Side Effects of bacillus calmette-guerin (bcg) vaccine: A Synthesis of Findings from 26 Studies

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Original Abstract of the Article

Main research findings

The BCG vaccine is the only way to prevent tuberculosis, a fatal infectious disease. Although the BCG vaccine is effective, especially against infant meningitis, it has some limitations due to a variety of adverse effects. 11 surveyed all studies that have been published about adverse effects of the 1173 P2 strain of BCG vaccine in Iran, which is used for BCG vaccination in Iran. These studies used different standardization and sampling methods. This review showed that the side effects of BCG vaccine were diverse.

Intravesical BCG therapy has proved to be effective in the treatment of superficial bladder tumors. However, it can cause various side effects, such as local infections and disseminated BCG infection. 3 reported a case of granulomatous hepatitis revealing a Mycobacterium bovis widespread infection after intravesical BCG therapy. In addition, 25 described a case of Reiter’s syndrome postintravesical Bacillus Calmette-Guérin instillations. These studies showed that BCG therapy has the potential to cause a wide range of serious side effects.

Reasons for side effects

The BCG vaccine is made with a weakened strain of the tuberculosis bacteria. Although weakened, the bacteria are still alive. Once they are injected, they start to activate the immune system, which can cause various side effects.

BCG therapy, used for bladder cancer, is an immunotherapy that involves injecting BCG directly into the bladder to induce an immune response against cancer cells. This method can trigger inflammatory reactions and infections in the bladder, leading to potential side effects.

Common side effects

Fever

Fever is a common side effect of the BCG vaccine. 24 reported fever as a side effect of the BCG vaccine. It occurs because BCG activates the immune system and triggers inflammatory reactions in the body.

Rash

Rash is a possible side effect of the BCG vaccine. 24 reported rash as a side effect of the BCG vaccine. It can occur due to an allergic reaction to the BCG.

Swollen lymph nodes

Swollen lymph nodes are a common side effect of the BCG vaccine. 24 reported swollen lymph nodes as a side effect of the BCG vaccine. It is caused by the immune response to the BCG and is usually temporary.

Cystitis

Cystitis, or inflammation of the bladder, is a common side effect of BCG therapy. reviewed the available options for preventing and treating cystitis related to BCG therapy. This side effect occurs because BCG acts directly on the bladder and triggers inflammatory reactions. 10 also reported cystitis as a side effect of BCG therapy.

Fever, chills, fatigue

Fever, chills, and fatigue are common systemic side effects of BCG therapy. 25 reported fever and fatigue as side effects of BCG therapy. These symptoms are believed to be caused by the activation of the immune system by BCG. 22 reported other symptoms like fever, chills, and fatigue as side effects of BCG therapy.

Others

There are other, less common side effects of the BCG vaccine and BCG therapy. 14 reported a case of cerebellar abscess after BCG therapy. 19 reported a case of disseminated BCG infection after BCG vaccination. These rare but serious side effects show that BCG vaccine and BCG therapy can have serious complications.

Countermeasures for side effects

Fever

If you experience fever after receiving the BCG vaccine or BCG therapy, you should seek appropriate treatment such as antipyretics. It is also essential to stay hydrated and rest.

Rash

If you experience a rash after receiving the BCG vaccine, you should seek appropriate treatment, such as antihistamines. Avoid scratching the rash and keep the area clean.

Swollen lymph nodes

Swollen lymph nodes are usually temporary and do not require treatment. However, if the swelling is severe or painful, you should consult a doctor.

Cystitis

Cystitis caused by BCG therapy requires treatment with antibiotics. It is also important to stay hydrated and avoid anything that irritates the bladder.

Comparison between studies

Commonalities in studies

Most studies show that the BCG vaccine and BCG therapy can cause various side effects. Moreover, these side effects can vary greatly from person to person. This underscores the importance of discussing the risks of side effects with your doctor before receiving the BCG vaccine or BCG therapy.

Differences in studies

The frequency and severity of side effects from BCG vaccine and BCG therapy can vary across different studies. This is likely due to differences in the populations studied, the BCG strain used, and other factors. It is essential to consider multiple study results comprehensively rather than relying on individual study results.

Points to note regarding application in real life

The BCG vaccine is an effective preventive measure against tuberculosis. However, you should understand the potential risks of side effects. Before getting the BCG vaccine, discuss the risks and benefits with your doctor and make an informed decision.

