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

NCT06732583 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • PT Etana Biotechnologies Indonesia

    collaborator UNKNOWN

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Erlina Burhan · Respiratory Programmatic Implementation and Research Institute & RSUP Persahabatan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-13
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Indonesia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06732583 on ClinicalTrials.gov