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Clinical Study of BCG Vaccine for Intradermal Injection

NCT04563273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-05-09

No results posted yet for this study

Summary

The study used a randomized, dose-escalation, blinded, placebo-controlled trial design.

In this trial, 160 subjects were enrolled. The test vaccines are divided into four dose groups: dose group 1 (0.025mg / 0.1ml / person), dose group 2 (0.05mg / 0.1ml / person), dose group 3 (0.075mg / 0.1ml / person), dose group 4 (0.1mg / 0.1ml / person), each Each dose group was enrolled according to 18-45、 46-65 、6-10、11-17years old .

The 4 doses are in descending order in the order of 18-45, 46-65, 11-17, and 6-10 years old. Each age group in the same dose group was enrolled in 8 experimental BCG subjects and 2 placebo subjects.

Among subjects aged 6-65 years, the dose group 2 study will be carried out after the safety assessment 14 days after the dose group 1 vaccination, and the dose group 3 study will be carried out after completing the safety assessment 14 days after the dose group 2 vaccination. Dose group 3 studies were carried out after safety assessment 14 days after vaccination. Within the same dose group, after completing the safety assessment 14 days after vaccination for the previous age group, vaccination for the next age group is carried out.

Conditions

Interventions

BIOLOGICAL

BCG vaccine 1（0.025mg/0.1ml/person）

Intradermal injection of 0.025mg/0.1ml/person dose BCG.

BIOLOGICAL

BCG vaccine 2 （0.05mg/0.1ml/person）

Intradermal injection of 0.05mg/0.1ml/person dose BCG.

BIOLOGICAL

BCG vaccine 3（0.075mg/0.1ml/person）

Intradermal injection of 0.075mg/0.1ml/person dose BCG.

BIOLOGICAL

BCG vaccine 4 （0.075mg/0.1ml/person）

Intradermal injection of 0.075mg/0.1ml/person dose BCG.

BIOLOGICAL

Placebo of BCG vaccine （0.1ml/person）

Intradermal injection of 0.1ml/person dose Placebo.

Sponsors & Collaborators

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ting Huang, Master · Sichuan Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2022-10-30
Completion
2022-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04563273 on ClinicalTrials.gov