Drugs / BCG vaccine
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BCG vaccine

Vaccine

Developed for
COVID-19 · urinary bladder cancer · tuberculosis · Alzheimer disease · bladder transitional cell carcinoma · breast cancer · fibromyalgia · human papilloma virus infection
+10 more · malaria · ovarian carcinoma · rectal cancer · respiratory system disorder · respiratory tract infectious disorder · small cell lung carcinoma · transitional cell carcinoma · type 2 diabetes mellitus · HIV infectious disease · infectious disease with sepsis
Investigated by
Bandim Health Project · Radboud University Medical Center · University of Southern Denmark · National Cancer Institute (NCI) · All India Institute of Medical Sciences · Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
+58 more · Harvard Medical School (HMS and HSDM) · Tuberculosis Research Centre, India · UnitedHealthcare · All India Institute of Medical Sciences, Bhubaneswar · Anchiano Therapeutics Israel Ltd. · Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Anthra Pharmaceuticals · Assiut University · Bill and Melinda Gates Foundation · Centenary Institute · Chang-Hua Hospital · Danish National Research Foundation · European Organisation for Research and Treatment of Cancer - EORTC · Federal University of Rio de Janeiro · Flinders University · Government Vellore Medical College, Vellore · Gynecologic Oncology Group · Hebrew University of Jerusalem · Hellenic Institute for the Study of Sepsis · Hospital Nacional Simao Mendes, Bissau · Hospital Universitario Dr. Jose E. Gonzalez · Hvidovre University Hospital · ICMR-National Institute for Research in Tuberculosis, Chennai, Tamil Nadu · Institute of Child Health, Chennai · King Edward Memorial Hospital · Kolding Sygehus · London School of Hygiene and Tropical Medicine · Lone Graff Stensballe · Ludwig Institute for Cancer Research · Madurai Medical College · Massachusetts General Hospital · Medical Research Council · Ministry of Science and Technology, Brazil · Murdoch Childrens Research Institute · National Cancer Institute (NCI) · National Institute for Implementation Research on Non-Communicable Disease · National Institute for Research in Environmental Health, Bhopal, Madhya Pradesh · National Institute of Occupational Health, Ahmedabad, Gujarat · National Institute of Tuberculosis and Respiratory Diseases, New Delhi · Rajendra Institute of Medical Sciences, Ranchi · Rajiv Gandhi Hospital, Chennai · Research Center for Vitamins and Vaccines (CVIVA) · Roswell Park Cancer Institute · Royal Adelaide Hospital · Royal Children's Hospital · South Australian Health and Medical Research Institute · Statens Serum Institut · Steno Diabetes Center Copenhagen · Sydvestjysk Sygehus · Tamir Ben-Hur · Telethon Kids Institute · Texas Medical Research Associates, L.L.C. · The Grant Medical College & Sir J.J. Group of Hospitals · The University of Western Australia · UMC Utrecht · University of Coimbra · University of Sydney · Université Libre de Bruxelles

