Drugs / BCG vaccine
BCG vaccine
Trials 31
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT07182838 | Oct 2026 → Jun 2027 expected | HIV infectious disease | Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair | Active not recruiting | No outcome recorded |
| 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 14 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 | 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| Phase 2 | NCT03582085 | Jan 2026 → Jan 2027 | fibromyalgia | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04659941 | Oct 2020 → Oct 2022 | — | Federal University of Rio de Janeiro | Unknown | No outcome recorded |
| Phase 2 | NCT00003386 | Jul 1999 → Apr 2001 | ovarian carcinoma | Gynecologic Oncology Group | Terminated | No outcome recorded |
| Phase 2 | NCT00004122 | Jul 1999 → Apr 2001 | urinary bladder cancer | Roswell Park Cancer Institute | Completed | 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2/3 | NCT04938323 | May → Jul 2022 | respiratory tract infectious disorder | Harvard Medical School (HMS and HSDM) | Withdrawn | No outcome recorded |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 · 2 missed | ||||||
| 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| Phase 3 | NCT04534803 | Sep 2021 → May 2022 | COVID-19 | Harvard Medical School (HMS and HSDM) | Withdrawn | No outcome recorded |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 | Missed primary |
| 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 | Missed primary |
| Phase 3 | NCT00002490 | Sep 1991 → ? | urinary bladder cancer | Medical Research Council | Completed | No outcome recorded |
| Phase 48 trials · 2 missed | ||||||
| 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 | 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 | Missed primary |
| 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 | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT03548233 | May → Dec 2021 | — | Assiut University | Unknown | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 1/2 | NCT00007826 Background | Apr 2000 → ? | colorectal cancer | Onyvax | Unknown | No outcome recorded |
| Phase 2 | NCT06187506 Background | Dec 2023 → Sep 2026 overdue | 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 Stop: Enrollment |
| Phase 2/3 | NCT02085590 Comparator | Mar → Oct 2014 | infectious disease with sepsis | Radboud University Medical Center | 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 Stop: Enrollment |
| — | NCT02444611 Comparator | Mar 2015 → Jun 2016 | — | Murdoch Childrens Research Institute | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-05-19 | ImmunityBio, Inc. | Regulatory ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA® Plus BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Papillary Disease; PDUFA Date Set for January 6, 2027 immunitybio.com ↗ |
| 2025-04-26 | Pfizer | Results Pfizer’s Sasanlimab Combination Significantly Improves Event-Free Survival in BCG-Naïve, High-Risk Non-Muscle Invasive Bladder Cancer pfizer.com ↗ |
| 2025-01-10 | Pfizer | Results Pfizer’s Sasanlimab in Combination with BCG Improves Event-Free Survival in Patients with BCG-Naïve, High-Risk Non-Muscle Invasive Bladder Cancer pfizer.com ↗
The study met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance). |
All press releases naming this drug 4 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 44 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BCG vaccine | “BCG vaccine is given at or shortly after birth in many developing countries to prevent tuberculosis.” NCT00131794 ↗36“The BCG vaccine is administered to protect against tuberculosis” PMID 27443836 ↗ Jul 2016 |
| Known as | Bacille Calmette-Guérin | “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 20201“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 ↗ |
| 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 ↗2“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 |
| 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) vaccine” PMID 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 ↗7“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 “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) vaccination compared to placebo” NCT04534803 ↗ “vaccine - Bacille Calmette-Guérin vaccine (BCG )” NCT05330884 ↗ “The Bacillus Calmette-Guérin (BCG) vaccine” PMID 27060379 ↗ Apr 2016 |
| 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 ↗1“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 |
| 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 ↗ |
| Action | Activate | “BCG use different ways to stimulate the immune system” NCT00004122 ↗ |
| Modality | Vaccine | “BCG vaccine” NCT00002490 ↗ |
| Route | Other | “BCG intradermally” NCT00003279 ↗ |