SafetyPhase 1/2NCT03681860
EMaBS TB Vaccine Study
A Phase 1/2 study testing ChAdOx185A, MVA85A and BCG in people with Safety and Immunogenicity, run by University of Oxford at 2 sites in 2 countries.
Trial summary
The study will commence with a dose-escalation and age de-escalation study in healthy adults and adolescents from the previous Entebbe Mother and Baby Study (EMaBS) in Entebbe, Uganda, focusing on ChAdOx1 85A, to provide safety data for ChAdOx1 85A in this population. Read more about this study
- Who is it for?
- Ages 12 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Immunogenicity
- What is being tested?
- ChAdOx185A, MVA85A and BCG
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jul 2019to 24 May 2021
- Phase
- Phase 1/2
- 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 12 to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Resident within the study area and planning to be resident in the study area for the duration of the study or participants with documented good attendance who are willing to attend as required
- Participant in the Entebbe Mother and Baby Study; healthy; aged 12 to 17 [or, for adults, a parent or guardian of a participant; healthy; aged 18 to 49]
- Documented immunisation within two weeks of birth with BCG Russia (BCG-I strain from Moscow, Serum Institute of India, India) [adolescents only]
- BCG scar or documented previous BCG immunisation [adults only]
- No relevant findings in medical history or on physical examination
- Written informed consent by parent or guardian [or by the volunteer themselves, for adults]
Show all 10Show fewer
- Written informed assent by subject [for adolescents]
- Agreed to refrain from blood donation during the trial [adults only; adolescents under age 18 are not eligible to give blood]
- Agree to avoid pregnancy for the duration of the trial (female only)
- Able and willing (in the Investigator's opinion) to comply with all the study requirements
Who cannot join
- Clinical, radiological, or laboratory evidence of current active TB disease
- Laboratory evidence at screening of latent M.tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens
- Previous treatment for active or latent tuberculosis infection
- Shared a residence with an individual who has started on anti-tuberculosis treatment, or been diagnosed with culture or smear-positive pulmonary tuberculosis, within six months prior to day 0
- Received a TST within 90 days prior to day 0
- Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer, cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness, drug or alcohol abuse
Show all 15Show fewer
- History of serious psychiatric condition or disorder
- Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents within 2 months prior to enrollment
- History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the study vaccine, including eggs
- Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the volunteer in the study
- Positive HBsAg, HCV or HIV antibodies
- Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the study vaccine for 30 days prior to dosing with the study vaccine, or planned use during the study period
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date
- Female currently lactating, confirmed pregnancy or intention to become pregnant during the trial period
- Screening blood sample positive for malaria by microscopy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital
Oxford, Oxfordshire, OX3 7LJ
About this study
Official title: Open Label, Dose Escalation and Age De-escalation for ChAdOx1 85A in Ugandan Adults and Adolescents, Followed by a Phase IIa Randomised, Open-label Trial Among Adolescents Comparing ChAdOx1 85A Prime Followed by MVA 85A Boost Versus BCG Re-vaccination.
The study will commence with a dose-escalation and age de-escalation study in healthy adults and adolescents from the previous Entebbe Mother and Baby Study (EMaBS) in Entebbe, Uganda, focusing on ChAdOx1 85A, to provide safety data for ChAdOx1 85A in this population. These measures are not required for MVA85A since this vaccine has been more widely used, including among adolescents in Uganda, and the dose has been standardised. ChAdOx1 85A dose escalation and age de-escalation will be followed by a Phase IIa randomised trial comparing the immunogenicity of ChAdOx1 85A and MVA85A with the immunogenicity of BCG revaccination. ChAdOx1 85A and MVA85A will be administered via the intramuscular route. The target dose for the Phase IIa trial is 2.5x10^10 viral particles (vp) because the lower dose is expected to have lower immunogenicity, based on the Oxford study, TB034. Data from the Oxford study suggest that this dose will be well tolerated. However, if this dose is not tolerated then the lower dose will be used. The dose of MVA85A will be 1 x 10^8 plaque-forming units (pfu) in the groups in which it is given. There will be 6 study groups with 3 to 30 volunteers in each group.
Dose escalation for ChAdOx1 85A in adults Group 1:
Read more
The first three adults will receive ChAdOx1 85A at 5 x10^9 vp.
Group 2:
The next three adults will be enrolled after safety data has been reviewed by the trial management team to one week after ChAdOx1 85A vaccination in group 1. These adults will receive ChAdOx1 85A at 2.5 x10^10 vp.
