Information

This phase I randomized, double-blind, placebo-controlled, dose-escalation study will enroll 36 healthy adults aged 18–49 years to evaluate the safety and immunogenicity of the viral vector–based TB vaccine candidate Ad5-105K. The primary objective is to assess safety and tolerability, while secondary objectives include detailed safety evaluation and measurement of humoral and cellular immune responses. Exploratory assessments focus on mucosal and long-term systemic immunity and characterization of immune pathway profiles using BALF and PBMC samples.

CanSino Biologics Inc.

PT. Etana Biotechnologies Indonesia

Type of Study

Stakeholders Involved

TB Vaccine Trial

Background

Tuberculosis (TB) remains one of the leading infectious causes of morbidity and mortality worldwide, particularly in low- and middle-income countries. Despite global progress toward TB control, the COVID-19 pandemic has significantly disrupted diagnostic and treatment services, leading to setbacks in achieving the WHO End TB Strategy milestones. Indonesia carries the second-highest TB burden globally, with high incidence and mortality rates—including among individuals with HIV and those with drug-resistant TB. Current preventive strategies are limited, and the only licensed TB vaccine, BCG, offers substantial protection for infants but provides insufficient and inconsistent protection against adult pulmonary TB, which drives most TB transmission. These challenges highlight a critical need for new TB vaccines that can induce robust and durable immunity in adults.

Ad5-105K, a viral vector–based TB vaccine candidate, is being evaluated to address this need by targeting key immune pathways involved in protection against Mycobacterium tuberculosis. Assessing its safety and immunogenicity in adults aged 18–49 years is particularly important, as this demographic constitutes the primary reservoir for TB transmission in Indonesia. This phase I trial is designed to generate foundational data on safety, tolerability, and immune responses—including humoral, cellular, and mucosal immunity—within the Indonesian population. The findings will inform dose selection and support the advancement of Ad5-105K into subsequent clinical phases, ultimately contributing to the development of an effective adult TB vaccine that could meaningfully reduce TB burden in Indonesia.

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