MERS (Middle East Respiratory Syndrome)Phase 1NCT03399578

Safety and Immunogenicity of a Candidate MERS-CoV Vaccine (MERS001)

A Phase 1 study testing ChAdOx1 MERS in people with MERS (Middle East Respiratory Syndrome), run by University of Oxford at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: MERS (Middle East Respiratory Syndrome)
What is being tested?: ChAdOx1 MERS
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited Kingdom
Study dates: 14 Mar 2018to 17 Sep 2021
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

The volunteer must satisfy all the following criteria to be eligible for the study:
Healthy 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 discuss the volunteer's medical history with their General Practitioner or access this medical history electronically.
For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination
Agreement to refrain from blood donation during the course of the study
Provide written informed consent

Who cannot join

The volunteer may not enter the study if any of the following apply:
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 (e.g. Adenovirus vectored vaccine).
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

Show all 22Show fewer

Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
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 abuse as defined by an alcohol intake of greater than 42 units every week
Suspected or known injecting 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
Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate
Prior exposure to MERS-CoV (serology will be requested at the discretion of the investigator)
History of allergic reaction to Aminoglycoside antibiotics

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford

Other trials in United Kingdom

About this study

Official title: A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in UK Healthy Adult Volunteers

Read the detailed description

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.

Conditions: MERS (Middle East Respiratory Syndrome)
Being tested: ChAdOx1 MERS
Medical subject headings: Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ChAdOx1 MERSBiological
The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.

Study groups in NCT03399578
Study group	Role	What they receive
Group 1	Experimental	Group 1 volunteers (n= 6) will be administered ChAdOx1 MERS, 5 x 10^9 vp through intramuscular route. Receives: Biological: ChAdOx1 MERS
Group 2	Experimental	Group 2 volunteers (n= 9) will be administered ChAdOx1 MERS, 2.5 x 10^10 vp through intramuscular route. Receives: Biological: ChAdOx1 MERS
Group 3	Experimental	Group 3 volunteers (n= 9) will be administered ChAdOx1 MERS, 5 x 10^10 vp through intramuscular route. Receives: Biological: ChAdOx1 MERS
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. Receives: Biological: ChAdOx1 MERS
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. 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: up to 28 days following 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: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 201817 Sep 2021

First posted16 Jan 2018
Study start14 Mar 2018
Primary completion17 Sep 2021
Study completion17 Sep 2021

Why it stopped: 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.

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 MERS (Middle East Respiratory Syndrome)Studies of the same condition, open and under way.
More trials run by University of OxfordThe sponsor's other registered studies.
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
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03399578
Sponsor's protocol ID: MERS001
Status last verified: Oct 2021
First submitted: 8 Jan 2018
Last updated: 20 Oct 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 32325038

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in UK Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT03399578
Acronym / sponsor ID: MERS001
Conditions: MERS (Middle East Respiratory Syndrome)
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 29 participants (actual)
Lead sponsor: University of OxfordUniversity, hospital or other
Study start: 14 Mar 2018 (actual)
Primary completion: 17 Sep 2021 (actual)
Study completion: 17 Sep 2021 (actual)
First posted: 16 Jan 2018 (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.

Detailed description

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.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group 1	Experimental	Biological: ChAdOx1 MERSGroup 1 volunteers (n= 6) will be administered ChAdOx1 MERS, 5 x 10^9 vp through intramuscular route.
Group 2	Experimental	Biological: ChAdOx1 MERSGroup 2 volunteers (n= 9) will be administered ChAdOx1 MERS, 2.5 x 10^10 vp through intramuscular route.
Group 3	Experimental	Biological: ChAdOx1 MERSGroup 3 volunteers (n= 9) will be administered ChAdOx1 MERS, 5 x 10^10 vp through intramuscular route.
Group 4	Experimental	Biological: ChAdOx1 MERSGroup 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	Biological: ChAdOx1 MERSGroup 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.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Healthy 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 discuss the volunteer's medical history with their General Practitioner or access this medical history electronically.
For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination
Agreement to refrain from blood donation during the course of the study

Key exclusion criteria (22 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 (e.g. Adenovirus vectored vaccine).
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 MERSThe ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.	Biological	Group 1, Group 2, Group 3, Group 4, Group 5

Primary outcome

Occurrence of solicited and unsolicited local and systemic adverse events
Time frame: up to 28 days following 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: 12 months

Results and safety

The study was stopped early (reason given: 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.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
Derived from this study: PubMed 32325038Folegatti 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.

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.

Adrian V Hill, DPhil FRCP principal investigator

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom

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 MERS (Middle East Respiratory Syndrome), run by University of Oxford at 1 site in United Kingdom.

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 7 inclusion and 22 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: stopped early, as of the sponsor's last update on 20 Oct 2021. 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 United Kingdom. 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?

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: up to 28 days following 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 NCT03399578, 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 20 Oct 2021.