Middle East Respiratory Syndrome CoronavirusPhase 1NCT04170829
A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate MERS-CoV Vaccine (MERS002)
A Phase 1 study testing ChAdOx1 MERS in people with Middle East Respiratory Syndrome Coronavirus, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial summary
A phase Ib study to determine the safety and immunogenicity of the candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) vaccine ChAdOx1 MERS in healthy adult Middle Eastern volunteers Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Middle East Respiratory Syndrome Coronavirus
- What is being tested?
- ChAdOx1 MERS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 17 Dec 2019to 26 Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy* ME adults aged 18 to 50 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to access the volunteer's medical history.
- For females only, not planning to get pregnant during the study and a negative pregnancy test on the day(s) of screening and vaccination. Effective methods of contraception must be used. See section 6.3.3
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
Who cannot join
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
Show all 21Show fewer
- Any history of anaphylaxis in relation to vaccination
- Pregnancy, lactation or willingness/intention to become pregnant during the study
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition likely to affect participation in the study
- Bleeding disorder (eg. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
- Any other serious chronic illness requiring hospital specialist supervision
- Suspected or known current alcohol use.
- Suspected or known drug abuse in the 5 years preceding enrolment
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- 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
- History of exposure to MERS-CoV *
- History of contact with camels. Defined as working in farms or barns; having been within 6 feet (2 meters) of a sick camel without PPE; or consumption of raw milk or uncooked meat. For this study, 30 days prior to screening will be considered.
- History of allergic reaction to Aminoglycoside antibiotics. *rRT-PCR testing of nasopharyngeal specimen , at the discretion of PI, may be indicated when a volunteer is suspected to be asymptomatic carrier.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, 11426
About this study
Official title: A Phase Ib Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in Healthy Adult Middle Eastern Volunteers
A phase Ib study to determine the safety and immunogenicity of the candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) vaccine ChAdOx1 MERS in healthy adult Middle Eastern volunteers
Read the detailed description
This is an open-label, dose escalation phase 1b trial to assess the safety and immunogenicity of the candidate ChAdOx1 MERS vaccine in healthy Middle Eastern adult volunteers aged 18-50. The first-in-human trial is now being conducted in Oxford in UK healthy adult volunteers. The vaccine will be administered intramuscularly.
Volunteers will be recruited and vaccinated at the King Abdulaziz Medical City, M-NGHA, Riyadh. There will be 3 study groups and a total of 24 volunteers will be enrolled. Staggered enrolment will apply for the first three volunteers within each group. Volunteers will be first recruited into Group 1 and subsequently into Groups 2 and 3 following interim clinical safety reviews. Volunteers will be allocated to a study group by selecting eligible volunteers for enrolment in the order in which they were deemed eligible, following screening.
- Being tested
- ChAdOx1 MERS
- Keywords
- MERS-CoV, ChAdOx1 MERS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1 MERSBiological
a replication-deficient simian adenoviral vector expressing the spike (S) protein of MERS Coronavirus.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (n=6) | Experimental | will be administered ChAdOx1 MERS: 5 x 109 vp ChAdOx1 MERS Receives: Biological: ChAdOx1 MERS |
| Group 2 (n=9) | Experimental | will be administered ChAdOx1 MERS: 2.5 x 1010 vp ChAdOx1 MERS Receives: Biological: ChAdOx1 MERS |
| Group 3 (n=9) | Experimental | will be administered ChAdOx1 MERS: 5 x 1010 vp ChAdOx1 MERS Receives: Biological: ChAdOx1 MERS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days following the vaccination
Secondary outcomes (1)
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
Measured: 6.5 months following completion of the vaccination regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start17 Dec 2019
- Primary completion26 Nov 2020
- Study completion26 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Middle East Respiratory Syndrome CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-labelled, non-randomised, dose escalation, extension for a first-in-human, single centre, phase Ib clinical trial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Mohammad Bosaeed, MD, Principal investigator, Ministry of National Guard-Health Affairs (MNGHA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170829
- Sponsor's protocol ID
- CT18/004/R
- Other IDs
- MERS002
- Status last verified
- Nov 2020
- First submitted
- 14 Nov 2019
- Last updated
- 1 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bosaeed M, Balkhy HH, Almaziad S, Aljami HA, Alhatmi H, Alanazi H, Alahmadi M, Jawhary A, Alenazi MW, Almasoud A, Alanazi R, Bittaye M, Aboagye J, Albaalharith N, Batawi S, Folegatti P, Ramos Lopez F, Ewer K, Almoaikel K, Aljeraisy M, Alothman A, Gilbert SC, Khalaf Alharbi N. Safety and immunogenicity of ChAdOx1 MERS vaccine candidate in healthy Middle Eastern adults (MERS002): an open-label, non-randomised, dose-escalation, phase 1b trial. Lancet Microbe. 2022 Jan;3(1):e11-e20. doi: 10.1016/S2666-5247(21)00193-2. Epub 2021 Nov 3.
