Tuberculosis (TB): Practice Essentials, Background, Pathophysiology

TB Vaccine MTBVAC Gets CDSCO Nod For Phase II Trials

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The Central Drug Standard Control Organisation's (CDSCO) Subject Expert Committee (SEC) has approved Bharat Biotech International's proposal to conduct the phase II clinical trial of the Mycobacterium Tuberculosis (Live Attenuated) Vaccine to assess the safety and immunogenicity in healthy adolescent and adult populations.

According to a release issued by the Company, the MTBVAC is the first vaccine against TB derived from a human source to begin clinical trials in adults in India.

"Studying the safety, immunogenicity, and efficacy of MTBVAC in the most populated country in the world and the one with the highest number of cases of this infectious disease is key to continue advancing in this vaccine. Bharat Biotech International Limited in collaboration with Spanish biotechnology company Biofabri have started a series of clinical trials to evaluate the safety, immunogenicity, and efficacy of MTBVAC in India. MTBVAC is being developed for two purposes - as a more effective and potentially longer-lasting vaccine than BCG for newborn children, and for the prevention of TB in adults and adolescents, for whom there is currently no effective vaccine," the statement said.

It added that MTBVAC is the only vaccine against tuberculosis in clinical trials based on a genetically modified form of the pathogen isolated from humans Mycobacterium tuberculosis which, unlike BCG, contains all the antigens present in strains that infect humans.

This vaccine was developed in the laboratory of the University of Zaragoza, in collaboration with Dr. Brigitte Gicquel of the Pasteur Institute in Paris. The University of Zaragoza has the Spanish biotechnology company Biofabri as an industrial partner.

"The only vaccine in use today, BCG [Bacillus Calmette and Guérin], is an attenuated variant of the bovine TB pathogen. It is more than a hundred years old and has a very limited effect on pulmonary tuberculosis," the statement by the Company added.

Meanwhile, the most recent announcement by the SEC on the next stage of trial comes with the condition that the firm should revise the exclusion criteria and the expert panel also suggested performing Molecular-based RT-PCR (Real-Time Reverse Transcription – Polymerase Chain) tests instead of Sputum AFB (Acid-Fast Bacilli) smear tests for diagnosis of TB. The committee further added that DSMB (Data and Safety Monitoring Board) review should be performed after day 28 and day 56 follow up and the same should be submitted to CDSCO at the time of phase III clinical trial application.

At the recent SEC meeting for the vaccine held on April 30, 2024, the expert panel reviewed the phase I clinical trial report with 28 days of safety results along with the phase II clinical trial protocol titled "A phase II, randomised, double-blind trial to assess the Safety and Immunogenicity of MTBVAC (BBV169), with BCG vaccine as a comparator in Healthy adolescent and adult populations". 

Bharat Biotech International Gets CDSCO Panel Nod To Study Mycobacterium Tuberculosis Live Attenuated Vaccine

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved vaccine major Bharat Biotech International's proposal to conduct the Phase II clinical trial of Mycobacterium Tuberculosis (Live Attenuated) Vaccine to assess the safety and immunogenicity in healthy adolescent and adult populations.

This came after Bharat Biotech International presented a Phase I clinical trial report with 28 days of safety results along with Phase II clinical trial protocol titled "A Phase II, randomized, double-blind trial to assess the Safety and Immunogenicity of MTBVAC (BBV169), with BCG vaccine as a comparator in Healthy adolescent and adult populations".

However, this approval is subject to the condition that the firm should revise the Exclusion criteria by excluding HIV-positive subjects and Diabetic subjects from the study. In addition, the expert panel suggested performing Molecular-based RT-PCR (Real-Time Reverse Transcription – Polymerase Chain) tests instead of Sputum AFB (Acid- Fast Bacilli) smear tests for diagnosis of TB.

The committee further added that DSMB (Data and Safety Monitoring Board) review should be performed after the day 28 and day 56 follow up and the same should be submitted to CDSCO at the time of Phase III clinical trial application.

MTBVAC is a global public-private project that will be a milestone in the field of vaccinology and in the approach to this highly communicable disease global epidemic with high morbidity and mortality. MTBVAC is one of the most promising vaccine candidates in the current global TB vaccine pipeline. The only currently available TB vaccine, the Bacillus Calmette-Guérin vaccine (BCG), was developed 100 years ago and has limited efficacy in preventing pulmonary TB in adults, who, along with adolescents, are the biggest spreaders of the disease.

At the recent SEC meeting for the Vaccine held on 30th April 2024, the expert panel reviewed the Phase I clinical trial report with 28 days of safety results along with the Phase II clinical trial protocol titled "A Phase II, randomized, double-blind trial to assess the Safety and Immunogenicity of MTBVAC (BBV169), with BCG vaccine as a comparator in Healthy adolescent and adult populations".

The committee noted the Phase I Clinical trial report results with 28 days of safety results as per the approved protocol.

After detailed deliberation of the Phase II protocol, the committee recommended the grant of permission to conduct Phase II clinical trial as per protocol presented with the following conditions:

1) Exclusion criteria should be revised to mention clearly

(a) HIV-positive subjects will be excluded from the study.

