Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438978
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-12-11
Brief Title:
Tuberculosis Vaccine in Healthy Indian Adults
Sponsor:
Bharat Biotech International Limited
Organization:
Bharat Biotech International Limited
Study Overview
Official Title:
An Open-Labelled Phase I Clinical Trial to Assess the Safety Reactogenicity Tolerability and Immunogenicity of a Tuberculosis Vaccine BBV169 MTBVAC in Healthy Indian Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BBV1692023
Brief Summary:
An Open-labelled Phase I Clinical Trial to Assess the Safety Reactogenicity Tolerability and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region DSMB meetings will be conducted after Day 28 Day 90 Day 180 after vaccinating all subjects
Detailed Description:
An Open-labelled Phase I Clinical Trial to Assess the Safety Reactogenicity Tolerability and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region DSMB meetings will be conducted after Day 28 Day 90 Day 180 after vaccinating all subjects
Study Objectives
Primary Objective To evaluate the safety and reactogenicity of MTBVAC
End points
1 The occurrence of immediate adverse events within 30mins of vaccination Time Frame 30 mins
2 The occurrence of solicited adverse events within fourteen days of vaccination Time Frame daily follow- up for 14 days
3 The injection site reactions will be followed-up for 90 days
4 The occurrence of any unsolicited adverse events throughout the study duration Time Frame throughout the trial duration
5 The occurrence of serious adverse events SAEs Time Frame throughout the trial duration
6 AESI Adverse Event of Special Interest is to be considered throughout the trial period
7 Hematological biochemical safety test levels before and after vaccination
Study design
An Open-labelled Phase I Clinical Trial to Assess the Safety Reactogenicity Tolerability and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region DSMB meetings will be conducted after Day 28 Day 90 Day 180 after vaccinating all subjects
1 Safety Lab investigations -10ml of blood on Day of screening Day 28 90180
2 Sputum GeneXpert Ultra Test - Sputum sample at screening for all participants and participants with suspected TB
3 Urine test- CUE for all participants at screening Day 2890180 and UPT female participant of the child bearing age group on Day0 2890180
4 Quantiferon Gold Plus assay -5ml of blood on Day of screening Day 2890 180
5 Antigen specific CD4CD8 response--10ml of blood atDay0 2890 180
Study Procedure
Visit1 Screening-7 to 0
1 Screening of healthy adults of age 18-65 years to assess eligibility by inclusion and exclusion criteria for the trial will take place
2 After obtaining written informed consent from the healthy participants
3 Demographic information age gender date of birth weight kg and height cm body mass index addresscorresponding and permanent Contact number alcohol consumptionsubstance use and smoking statustobacco usemedical history co-morbid conditions and concomitant medication will be noted
4 A physical examination of the subject will be carried out ECG Chest X-ray USG abdomen and sputum for AFB GeneXpert ultra test will be done for all subjects
5 10ml of the blood sample will be collected for screening lab investigations which include CBP liver function tests kidney function tests lipid profile ESR RBS CRP CUE TSH beta HCG female subjects of child bearing age group and serology for HIV1 and 2 HbsAg and HCV
6 5ml of the blood sample will be collected for Quantiferon Gold Plus assay
7 QFT Plus negative subjects will be recruited
Visit 2Baseline Day 0
1 From the eligible subjects in good general health or stable preexisting disease as per the discretion of the principal investigator blood samples will be withdrawn for Immunogenicity analysis and urine for UPT for females of child bearing potential will be done before vaccination
2 After administration of the trial vaccine the subjects will remain at the trial site for at least 30 minutes of observation to record any immediate adverse event
3 An injection site Photograph will be captured after the assessment of injection site reactions
4 Diary cards will be distributed to the subjects
5 Telephonic follow-up is done for 6 days to assess the solicited events and health status
Visit3 Day71
1 The subjects will visit the trial site 7 days after vaccination for safety assessment which includes solicited and unsolicited adverse events medical history vital signs physical examination and concomitant medications The participant will be interviewed for any suspected TB symptoms and concomitant medication During this visit the trial personnel will review and collect the diary card
2 New Diary card will be distributed
3 An injection site photograph will be captured after the assessment of injection site reactions
4 Telephonic follow-up will be done for next 7 days to assess the solicited events and health status
Visit4 Day 282
1 The subjects will visit the trial site 282 days after vaccination During this visit the subjects will be examined physically and the history of any adverse events suspected TB symptoms and concomitant medications will be asked The trial personnel will review and collect the diary card Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations-CBP Liver function tests Kidney function tests Lipid Profile ESR CRP and RBS
