TuberculosisPhase 1NCT06732583
A Study to Evaluate the Safety and Immunogenicity of Ad5-105K in Adults Aged 18 to 49 Years
A Phase 1 study testing Tuberculosis (TB) vaccine (Ad5-105K) and Ad5-105K in people with Tuberculosis, run by CanSino Biologics Inc. at 1 site in Indonesia.
Trial summary
This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups (Group A and B). In each treatment group, 18 participants will be randomly assigned to receive either the investigational vaccine (Dose A or Dose B of Ad5-105K) or a placebo in a ratio of 2:1. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Tuberculosis (TB) vaccine (Ad5-105K) and Ad5-105K
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Nov 2025to Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who, in the opinion of the investigator, are able and willing to comply with the requirements of the protocol (e.g., completion of diary cards, returning for follow-up visits).
- Healthy male or female participants aged 18 to 49 years, at the time of obtaining informed consent.
- Written (or thumb printed and witnessed) informed consent obtained from the participant.
- Positive IGRA test with no history of TB disease or treatment.
- Female participants of childbearing potential must have a negative urine pregnancy test at screening and on the day of vaccination. Male and female participants of childbearing potential must agree to use adequate contraception for the entire duration of their participation in the study.
- History of BCG vaccination.
Who cannot join
- Current TB disease, or a history of TB disease and/or treatment for TB (including Tuberculosis Preventive Therapy (TPT)).
- Known history of close or household contact with active TB patient.
- Axillary temperature ≥37.5°C.
- Presence of congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Lactating women.
- Individuals who smoke more than 10 cigarettes per day within the last 3 months and/or more than 2 cigars per day, and/or vapers who use more than 5 ml of e-liquid daily.
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- Individuals with positive HIV, HBV, HCV, or TP (Treponema pallidum) test.
- History of immunosuppressive treatment, cytotoxic treatment, or glucocorticoid treatment, etc. (excluding local treatments, surface treatments for acute non-concurrent dermatitis or spray treatment for allergic rhinitis) in the past 6 months (internal time <6 months).
- History of, or plans to use, blood/plasma products or immunoglobulins within 60 days prior to study vaccination or at any time during the study period.
- Uncontrolled severe hypertension (at the time of field measurement: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg).
- Suffering from a serious chronic disease or a condition that is in a progressive stage and cannot be adequately controlled (e.g., thyroid disease), or having known or suspected diseases that at investigators' discretion, may affect vaccination or immunogenicity test results (e.g., diagnosed with asthma within the last 20 years, severe respiratory disease, acute infection or active chronic disease, severe cardiovascular disease, severe liver or kidney disease, malignancy, severe infectious or allergic skin disease).
- History of serious adverse reactions associated with the adenovirus vector-based vaccine and/or history of severe allergic reactions (e.g., systemic allergic reactions) to any component of the study vaccine.
- Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and/or physical examination (e.g., HIV infection, or a history of pancreatic, liver, spleen, kidney disease, or a history of organ resection).
- Bleeding constitution or condition associated with prolonged bleeding for which IM injection is contraindicated, in the opinion of the investigator.
- History of administration of any vaccine within the past three months.
- History of receiving experimental Mycobacterium tuberculosis (Mtb) vaccines or participation in other interventional studies within 28 days prior to screening and/or during study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomized, Double-blind, Placebo-controlled and Dose Escalation Study to Evaluate the Safety and Immunogenicity of a Viral Vector-based Tuberculosis (TB) Vaccine Ad5-105K Against TB Disease in Adults Aged 18 to 49 Years
This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups (Group A and B). In each treatment group, 18 participants will be randomly assigned to receive either the investigational vaccine (Dose A or Dose B of Ad5-105K) or a placebo in a ratio of 2:1. The distribution of participant's gender and age should be balanced in each group.