(b) Diabetic subjects will be excluded.

2) Molecular-based RT-PCR test should be performed instead of Sputum AFB smear test for diagnosis of TB.

3) DSMB review should be performed after day 28 and day 56 follow up and the same should be submitted to CDSCO at the time of Phase III clinical trial application.

Accordingly, the expert panel stated that the revised Phase II protocol should be submitted to CDSCO for approval.

Also Read:Alkem Laboratories Gets CDSCO Panel Nod to Study Amoxicillin,Clavulanate Powder for reconstitution into suspension

High School Track & Field Results May 2-4

TEAM: Thunder Basin 160, Kelly Walsh 151, Natrona County 126, Buffalo 82, Gillette 45, Douglas 40.5, Tongue River 23, Big Horn 18.5, Moorcroft 9, Sheridan 9, Rapid City Christian 5

100: Madeline Thorne, KW, 12.47; Grace Miller, TB, 12.54; Cami Costello, NC, 12.89; Hannah Kurz, TB, 12.96.

200: Cami Costello, NC, 26.19; Chloe Crabtree, TB, 26.96; Kaitlyn Bradach, NC, 27.01; Makenna Lorenzen, KW, 27.09.

400: Ashley Gross, NC, 1:01.85; Brooklyn Brooks, KW, 1:03.92; Caroline Crago, Buf, 1:04.20; Sara Lester, NC, 1:04.55.

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800: Megan Doherty, TB, 2:23.95; Ally Wheeler, NC, 2:24.28; Carlee Roth, TB, 2:30.10; Kendra Jensen, Gil, 2:31.57.

1600: Ally Wheeler, NC, 5:24.03; Ashley Gross, NC, 5:28.06; Mallory Jones, TB, 5:40.45; Lexi Longhurst, KW, 5:50.73.

3200: Nicole Clark, NC, 11:51.78; Maya Hall, TB, 12:00.88; Megan Doherty, TB, 12:58.98; Syrei Johnson, TB, 13:24.80.

100 hurdles: Carly Norman, Buf, 14.93; Tristyn Buss, KW, 15.51; Jordan Kroeger, KW, 15.58; Natalie Neugebauer, Dou, 16.39.

300 hurdles: Tristyn Buss, KW, 47.33; London McCrea, Mor, 48.19; Jordan Kroeger, KW, 48.87; Faith Clem, Gil, 49.19.

4x100 relay: Thunder Basin (Hannah Kurz, Grace Miller, Liliana Shannon, Chloe Crabtree) 50.28; Kelly Walsh 50.71.

4x400 relay: Kelly Walsh (Makenna Lorenzen, Alyssa Langley, Madeline Thorne, Madyn Waring) 4:16.08; Thunder Basin 4:22.78.

4x800 relay: Natrona County (Nicole Clark, Ally Wheeler, Reese Ostrander, Ashley Gross) 9:59.01; Gillette 10:17.16.

1600 sprint medley: Thunder Basin (Hannah Kurz, Chloe Crabtree, Aleigh Carter, Carlee Roth) 4:30.82; Buffalo 4:49.19.

High jump: Skyleigh Smith, Dou, 4-11; Ashley Rogge, TB, 4-11; Kendal Allaire, KW, 4-11; Lillian Hudson, KW, 4-11.

Pole vault: Reese Dorr, Gil, 10-06; Saige Sheehan, Gil, 10-06; Delaney Gibson, Gil, 9-06; Erin Aune, NC, 9-00.

Long jump: Jordan Kroeger, KW, 16-11.25; Tess Rule, Buf, 16-08.5; Ashley Rogge, TB, 16-08.

Triple jump: Sophie Berglund, Buf, 34-08; Gabi Hall, Buf, 32-09; Caroline Crago, Buf, 32-08; Aleigh Carter, TB, 32-07.5.

Shot put: Teagan Becker, KW, 43-01; Jalyn Shepherd, TB, 39-06; Amara Caywood, She, 38-02.25; Emma Schubach, TB, 37-08.75.

Discus: Teagan Becker, KW, 126-06; Jalyn Shepherd, TB, 119-04; Grace Finkle, Buf, 117-04; Lillian Hudson, KW, 115-09.

TEAM: Kelly Walsh 150, Thunder Basin 141, Natrona County 130.5, Douglas 68, Gillette 67.5, Buffalo 36, Tongue River 32, Sheridan 17, Big Horn 10, Moorcroft 6, Rapid City Christian 5

100: Adam Gibson, Gil, 10.85; Bridger Norton, TB, 11.07; Logan Borden, NC, 11.22; Nomar Gonzalez, NC, 11.25; Aidan Dorr, Gil, 11.25.

200: Bradley Ekstrom, TB, 22.08; Caleb Ortberg, KW, 22.29; Eric Whitley, KW, 22.63; Landon Scalise, TB, 22.69.

400: Cameron Pilcher, TB, 51.37; Jackson Brooks, KW, 52.82; Carter Cox, NC, 52.94; Lawson Lutgen, TB, 53.38.

