# A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)

> **NCT05284812** · PHASE2 · SUSPENDED · sponsor: **Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.** · enrollment: 200 (estimated)

## Conditions studied

- Tuberculosis

## Interventions

- **BIOLOGICAL:** Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
- **BIOLOGICAL:** High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
- **BIOLOGICAL:** High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
- **BIOLOGICAL:** Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo

## Key facts

- **NCT ID:** NCT05284812
- **Lead sponsor:** Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** SUSPENDED
- **Start date:** 2022-02-10
- **Primary completion:** 2024-06-30
- **Final completion:** 2024-12-31
- **Target enrollment:** 200 (ESTIMATED)
- **Why stopped:** It is planned to restart the clinical study after the completion of the clinical trial protocol modification.
- **Last updated:** 2023-11-28


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05284812

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05284812, "A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT05284812. Licensed CC0.

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