BCG Vaccination to Prevent COVID-19

NCT ID: NCT04632537

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2021-03-23

Brief Summary

The current COVID-19 epidemic threatens to overwhelm the capacity of many countries to meet their populations' health care needs. Although several vaccines specific for SARS-CoV-2 have been or are being developed, these require testing in animal and human safety studies and they are unlikely to be available during the expected peak periods of the growing epidemic. Two groups at especially high risk of infection and disease are front line health care workers working directly with COVID-19 patients and elderly residents of group homes or facilities that provide skilled nursing care to this frail population. Interim measures to protect these groups while we await a high efficacy vaccine are desperately needed.

Based on the capacity of BCG to (1) reduce the incidence of respiratory tract infections in children and adults; (2) exert antiviral effects in experimental models; and (3) reduce viremia in an experimental human model of viral infection, we hypothesize that BCG vaccination may induce (partial) protection against susceptibility to and/or severity of SARS-CoV-2 infection.

This study will evaluate the efficacy of BCG to reduce risk of infection by SARS-CoV-2 and mitigate COVID-19 disease severity in at risk health care providers.

A phase III randomized controlled trial provides the highest validity to answer this research question. Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with a highly feasible primary endpoint, which can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would allow other at-risk individuals, including the control population, to also benefit from the intervention if and as soon as it has demonstrated efficacy and safety.

Detailed Description

This study is a multi-center, prospective, double-blind, randomized placebo-controlled trial to assess the efficacy of intradermal TICE BCG (for intravesical use, Merck) BCG LIVE or placebo vaccine, in reducing the incidence of infection of SARS-CoV2 and severity of COVID-19 disease. This study proposes to examine BCG-induced nonspecific trained immunity to provide protection from SARS-CoV2 among health care workers who are likely to care for patients with COVID-19 illness, 18-64 years of age.

Up to 670 individuals will be screened to enroll 550 participants with a planned 50 person enrollment at USU site, 300 persons at Darnall Medical Center (CRDMC) and 200 persons at Brooke Army Medical Center (BAMC), resulting in 275 receiving BCG vaccine and 275 receiving placebo. To account for attrition prior to vaccination we will enroll up to 70 at USU, up to 350 at CRDMC and up to 250 at BAMC.

There are three phases in which research procedures will be completed: (1) initial screening for eligibility, consent, baseline testing; (2) enrollment, randomization, if pertains- prior to vaccination research blood draw for peripheral blood mononuclear cells (PBMC), and immunization with study vaccine (BCG or placebo); and (3) follow-up screening and testing.

Participants will be followed to assess whether infection with SARS-CoV-2 occurs:

Participants will complete intermittent surveys via an electronic system every 2 weeks to assess the presence of any flu-like symptom. Any positive response on the survey will trigger a nasopharyngeal swab to be collected to test for COVID-19 via rt-PCR.

All participants, regardless of survey responses, will have serology (4mL SST tube) for COVID-19 tested at monthly intervals during the 6 month follow-up period or until a positive test result occurs.

If a participant completes the follow-up period and does not test positive for COVID disease, study participation is complete.

If a participant does test positive for COVID-19 disease at any point during follow-up, disease status will be ascertained for up to two months from the time of positive test or until an outcome is available through one of the following mechanisms:

(1) an electronic survey if not admitted to the hospital, including questions about the number of days ill, daily fever, and other symptoms; or (2) if admitted to the hospital, ordinal outcomes for disease severity will be extracted from the hospital's medical records system for the 2 month period of highest acuity. Participants will have a final study visit after hospitalization when cleared for outpatient follow up.

During the first 6 weeks of follow-up post vaccination, all participants will be asked about any adverse events; thereafter, participants will report vaccine-related and solicited adverse events (AE), as well as unsolicited AEs through the electronic survey.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

TICE BCG (for intravesical use, Merck) BCG LIVE

Participants randomized to the BCG arm will receive Tice® BCG (for intravesical use) BCG LIVE is a live freeze-dried vaccine made from an attenuated strain of Mycobacterium bovis. The freeze-dried vaccine will be delivered in vials, each containing 1 to 8 x108 colony forming units (CFU). Tice® BCG (for intravesical use) BCG LIVE will be reconstituted in \~5 mL of preservative-free saline, as needed for yielding 2- x107 CFU/ mL. \[34\] Administration of 0.1 mL will contain 2x106 CFU, which accounts for approximately 0.1 mg of the attenuated Mycobacterium bovis. Administration of 0.1 mL of diluted vaccine will be given per dose, intradermally. A sterile tuberculin 1mL syringe and sterile fine short needle (25 or 26 gauge with 3/8-3/4 length), will be used for each injection. The injection should be made slowly after inserting the needle \~2 mm into the superficial layer of the dermis of the upper arm (usually deltoid area), to make a symmetrical superficial bleb.