- Conditions
- Tuberculosis
- Being tested
- Tuberculosis (TB) vaccine (Ad5-105K), Placebo, Ad5-105K
- Keywords
- Vaccine, Ad5-105K, Immunogenicity, Safety, 18-49 years, TB
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuberculosis (TB) vaccine (Ad5-105K)Biological
1 doses of Ad5-105K vaccine (1 x 10^8 vp)) on Day 0, Nebulized Inhalation (IH) through mouth
PlaceboBiological
1 doses of placebo on Day 0, IH
Ad5-105KBiological
1 doses of Ad5-105K vaccine (2 x 10^8 vp)) on Day 0, IH
PlaceboBiological
1 doses of placebo on Day 0, IH
| Study group | Role | What they receive |
|---|---|---|
| Experimental vaccine group, Low dose | Experimental | 1 doses of Ad5-105K vaccine (0.1ml) on Day 0 Receives: Biological: Tuberculosis (TB) vaccine (Ad5-105K) |
| Placebo Group, Low dose | Placebo comparator | 1 doses of placebo (0.1ml) on Day 0 Receives: Biological: Placebo |
| Experimental vaccine group, High dose | Active comparator | 1 doses of Ad5-105K vaccine (0.2ml) on Day 0 Receives: Biological: Ad5-105K |
| Placebo Group, High dose | Placebo comparator | 1 doses of placebo (0.2ml) on Day 0 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited adverse events (AEs)
Measured: Within 7 days after vaccination
Secondary outcomes (6)
Occurrence of solicited AEs
Measured: Within 30 mins after vaccination
Occurrence of unsolicited AEs
Measured: Within 28 days after vaccination
Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESI)
Measured: Through study completion, an average of 6 months
Occurrence of abnormal hematology and chemistry laboratory assessments
Measured: On Day 3 after vaccination
Geometric mean titer (GMT) of anti-TB75K and anti-Ag85A IgG antibodies before vaccination
Measured: On Day 14 and Day 28 post-vaccination
Expression level of IFN-γ, TNF-α, IL-2, and IL-17 in 105K specific CD4+/CD8+ T cells evaluated by ICS
Measured: Before vaccination and on Day 14 and Day 28 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start13 Nov 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
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 CanSino Biologics Inc.The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT Etana Biotechnologies Indonesia
- Responsible party
- Sponsor
- Investigators
- Erlina Burhan, Principal investigator, Respiratory Programmatic Implementation and Research Institute & RSUP Persahabatan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732583
- Sponsor's protocol ID
- CTP-ADTB-001
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-blind, Placebo-controlled and Dose Escalation Study to Evaluate the Safety and Immunogenicity of a Viral Vector-based Tuberculosis (TB) Vaccine Ad5-105K Against TB Disease in Adults Aged 18 to 49 Years
- ClinicalTrials.gov ID
- NCT06732583
- Acronym / sponsor ID
- CTP-ADTB-001
- Conditions
- Tuberculosis
- Keywords
- Vaccine, Ad5-105K, Immunogenicity, Safety, 18-49 years, TB
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Collaborators
- PT Etana Biotechnologies Indonesia
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 Dec 2024 (actual)
- 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 a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups (Group A and B). In each treatment group, 18 participants will be randomly assigned to receive either the investigational vaccine (Dose A or Dose B of Ad5-105K) or a placebo in a ratio of 2:1. The distribution of participant's gender and age should be balanced in each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental vaccine group, Low dose | Experimental | Biological: Tuberculosis (TB) vaccine (Ad5-105K)1 doses of Ad5-105K vaccine (0.1ml) on Day 0 |
| Placebo Group, Low dose | Placebo comparator | Biological: Placebo1 doses of placebo (0.1ml) on Day 0 |
| Experimental vaccine group, High dose | Active comparator | Biological: Ad5-105K1 doses of Ad5-105K vaccine (0.2ml) on Day 0 |
| Placebo Group, High dose | Placebo comparator | Biological: Placebo1 doses of placebo (0.2ml) on Day 0 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants who, in the opinion of the investigator, are able and willing to comply with the requirements of the protocol (e.g., completion of diary cards, returning for follow-up visits).
- Healthy male or female participants aged 18 to 49 years, at the time of obtaining informed consent.
- Written (or thumb printed and witnessed) informed consent obtained from the participant.
- Positive IGRA test with no history of TB disease or treatment.
- Female participants of childbearing potential must have a negative urine pregnancy test at screening and on the day of vaccination. Male and female participants of childbearing potential must agree to use adequate contraception for the entire duration of their participation in the study.
Key exclusion criteria (16 listed)
- Current TB disease, or a history of TB disease and/or treatment for TB (including Tuberculosis Preventive Therapy (TPT)).
- Known history of close or household contact with active TB patient.
- Axillary temperature ≥37.5°C.
- Presence of congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Lactating women.
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 |
|---|---|---|
| Tuberculosis (TB) vaccine (Ad5-105K)1 doses of Ad5-105K vaccine (1 x 10^8 vp)) on Day 0, Nebulized Inhalation (IH) through mouth | Biological | Experimental vaccine group, Low dose |
| Placebo1 doses of placebo on Day 0, IH | Biological | Placebo Group, Low dose |
| Ad5-105K1 doses of Ad5-105K vaccine (2 x 10^8 vp)) on Day 0, IH | Biological | Experimental vaccine group, High dose |
| Placebo1 doses of placebo on Day 0, IH | Biological | Placebo Group, High dose |
Primary outcome
Occurrence of solicited adverse events (AEs)
Time frame: Within 7 days after vaccination
6 secondary outcomes
Occurrence of solicited AEs
Time frame: Within 30 mins after vaccination
Occurrence of unsolicited AEs
Time frame: Within 28 days after vaccination
Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESI)
Time frame: Through study completion, an average of 6 months
Occurrence of abnormal hematology and chemistry laboratory assessments
Time frame: On Day 3 after vaccination
Geometric mean titer (GMT) of anti-TB75K and anti-Ag85A IgG antibodies before vaccination
Time frame: On Day 14 and Day 28 post-vaccination
Expression level of IFN-γ, TNF-α, IL-2, and IL-17 in 105K specific CD4+/CD8+ T cells evaluated by ICS
Time frame: Before vaccination and on Day 14 and Day 28 post-vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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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.
Erlina Burhan principal investigator
Respiratory Programmatic Implementation and Research Institute & RSUP Persahabatan
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 Tuberculosis (TB) vaccine (Ad5-105K) and Ad5-105K in people with Tuberculosis, run by CanSino Biologics Inc. at 1 site in Indonesia.
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 6 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Occurrence of solicited adverse events (AEs) (time frame: Within 7 days after vaccination). 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 30 Apr 2026.