TuberculosisPhase 1NCT04563273
Clinical Study of BCG Vaccine for Intradermal Injection
A Phase 1 study testing BCG vaccine 1（0.025mg/0.1ml/person）, BCG vaccine 2 （0.05mg/0.1ml/person） and BCG vaccine 3（0.075mg/0.1ml/person） in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- BCG vaccine 1（0.025mg/0.1ml/person）, BCG vaccine 2 （0.05mg/0.1ml/person） and BCG vaccine 3（0.075mg/0.1ml/person）
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2020to 30 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, 610041
About this study
Official title: Randomized, Blinded, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of BCG Vaccine for Intradermal Injection in 6-65 Year Olds
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 .
Read more
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.
Read the detailed 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.
- Conditions
- Tuberculosis
- Being tested
- 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）
- Keywords
- Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG vaccine 1（0.025mg/0.1ml/person）Biological
Intradermal injection of 0.025mg/0.1ml/person dose BCG.
BCG vaccine 2 （0.05mg/0.1ml/person）Biological
Intradermal injection of 0.05mg/0.1ml/person dose BCG.
BCG vaccine 3（0.075mg/0.1ml/person）Biological
Intradermal injection of 0.075mg/0.1ml/person dose BCG.
BCG vaccine 4 （0.075mg/0.1ml/person）Biological
Intradermal injection of 0.075mg/0.1ml/person dose BCG.
Placebo of BCG vaccine （0.1ml/person）Biological
Intradermal injection of 0.1ml/person dose Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Healthy people aged 18-45 | Experimental | Healthy people aged 18-45 has 40 subjects,and it is considered as BCG purified protein derivative(BCG-PPD) skin test and Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10（EC） detection result all negative. Receives: Biological: BCG vaccine 1（0.025mg/0.1ml/person）; Biological: BCG vaccine 2 （0.05mg/0.1ml/person）; Biological: BCG vaccine 3（0.075mg/0.1ml/person）; Biological: BCG vaccine 4 （0.075mg/0.1ml/person）; Biological: Placebo of BCG vaccine （0.1ml/person） |
| Healthy people aged 46-65 | Experimental | Healthy people aged 46-65 has 40 subjects,and it is considered as BCG purified protein derivative(BCG-PPD) skin test and Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10（EC） detection result all negative. Receives: Biological: BCG vaccine 1（0.025mg/0.1ml/person）; Biological: BCG vaccine 2 （0.05mg/0.1ml/person）; Biological: BCG vaccine 3（0.075mg/0.1ml/person）; Biological: BCG vaccine 4 （0.075mg/0.1ml/person）; Biological: Placebo of BCG vaccine （0.1ml/person） |
| Healthy people aged 11-17. | Experimental | Healthy people aged 11-17 40 subjects,and it is considered as BCG purified protein derivative(BCG-PPD) skin test and Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10（EC） detection result all negative. Receives: Biological: BCG vaccine 1（0.025mg/0.1ml/person）; Biological: BCG vaccine 2 （0.05mg/0.1ml/person）; Biological: BCG vaccine 3（0.075mg/0.1ml/person）; Biological: BCG vaccine 4 （0.075mg/0.1ml/person）; Biological: Placebo of BCG vaccine （0.1ml/person） |
| Healthy people aged 6-10 | Experimental | Healthy people aged 6-10 has 40 subjects,and it is considered as BCG purified protein derivative(BCG-PPD) skin test and Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10（EC） detection result all negative. Receives: Biological: BCG vaccine 1（0.025mg/0.1ml/person）; Biological: BCG vaccine 2 （0.05mg/0.1ml/person）; Biological: BCG vaccine 3（0.075mg/0.1ml/person）; Biological: BCG vaccine 4 （0.075mg/0.1ml/person）; Biological: Placebo of BCG vaccine （0.1ml/person） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events after vaccination
Evaluate safety indicators before vaccination, 30 minutes, 7 days, and 14 days after vaccination. Collect all AEs 30 minutes after vaccination, 0-14 days of collected adverse events, 0-30 days of non-collected adverse events, within 6 months SAE, to evaluate the safety and tolerability of BCG vaccine for intradermal injection used in the test in people aged 6 to 65 years old with negative BCG-PPD and EC skin test
Measured: Up to 6 months after the sixth time injection
Secondary outcomes (2)
Positive conversion rate of BCG-PPD skin test 12 weeks and 6 months after vaccination
BCG-PPD skin tests were conducted 12 weeks and 6 months after inoculation of the corresponding test drugs and placebo to evaluate the positive conversion rate of BCG-PPD after BCG vaccination for intradermal injection
Measured: Up to 6 months after the sixth time injection
Positive conversion rate of EC skin test 12 weeks and 6 months after vaccination
EC skin tests were conducted 12 weeks and 6 months after inoculation of the corresponding test drugs and placebo to evaluate the positive conversion rate of EC after BCG vaccination for intradermal injection
Measured: Up to 6 months after the sixth time injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start21 Oct 2020
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ting Huang, Master, Principal investigator, Sichuan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563273
- Sponsor's protocol ID
- BCG-I-healthy
- Status last verified
- May 2023
- First submitted
- 19 Jun 2020
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tuberculosis Prevention Trial. Trial of BCG vaccines in south India for tuberculosis prevention. 1979. Indian J Med Res. 2013 Mar;137(3):571. No abstract available.