Age de-escalation and dose escalation for ChAdOx1 85A in adolescents Group 3:
The first three adolescents will be enrolled after safety data has been reviewed to one week after ChAdOx1 85A vaccination in group 2. These three adolescents will receive ChAdOx1 85A at 5 x10^9 vp Group 4. The next three adolescents will be enrolled after safety data has been reviewed to one week after ChAdOx1 85A vaccination in group 2. These three adolescents will receive ChAdOx1 85A at 2.5 x10^10 vp.
Randomised comparison of ChAdOx1 85A-MVA85A versus BCG revaccination:
Once safety data has been reviewed for groups 1 to 4 to one week post ChAdOx1 85A vaccination, recruitment to the randomised trial will commence. Sixty adolescents will be randomised, 30 (group 5) to receive ChAdOx1 85A at 2.5 x10^10 vp followed by MVA85A boost and 30 (group 6) to receive BCG revaccination.
BCG will be obtained from the Serum Institute of India, an approved provider for Uganda, and used at the standard dose of 0.1mL. BCG will be given intradermally.
Read the detailed description
This trial will be financed by a research grant from Medical Research Council. The reference number of the grant held by MRC-UKRI is MC_UU_00027/5.
- Conditions
- Safety, Immunogenicity
- Being tested
- ChAdOx185A, MVA85A, BCG
- Keywords
- BCG, Tuberculosis, Vaccination
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx185ABiological
ChAdOx1 85A is an adenoviral vaccine based on a vector that is a chimpanzee adenovirus isolate Y25 expressing the M.tb antigen 85A. Adenoviruses are attractive candidates for use as viral vectors and have been used as vaccine vectors for a number of conditions; however, the use has been limited by the high level of anti-vector immunity present in humans in whom adenovirus is a ubiquitous infection. This has led to the consideration of simian adenoviruses, which are not known to cause pathology or illness in humans and to which the prevalence of anti-vector antibodies is low. The ChAdOx1 vector has been developed by the University of Oxford and been used with different inserts for vaccination, for example the vaccine ChAdOx1 NP+M1 has demonstrated an excellent safety profile in the Influenza trial FLU004. A BCG - ChAdOx1 85A - MVA85A prime boost regime is more protective than BCG alone in mice.
MVA85ABiological
Modified vaccinia virus Ankara (MVA) is a highly-attenuated strain of vaccinia virus which cannot replicate in human cells. It is known to be highly immunogenic in UK adults but has been less immunogenic in African children and infants. It is suitable for use as a viral vector in a prime-boost regime in new vaccine development. It has an excellent safety record as it was administered intradermally to approximately 120,000 people during the smallpox eradication campaign, and has since been used in numerous clinical trials of candidate vaccines against viral, mycobacterial and protozoal infections.
BCGBiological
BCG is the only vaccine currently approved for use against Tuberculosis.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Dose Escalation Adults | Other | 3 adults who are parents of EMaBS participants, to receive ChAdOx1 85A at 5 x10^9 vp Receives: Biological: ChAdOx185A |
| Group 2 Dose Escalation Adults | Other | 3 adults who are parents of EMaBS participants, to receive ChAdOx1 85A at 2.5 x10^10 vp Receives: Biological: ChAdOx185A |
| Group 3 Age De-escalation Adolescents | Other | 3 adolescents who are EMaBS participants, to receive ChAdOx1 85A at 5 x10^9 vp Receives: Biological: ChAdOx185A |
| Group 4 Age De-escalation Adolescents | Other | 3 adolescents who are EMaBS participants, to receive ChAdOx1 85A at 2.5 x10^10 vp Receives: Biological: ChAdOx185A |
| Group 5/6 Randomised Comparison | Experimental | 30 adolescents who are EMaBS participants, to receive ChAdOx1 85A at 2.5 x10^10 vp followed by MVA85A boost versus 30 adolescents who are EMaBS participants, to receive BCG revaccination Receives: Biological: ChAdOx185A; Biological: MVA85A; Biological: BCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Solicited Adverse Events
Actively and passively collected data on adverse events
Measured: 30 months
Immunogenicity: T-cell response to 85A
T-cell Interferon-gamma ELIspot response to antigen 85A
Measured: 30 months
Secondary outcomes (4)
Immunogenicity: antibodies to 85A
ELISA antigen 85A to show antibody response to antigen 85A in blood/serum after vaccination
Measured: 30 months
Exploratory immunology: Flow cytometry
Innate and B-cell flow cytometry panel to characterize surface cell markers on B-cells and Neutrophils after vaccination
Measured: 30 months
Exploratory immunology: gene expression
Gene expression array (CHIP) to identify the genes expressed during immune response to vaccination
Measured: 30 months
Exploratory immunology: mycobacterial killing assay
Assay to show ability or improvement of immune cells to kill mycobacteria after vaccination
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Jul 2019
- Primary completion24 May 2021
- Study completion24 May 2021
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 SafetyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- MRC/UVRI and LSHTM Uganda Research Unit
- Responsible party
- Sponsor
- Investigators
- Helen McShane, Professor, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681860
- Sponsor's protocol ID
- TB042
- Status last verified
- Aug 2022
- First submitted
- 4 Sep 2018
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Webb EL, Walusimbi B, Komata R, Elliott AM, The EMaBS Study Team. Cohort profile: the Entebbe Mother and Baby Study (EMaBS). BMJ Open. 2026 Aug 26;16(8):e118325. doi: 10.1136/bmjopen-2026-118325.
