Clinical Study of BCG Vaccine for Intradermal Injection

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    160
  • sponsor
    Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Updated on 16 March 2022
Accepts healthy volunteers

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.

Description

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.

BCG-PPD and EC skin test were performed during the screening period, and the skin test results were followed up at 48 hours; blood routine, urine routine, blood biochemistry, HIV antibody test, electrocardiogram, chest X-ray examination, physical examination, vital signs (heart rate, blood pressure) And body temperature), female subjects of childbearing age undergo a blood pregnancy test. Those eligible for entry will receive a dose of the trial vaccine or placebo on the same day (day 0); Observe vital signs (heart rate, blood pressure and body temperature), reactions at the inoculation site, and reactions at the non-inoculation site at 30 minutes, 7 days, and 14 days after vaccination; Blood routine, urine routine, blood biochemistry, electrocardiogram examination on the 14th day after vaccination; BCG-PPD and EC skin tests were performed on the 84th and 180th days after inoculation.

If the blood routine, urine routine, blood biochemistry, electrocardiogram examinations after vaccination are abnormal and have clinically meaningful results, a re-test is required. Under special circumstances, the number of re-tests can be appropriately increased until the follow-up outcome.

Details
Condition Tuberculosis
Treatment BCG vaccine 1(0.025mg/0.1ml/person), BCG vaccine 2 (0.05mg/0.1ml/person), BCG vaccine 3(0.075mg/0.1ml/person), BCG vaccine 4 (0.075mg/0.1ml/person), Placebo of BCG vaccine (0.1ml/person)
Clinical Study IdentifierNCT04563273
SponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Last Modified on16 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 6-65 years old, able to provide legal identification
The guardian and/or I agree to participate in this trial, and have the ability to understand the research procedures and sign an informed consent form, and are willing and able to comply with the requirements of the research protocol
The female agrees to have no birth plan within 180 days after participating in the research and voluntarily take effective contraceptive measures
There is no contraindication to BCG vaccination (①Known allergy to any component of this vaccine; ②Patients suffering from acute disease, severe chronic disease, acute episode of chronic disease and fever; ③Immune deficiency, immunocompromised or receiving immunosuppression Treatment; ④patients with encephalopathy, uncontrolled epilepsy and other progressive neurological diseases; ⑤pregnant women; ⑥patients with eczema or other skin diseases), no history of tuberculosis
There are no contraindications to the use of BCG-PPD and EC (patients suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, patients with extensive skin diseases and allergic constitution)
According to the medical history, physical examination and laboratory index test results, the investigator judges to be healthy (for example: no history of tumor, abnormal laboratory index but no clinical significance)
The average diameter of BCG-PPD 48-hour skin test induration is less than 5mm without double circles, blisters, necrosis and lymphangitis. The average diameter of EC 48-hour skin test induration and redness is less than 5mm without blisters, necrosis, and lymphangitis. reaction

Exclusion Criteria

Any previous history of severe side effects of vaccines or drugs, such as urticaria, dyspnea, angioedema
The interval between inoculation of live attenuated vaccine is less than 28 days, and the interval of other vaccines is less than 14 days
Those who have a history of convulsions, epilepsy, mental illness and/or family history of mental illness
Human immunodeficiency virus (HIV) antibody test results are positive
Have received blood or blood-related products within 3 months before screening
A history of drug abuse upon inquiry
Women who are breastfeeding
Those who have participated in other clinical trials in the past 3 months and used study drugs
6-17 years old systolic blood pressure ≥120mmHg and/or diastolic blood pressure ≥80 mmHg; 18-65 years old diastolic blood pressure ≥90mmHg and/or systolic blood pressure ≥140mmHg
Those with axillary body temperature ≥37.3℃
Disabled upper limbs
The researcher believes that the subject has any conditions that may affect the evaluation of the research purpose
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note