TuberculosisPhase 1NCT00423566
A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers.
A Phase 1 study testing MVA85A (Tuberculosis vaccine) in people with Tuberculosis, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia Ankara (MVA) expressing the 85A antigen (from Mycobacterium. tuberculosis). This vaccine is delivered intrdermally by a needle injection in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- MVA85A (Tuberculosis vaccine)
- Type of treatment
- Vaccines
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2002to Jul 2003
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult aged 18-45 years.
- Normal medical history and physical examination.
- Normal urine dipstick, blood count, liver enzymes, and creatinine.
Who cannot join
- Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area.
- Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
- Oral or systemic steroid medication or the use of immunosuppressive agents.
- Positive HIV antibody test, HCV antibody test or positive HBV serology except post-vaccination.
- Positive Heaf test
- Confirmed pregnancy
- Previous MVA immunisations
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Oxford, Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LJ
About this study
This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia Ankara (MVA) expressing the 85A antigen (from Mycobacterium. tuberculosis). This vaccine is delivered intrdermally by a needle injection in healthy volunteers.
Read the detailed description
- This is a phase I study to assesss the safety and immunogenicity a recombinant MVA encoding a secreted antigen from Mycobacterium. tuberculosis Antigen 85A, delivered intrdermally by a needle injection in healthy BCG naive volunteers.
- Selection of volunteers Volunteers for the study will be recruited through advertisements. Each volunteer will have received an information sheet concerning the study and will have agreed to participate in writing. Volunteers will be given at least 48 hours between reading the information leaflet and agreeing to participate. Female volunteers will be told of the theoretical risk of congenital anomaly should they become pregnant during the study and only those who undertake to take precautions to avoid pregnancy during the study period will be eligible. Volunteers will give signed consent for their GP's to be notified about their participation in the trial. The GP will be faxed a letter on the day of screening and asked to reply if they know of a reason why the volunteer should not take part. The signed consent form will also be faxed with the letter.
- Screening Volunteers will be asked to sign the informed consent form for screening. The following will be performed:
- Medical history and examination
- Laboratory evaluations - including clinical chemistry, haematology, HLA typing, anti-vaccinia antibodies, anti-HBV antibodies, anti-HCV antibodies, anti-HIV antibodies
- Heaf test - to exclude prior exposure to TB
- Urinalysis and urine pregnancy test if female
- Inclusion Criteria
- Healthy adult aged 18-45 years.
- Normal medical history and physical examination.
- Normal urine dipstick, blood count, liver enzymes, and creatinine.
- Exclusion Criteria
- Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area.
- Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
- Oral or systemic steroid medication or the use of immunosuppressive agents.
- Positive HIV antibody test, HCV antibody test or positive HBV serology except post-vaccination.
- Positive Heaf test
- Confirmed pregnancy
- Previous MVA immunisations
- Withdrawal Criteria
- Withdrawal of consent by subject for any reason
- Loss to follow-up
- Non-compliance with study procedures
- Protocol violation
- Serious adverse event (as defined in Appendix 3)
- Any other reason at discretion of the Principal Investigator
- Confirmed pregnancy during study period 7 Immunisation On Day 0 and Day 21, subjects will receive a single intradermal injection of 5 x 107pfu in 0.1ml over the deltoid muscle. Subjects will be observed for an hour after all immunisations. Vital signs will be monitored at 30 and 60 minutes post-immunisation. Local reactions at the site of administration will be evaluated at 60 minutes. A photograph of the injection site may be taken at 48 hours (with written consent). The injection site will be reviewed 7 days after each immunization. Blood will be taken at the following time points: At the screening visit*, prior to the first vaccination, *1 week after the first vaccination, prior to the second vaccination, *1 week after the second vaccination, 4 weeks, 8 weeks, *12 weeks and 24 weeks after the second vaccination. Up to 55 mls will be taken at any one time with the total being no more than 500 mls over the study period. *Samples taken on these dates will be tested for full blood count and biochemical screen. Immunological assays will be performed at all time points to determine vaccine immunogenicity. A pregnancy test will be performed on screening and each vaccination day prior to vaccination for female volunteers. Peripheral blood mononuclear cells will be prepared for cellular immunological assays to be performed without or following cryopreservation. Other serological measures of immune response, i.e. antibody titres, will be assayed on frozen plasma samples. At the end of the six month follow-up period, volunteers will be offered BCG immunisation. If they accept, imunological monitering will continue for a further six months. 50mls of blood will be taken for cellular immunological assays 1 week, 2 weeks, 1 month, 2 months, 3 months and 6 months after BCG immunisation. All blood tests will be taken within 1-3 days of the due date as described in the schedule above. 8 Endpoints The occurance and severity of local side-effects. The occurance and severity of systemic side-effects. The induction of T cell responses (as measured by an interferon-gamma Elispot assay). Proliferation assays and cytotoxic T cell assays will be performed on strong CD4+ and CD8+ responses respectively. This study has been completed.
- Conditions
- Tuberculosis
- Being tested
- MVA85A (Tuberculosis vaccine)
- Keywords
- Mycobacterium tuberculosis, 85A antigen, Recombinant Modified Vaccinia virus Ankara, Phase I study, Immunogenicity
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA85A (Tuberculosis vaccine)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic reactions will be monitored 30 and 60 minutes after administration.
A photograph of the injection will be taken at 48 hours and this injection site will be reviewed 7 days after each immunisation.
Blood will be taken: 1 week after the first vaccination, 1 week after the second vaccination and then at 4, 8, 12 and 24 weeks. The blood is used for a full blood count and biochemical screen.
Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay).