Trials 32 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT06959563 Apr 2025 → Oct 2026 expected human papilloma virus infection Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair Active not recruiting No outcome recorded
Phase 0 NCT06078891 Jul 2023 → Dec 2025 overdue Alzheimer disease Tamir Ben-Hur Enrolling by invitation No outcome recorded
Phase 15 trials
Phase 1 NCT02403505 Dec 2021 → Nov 2026 expected rectal cancer Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair Active not recruiting No outcome recorded
Phase 1 NCT04563273 Oct 2020 → Oct 2022 tuberculosis Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. Completed No outcome recorded
Phase 1 NCT01878188 Feb 2013 → Oct 2015 bladder transitional cell carcinoma Anchiano Therapeutics Israel Ltd. Completed No outcome recorded
Phase 1 NCT00070070 Oct 2003 → Jan 2006 transitional cell carcinoma Ludwig Institute for Cancer Research Completed No outcome recorded
Phase 1 NCT00003184 Aug 1996 → Jul 2003 breast cancer National Cancer Institute (NCI) Completed No outcome recorded
Phase 25 trials
Phase 2 NCT03582085 Jan 2026 → Jan 2027 fibromyalgia Massachusetts General Hospital Withdrawn No outcome recorded
Phase 2 NCT04659941 Oct 2020 → Oct 2022 Federal University of Rio de Janeiro Unknown No outcome recorded
Phase 2 NCT00004122 Jul 1999 → Apr 2001 urinary bladder cancer Roswell Park Cancer Institute Completed No outcome recorded
Phase 2 NCT00003386 Jul 1999 → Apr 2001 ovarian carcinoma Gynecologic Oncology Group Terminated No outcome recorded
Phase 2 NCT00003759 Nov 1998 → Nov 2002 urinary bladder cancer Anthra Pharmaceuticals Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04938323 May → Jul 2022 respiratory tract infectious disorder Harvard Medical School (HMS and HSDM) Withdrawn No outcome recorded
Phase 39 trials
Phase 3 NCT05330884 Jul 2024 → Jun 2027 tuberculosis Tuberculosis Research Centre, India Suspended No outcome recorded
Phase 3 NCT04534803 Sep 2021 → May 2022 COVID-19 Harvard Medical School (HMS and HSDM) Withdrawn No outcome recorded
Phase 3 NCT04461379 Jul 2020 → Jan 2021 COVID-19 Hospital Universitario Dr. Jose E. Gonzalez Unknown No outcome recorded
Phase 3 NCT04475302 Jul 2020 → Sep 2021 COVID-19 Tuberculosis Research Centre, India Completed No outcome recorded
Phase 3 NCT04327206 Mar 2020 → Nov 2021 COVID-19, respiratory system disorder Murdoch Childrens Research Institute Completed No outcome recorded
Phase 3 NCT04328441 Mar 2020 → Mar 2021 COVID-19 UMC Utrecht Completed No outcome recorded
Phase 3 NCT00131794 Jan → Dec 2003 malaria London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 3 NCT00003279 Mar 1998 → Jan 2000 small cell lung carcinoma European Organisation for Research and Treatment of Cancer - EORTC Completed No outcome recorded
Phase 3 NCT00002490 Sep 1991 → ? urinary bladder cancer Medical Research Council Completed No outcome recorded
Phase 49 trials
Phase 4 NCT07005726 May 2025 → May 2030 expected Bandim Health Project Enrolling by invitation No outcome recorded
Phase 4 NCT05591339 Dec 2023 → Aug 2027 expected type 2 diabetes mellitus Bandim Health Project Active not recruiting No outcome recorded
Phase 4 NCT06148025 Nov 2023 → Oct 2027 expected South Australian Health and Medical Research Institute Recruiting No outcome recorded
Phase 4 NCT05397678 Oct 2022 → Jul 2024 Bandim Health Project Unknown No outcome recorded
Phase 4 NCT04899765 May 2021 → Dec 2025 overdue measles Bandim Health Project Recruiting No outcome recorded
Phase 4 NCT04414267 May 2020 → Apr 2021 COVID-19, chronic obstructive pulmonary disease, coronary artery disorder Hellenic Institute for the Study of Sepsis Completed No outcome recorded
Phase 4 NCT04417335 Apr 2020 → May 2021 COVID-19 Radboud University Medical Center Unknown No outcome recorded
Phase 4 NCT02771782 Jan 2015 → Jul 2016 pertussis Radboud University Medical Center Unknown No outcome recorded
Phase 4 NCT01694108 Sep 2012 → Jan 2015 Lone Graff Stensballe Completed No outcome recorded
Phase not applicable1 trial
NCT03548233 May → Dec 2021 Assiut University Unknown No outcome recorded
Also used as a comparator or background therapy in 11 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT00007826 Background Apr 2000 → ? colorectal cancer Onyvax Unknown No outcome recorded
Phase 23 trials
Phase 2 NCT06187506 Background Dec 2023 → Sep 2026 expected urinary bladder cancer Fudan University Active not recruiting No outcome recorded
Phase 2 NCT05004038 Comparator Jan 2022 → Sep 2023 HIV infectious disease University of Zurich Completed No outcome recorded
Phase 2 NCT00003715 Background Dec 1998 → ? cutaneous melanoma AVAX Technologies Terminated No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT02085590 Comparator Mar → Oct 2014 infectious disease with sepsis Radboud University Medical Center Completed No outcome recorded
Phase 34 trials
Phase 3 NCT04542330 Comparator Sep 2020 → Jan 2023 COVID-19 Bandim Health Project Completed No outcome recorded
Phase 3 NCT04373291 Comparator May 2020 → Jul 2021 COVID-19 Bandim Health Project Completed No outcome recorded
Phase 3 NCT04350931 Comparator Apr → Oct 2020 COVID-19 Ain Shams University Unknown No outcome recorded
Phase 3 NCT00352079 Comparator Jan 2007 → Jan 2012 bladder transitional cell carcinoma NCIC Clinical Trials Group Terminated No outcome recorded
Phase 41 trial
Phase 4 NCT04641858 Comparator Dec 2020 → Jul 2022 COVID-19 University of Southern Denmark Completed No outcome recorded
Phase not applicable1 trial
NCT02444611 Comparator Mar 2015 → Jun 2016 Murdoch Childrens Research Institute Completed No outcome recorded

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 49 sources stand behind the page.