800: Zach Friese, Buf, 1:58.64; John-Paul Dammeyer, Dou, 1:58.72; Patrick Hardesty, TB, 2:00.13; Cole Rasmuson, Buf, 2:00.71.

1600: Micah Colling, KW, 4:44.68; Spencer Erickson, TB, 4:46.27; Bodey Kejr, Dou, 4:46.59; Isaia Cotes, TR, 4:48.29.

3200: Kalel Brubaker, NC, 9:53.80; David McDivitt, NC, 10:46.59; Caleb Crabtree, TB, 11:08.81; Thomas Walters, NC, 11:17.06.

110 hurdles: Caleb Ortberg, KW, 14.60; Jack Nicholls, KW, 15.24; Kaecen Paden, KW, 15.31; Caleb Kilbride, TR, 15.87.

300 hurdles: Seth Condelario, NC, 41.53; Jack Nicholls, KW, 41.96; Jack Bouzis, TB, 43.86; Brayden New, TB, 44.16.

4x100 relay: Natrona County (Cooper Cox, Nomar Gonzalez, Bridger Anderson, Carson Lundberg) 43.32; Thunder Basin 43.82.

4x400 relay: Thunder Basin (Nolan Hottell, Bridger Norton, Bradley Ekstrom, Zander Kumm) 3:28.32; Natrona County 3:32.52.

4x800 relay: Kelly Walsh (Micah Colling, Fisk Johansson, Luke Pearson, Everett Roberson) 8:37.39; Natrona County 8:46.17.

1600 sprint medley: Big Horn (Conner Horsley, Paul Lobdell, Dane Brown, Jacob Sage) 3:56.04; Kelly Walsh 4:03.65.

High jump: Trennan Pearson, Dou, 6-00; Caleb Kilbride, TR, 5-10; Nolan Hottell, TB, 5-10; Eric Whitley, KW, 5-10.

Pole vault: Kavin Hoff, NC, 14-06; Jace Dees, KW, 12-06; Reece Doner, KW, 12-00; Carson Shear, TB, 11-06.

Long jump: Adam Gibson, Gil, 21-04.25; Josiah Coleman, NC, 21-03.25; Zaven Thomas, NC, 20-11; Gracin Peak, TB, 20-02.25.

Triple jump: Caleb Kilbride, TR, 43-08.5; Gage Brooks, NC, 43-00; Nolan Hottell, TB, 42-01; Frederick Bothe, KW, 42-01.

Shot put: Tegen Seeds, Dou, 56-04.75; Raynor Ranum, Gil, 56-00.75; Carter Archuleta, Dou, 51-10.5; Braydn Ballard, Gil, 50-05.25.

Discus: Alex Haswell, She, 162-02; Tegen Seeds, Dou, 149-04; Raynor Ranum, Gil, 145-07; Carter Archuleta, Dou, 145-04.

TEAM: Worland 165, Powell 135, Kemmerer 74, Big Piney 53, Thermopolis 47, Rawlins 45, Lovell 43, Burlington 29.5, Pinedale 26, Saratoga 17, Riverside 15, Rocky Mountain 12.5, Dubois 11, Glenrock 8, Snake River 7, Greybull 6, Wind River 3, Farson 2

TEAM: Lovell 109, Worland 101.5, Thermopolis 101, Powell 91, Rawlins 79, Burlington 59, Kemmerer 29, Dubois 26, Glenrock 24, Ten Sleep 18, Big Piney 16, Snake River 15, Pinedale 12, Saratoga 11, Meeteetse 3, Riverside 2.5, Arapahoe Charter 2, Wind River 2, Fort Washakie 1

TEAM: Laramie 180, Cheyenne Central 128, Torrington 106, Cheyenne East 103, Wheatland 51, Encampment 23, Cheyenne South 21, Lusk 8, Southeast 3, Guernsey 1

TEAM: Cheyenne Central 177, Laramie 170, Cheyenne East 111, Wheatland 65, Torrington 55, Encampment 41, Cheyenne South 25, Guernsey 15, Lusk 1, Prairie View 1

TEAM: Lander 209.5, Rock Springs 127, Kemmerer 112, Riverton 50, Saratoga 32.5, Wyoming Indian 27, Dubois 22, St. Stephens 14, Wind River 10.5, Shoshoni 9, Farson 6, Western Heritage Lutheran Academy 2

TEAM: Rock Springs 242, Riverton 122.5, Lander 105.5, Dubois 57, Kemmerer 45, Saratoga 36, Wyoming Indian 28, Wind River 12, Cody 6, Shoshoni 6, Western Heritage Lutheran Academy 2, Arapahoe Charter 1

TEAM: Lingle-Fort Laramie 147, Burns 112.5, Southeast 105, Lusk 101, Pine Bluffs 70.5

TEAM: Lingle-Fort Laramie 157, Burns 151.5, Pine Bluffs 106, Lusk 103.5, Southeast 27

Follow sports editor Jack Nowlin on Twitter @wyovarsity

Follow sports editor Jack Nowlin on Twitter @wyovarsity

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