Not provided
Not provided
Not provided
Not provided
Not provided
The scientific questions proposed remain relevant, but will now be addressed in a larger phase II immunogenicity trial of the ChAdOx1 MERS vaccine given at 2 doses.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a clinical trial in which healthy volunteers will be administered an experimental MERS vaccine. The vaccine ChAdOx1 MERS will be administered alone both as a single administration and with a homologous prime-booster.
All vaccinations will be administered intramuscularly. In Groups 1-3, each volunteer will receive one vaccination in total. In Groups 4 and 5, each volunteer will receive two vaccinations in total.
There are five different vaccine schedules:
Group 1 (n=6) will receive 5 x 10^9 vp ChAdOx1 MERS .
Group 2 (n=9) will receive 2.5 x 10^10 vp ChAdOx1 MERS.
Group 3 (n=9) will receive 5 x 10^10 vp ChAdOx1 MERS.
Group 4 (n=6-12) will receive 2.5 x 10^10 vp ChAdOx1 MERS at week 0 followed by a boost of 2.5 x 10^10 vp ChAdOx1 MERS at week 26.
Group 5 (n=6-12) will receive 2.5 x 10^10 vp ChAdOx1 MERS at week 0 followed by a boost of 2.5 x 10^10 vp ChAdOx1 MERS at week 4.
The study will assess the safety of the vaccines, and the immune responses to the vaccinations. Immune responses are measured by tests on blood samples.
Healthy adult volunteers will be recruited in Oxford, England.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1 volunteers (n= 6) will be administered ChAdOx1 MERS, 5 x 10^9 vp through intramuscular route. |
|
| Group 2 | Experimental | Group 2 volunteers (n= 9) will be administered ChAdOx1 MERS, 2.5 x 10^10 vp through intramuscular route. |
|
| Group 3 | Experimental | Group 3 volunteers (n= 9) will be administered ChAdOx1 MERS, 5 x 10^10 vp through intramuscular route. |
|
| Group 4 | Experimental | Group 4 volunteers (n=6-12) will be administered ChAdOx1 MERS, 2.5 x 10^10 vp at week 0, followed by ChAdOx1 MERS, 2.5 x 10^10 vp at week 26. Both administrations will be given through intramuscular route. |
|
| Group 5 | Experimental | Group 5 volunteers (n=6-12) will be administered ChAdOx1 MERS, 2.5 x 10^10 vp at week 0, followed by ChAdOx1 MERS, 2.5 x 10^10 vp at week 4. Both administrations will be given through intramuscular route. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChAdOx1 MERS | Biological | The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited and unsolicited local and systemic adverse events | The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. Change from baseline for safety laboratory measures will also be collected. Occurrence of serious adverse events will be collected during the whole study duration | up to 28 days following vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of immunogenicity to the ChAdOx1 MERS vaccine | ELISA to quantify antibodies to MERS Spike protein antigen Ex vivo ELISpot responses to MERS Spike protein antigen | 12 months |
Not provided
Inclusion Criteria:
The volunteer must satisfy all the following criteria to be eligible for the study:
Exclusion Criteria:
The volunteer may not enter the study if any of the following apply:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adrian V Hill, DPhil FRCP | Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital | Oxford | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32325038 | Derived | Folegatti PM, Bittaye M, Flaxman A, Lopez FR, Bellamy D, Kupke A, Mair C, Makinson R, Sheridan J, Rohde C, Halwe S, Jeong Y, Park YS, Kim JO, Song M, Boyd A, Tran N, Silman D, Poulton I, Datoo M, Marshall J, Themistocleous Y, Lawrie A, Roberts R, Berrie E, Becker S, Lambe T, Hill A, Ewer K, Gilbert S. Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial. Lancet Infect Dis. 2020 Jul;20(7):816-826. doi: 10.1016/S1473-3099(20)30160-2. Epub 2020 Apr 21. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705427 | Middle East respiratory syndrome vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D007239 |
| Infections |