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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study to Evaluate the Safety and Immunogenicity of Ad5-105K in Adults Aged 18 to 49 Years

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

A Study to Evaluate the Safety and Immunogenicity of Ad5-105K in Adults Aged 18 to 49 Years (NCT06732583) is a Phase 1 interventional studying Tuberculosis, sponsored by CanSino Biologics INC.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Tuberculosis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 36 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. - Written (or thumb printed and witnessed) willing to sign a consent form 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 Should NOT Join This Trial: - 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. - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Treatments Being Tested

BIOLOGICAL

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

Placebo

1 doses of placebo on Day 0, IH

BIOLOGICAL

Ad5-105K

1 doses of Ad5-105K vaccine (2 x 10\^8 vp)) on Day 0, IH

BIOLOGICAL

Placebo

1 doses of placebo on Day 0, IH

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Rumah Sakit Islam Jakarta Cempaka Putih
Jakarta, Indonesia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06732583), the sponsor (CanSino Biologics INC.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06732583 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06732583?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06732583?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06732583. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06732583. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.