NCT06732583

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-13
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-12-13
• Last updated: 2025-12-11

Locations

1 site across 1 country: Indonesia