TuberculosisPhase 1NCT00731471
A Phase I Study of a New Tuberculosis (TB) Vaccine, MVA85A, in Healthy Volunteers With HIV
A Phase 1 study testing MVA85A in people with Tuberculosis, run by University of Oxford at 1 site in Senegal.
Trial summary
This is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are infected with HIV. It is designed to study the safety and immunogenicity of the vaccine. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- MVA85A
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSenegal
- Study dates
- Aug 2008to Jan 2011
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Healthy adults aged 18 to 50 years
- Resident in or near Dakar for the duration of the study
- Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's HIV lead physician
- Willing to use effective contraception throughout duration of study (if female)
- HIV antibody positive; diagnosed at least 6 months previously
- CD4 count >300
Show all 9Show fewer
- Arm 1: HIV viral load not >100,000 copies per millilitre
- Arm 2: Undetectable HIV viral load
- Written informed consent
Who cannot join
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or on urinalysis
- Group 1 only: Any ARV therapy within the past 6 months
- Previous history of TB disease and/or treatment
- Any AIDS defining illness
- Group 1: CD4 count nadir <300
- Group 2: CD4 count nadir <100
Show all 23Show fewer
- CXR showing TB or evidence of other active infection
- Prior receipt of a recombinant MVA or Fowlpox vaccine
- Use of any investigational or non-registered drug, live vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
- Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisolone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
- Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine (including evidence of cardiovascular disease, history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ), history of insulin requiring diabetes mellitus, any ongoing chronic illness requiring ongoing specialist supervision (e.g., gastrointestinal), and chronic or active neurological disease)
- History of > 2 hospitalisations for invasive bacterial infections (pneumonia, meningitis)
- Suspected or known current drug and/or alcohol abuse
- Seropositive for hepatitis B surface antigen (HBsAg) and/ or hepatitis C (antibodies to HCV)
- Evidence of serious psychiatric condition
- Any other on-going chronic illness requiring hospital specialist supervision
- Any confirmed or suspected immunosuppressive or immunodeficient condition, other than HIV infection, such as asplenia
- Evidence of hepatomegaly
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Pregnant/lactating female and any female who is willing or intends to become pregnant during the study
- Any history of anaphylaxis in reaction to vaccination
- PI assessment of lack of willingness to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the participant's risk of suffering an adverse outcome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Infected With HIV
This is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are infected with HIV. It is designed to study the safety and immunogenicity of the vaccine.
Read the detailed description
This study is designed to evaluate the safety of MVA85A in healthy volunteers in Senegal who are infected with HIV. In phase I studies, a single vaccination with MVA85A, when administered at a dose of 5 x 107pfu intradermally, has been shown to be safe in both mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected individuals. We will use 1 x 10^8 pfu MVA85A intradermally in this study. A trial in BCG vaccinated subjects showed that the higher dose (1 x 10^8 pfu MVA85A) induced a significantly higher immune response but did not have a higher AE profile. In addition, because of a variable immune response, the trial in HIV positive subjects in the UK is split into two groups, the first getting 5 x 10^7 pfu and the second getting 1 x 10^8 pfu MVA85A. It has, therefore, been decided to use the higher dose in order to maximise the immune response whilst maintaining a good safety profile.
- Conditions
- Tuberculosis
- Being tested
- MVA85A
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA85ABiological
Modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Both arms will receive two vaccinations six months apart.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 12 Healthy adults infected with HIV Receives: Biological: MVA85A |
| 2 | Experimental | 12 HIV+ adults on antiretroviral therapy Receives: Biological: MVA85A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of MVA85A
Measured: Six months
Secondary outcomes (1)
Immunogenicity of MVA85A
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2011
- Study completionJan 2011
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 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Le Dantec, Dakar, Senegal
- Investigators
- Helen McShane, Principal investigator, University of OxfordSouleymane Mboup, Principal investigator, Centre Hospitalier Universitaire Le Dantec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731471
- Sponsor's protocol ID
- TB019
- Status last verified
- Mar 2011
- First submitted
- 6 Aug 2008
- Last updated
- 28 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dieye TN, Ndiaye BP, Dieng AB, Fall M, Brittain N, Vermaak S, Camara M, Diop-Ndiaye H, Ngom-Gueye NF, Diaw PA, Toure-Kane C, Sow PS, Mboup S, McShane H. Two doses of candidate TB vaccine MVA85A in antiretroviral therapy (ART) naive subjects gives comparable immunogenicity to one dose in ART+ subjects. PLoS One. 2013 Jun 28;8(6):e67177. doi: 10.1371/journal.pone.0067177. Print 2013.
PubMed 23840618
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Infected With HIV
- ClinicalTrials.gov ID
- NCT00731471
- Acronym / sponsor ID
- TB019
- Conditions
- Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Le Dantec, Dakar, Senegal
- Study start
- Aug 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 11 Aug 2008 (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 is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are infected with HIV. It is designed to study the safety and immunogenicity of the vaccine.
Detailed description
This study is designed to evaluate the safety of MVA85A in healthy volunteers in Senegal who are infected with HIV. In phase I studies, a single vaccination with MVA85A, when administered at a dose of 5 x 107pfu intradermally, has been shown to be safe in both mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected individuals. We will use 1 x 10^8 pfu MVA85A intradermally in this study. A trial in BCG vaccinated subjects showed that the higher dose (1 x 10^8 pfu MVA85A) induced a significantly higher immune response but did not have a higher AE profile. In addition, because of a variable immune response, the trial in HIV positive subjects in the UK is split into two groups, the first getting 5 x 10^7 pfu and the second getting 1 x 10^8 pfu MVA85A. It has, therefore, been decided to use the higher dose in order to maximise the immune response whilst maintaining a good safety profile.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MVA85A12 Healthy adults infected with HIV |
| 2 | Experimental | Biological: MVA85A12 HIV+ adults on antiretroviral therapy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adults aged 18 to 50 years
- Resident in or near Dakar for the duration of the study
- Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's HIV lead physician
- Willing to use effective contraception throughout duration of study (if female)
- HIV antibody positive; diagnosed at least 6 months previously
Key exclusion criteria (23 listed)
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or on urinalysis
- Group 1 only: Any ARV therapy within the past 6 months
- Previous history of TB disease and/or treatment
- Any AIDS defining illness
- Group 1: CD4 count nadir <300
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 |
|---|---|---|
| MVA85AModified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Both arms will receive two vaccinations six months apart. | Biological | 1, 2 |
Primary outcome
Safety of MVA85A
Time frame: Six months
1 secondary outcome
Immunogenicity of MVA85A
Time frame: Six 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 28 Mar 2011.
- Derived from this study: PubMed 23840618Dieye TN, Ndiaye BP, Dieng AB, Fall M, Brittain N, Vermaak S, Camara M, Diop-Ndiaye H, Ngom-Gueye NF, Diaw PA, Toure-Kane C, Sow PS, Mboup S, McShane H. Two doses of candidate TB vaccine MVA85A in antiretroviral therapy (ART) naive subjects gives comparable immunogenicity to one dose in ART+ subjects. PLoS One. 2013 Jun 28;8(6):e67177. doi: 10.1371/journal.pone.0067177. Print 2013.
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
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 principal investigator
University of Oxford
Souleymane Mboup principal investigator
Centre Hospitalier Universitaire Le Dantec
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 in people with Tuberculosis, run by University of Oxford at 1 site in Senegal.
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 9 inclusion and 23 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 28 Mar 2011. 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 Senegal. 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?
Safety of MVA85A (time frame: Six months). 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 NCT00731471, 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 28 Mar 2011.