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RECRUITING
NCT06732583
PHASE1

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

Sponsor: CanSino Biologics Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-11-13

Completion Date

2026-08

Last Updated

2025-12-11

Healthy Volunteers

Yes

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

Locations (1)

Rumah Sakit Islam Jakarta Cempaka Putih

Jakarta, Indonesia