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

NCT06732583 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: CTP-ADTB-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. The distribution of participant's gender and age should be balanced in each group.

Conditions

Tuberculosis

Keywords

Vaccine; Ad5-105K; Immunogenicity; Safety; 18-49 years; TB

Outcome Measures

Primary Outcomes (1)

• Occurrence of solicited adverse events (AEs)

  Within 7 days after vaccination

Secondary Outcomes (6)

• Occurrence of solicited AEs

  Within 30 mins after vaccination

• Occurrence of unsolicited AEs

  Within 28 days after vaccination

• Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESI)

  Through study completion, an average of 6 months

• Occurrence of abnormal hematology and chemistry laboratory assessments

  On Day 3 after vaccination

• Geometric mean titer (GMT) of anti-TB75K and anti-Ag85A IgG antibodies before vaccination

  On Day 14 and Day 28 post-vaccination

Study Arms (4)

Experimental vaccine group, Low dose

EXPERIMENTAL

1 doses of Ad5-105K vaccine (0.1ml) on Day 0

Biological: Tuberculosis (TB) vaccine (Ad5-105K)

Placebo Group, Low dose

PLACEBO COMPARATOR

1 doses of placebo (0.1ml) on Day 0

Biological: Placebo

Experimental vaccine group, High dose

ACTIVE COMPARATOR

1 doses of Ad5-105K vaccine (0.2ml) on Day 0

Biological: Ad5-105K

Placebo Group, High dose

PLACEBO COMPARATOR

1 doses of placebo (0.2ml) on Day 0

Biological: Placebo

Interventions

Placebo BIOLOGICAL

1 doses of placebo on Day 0, IH

Placebo Group, Low dose

Ad5-105K BIOLOGICAL

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

Experimental vaccine group, High dose

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

Experimental vaccine group, Low dose

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PT Etana Biotechnologies Indonesia: collaborator
• CanSino Biologics Inc.: lead

Study Sites (1)

Rumah Sakit Islam Jakarta Cempaka Putih

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Erlina Burhan

  Respiratory Programmatic Implementation and Research Institute & RSUP Persahabatan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: November 13, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-12

Locations

ID (1)