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TuberculosisPhase 1NCT02337270

Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol

A Phase 1 study testing Ad5Ag85A in people with Tuberculosis, run by McMaster University at 1 site in Canada.

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

This is a phase 1 study, in healthy volunteers who have previously been immunized with bacilli Calmette Guerin (BCG), to evaluate the safety and immune responses that develop in the blood and lungs following the administration by aerosol of a new experimental adenovirus-based vaccine for tuberculosis (TB), Ad5Ag85A. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Tuberculosis
What is being tested?
Ad5Ag85A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteCanada
Study dates
5 Sep 2017to 7 Sep 2021
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy human subjects who are between 18 and 55 years of age with a history of BCG vaccination.
  • HIV antibody negative
  • Able to understand and comply with protocol requirements and instructions; able to attend scheduled study visits and complete required investigations.
  • For women, negative pregnancy test and practicing two acceptable forms of contraception for the duration of the study (barrier contraceptive, birth control pill, surgically sterile, post-menopausal 2 years, abstinence)
  • For men, using barrier contraception for the duration of the study

Who cannot join

  • Pregnant or lactating women
  • Subjects who have any acute or chronic illnesses including active tuberculosis, any relevant findings on physical examination or are receiving any drug treatment in the opinion of the investigator likely to affect the immune system including current use of inhaled or nasal steroids.
  • Subjects with a history of any bleeding disorder or receiving any drug treatment that in the opinion of the investigator may increase the risk of bleeding
  • Subjects with a history of respiratory disease, e.g. asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD).
  • Current smokers, including e-cigarettes, and ex-smokers who have quit within the last year, as reported by the subject
  • Subjects with clinically significant abnormality of baseline spirometry tests
Show all 17Show fewer
  • Any health-related condition for which study bronchoscopy is contraindicated
  • Subjects who have a history of active or latent TB infection or whose PBMC's are responsive to ESAT6/CFP10 stimulation using a commercial interferon gamma release assay for TB [consistent with latent TB infection].
  • Subjects whose baseline laboratory values are outside of the normal range unless the abnormality is considered not to be of clinical relevance by the Investigator. A single repeat test is allowed during the screening period.
  • Subjects whose use of alcohol or drugs would, in the opinion of the investigator, interfere with adherence to the study protocol.
  • Subjects who are using, or have a history of using, inhaled cocaine, metamphetamine or other inhaled or smoked recreational drugs. Subjects who give a history of last smoking marijuana more than a year ago may be enrolled, as long as they do not smoke marijuana for the duration of the study.
  • Failure to provide written consent.
  • Known allergy to vaccine components
  • Previous vaccination with Ad5Ag85A or any other experimental TB vaccine
  • Known exposure to active TB within past 6 months or subjects whose occupation puts them at increased risk of TB exposure (based on Hamilton Health Science/St Joseph Healthcare list of high risk personnel)
  • Any abnormality on chest x-ray suggestive of active or remote tuberculosis infection or evidence on chest-x-ray of clinically significant respiratory disease.
  • PPD skin test within last 12 months

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5

Other trials in Canada

About this study

Official title: Phase 1, Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine Administered by Aerosol

This is a phase 1 study, in healthy volunteers who have previously been immunized with bacilli Calmette Guerin (BCG), to evaluate the safety and immune responses that develop in the blood and lungs following the administration by aerosol of a new experimental adenovirus-based vaccine for tuberculosis (TB), Ad5Ag85A.

Read the detailed description

This is a phase 1, open label study to evaluate the safety and immunogenicity of a single administration of one of two doses of a recombinant replication deficient human adenoviral (Ad5) TB vaccine containing the immunodominant antigen Ag85A delivered to the respiratory tract by aerosol in healthy volunteers with a history of BCG immunization.