PubMed 42648772
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Dose Escalation and Age De-escalation for ChAdOx1 85A in Ugandan Adults and Adolescents, Followed by a Phase IIa Randomised, Open-label Trial Among Adolescents Comparing ChAdOx1 85A Prime Followed by MVA 85A Boost Versus BCG Re-vaccination.
- ClinicalTrials.gov ID
- NCT03681860
- Acronym / sponsor ID
- TB042
- Conditions
- Safety, Immunogenicity
- Keywords
- BCG, Tuberculosis, Vaccination
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- MRC/UVRI and LSHTM Uganda Research Unit
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 24 Sep 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.
The study will commence with a dose-escalation and age de-escalation study in healthy adults and adolescents from the previous Entebbe Mother and Baby Study (EMaBS) in Entebbe, Uganda, focusing on ChAdOx1 85A, to provide safety data for ChAdOx1 85A in this population. These measures are not required for MVA85A since this vaccine has been more widely used, including among adolescents in Uganda, and the dose has been standardised. ChAdOx1 85A dose escalation and age de-escalation will be followed by a Phase IIa randomised trial comparing the immunogenicity of ChAdOx1 85A and MVA85A with the immunogenicity of BCG revaccination. ChAdOx1 85A and MVA85A will be administered via the intramuscular route. The target dose for the Phase IIa trial is 2.5x10^10 viral particles (vp) because the lower dose is expected to have lower immunogenicity, based on the Oxford study, TB034. Data from the Oxford study suggest that this dose will be well tolerated. However, if this dose is not tolerated then the lower dose will be used. The dose of MVA85A will be 1 x 10^8 plaque-forming units (pfu) in the groups in which it is given. There will be 6 study groups with 3 to 30 volunteers in each group.
Dose escalation for ChAdOx1 85A in adults Group 1:
The first three adults will receive ChAdOx1 85A at 5 x10^9 vp.
Group 2:
The next three adults will be enrolled after safety data has been reviewed by the trial management team to one week after ChAdOx1 85A vaccination in group 1. These adults will receive ChAdOx1 85A at 2.5 x10^10 vp.
Age de-escalation and dose escalation for ChAdOx1 85A in adolescents Group 3:
The first three adolescents will be enrolled after safety data has been reviewed to one week after ChAdOx1 85A vaccination in group 2. These three adolescents will receive ChAdOx1 85A at 5 x10^9 vp Group 4. The next three adolescents will be enrolled after safety data has been reviewed to one week after ChAdOx1 85A vaccination in group 2. These three adolescents will receive ChAdOx1 85A at 2.5 x10^10 vp.
Randomised comparison of ChAdOx1 85A-MVA85A versus BCG revaccination:
Once safety data has been reviewed for groups 1 to 4 to one week post ChAdOx1 85A vaccination, recruitment to the randomised trial will commence. Sixty adolescents will be randomised, 30 (group 5) to receive ChAdOx1 85A at 2.5 x10^10 vp followed by MVA85A boost and 30 (group 6) to receive BCG revaccination.
BCG will be obtained from the Serum Institute of India, an approved provider for Uganda, and used at the standard dose of 0.1mL. BCG will be given intradermally.