BCG therapy is a proven treatment for bladder cancer, but it carries the risk of serious side effects. Before starting BCG therapy, talk to your doctor to understand the risks and only proceed with treatment after making an informed decision. If you experience any unusual symptoms during treatment, consult your doctor immediately.

Current limitations of research

Research on the side effects of the BCG vaccine and BCG therapy is still incomplete. More research is needed, especially on the long-term effects of BCG therapy and rare side effects.

Directions for future research needed

To better understand the side effects of the BCG vaccine and BCG therapy, further research is essential. The following areas of research are crucial:

  • Research on the side effects of different BCG strains
  • Research on the long-term impact of side effects from BCG therapy
  • Research on the mechanisms behind the occurrence of side effects from BCG therapy
  • Research on methods to prevent side effects from BCG therapy

Conclusion

The BCG vaccine and BCG therapy are effective preventive and therapeutic measures, but they can cause side effects. It is crucial to understand the risks of side effects and choose appropriate preventive measures and treatment methods. Consult your doctor if you have any questions or concerns.

Literature analysis of 26 papers
Positive Content
17
Neutral Content
4
Negative Content
5
Article Type
3
1
3
5
24
1.

Safety and Efficacy of Intravesical Bacillus Calmette-Guérin Immunotherapy in Patients with Non-Muscle-Invasive Bladder Cancer Presenting with Asymptomatic Bacteriuria: A Systematic Review.

Author: PoletajewSławomir, ZapałaPiotr, RadziszewskiPiotr

Safe BCG immunotherapy

This systematic review examines the safety and efficacy of intravesical Bacillus Calmette-Guérin (BCG) immunotherapy in bladder cancer patients with asymptomatic bacteriuria (ABU). The findings suggest that BCG instillations in patients with ABU do not increase the risk of symptomatic urinary tract infections and do not negatively impact recurrence-free or progression-free survival. The review concludes that routine urine analysis before BCG instillation is not necessary.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

2.

A systematic review of preventive and therapeutic options for symptoms of cystitis in patients with bladder cancer receiving intravesical bacillus Calmette-Guérin immunotherapy.

Author: PoletajewSławomir, KrajewskiWojciech, AdamowiczJan, RadziszewskiPiotr

BCG immunotherapy
BCG side effects
Cystitis

BCG intravesical instillations for bladder cancer can cause cystitis. This review explored options for prevention and treatment, including BCG dose reduction, hyaluronic acid instillations, and oral antibiotics. However, more research is needed to determine their effectiveness and safety.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

3.

[Granulomatous hepatitis revealing a Mycobacterium bovis widespread infection following intravesical BCG therapy].

Author: RaffrayL, RivièreP, BonnetH, DuffauP, Longy-BoursierM

Superficial bladder tumor treatment
Disseminated BCG infection
Local infections

Intravesical therapy with bacillus Calmette-Guérin (BCG) has proved to be effective in the treatment of superficial bladder tumors. Side-effects include local infections and rarely disseminated BCG infection with multiple end organ complications.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : French

6.

Killed but metabolically active Mycobacterium bovis bacillus Calmette-Guérin retains the antitumor ability of live bacillus Calmette-Guérin.

Author: Secanella-FandosSilvia, Noguera-OrtegaEstela, OlivaresFrancesc, LuquinMarina, JuliánEsther

Safer alternative to live BCG

This study explores the potential of using killed but metabolically active bacillus Calmette-Guérin (BCG) as a safer alternative to live BCG for treating high-risk bladder cancer.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Reduction of Bladder Volume after BCG Immunotherapy.

Author: YangChangzhao, LvZhengtong, LiYuan

Bladder volume restoration
Reduced bladder volume

This case report describes a patient experiencing significantly reduced bladder volume after BCG instillation for bladder cancer treatment. The patient was suspected of having a tuberculosis infection, and after a 3-month antitubercular therapy, bladder volume returned to normal. This suggests that antitubercular therapy may be effective in treating bladder volume reduction caused by BCG instillation.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Rare osteoarticular complications on [18F]FDG-PET/CT - following intravesical BCG immunotherapy for bladder cancer.