PubMed 23776969Expanded programme on immunization. Immunization schedules in the WHO European Region, 1995. Wkly Epidemiol Rec. 1995 Aug 4;70(31):221. No abstract available. English, French.
PubMed 7662525
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blinded, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of BCG Vaccine for Intradermal Injection in 6-65 Year Olds
- ClinicalTrials.gov ID
- NCT04563273
- Acronym / sponsor ID
- BCG-I-healthy
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy people aged 18-45 | Experimental | Biological: BCG vaccine 1（0.025mg/0.1ml/person）, Biological: BCG vaccine 2 （0.05mg/0.1ml/person）, Biological: BCG vaccine 3（0.075mg/0.1ml/person）, Biological: BCG vaccine 4 （0.075mg/0.1ml/person）, Biological: Placebo of BCG vaccine （0.1ml/person）Healthy people aged 18-45 has 40 subjects,and it is considered as BCG purified protein derivative(BCG-PPD) skin test and Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10（EC） detection result all negative. |
| Healthy people aged 46-65 | Experimental | Biological: BCG vaccine 1（0.025mg/0.1ml/person）, Biological: BCG vaccine 2 （0.05mg/0.1ml/person）, Biological: BCG vaccine 3（0.075mg/0.1ml/person）, Biological: BCG vaccine 4 （0.075mg/0.1ml/person）, Biological: Placebo of BCG vaccine （0.1ml/person）Healthy people aged 46-65 has 40 subjects,and it is considered as BCG purified protein derivative(BCG-PPD) skin test and Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10（EC） detection result all negative. |
| Healthy people aged 11-17. | Experimental | Biological: BCG vaccine 1（0.025mg/0.1ml/person）, Biological: BCG vaccine 2 （0.05mg/0.1ml/person）, Biological: BCG vaccine 3（0.075mg/0.1ml/person）, Biological: BCG vaccine 4 （0.075mg/0.1ml/person）, Biological: Placebo of BCG vaccine （0.1ml/person）Healthy people aged 11-17 40 subjects,and it is considered as BCG purified protein derivative(BCG-PPD) skin test and Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10（EC） detection result all negative. |
| Healthy people aged 6-10 | Experimental | Biological: BCG vaccine 1（0.025mg/0.1ml/person）, Biological: BCG vaccine 2 （0.05mg/0.1ml/person）, Biological: BCG vaccine 3（0.075mg/0.1ml/person）, Biological: BCG vaccine 4 （0.075mg/0.1ml/person）, Biological: Placebo of BCG vaccine （0.1ml/person）Healthy people aged 6-10 has 40 subjects,and it is considered as BCG purified protein derivative(BCG-PPD) skin test and Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10（EC） detection result all negative. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG vaccine 1（0.025mg/0.1ml/person）Intradermal injection of 0.025mg/0.1ml/person dose BCG. | Biological | Healthy people aged 11-17., Healthy people aged 18-45, Healthy people aged 46-65, Healthy people aged 6-10 |
| BCG vaccine 2 （0.05mg/0.1ml/person）Intradermal injection of 0.05mg/0.1ml/person dose BCG. | Biological | Healthy people aged 11-17., Healthy people aged 18-45, Healthy people aged 46-65, Healthy people aged 6-10 |
| BCG vaccine 3（0.075mg/0.1ml/person）Intradermal injection of 0.075mg/0.1ml/person dose BCG. | Biological | Healthy people aged 11-17., Healthy people aged 18-45, Healthy people aged 46-65, Healthy people aged 6-10 |
| BCG vaccine 4 （0.075mg/0.1ml/person）Intradermal injection of 0.075mg/0.1ml/person dose BCG. | Biological | Healthy people aged 11-17., Healthy people aged 18-45, Healthy people aged 46-65, Healthy people aged 6-10 |
| Placebo of BCG vaccine （0.1ml/person）Intradermal injection of 0.1ml/person dose Placebo. | Biological | Healthy people aged 11-17., Healthy people aged 18-45, Healthy people aged 46-65, Healthy people aged 6-10 |
Primary outcome
Incidence of adverse events after vaccination
Time frame: Up to 6 months after the sixth time injection
Evaluate safety indicators before vaccination, 30 minutes, 7 days, and 14 days after vaccination. Collect all AEs 30 minutes after vaccination, 0-14 days of collected adverse events, 0-30 days of non-collected adverse events, within 6 months SAE, to evaluate the safety and tolerability of BCG vaccine for intradermal injection used in the test in people aged 6 to 65 years old with negative BCG-PPD and EC skin test
2 secondary outcomes
Positive conversion rate of BCG-PPD skin test 12 weeks and 6 months after vaccination
Time frame: Up to 6 months after the sixth time injection
Positive conversion rate of EC skin test 12 weeks and 6 months after vaccination
Time frame: Up to 6 months after the sixth time injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 23776969Tuberculosis Prevention Trial. Trial of BCG vaccines in south India for tuberculosis prevention. 1979. Indian J Med Res. 2013 Mar;137(3):571. No abstract available.
- Background: PubMed 7662525Expanded programme on immunization. Immunization schedules in the WHO European Region, 1995. Wkly Epidemiol Rec. 1995 Aug 4;70(31):221. No abstract available. English, French.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Huang, Master principal investigator
Sichuan Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCG vaccine 1（0.025mg/0.1ml/person）, BCG vaccine 2 （0.05mg/0.1ml/person） and BCG vaccine 3（0.075mg/0.1ml/person） in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events after vaccination (time frame: Up to 6 months after the sixth time injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04563273, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.