2 An injection site photograph will be captured after assessment of injection site reactions
3 Urine samples will be collected for complete urine examination for all and UPT wherever required
Visit5 Day 907
1 The subjects will visit the trial site 907 days after vaccination During these visits the subjects will be physically examined and a history of any adverse events suspected TB symptoms and concomitant medications will be asked Injection site Photograph will be captured after assessment of injection site reactions Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations- CBP Liver function tests Kidney function tests Lipid Profile ESR CRP and RBS
2 Urine samples will be collected for complete urine examination for all and UPT wherever required
Visit6Day1807
1 The subjects will visit the trial site 6 months after vaccination During this visit the subjects will be physically examined and the history of any adverse events suspected TB symptoms and concomitant medications will be asked Injection site Photograph will be captured after assessment of injection site reactions Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations-CBP Liver function tests Kidney function tests Lipid Profile ESR CRP and RBS
2 Urine samples will be collected for complete urine examination for all and UPT wherever required
Visit for Clinically suspected TB during follow-up
1 If any participant develops TB symptoms including but not limited to persistent cough hemoptysis fever unintended weight loss fatigue or lethargy night sweats or pleuritic chest pain during the follow-up after vaccination heshe will be advised to report to the trial clinic
2 A detailed medical history with a thorough physical examination will be done
Based on the results subjects will be classified as follows
1 In suspected PTB the trial investigator will undertake investigations bacteriological microbiological and radiological as per National Tuberculosis Elimination Program NTEP guidelines for confirming PTB If confirmed the trial investigator will providerefer participant to concerned department for the required treatment as per NTEP guidelines and will ensure safety follow-up till the end of the trial
2 In suspected EPTB the trial investigator will undertake the required investigations for confirming the diagnosis of EPTB as per NTEP guidelines If confirmed the trial investigator will providerefer participant to concerned department for the required treatment as per NTEP guidelines and will ensure safety followup till the end of the trial
3 If any subject is confirmed with any form of TB they will not be assessed for Immunogenicity further But safety will be followed up to 180days
4 If the participant is not diagnosed with TB PTB or EPTB as per NTEP guidelines heshe will be continued in to the trial and followed up till the end of the trial period
5 All the TB cases will be reviewed by the Adjudication committee
Study Objectives
Primary Objective To evaluate the safety and reactogenicity of MTBVAC
End points
1 The occurrence of immediate adverse events within 30mins of vaccination Time Frame 30 mins
2 The occurrence of solicited adverse events within fourteen days of vaccination Time Frame daily follow- up for 14 days
3 The injection site reactions will be followed-up for 90 days
4 The occurrence of any unsolicited adverse events throughout the study duration Time Frame throughout the trial duration
5 The occurrence of serious adverse events SAEs Time Frame throughout the trial duration
6 AESI Adverse Event of Special Interest is to be considered throughout the trial period
7 Hematological biochemical safety test levels before and after vaccination
Study design
An Open-labelled Phase I Clinical Trial to Assess the Safety Reactogenicity Tolerability and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region DSMB meetings will be conducted after Day 28 Day 90 Day 180 after vaccinating all subjects
1 Safety Lab investigations -10ml of blood on Day of screening Day 28 90180
2 Sputum GeneXpert Ultra Test - Sputum sample at screening for all participants and participants with suspected TB
3 Urine test- CUE for all participants at screening Day 2890180 and UPT female participant of the child bearing age group on Day0 2890180
4 Quantiferon Gold Plus assay -5ml of blood on Day of screening Day 2890 180
5 Antigen specific CD4CD8 response--10ml of blood atDay0 2890 180
Study Procedure
Visit1 Screening-7 to 0
1 Screening of healthy adults of age 18-65 years to assess eligibility by inclusion and exclusion criteria for the trial will take place
2 After obtaining written informed consent from the healthy participants
3 Demographic information age gender date of birth weight kg and height cm body mass index addresscorresponding and permanent Contact number alcohol consumptionsubstance use and smoking statustobacco usemedical history co-morbid conditions and concomitant medication will be noted
4 A physical examination of the subject will be carried out ECG Chest X-ray USG abdomen and sputum for AFB GeneXpert ultra test will be done for all subjects