Author: SchierzJan-Henning, McLeodAnke, AliFarzana

Osteoarticular complications

This case report describes a 55-year-old male with high-risk non-muscle-invasive bladder cancer (NMIBC) who developed reactive arthritis (ReA) as a rare complication of Bacillus Calmette-Guérin (BCG) immunotherapy.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

Bacillus Calmette-Guérin strain differences have an impact on clinical outcome in bladder cancer immunotherapy.

Author: RentschCyrill A, BirkhäuserFrédéric D, BiotClaire, GsponerJoël R, BisiauxAurélie, WetterauerChristian, LagranderieMicheline, MarchalGilles, OrgeurMickael, BouchierChristiane, BachmannAlexander, IngersollMolly A, BroschRoland, AlbertMatthew L, ThalmannGeorge N

NMIBC recurrence prevention
BCG therapy-related side effects

Treatment with BCG Connaught conferred significantly greater 5-yr recurrence-free survival compared with treatment with BCG Tice. BCG Connaught induced stronger T-helper cell 1-biased responses, greater priming of BCG-specific CD8(+) T cells, and more robust T-cell recruitment to the bladder than BCG Tice.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

[Bacillus Calmette-Guerin maintenance treatment in non-invasive bladder tumors: 1 year follow-up results of multicenter URO-BCG-4 trial].

Author: GalliotI, Le GallS, RigaudJ, SaintF, ColombelM, GuyL, WallerandH, FantoniJ C, StaermanF, IraniJ, SoulieM, PfisterC,

Improved NMIBC management

Intravesical BCG instillations are the standard treatment for intermediate and high-risk non-muscle invasive bladder cancer. Maintenance therapy is recommended but often discontinued due to side effects. This study evaluated a new maintenance schedule with reduced BCG dose and fewer instillations per cycle.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : French

11.

Adverse effects of BCG vaccine 1173 P2 in Iran: A meta-analysis.

Author: MostaanSaied, YazdanpanahBahador, MoukhahRasool, HozouriHamid Reza, RostamiManouchehr, KhorashadizadehMohsen, ZerehsazJavad, MahabadiRamin Pirhajati, SaadiArya, KhanahmadHossein, PooyaMohammad

Tuberculosis prevention
Adverse effects

This review summarizes studies on the adverse effects of the 1173 P2 strain of the Bacillus Calmette-Guerin (BCG) vaccine in Iran. These studies have used different standardization and sampling methods, which makes it difficult to draw definitive conclusions about the side effects of this vaccine.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

12.

Miliary pulmonary infection after BCG intravesical instillation: a rare, misdiagnosed and mistreated complication.

Author: CallerisGiorgio, MarraGiancarlo, CorcioneSilvia, OderdaMarco, CardellinoChiara, AudagnottoSabrina, FreaBruno, De RosaFrancesco Giuseppe, GonteroPaolo

bladder cancer treatment
BCG infection

This case report describes a patient who developed miliary pulmonary Bacillus Calmette-Guérin (BCG) infection after receiving intravesical BCG immunotherapy for non-muscle-invasive bladder cancer. The authors emphasize the importance of considering BCG infection in the differential diagnosis of pulmonary symptoms in patients receiving BCG therapy.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

14.

Mycobacterium bovis Cerebellar Abscess Following Treatment With Bacillus Calmette-Guérin.

Author: SheronMollie W, HoltShannon L, IngramChristopher W

Successful treatment
CNS infections

This case report describes a 74-year-old man who developed a Mycobacterium bovis cerebellar abscess after receiving intravesical Bacillus Calmette-Guérin (BCG) therapy for bladder cancer. The case emphasizes the potential for rare and serious systemic complications, including central nervous system infections, associated with BCG therapy.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

15.

Determining optimal maintenance schedules for adjuvant intravesical bacillus Calmette-Guerin immunotherapy in non-muscle-invasive bladder cancer: a systematic review and network meta-analysis.

Author: HuangZixiong, LiuHuixin, WangYizeng, ZhangChunfang, XuTao

Reduced tumor progression
Reduced tumor recurrence
Cystitis
Fever
Hematuria
Malaise

Longer BCG maintenance therapy (such as 3 years) was not superior to shorter maintenance therapy (such as 1 year) in patients with non-muscle-invasive bladder cancer (NMIBC). But maintenance therapy overall is better than induction-only BCG therapy while not increasing side effects. The study suggests the common use of 1 year intravesical BCG instillation for NMIBC patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

16.

Role of immunotherapy in bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer.

