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

April 29, 2026 updated by: CanSino Biologics Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Rumah Sakit Islam Jakarta Cempaka Putih

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental vaccine group, Low dose
1 doses of Ad5-105K vaccine (0.1ml) on Day 0
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
Placebo Comparator: Placebo Group, Low dose
1 doses of placebo (0.1ml) on Day 0
Biological: Placebo
1 doses of placebo on Day 0, IH
Active Comparator: Experimental vaccine group, High dose
1 doses of Ad5-105K vaccine (0.2ml) on Day 0
Biological: Ad5-105K
1 doses of Ad5-105K vaccine (2 x 10^8 vp)) on Day 0, IH
Placebo Comparator: Placebo Group, High dose
1 doses of placebo (0.2ml) on Day 0
Biological: Placebo
1 doses of placebo on Day 0, IH

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Occurrence of solicited adverse events (AEs)
Time Frame: Within 7 days after vaccination
Within 7 days after vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Occurrence of solicited AEs
Time Frame: Within 30 mins after vaccination
Within 30 mins after vaccination
Occurrence of unsolicited AEs
Time Frame: Within 28 days after vaccination
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
Through study completion, an average of 6 months
Occurrence of abnormal hematology and chemistry laboratory assessments
Time Frame: On Day 3 after vaccination
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
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
Before vaccination and on Day 14 and Day 28 post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CanSino Biologics Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PT Etana Biotechnologies Indonesia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erlina Burhan, Respiratory Programmatic Implementation and Research Institute & RSUP Persahabatan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTP-ADTB-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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