COVID-19 prophylactic drug trials for the duration of the study. Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization due to COVID-19. The study team should be informed as soon as possible; 2. Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study. Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. 3. Participation in this trial can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys; 4. Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination; 5. Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus or SARS vaccines); 6. Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate; 7. Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV status; asplenia; recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within the past 6 months; 8. Topical steroids or short-term (course lasting <= 14 days) oral steroids are not an exclusion; 9. History of allergic disease or reactions likely to be exacerbated by any component of Ad5-nCoV; 10. Any history of angioedema; 11. Any history of anaphylaxis to any vaccine component; 12. Pregnancy, lactation or willingness/intention to become pregnant within 90 days after receiving study vaccine; 13. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ); 14. History of serious psychiatric condition likely to affect participation in the study; 15. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture; 16. Suspected or known current alcohol or drug dependency; 17. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well-controlled comorbidities are allowed); 18. History of laboratory-confirmed COVID-19; 19. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban); 20. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease occurring 28 days to 52 weeks after vaccination, regardless of severity;To evaluate the incidence of serious adverse events (SAE) and medically attended adverse events (MAE) within 52 weeks after vaccination in all participants; | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease occurring 14 days to 52 weeks after vaccination, regardless of severity;To evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection from 14 and 28 days, to 24 and 52 weeks after vaccination;Evaluate the incidence of solicited adverse reactions within 7 days after vaccination ;Evaluate the incidence of unsolicited adverse events within 28 days after vaccination ;Evaluate the seroconversion rate of S-RBD IgG antibody on Day 28, Week 24 and Week 52 after vaccination, measured by ELISA ;Evaluate the GMT of S-RBD IgG antibody on Day 28, Week 24 and Week 52 after vaccination, measured by ELISA ;Evaluate the GMI of S-RBD IgG antibody on Day 28, Week 24 and Week 52 after vaccination, measured by ELISA;Evaluate the seroconversion rate of pseudo-virus neutralizing antibody on Day 28, Week 24 and Week 52 after vaccination;Evaluate the GMT of pseudo-virus neutralizing antibody on Day 28, Week 24 and Week 52 after vaccination;Evaluate the GMI of pseudo-virus neutralizing antibody on Day 28, Week 24 and Week 52 after vaccination;Evaluate the positive rate and level of IFN-? stimulated by peptide pool of S protein on Day 28, and Weeks 24 and Week 52 after vaccination, measured by ELISpot;Evaluate the positive rate and level of IL-2, IL-4, IL-13, IFN-? stimulated by peptide pool of S protein on Day 28, and Weeks 24 and Week 52 after vaccination; | — |
Countries
Russia
Contacts
Public ContactScott A Halperin
Canadian Center for Vaccinology Dalhousie University/IWK Health Centre
Outcome results
None listed