Secondary outcomes (1)
Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startSep 2002
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Investigators
- Helen McShane, MD and PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423566
- Sponsor's protocol ID
- TB002
- Status last verified
- Dec 2006
- First submitted
- 17 Jan 2007
- Last updated
- 18 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00423566
- Acronym / sponsor ID
- TB002
- Conditions
- Tuberculosis
- Keywords
- Mycobacterium tuberculosis, 85A antigen, Recombinant Modified Vaccinia virus Ankara, Phase I study, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Sep 2002
- Study completion
- Jul 2003
- First posted
- 18 Jan 2007 (estimated)
- 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.
This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia Ankara (MVA) expressing the 85A antigen (from Mycobacterium. tuberculosis). This vaccine is delivered intrdermally by a needle injection in healthy volunteers.
Detailed description
- This is a phase I study to assesss the safety and immunogenicity a recombinant MVA encoding a secreted antigen from Mycobacterium. tuberculosis Antigen 85A, delivered intrdermally by a needle injection in healthy BCG naive volunteers.
- Selection of volunteers Volunteers for the study will be recruited through advertisements. Each volunteer will have received an information sheet concerning the study and will have agreed to participate in writing. Volunteers will be given at least 48 hours between reading the information leaflet and agreeing to participate. Female volunteers will be told of the theoretical risk of congenital anomaly should they become pregnant during the study and only those who undertake to take precautions to avoid pregnancy during the study period will be eligible. Volunteers will give signed consent for their GP's to be notified about their participation in the trial. The GP will be faxed a letter on the day of screening and asked to reply if they know of a reason why the volunteer should not take part. The signed consent form will also be faxed with the letter.
- Screening Volunteers will be asked to sign the informed consent form for screening. The following will be performed:
- Medical history and examination
- Laboratory evaluations - including clinical chemistry, haematology, HLA typing, anti-vaccinia antibodies, anti-HBV antibodies, anti-HCV antibodies, anti-HIV antibodies
- Heaf test - to exclude prior exposure to TB
- Urinalysis and urine pregnancy test if female
- Inclusion Criteria
- Healthy adult aged 18-45 years.
- Normal medical history and physical examination.
- Normal urine dipstick, blood count, liver enzymes, and creatinine.
- Exclusion Criteria
- Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area.
- Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
- Oral or systemic steroid medication or the use of immunosuppressive agents.
- Positive HIV antibody test, HCV antibody test or positive HBV serology except post-vaccination.
- Positive Heaf test
- Confirmed pregnancy
- Previous MVA immunisations
- Withdrawal Criteria
- Withdrawal of consent by subject for any reason
- Loss to follow-up
- Non-compliance with study procedures
- Protocol violation
- Serious adverse event (as defined in Appendix 3)
- Any other reason at discretion of the Principal Investigator
- Confirmed pregnancy during study period 7 Immunisation On Day 0 and Day 21, subjects will receive a single intradermal injection of 5 x 107pfu in 0.1ml over the deltoid muscle. Subjects will be observed for an hour after all immunisations. Vital signs will be monitored at 30 and 60 minutes post-immunisation. Local reactions at the site of administration will be evaluated at 60 minutes. A photograph of the injection site may be taken at 48 hours (with written consent). The injection site will be reviewed 7 days after each immunization. Blood will be taken at the following time points: At the screening visit*, prior to the first vaccination, *1 week after the first vaccination, prior to the second vaccination, *1 week after the second vaccination, 4 weeks, 8 weeks, *12 weeks and 24 weeks after the second vaccination. Up to 55 mls will be taken at any one time with the total being no more than 500 mls over the study period. *Samples taken on these dates will be tested for full blood count and biochemical screen. Immunological assays will be performed at all time points to determine vaccine immunogenicity. A pregnancy test will be performed on screening and each vaccination day prior to vaccination for female volunteers. Peripheral blood mononuclear cells will be prepared for cellular immunological assays to be performed without or following cryopreservation. Other serological measures of immune response, i.e. antibody titres, will be assayed on frozen plasma samples. At the end of the six month follow-up period, volunteers will be offered BCG immunisation. If they accept, imunological monitering will continue for a further six months. 50mls of blood will be taken for cellular immunological assays 1 week, 2 weeks, 1 month, 2 months, 3 months and 6 months after BCG immunisation. All blood tests will be taken within 1-3 days of the due date as described in the schedule above. 8 Endpoints The occurance and severity of local side-effects. The occurance and severity of systemic side-effects. The induction of T cell responses (as measured by an interferon-gamma Elispot assay). Proliferation assays and cytotoxic T cell assays will be performed on strong CD4+ and CD8+ responses respectively. This study has been completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult aged 18-45 years.
- Normal medical history and physical examination.
- Normal urine dipstick, blood count, liver enzymes, and creatinine.
Key exclusion criteria (7 listed)
- Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area.
- Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
- Oral or systemic steroid medication or the use of immunosuppressive agents.
- Positive HIV antibody test, HCV antibody test or positive HBV serology except post-vaccination.
- Positive Heaf test
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 |
|---|---|---|
| MVA85A (Tuberculosis vaccine) | Biological | – |
Primary outcome
Local and systemic reactions will be monitored 30 and 60 minutes after administration.
A photograph of the injection will be taken at 48 hours and this injection site will be reviewed 7 days after each immunisation.
Blood will be taken: 1 week after the first vaccination, 1 week after the second vaccination and then at 4, 8, 12 and 24 weeks. The blood is used for a full blood count and biochemical screen.
Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay).
1 secondary outcome
Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay).
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 18 Jan 2007.
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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, MD and PhD principal investigator
University of Oxford
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 MVA85A (Tuberculosis vaccine) in people with Tuberculosis, 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 3 inclusion and 7 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 18 Jan 2007. 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?
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?
Local and systemic reactions will be monitored 30 and 60 minutes after administration.. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2007.