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TuberculosisPhase 1/2A-050NCT02933281

MTBVAC Study in Adults With and Without Latent Tuberculosis Infection in South Africa

A Phase 1/2 study testing MTBVAC and BCG in people with Tuberculosis, run by International AIDS Vaccine Initiative at 1 site in South Africa.

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

MTBVAC at four dose levels: 5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU. The active control is BCG (5 x 10^5 CFU). Participants will receive a single dose of MTBVAC or BCG revaccination administered intradermally on Study Day 0. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Tuberculosis
What is being tested?
MTBVAC and BCG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteSouth Africa
Study dates
14 May 2018to 5 Sep 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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Has completed the written informed consent process.
  • Is male or female aged 18 through 50 years on Study Day 0.
  • Agrees to stay in contact with the clinical trial site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study.
  • For female participants: agrees to avoid pregnancy from 21 days prior to Study Day 0 and for the full duration of the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, or intrauterine device (IUD).
  • For male participants: agrees to use barrier contraception with his partner for at least 2 weeks after dosing with MTBVAC or BCG.
  • Has general good health, confirmed by medical history and physical examination.
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  • Had BCG vaccination, documented through medical history or presence of scar.
  • Has not shared enclosed living or work space with someone diagnosed with TB during the 3 months prior to Study Day 0.
  • [Cohorts 1-4] Does not have LTBI, determined by a negative QFT test at screening or [Cohorts 5-8] Has LTBI, determined by a positive QFT test at screening.

Who cannot join

  • Acute illness on Study Day 0.
  • Axillary temperature >or= 37.5C on Study Day 0.
  • Abnormal laboratory values from most recent blood collection prior to Study Day 0 randomization that are equivalent to Grade 2 or more toxicity, per the protocol toxicity table, or if deemed clinically significant.
  • Severe anemia, defined as <10 g/dL hemoglobin or hematocrit <30%.
  • Screening thyroid stimulating hormone (TSH) >upper limit of normal per local laboratory range.
  • Suspicion or evidence (including but not limited to sputum Xpert MTB/RIF positive) of active TB disease at any site. An attempt must be made to obtain sputum from each participant; persons who are sputum unproductive will be assumed to be Xpert MTB/RIF negative.
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  • History of treatment for TB disease.
  • History of autoimmune disease or immunosuppression.
  • Used immunosuppressive medication within 42 days before Study Day 0 (inhaled and topical corticosteroids are permitted).
  • Received immunoglobulin or blood products within 42 days before Study Day 0.
  • Received any investigational drug or investigational vaccine within 182 days before Study Day 0, or planned participation in any other investigational study during the study period.
  • Received investigational vaccine against TB at any time prior to Study Day 0.
  • Planned administration/administration of a licensed vaccine in the period starting 28 days before and ending 28 days after dosing with investigational product.
  • History or laboratory evidence of any past, present, or future possible immunodeficiency state including but not limited to any laboratory indication of HIV-1 infection.
  • History of allergic disease or reactions, including eczema, likely to be exacerbated by any component of the investigational product.
  • Previous medical history that may compromise the safety of the participant in the study, including but not limited to: impairment of pulmonary function from TB infection or other pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease; uncontrolled epilepsy or infantile spasms; or diabetes mellitus.
  • History or evidence on physical examination of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine, including axillary lymphadenopathy.
  • Female participants: currently pregnant or lactating/nursing; or positive urine pregnancy test during screening or pre-vaccination on Study Day 0.
  • Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, could endanger the participant or make it unlikely that the participant will comply with the protocol.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • SATVI: Worcester

    Worcester, 6850

Other trials in South Africa

About this study

Official title: MTBVAC Phase 1b/2a Randomized, Double-blind, Active-controlled,Safety, Immunogenicity, and Dose-escalation Study in Adults With and Without Latent Tuberculosis Infection in South Africa

MTBVAC at four dose levels: 5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU. The active control is BCG (5 x 10^5 CFU). Participants will receive a single dose of MTBVAC or BCG revaccination administered intradermally on Study Day 0.

Read the detailed description

This is a Phase 1b/2a, double-blind, randomized, BCG-controlled, dose-escalation safety and immunogenicity study in 144 healthy adults with and without LTBI. All participants will have received previous BCG vaccination in infancy. The investigational product is MTBVAC at four dose levels: 5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU. The active control is BCG (5 x 10^5 CFU).