PubMed 34751259
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in Healthy Adult Middle Eastern Volunteers
- ClinicalTrials.gov ID
- NCT04170829
- Acronym / sponsor ID
- CT18/004/R
- Keywords
- MERS-CoV, ChAdOx1 MERS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase Ib study to determine the safety and immunogenicity of the candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) vaccine ChAdOx1 MERS in healthy adult Middle Eastern volunteers
Detailed description
This is an open-label, dose escalation phase 1b trial to assess the safety and immunogenicity of the candidate ChAdOx1 MERS vaccine in healthy Middle Eastern adult volunteers aged 18-50. The first-in-human trial is now being conducted in Oxford in UK healthy adult volunteers. The vaccine will be administered intramuscularly.
Volunteers will be recruited and vaccinated at the King Abdulaziz Medical City, M-NGHA, Riyadh. There will be 3 study groups and a total of 24 volunteers will be enrolled. Staggered enrolment will apply for the first three volunteers within each group. Volunteers will be first recruited into Group 1 and subsequently into Groups 2 and 3 following interim clinical safety reviews. Volunteers will be allocated to a study group by selecting eligible volunteers for enrolment in the order in which they were deemed eligible, following screening.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-labelled, non-randomised, dose escalation, extension for a first-in-human, single centre, phase Ib clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 (n=6) | Experimental | Biological: ChAdOx1 MERSwill be administered ChAdOx1 MERS: 5 x 109 vp ChAdOx1 MERS |
| Group 2 (n=9) | Experimental | Biological: ChAdOx1 MERSwill be administered ChAdOx1 MERS: 2.5 x 1010 vp ChAdOx1 MERS |
| Group 3 (n=9) | Experimental | Biological: ChAdOx1 MERSwill be administered ChAdOx1 MERS: 5 x 1010 vp ChAdOx1 MERS |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy* ME adults aged 18 to 50 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to access the volunteer's medical history.
- For females only, not planning to get pregnant during the study and a negative pregnancy test on the day(s) of screening and vaccination. Effective methods of contraception must be used. See section 6.3.3
- Agreement to refrain from blood donation during the course of the study
Key exclusion criteria (21 listed)
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChAdOx1 MERSa replication-deficient simian adenoviral vector expressing the spike (S) protein of MERS Coronavirus. | Biological | Group 1 (n=6), Group 2 (n=9), Group 3 (n=9) |
Primary outcome
Occurrence of solicited and unsolicited local and systemic adverse events
Time frame: 28 days following the vaccination
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
1 secondary outcome
Measures of immunogenicity to the ChAdOx1 MERS vaccine
Time frame: 6.5 months following completion of the vaccination regimen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Derived from this study: PubMed 34751259Bosaeed M, Balkhy HH, Almaziad S, Aljami HA, Alhatmi H, Alanazi H, Alahmadi M, Jawhary A, Alenazi MW, Almasoud A, Alanazi R, Bittaye M, Aboagye J, Albaalharith N, Batawi S, Folegatti P, Ramos Lopez F, Ewer K, Almoaikel K, Aljeraisy M, Alothman A, Gilbert SC, Khalaf Alharbi N. Safety and immunogenicity of ChAdOx1 MERS vaccine candidate in healthy Middle Eastern adults (MERS002): an open-label, non-randomised, dose-escalation, phase 1b trial. Lancet Microbe. 2022 Jan;3(1):e11-e20. doi: 10.1016/S2666-5247(21)00193-2. Epub 2021 Nov 3.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Bosaeed, MD principal investigator
Ministry of National Guard-Health Affairs (MNGHA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ChAdOx1 MERS in people with Middle East Respiratory Syndrome Coronavirus, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of solicited and unsolicited local and systemic adverse events (time frame: 28 days following the vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04170829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.