Author: MukherjeeNeelam, SvatekRobert S, MansourAhmed M

BCG intolerance
BCG-failures

This review discusses the use of immune checkpoint inhibitors in patients with non-muscle-invasive bladder cancer (NMIBC) who have failed bacillus Calmette-Guérin (BCG) therapy. While the potential of these inhibitors is promising, further research is needed to determine their efficacy in this setting.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

18.

Successful treatment of a mycotic multifocal thoracoabdominal aortic aneurysm as a late sequelae of intravesical bacillus Calmette-Guerin therapy: case report and literature review.

Author: DavisFrank M, MillerDavid J, NewtonDuane, AryaShipra, EscobarGuillermo A

Vascular infection

This study reports the first successful repair of a symptomatic, multifocal thoracoabdominal aortic aneurysm secondary to Mycobacterium bovis manifesting 17 months after intravesical BCG therapy.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

19.

[A case diagnosed with chronic granulomatous disease after disseminated infection following BCG vaccination].

Author: DelibaltaGüler, SeringeçMurat, ÖncülOral

Protection against TB
Disseminated BCG infection

A 3-month-old infant with unknown chronic granulomatous disease developed disseminated BCG infection after receiving the BCG vaccine, highlighting the importance of evaluating newborns with a family history of CGD before vaccination.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Turkish

22.

Myths and mysteries surrounding bacillus Calmette-Guérin therapy for bladder cancer.

Author: KamatAshish M, PortenSima

Reduced death
Reduced progression
Reduced recurrence
Side effects

This study discusses the proven effects of intravesical therapy with bacillus Calmette-Guérin (BCG) for reducing recurrence, progression, and death from non-muscle-invasive bladder cancer.

EditorialAn article in which the editor or publisher expresses their opinion or perspective on a particular topic or issue. Its purpose is to convey a specific message or idea to the reader.

Language : English

23.

Final results of the phase III URO-BCG 4 multicenter study: efficacy and tolerance of one-third dose BCG maintenance in nonmuscle invasive bladder cancer.

Author: NouhaudFrançois X, RigaudJérome, SaintFabien, ColombelMarc, IraniJacques, SoulieMichel, PfisterChristian

NMIBC treatment
BCG toxicity

This study investigated the efficacy and safety of a reduced-dose bacillus Calmette-Guerin (BCG) maintenance treatment for non-muscle invasive bladder cancer (NMIBC). Two groups received one-third dose BCG instillations every 6 months (group I) or every 3 months (group II) for 3 years. Both groups had similar rates of tumor recurrence and muscle invasion at 36 months. However, group I experienced significantly lower side effects and fewer major adverse events.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

24.

Adverse Reactions Due to the Bacillus Calmette-Guerin Vaccine: Twenty Tunisian Cases.

Author: SellamiKhadija, AmouriMeriem, KmihaSana, BahloulEmna, AloulouHajer, SfaihiLamia, GuiratR, MseddiMadiha, KamounT, HachichaMongia, TurkiHamida

BCG vaccine efficacy
BCG disseminated disease
BCG local reaction
Primary immunodeficiency

This retrospective study investigated BCG vaccine adverse reactions. 20 cases were identified over 10 years. 80% of patients presented local adverse reactions. The rate of disseminated BCG disease was 20%.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

25.

Reiter's syndrome postintravesical Bacillus Calmette-Guérin instillations.

Author: NgKeng Lim, ChuaChong Beng

TCC treatment
Reiter's syndrome

This case report describes a patient who developed Reiter's syndrome following intravesical Bacillus Calmette-Guérin (BCG) instillations for high-grade bladder TCC. Reiter's syndrome is a rare but known complication of BCG immunotherapy, highlighting the need for urologists to be aware of this potential side effect.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

26.

Bacillus Calmette-Guérin immunotherapy for bladder cancer: a review of immunological aspects, clinical effects and BCG infections.

Author: LarsenEmilie Stavnsbjerg, JoensenUlla Nordström, PoulsenAlicia Martin, GolettiDelia, JohansenIsik Somuncu

Lower progression
Lower recurrence
BCG infection
Dysuria
Flu-like symptoms

Bacillus Calmette-Guérin (BCG) immunotherapy is a standard treatment for high-grade non-muscle invasive bladder cancer (NMIBC). This article outlines the procedure, effects on recurrence and progression, and potential side effects of BCG instillations.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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