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TuberculosisPhase 2TB036NCT02178748

Trial to Investigate the Effect of Schistosoma Mansoni Infection on the Response to Vaccination With MVA85A in BCG-vaccinated African Adolescents

A Phase 2 study testing MVA85A in people with Tuberculosis, run by University of Oxford at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mycobacterium tuberculosis (M. tb) is a pathogen with worldwide distribution which infects humans causing tuberculosis (TB), a transmissible disease resulting in very high mortality and morbidity; development of an effective vaccine is a global health priority. Read more about this study

Who is it for?
Ages 12 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Tuberculosis
What is being tested?
MVA85A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUganda
Study dates
Jun 2014to Jan 2015
Phase
Phase 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 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Participants must meet all of the following criteria to enter the trial:
  • Healthy adolescents aged 12-17 years (both male and female)
  • Resident in the study area for the duration of the study period
  • Confirmation of prior vaccination with BCG not less than 6 months prior to projected study vaccination date (by visible BCG scar on examination or written documentation)
  • No relevant findings in medical history or on physical examination
  • Written informed consent by parent or guardian
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  • Written informed assent by subject
  • Refrain from blood donation during the trial
  • 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
  • Stool sample negative for S. mansoni (group 1) or positive for S. mansoni infection (group 2), based on the results of the Kato Katz stool analysis
  • Willing to delay treatment for schistosomiasis for at least one month (group 2)

Who cannot join

  • Participants may not enter the trial if ANY of the following apply:
  • 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 within one year prior to day 0 with an individual on anti-tuberculosis treatment or with culture or smear-positive pulmonary tuberculosis
  • Received a TST within 90 days prior to day 0
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  • Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness, drug or alcohol abuse
  • 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 enrolment
  • 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 or Mansonella perstans by microscopy
  • Schistosoma mansoni infection intensity greater than 2000 eggs per gram of stool
  • Any of the three screening stool samples positive for any helminths on Kato Katz examinations or for S. mansoni or Strongyloides stercoralis by PCR (group 1); or any of the three screening stool samples positive for helminths other than S. mansoni on Kato Katz examinations or for Strongyloides stercoralis by PCR (group 2)
  • Screening urine sample positive for S. mansoni infection (group 1)
  • Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the subject at risk or may influence the result of the trial or may affect the subject's ability to participate in the trial

Trial locations and contacts

1 site in 1 country.

Uganda1 site

  • MRC/UVRI Uganda Research Unit on AIDS

    Entebbe

Other trials in Uganda

About this study

Official title: A Phase II Open Label Trial to Investigate the Effect of Schistosoma Mansoni (Sm) Infection on the Immunogenicity of a Candidate TB Vaccine, MVA85A, in BCG-vaccinated African Adolescents

Mycobacterium tuberculosis (M. tb) is a pathogen with worldwide distribution which infects humans causing tuberculosis (TB), a transmissible disease resulting in very high mortality and morbidity; development of an effective vaccine is a global health priority.

Over a billion people worldwide are infected with one or more helminths. Helminths are parasitic worms, of which Schistosoma mansoni is one species. There is some evidence that helminth infection may affect a person's response to a vaccine. In this trial the investigators hope to investigate whether Schistosoma mansoni infection affects adolescents' responses to a candidate TB vaccine called MVA85A, as adolescents are a crucial target group for an effective TB vaccine.

Conditions
Tuberculosis
Being tested
MVA85A
Keywords
Tuberculosis, Phase II, MVA85A, Schistosoma mansoni
Medical subject headings
Tuberculosis, Schistosomiasis

What participants receive

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

  • MVA85ABiological

    Also called Modified Vaccinia Ankara 85A, AERAS-485

    Single dose of 1x10^8pfu MVA85A intramuscular vaccination

Study groups in NCT02178748
Study groupRoleWhat they receive
Group 1ExperimentalGroup 1 (Schistosoma mansoni uninfected): 12-24 BCG-vaccinated volunteers with no helminth infection. Single dose of 1x10^8pfu MVA85A intramuscular vaccination at D0.
Receives: Biological: MVA85A
Group 2ExperimentalGroup 2 (Schistosoma mansoni infected): 12-24 BCG-vaccinated volunteers with helminth infection. Single dose of 1x10^8pfu MVA85A intramuscular vaccination at D0.
Receives: Biological: MVA85A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. T cell immunogenicity by gamma-interferon ELISPOT of Ag85A response.

    To compare T cell immunogenicity in adolescents with and without S. mansoni infection.

    Measured: 8 weeks

Secondary outcomes (1)

  1. Evaluation of cytokines in supernatant of stimulated cells using Luminex and flow cytometry of Ag85A response.

    Effects of S. mansoni infection on other aspects of the immune response following MVA85A immunisation.

    Measured: 8 weeks

Timeline

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

  1. First posted1 Jul 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

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 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02178748
Sponsor's protocol ID
TB036
Acronym
TB036
Status last verified
Jan 2015
First submitted
3 Jun 2014
Last updated
30 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • Wajja A, Namutebi M, Apule B, Oduru G, Kiwanuka S, Akello M, Nassanga B, Kabagenyi J, Mpiima J, Vermaak S, Lawrie A, Satti I, Verweij J, Cose S, Levin J, Kaleebu P, Tukahebwa E, McShane H, Elliott AM. Lessons from the first clinical trial of a non-licensed vaccine among Ugandan adolescents: a phase II field trial of the tuberculosis candidate vaccine, MVA85A. Wellcome Open Res. 2018 Sep 19;3:121. doi: 10.12688/wellcomeopenres.14736.1. eCollection 2018.

    PubMed 30687792

  • Wajja A, Kizito D, Nassanga B, Nalwoga A, Kabagenyi J, Kimuda S, Galiwango R, Mutonyi G, Vermaak S, Satti I, Verweij J, Tukahebwa E, Cose S, Levin J, Kaleebu P, Elliott AM, McShane H. The effect of current Schistosoma mansoni infection on the immunogenicity of a candidate TB vaccine, MVA85A, in BCG-vaccinated adolescents: An open-label trial. PLoS Negl Trop Dis. 2017 May 4;11(5):e0005440. doi: 10.1371/journal.pntd.0005440. eCollection 2017 May.

    PubMed 28472067

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MVA85A in people with Tuberculosis, run by University of Oxford at 1 site in Uganda.

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 12 inclusion and 20 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 30 Jan 2015. 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 Uganda. 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 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?

T cell immunogenicity by gamma-interferon ELISPOT of Ag85A response. (time frame: 8 weeks). 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 NCT02178748, which also lists 2 linked publications.

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 30 Jan 2015.

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