Detailed description
This trial will be financed by a research grant from Medical Research Council. The reference number of the grant held by MRC-UKRI is MC_UU_00027/5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 Dose Escalation Adults | Other | Biological: ChAdOx185A3 adults who are parents of EMaBS participants, to receive ChAdOx1 85A at 5 x10^9 vp |
| Group 2 Dose Escalation Adults | Other | Biological: ChAdOx185A3 adults who are parents of EMaBS participants, to receive ChAdOx1 85A at 2.5 x10^10 vp |
| Group 3 Age De-escalation Adolescents | Other | Biological: ChAdOx185A3 adolescents who are EMaBS participants, to receive ChAdOx1 85A at 5 x10^9 vp |
| Group 4 Age De-escalation Adolescents | Other | Biological: ChAdOx185A3 adolescents who are EMaBS participants, to receive ChAdOx1 85A at 2.5 x10^10 vp |
| Group 5/6 Randomised Comparison | Experimental | Biological: ChAdOx185A, Biological: MVA85A, Biological: BCG30 adolescents who are EMaBS participants, to receive ChAdOx1 85A at 2.5 x10^10 vp followed by MVA85A boost versus 30 adolescents who are EMaBS participants, to receive BCG revaccination |
Who may qualify
- Ages
- 12 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Resident within the study area and planning to be resident in the study area for the duration of the study or participants with documented good attendance who are willing to attend as required
- Participant in the Entebbe Mother and Baby Study; healthy; aged 12 to 17 [or, for adults, a parent or guardian of a participant; healthy; aged 18 to 49]
- Documented immunisation within two weeks of birth with BCG Russia (BCG-I strain from Moscow, Serum Institute of India, India) [adolescents only]
- BCG scar or documented previous BCG immunisation [adults only]
- No relevant findings in medical history or on physical examination
Key exclusion criteria (15 listed)
- Clinical, radiological, or laboratory evidence of current active TB disease
- Laboratory evidence at screening of latent M.tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens
- Previous treatment for active or latent tuberculosis infection
- Shared a residence with an individual who has started on anti-tuberculosis treatment, or been diagnosed with culture or smear-positive pulmonary tuberculosis, within six months prior to day 0
- Received a TST within 90 days prior to day 0
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 |
|---|---|---|
| ChAdOx185AChAdOx1 85A is an adenoviral vaccine based on a vector that is a chimpanzee adenovirus isolate Y25 expressing the M.tb antigen 85A. Adenoviruses are attractive candidates for use as viral vectors and have been used as vaccine vectors for a number of conditions; however, the use has been limited by the high level of anti-vector immunity present in humans in whom adenovirus is a ubiquitous infection. This has led to the consideration of simian adenoviruses, which are not known to cause pathology or illness in humans and to which the prevalence of anti-vector antibodies is low. The ChAdOx1 vector has been developed by the University of Oxford and been used with different inserts for vaccination, for example the vaccine ChAdOx1 NP+M1 has demonstrated an excellent safety profile in the Influenza trial FLU004. A BCG - ChAdOx1 85A - MVA85A prime boost regime is more protective than BCG alone in mice. | Biological | Group 1 Dose Escalation Adults, Group 2 Dose Escalation Adults, Group 3 Age De-escalation Adolescents, Group 4 Age De-escalation Adolescents, Group 5/6 Randomised Comparison |
| MVA85AModified vaccinia virus Ankara (MVA) is a highly-attenuated strain of vaccinia virus which cannot replicate in human cells. It is known to be highly immunogenic in UK adults but has been less immunogenic in African children and infants. It is suitable for use as a viral vector in a prime-boost regime in new vaccine development. It has an excellent safety record as it was administered intradermally to approximately 120,000 people during the smallpox eradication campaign, and has since been used in numerous clinical trials of candidate vaccines against viral, mycobacterial and protozoal infections. | Biological | Group 5/6 Randomised Comparison |
| BCGBCG is the only vaccine currently approved for use against Tuberculosis. | Biological | Group 5/6 Randomised Comparison |
Primary outcome
Safety: Solicited Adverse Events
Time frame: 30 months
Actively and passively collected data on adverse events
Immunogenicity: T-cell response to 85A
Time frame: 30 months
T-cell Interferon-gamma ELIspot response to antigen 85A
4 secondary outcomes
Immunogenicity: antibodies to 85A
Time frame: 30 months
Exploratory immunology: Flow cytometry
Time frame: 30 months
Exploratory immunology: gene expression
Time frame: 30 months
Exploratory immunology: mycobacterial killing assay
Time frame: 30 months
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 5 Aug 2022.
- Derived from this study: PubMed 42648772Webb EL, Walusimbi B, Komata R, Elliott AM, The EMaBS Study Team. Cohort profile: the Entebbe Mother and Baby Study (EMaBS). BMJ Open. 2026 Aug 26;16(8):e118325. doi: 10.1136/bmjopen-2026-118325.
- Individual participant dataSharing planned: No
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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.
Helen McShane, Professor principal investigator
University of Oxford
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ChAdOx185A, MVA85A and BCG in people with Safety and Immunogenicity, run by University of Oxford at 2 sites in 2 countries.
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 10 inclusion and 15 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 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda, 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety: Solicited Adverse Events (time frame: 30 months). The study lists 2 primary outcomes in all. 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 NCT03681860, 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 5 Aug 2022.