CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02) +2 morebiological
Likely dose
Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04239313
NCT04239313Phase 1Completed
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Phase Ib Clinical Trial Evaluating the Safety and Immunogenicity of Freeze-dried Recombinant Tuberculosis Vaccine (AEC / BC02) in Healthy Adults

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.·interventional·Posted Jan 27, 2020·Updated Sep 6, 2022

In Brief

A Phase 1 clinical trial evaluating Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), Low-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02), and 1 other intervention for Tuberculosis. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Single-center, single-dose, placebo-controlled, open-label trials were used to evaluate the safety and immunogenicity of low-dose adjuvants and low-dose vaccines in the upper arm deltoid muscle intramuscularly in the double negative population. Thirty (PPD-QFT-) healthy adult subjects aged 18-45 were selected and divided into placebo group, low-dose adjuvant group, and low-dose vaccine group. During the test, each subject must not change groups and inoculate drugs. Every two weeks (0-2-4-6-8-10 weeks), alternately inject a dose of placebo or left and right upper arm deltoid muscles. Low-dose adjuvant or low-dose vaccine, a total of 6 doses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJan 27, 2020
Enrollment StartMay 27, 2020
Primary CompletionFeb 24, 2021
Study CompletionJun 20, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.4 years ago

Interventions

Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)biological

Population I are coxal muscle injection of low dose vaccine.

Low-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)biological

Population I are coxal muscle injection of low dose adjuvant.

Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebobiological

The placebo drug contains 20mg mannitol and 10 millimole(mM) phosphate buffer(PB).population I are coxal muscle injection of placebo.