FieldValueCited text
Known as BCG vaccine “Participants that are randomized in the active arm will receive an adult 0.1 ml dose of BCG vaccine (BCG-Denmark, AJ Vaccines) in the skin covering the right upper deltoid muscle.” NCT04641858
36

BCG vaccine is given at or shortly after birth in many developing countries to prevent tuberculosis.” NCT00131794

“The BCG vaccine is administered to protect against tuberculosis” PMID 27443836 Jul 2016

NCT04327206

NCT00352079

NCT03548233

NCT04938323

NCT04563273

NCT06148025

NCT00003386

NCT06078891

NCT04414267

NCT04659941

NCT02771782

NCT05330884

NCT04350931

NCT00003715

NCT00004122

NCT01878188

NCT04417335

NCT02403505

NCT02444611

NCT00003759

NCT00007826

NCT06959563

NCT00003184

NCT02085590

NCT04461379

NCT04899765

NCT04534803

NCT04475302

NCT05591339

NCT04328441

NCT00002490

NCT05004038

NCT00003279

NCT07005726

Known as Bacille Calmette Guerin “Certain vaccines, such as Bacille Calmette-Guérin (BCG), have nonspecific effects, which modulate innate immune responses and lead to protection against mortality from...” PMID 30919883 Jan 2020
3

“Biological therapies, such as Bacille Calmette Guerin (BCG) and sargramostim (GM-CSF), use different ways to stimulate the immune system and stop tumor cells from growing.” NCT00070070

“Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis” NCT04373291

“Bacille Calmette-Guérin (BCG) vaccination compared to placebo” NCT04534803

Known as Bacille Calmette-Guérin vaccine “vaccine - Bacille Calmette-Guérin vaccine (BCG )” NCT05330884
Known as Bacillus Calmette Guerin Vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT03582085
1

NCT06187506

Known as Bacillus Calmette-Guérin Bacillus Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but has also been shown to induce protection against various infections with a viral aetiology,...” NCT04417335
4

“Rationale: The Bacillus Calmette-Guerin (BCG) vaccine not only protects against Mycobacterium tuberculosis, but has also been shown to reduce morbidity and mortality caused by...” NCT02771782

“OBJECTIVES: Evatuate if Bacillus Calmette-Guérin (BCG) vaccine could be used as a tool against SARS-CoV-2 based on the concept of trained immunity.” PMID 36841502 Feb 2023

“The live-attenuated vaccines Bacillus Calmette-Guérin (BCG) and Vaccinia have been associated with beneficial non-specific effects.” PMID 38378387 Feb 2024

“attenuated Mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331” NCT04641858

Known as Bacillus Calmette-Guérin (BCG) “A Phase IIA Randomized Double-blind Placebo-controlled Single-centre Study of the Effect of Bacillus Calmette-Guérin (BCG) Vaccination on the HIV Latent Reservoir” NCT05004038
Known as Bacillus Calmette-Guérin (BCG) vaccine “The Bacillus Calmette-Guérin (BCG) vaccinePMID 27060379 Apr 2016
Known as BCG “Bacillus Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but has also been shown to induce protection against various infections with a viral aetiology,...” NCT04417335
9

“Rationale: The Bacillus Calmette-Guerin (BCG) vaccine not only protects against Mycobacterium tuberculosis, but has also been shown to reduce morbidity and mortality caused by...” NCT02771782

“Participants that are randomized in the active arm will receive an adult 0.1 ml dose of BCG vaccine (BCG-Denmark, AJ Vaccines) in the skin covering the right upper deltoid muscle.” NCT04641858

“OBJECTIVES: Evatuate if Bacillus Calmette-Guérin (BCG) vaccine could be used as a tool against SARS-CoV-2 based on the concept of trained immunity.” PMID 36841502 Feb 2023

“Arm II: Patients receive adjuvant monoclonal antibody BEC2 and BCG intradermally on day 1 of weeks 0, 2, 4, 6, and 10.” NCT00003279

“Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis” NCT04373291

“Bacille Calmette-Guérin (BCG) vaccination compared to placebo” NCT04534803

“vaccine - Bacille Calmette-Guérin vaccine (BCG )” NCT05330884

“The Bacillus Calmette-Guérin (BCG) vaccine” PMID 27060379 Apr 2016

NCT00131794

Known as BCG 1331 SSI “randomizing 4262 infants to either BCG vaccination (BCG 1331 SSI) or no intervention.” PMID 28774269 Aug 2017
Known as BCG vaccine (Freeze-dried) BCG vaccine (Freeze-dried) manufactured by Serum Institute of India, Pune.” NCT04475302
Known as BCG-Denmark “Participants that are randomized in the active arm will receive an adult 0.1 ml dose of BCG vaccine (e.g. BCG-Denmark or BCG-Japan) in the skin covering the left upper deltoid muscle.” NCT05591339
5

“receive a single 0.1 mL intradermal dose of BCG-Denmark (BCG group, n = 1999) or saline (placebo group, n = 1989).” PMID 39127450 Aug 2024

NCT05397678

NCT04641858

NCT04542330

NCT04373291

Known as BCG-Japan “Participants that are randomized in the active arm will receive an adult 0.1 ml dose of BCG vaccine (e.g. BCG-Denmark or BCG-Japan) in the skin covering the left upper deltoid muscle.” NCT05591339
Known as Copenhagen “In Egypt, the available BCG vaccine is the Copenhagen (Danish strain).” NCT04350931
Known as Mycobacterium bovis BCG “attenuated Mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331” NCT04641858
Known as TICE-strain BCG ClinicalTrials.gov intervention name — accepted as the source's own label NCT00070070
Action Activate “BCG use different ways to stimulate the immune system” NCT00004122
Modality Vaccine “BCG vaccineNCT00002490
Route Other “BCG intradermally” NCT00003279