5 10ml of the blood sample will be collected for screening lab investigations which include CBP liver function tests kidney function tests lipid profile ESR RBS CRP CUE TSH beta HCG female subjects of child bearing age group and serology for HIV1 and 2 HbsAg and HCV
6 5ml of the blood sample will be collected for Quantiferon Gold Plus assay
7 QFT Plus negative subjects will be recruited
Visit 2Baseline Day 0
1 From the eligible subjects in good general health or stable preexisting disease as per the discretion of the principal investigator blood samples will be withdrawn for Immunogenicity analysis and urine for UPT for females of child bearing potential will be done before vaccination
2 After administration of the trial vaccine the subjects will remain at the trial site for at least 30 minutes of observation to record any immediate adverse event
3 An injection site Photograph will be captured after the assessment of injection site reactions
4 Diary cards will be distributed to the subjects
5 Telephonic follow-up is done for 6 days to assess the solicited events and health status
Visit3 Day71
1 The subjects will visit the trial site 7 days after vaccination for safety assessment which includes solicited and unsolicited adverse events medical history vital signs physical examination and concomitant medications The participant will be interviewed for any suspected TB symptoms and concomitant medication During this visit the trial personnel will review and collect the diary card
2 New Diary card will be distributed
3 An injection site photograph will be captured after the assessment of injection site reactions
4 Telephonic follow-up will be done for next 7 days to assess the solicited events and health status
Visit4 Day 282
1 The subjects will visit the trial site 282 days after vaccination During this visit the subjects will be examined physically and the history of any adverse events suspected TB symptoms and concomitant medications will be asked The trial personnel will review and collect the diary card Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations-CBP Liver function tests Kidney function tests Lipid Profile ESR CRP and RBS
2 An injection site photograph will be captured after assessment of injection site reactions
3 Urine samples will be collected for complete urine examination for all and UPT wherever required
Visit5 Day 907
1 The subjects will visit the trial site 907 days after vaccination During these visits the subjects will be physically examined and a history of any adverse events suspected TB symptoms and concomitant medications will be asked Injection site Photograph will be captured after assessment of injection site reactions Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations- CBP Liver function tests Kidney function tests Lipid Profile ESR CRP and RBS
2 Urine samples will be collected for complete urine examination for all and UPT wherever required
Visit6Day1807
1 The subjects will visit the trial site 6 months after vaccination During this visit the subjects will be physically examined and the history of any adverse events suspected TB symptoms and concomitant medications will be asked Injection site Photograph will be captured after assessment of injection site reactions Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations-CBP Liver function tests Kidney function tests Lipid Profile ESR CRP and RBS
2 Urine samples will be collected for complete urine examination for all and UPT wherever required
Visit for Clinically suspected TB during follow-up
1 If any participant develops TB symptoms including but not limited to persistent cough hemoptysis fever unintended weight loss fatigue or lethargy night sweats or pleuritic chest pain during the follow-up after vaccination heshe will be advised to report to the trial clinic
2 A detailed medical history with a thorough physical examination will be done
Based on the results subjects will be classified as follows
1 In suspected PTB the trial investigator will undertake investigations bacteriological microbiological and radiological as per National Tuberculosis Elimination Program NTEP guidelines for confirming PTB If confirmed the trial investigator will providerefer participant to concerned department for the required treatment as per NTEP guidelines and will ensure safety follow-up till the end of the trial
2 In suspected EPTB the trial investigator will undertake the required investigations for confirming the diagnosis of EPTB as per NTEP guidelines If confirmed the trial investigator will providerefer participant to concerned department for the required treatment as per NTEP guidelines and will ensure safety followup till the end of the trial
3 If any subject is confirmed with any form of TB they will not be assessed for Immunogenicity further But safety will be followed up to 180days
4 If the participant is not diagnosed with TB PTB or EPTB as per NTEP guidelines heshe will be continued in to the trial and followed up till the end of the trial period
5 All the TB cases will be reviewed by the Adjudication committee
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BBILMTBVAC2023 | OTHER | Bharat Biotech International Limited | None |