Participants meeting the inclusion/exclusion criteria will be randomized within a study cohort to receive a single dose of MTBVAC or BCG revaccination administered intradermally on Study Day 0. The study will be conducted at one site in South Africa. Participants will be enrolled into one of eight cohorts and followed for safety and immunogenicity endpoints through Study Day 365. The estimated time to complete enrolment is approximately 12 months.

Cohorts 1-8 will include 72 QFT-negative (Cohorts 1-4) and 72 QFT-positive (Cohorts 5-8) participants. Participants will be randomized within each cohort, to receive either MTBVAC (N=96) or BCG (N=48). The cohorts will be enrolled as described in the protocol, as long as no pausing/stopping rules are triggered

Conditions
Tuberculosis
Being tested
MTBVAC, BCG
Medical subject headings
Tuberculosis

What participants receive

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

  • MTBVACBiological

    Escalating dose levels (5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU

  • BCGBiological

    Also called BCG 5 x 10^5 CFU

    BCG 5 x 10^5 CFU

Study groups in NCT02933281
Study groupRoleWhat they receive
Cohort 1: MTBVAC 5 x 10^3 CFUExperimentalQuantiferon (QFT) negative, 1 dose on Day 0
Receives: Biological: MTBVAC
Cohort 2: MTBVAC 5 x 10^4 CFUExperimentalQFT Negative, 1 dose on Day 0
Receives: Biological: MTBVAC
Cohort 3: MTBVAC 5 x 10^5 CFUExperimentalQFT Negative, 1 dose on Day 0
Receives: Biological: MTBVAC
Cohort 4: MTBVAC 5 x 10^6 CFUExperimentalQFT Negative, 1 dose on Day 0
Receives: Biological: MTBVAC
Cohort 5: MTBVAC 5 x 10^3 CFUExperimentalQFT Positive, 1 dose on Day 0
Receives: Biological: MTBVAC
Cohort 6: MTBVAC 5 x 10^4 CFUExperimentalQFT Positive, 1 dose on Day 0
Receives: Biological: MTBVAC
Cohort 7: MTBVAC 5 x 10^5 CFUExperimentalQFT Positive, 1 dose on Day 0
Receives: Biological: MTBVAC
Cohort 8: MTBVAC 5 x 10^6 CFUExperimentalQFT Positive, 1 dose on Day 0
Receives: Biological: MTBVAC
BCG 5 x 10^5 CFUActive comparatorBoth QFT positive and negative, 1 dose on Day 0
Receives: Biological: BCG

What is being measured

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

  1. Safety and reactogenicity of MTBVAC at escalating dose levels compared to BCG vaccine by assessing number of participants with AEs and SAEs

    Collection of systemic solicited and unsolicited adverse events; solicited and unsolicited injection site reactions; and serious adverse reactions.

    Measured: Study Days 0 to Day 365

Secondary outcomes (3)

  1. Difference in T cell response between MTBVAC dose levels across all post-immunization time points measured by percentage of MTBVAC-specific CD4 and CD8 T cells that produce any or a combination of relevant cytokines in ICS assay

    12 hour whole blood (WB) intracellular cytokine staining (ICS) assay

    Measured: Study Days 0, 28, 56, 182, and 365

  2. Qualitative and quantitative results from QuantiFERON® TB (QFT) test summarized using participant count (percentage) summaries conversion and reversion rates in participants receiving escalating dose levels of MTBVAC

    QFT Gold Plus assay

    Measured: Screening and Study Day 365 (all cohorts); and Study Days 28, 56, 84, and 182 (Cohorts 1-4)

  3. Qualitative and quantitative results from QFT test using percentage conversion and reversion rates of participants receiving escalating dose levels of MTBVAC compared to BCG dose levels of MTBVAC in comparison to BCG measured by QFT Gold Plus assay

    QFT Gold Plus assay

    Measured: Screening and Study Day 365 (all cohorts); and Study Days 28, 56, 84, and 182 (Cohorts 1-4)

Timeline

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

  1. First posted14 Oct 2016 (estimated)
  2. Study start14 May 2018
  3. Primary completion5 Sep 2021
  4. Study completion5 Sep 2021

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02933281
Sponsor's protocol ID
A-050
Acronym
A-050
Status last verified
Feb 2023
First submitted
10 Oct 2016
Last updated
27 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MTBVAC and BCG in people with Tuberculosis, run by International AIDS Vaccine Initiative at 1 site in South Africa.

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 19 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 27 Feb 2023. 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 South Africa. 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 and reactogenicity of MTBVAC at escalating dose levels compared to BCG vaccine by assessing number of participants with AEs and SAEs (time frame: Study Days 0 to Day 365). 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 NCT02933281.

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 27 Feb 2023.

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