28 healthy volunteers will be enrolled. The first cohort (n=8) will receive a lower dose of vaccine using the AeroNeb Solo Vibrating Mesh Nebulizer. For the second cohort (n=20) participants will be randomized to either a higher dose of vaccine by aerosol (n=10) or intramuscular administration (n=10). Cellular immune responses in the lung and peripheral blood will be evaluated

Conditions
Tuberculosis
Being tested
Ad5Ag85A
Keywords
Tuberculosis, Vaccine, Aerosol, Adenovirus, Immunogenicity
Medical subject headings
Tuberculosis, Adenoviridae Infections

What participants receive

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

  • Ad5Ag85ABiological

    Aerosol administration of Ad5Ag85A

Study groups in NCT02337270
Study groupRoleWhat they receive
Group 1 AerosolExperimentalReceive 10^6 Ad5Ag85A by aerosol at day 0
Receives: Biological: Ad5Ag85A
Group 2 AerosolExperimentalReceive 2x10^6 Ad5Ag85A by aerosol at day 0
Receives: Biological: Ad5Ag85A
Group 3 IntramuscularExperimentalReceive 10^8 Ad5Ag85A by intramuscular injection at day 0
Receives: Biological: Ad5Ag85A

What is being measured

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

  1. Number of participants reporting adverse events

    Adverse events will be assessed according to the CTCAE Expanded Common Toxicity Criteria at 48-72 hours after vaccination, and at weeks 2, 4, 8, 12, 16 and 24

    Measured: Over 24 weeks

Secondary outcomes (14)

  1. Immunogenicity of one of two doses of Ad5Ag85A administered by aerosol

    Change from baseline in the immune responses of specific T-cells in bronchoalveolar lavage [BAL] fluid (mucosal) and blood (systemic). Immune responses measured will include interferon Elispot assay, cytokine production and intracellular cytokine staining

    Measured: Two weeks after vaccination

  2. Immunogenicity of one of two doses of Ad5Ag85A administered by aerosol

    Measured: Eight (first cohort) or twelve (second cohort) weeks after vaccination

  3. Immunogenicity of inhaled administration of Ad5Ag85A compared with intramuscular administration

    Measured: Two weeks after vaccination

  4. Immunogenicity of inhaled administration of Ad5Ag85A compared with intramuscular administration

    Measured: Twelve weeks after vaccination

  5. Number of participants reporting adverse events with inhaled administration of Ad5Ag85A compared with intramuscular administration

    Measured: Over 24 weeks

  6. Immune responses measured from induced sputum compared with bronchoalveolar lavage

    For first cohort of 8 participants only

    Measured: Two weeks after vaccination

  7. immune responses measured from induced sputum compared with bronchoalveolar lavage

    For first cohort of 8 participants only

    Measured: Eight weeks after vaccination

  8. Number of participants developing a positive interferon release assay for TB after vaccination with Ad5Ag85A

    For first cohort of 8 patients only

    Measured: At 16 weeks

  9. Number of participants reporting adverse events correlated with level of pre-existing anti-adenoviral antibodies

    Measured: Over 24 weeks

  10. Immune response to vaccination correlated with pre-existing anti-adenoviral antibodies

    Measured: Two weeks after vaccination

  11. Immune response to vaccination correlated with pre-existing anti-adenoviral antibodies

    Measured: Eight weeks after vaccination

  12. Number of participants reporting adverse effects correlated with dose of vaccine received by inhalation

    Measured: Over 24 weeks

  13. Immune response to vaccine correlated with dose of vaccine received by inhalation

    Measured: Two weeks after vaccination

  14. Immune response to vaccine correlated with dose of vaccine received by inhalation

    Measured: Eight or 12 weeks after vaccination

Timeline

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

  1. First posted13 Jan 2015 (estimated)
  2. Study start5 Sep 2017
  3. Primary completion7 Sep 2021
  4. Study completion7 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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02337270
Sponsor's protocol ID
M002
Status last verified
Oct 2021
First submitted
19 Dec 2014
Last updated
1 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jeyanathan M, Fritz DK, Afkhami S, Aguirre E, Howie KJ, Zganiacz A, Dvorkin-Gheva A, Thompson MR, Silver RF, Cusack RP, Lichty BD, O'Byrne PM, Kolb M, Medina MFC, Dolovich MB, Satia I, Gauvreau GM, Xing Z, Smaill F. Aerosol delivery, but not intramuscular injection, of adenovirus-vectored tuberculosis vaccine induces respiratory-mucosal immunity in humans. JCI Insight. 2022 Feb 8;7(3):e155655. doi: 10.1172/jci.insight.155655.

    PubMed 34990408

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ad5Ag85A in people with Tuberculosis, run by McMaster University at 1 site in Canada.

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 5 inclusion and 17 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 1 Nov 2021. 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 Canada. 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?

Number of participants reporting adverse events (time frame: Over 24 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 NCT02337270, 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 1 Nov 2021.

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