Group Type: ACTIVE_COMPARATOR

Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine

Intervention Type: DRUG

Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine will be diluted in preservative-free saline and given intradermally (0.1mL) in the deltoid area.

placebo vaccine

Placebo will be administered in an intradermal route in the same location as the BCG vaccines: upper arm. Placebo will comprise 0.1 mL of the diluent (preservative-free saline) to ensure the same quantity and same color as the resuspended BCG vaccine, rendering the two indistinguishable.

Group Type: PLACEBO_COMPARATOR

Preservative-free saline

Intervention Type: DRUG

Placebo will be administered in an intradermal route in the same location as the BCG vaccines: upper arm. Placebo will comprise 0.1 mL of the diluent (preservative-free saline) to ensure the same quantity and same color as the resuspended BCG vaccine, rendering the two indistinguishable.

Interventions

Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine

Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine will be diluted in preservative-free saline and given intradermally (0.1mL) in the deltoid area.

Intervention Type: DRUG

Preservative-free saline

Placebo will be administered in an intradermal route in the same location as the BCG vaccines: upper arm. Placebo will comprise 0.1 mL of the diluent (preservative-free saline) to ensure the same quantity and same color as the resuspended BCG vaccine, rendering the two indistinguishable.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Physicians, physician assistants, nurse practitioners, nurses, medics, respiratory therapists and other HCWs who are likely to care for patients with COVID-19 illness
• Eligible for care in DoD facilities (DEERS eligible)*
• 18-64 years old
• Willingness to permit review of medical records
• Women of childbearing potential must be willing to use an effective form of birth control for 30 days post vaccination

Exclusion Criteria

• Previously (medical history) or currently infected or ill with COVID-19
• Previous TB disease
• Fever (>38 C) within the past 24 hours
• Currently pregnant or breastfeeding or planning on becoming pregnant within 30 days of enrollment
• Current serious underlying medical conditions including: diabetes mellitus, chronic kidney disease, or any other immunocompromising condition:

• Known infection by Human Immunodeficiency Virus (HIV)
• History of solid organ or bone marrow transplantation
• Currently under chemotherapy
• Currently on any anti-cytokine therapy
• History of immunodeficiency (including history of anti B cell therapy)
• Currently taking immunosuppressive drugs
• Treatment with oral or intravenous steroids, defined as daily doses of 10mg prednisone or equivalent for longer than 3 months
• Active solid or non-solid malignancy or lymphoma within the past two years
• Suspicion of active viral or bacterial infection
• Living with someone HIV+, who is immunocompromised, or is taking an immunosuppressive drug
• Known allergy to (components of) the BCG vaccine or a serious reaction to prior BCG administration
• Plan to terminate their employment at the participating health care facility or change duty stations within the next three months
• Not in possession of a smartphone
• Current participation in a COVID-19 interventional trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

Defense Health Agency

FED

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey R Livezey, MD

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Naomi E Aronson

Role: STUDY_CHAIR

Uniformed Services University of the Health Sciences

References

World Health Organization. Coronavirus disease 2019 (COVID-19): Situation Report - 23. COVID-19 Situational Reports (2020). Accessed on April 1, 2020 at: https://www.who.int/docs/default- source/coronaviruse/situation-reports/20200212-sitrep-23-nCoV.pdf?sfvrsn=41e9fb78_4

Reference Type: BACKGROUND

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

Reference Type: BACKGROUND

PMID: 31986264 (View on PubMed)

Chang D, Xu H, Rebaza A, Sharma L, Dela Cruz CS. Protecting health-care workers from subclinical coronavirus infection. Lancet Respir Med. 2020 Mar;8(3):e13. doi: 10.1016/S2213-2600(20)30066-7. Epub 2020 Feb 13. No abstract available.

Reference Type: BACKGROUND

PMID: 32061333 (View on PubMed)

Zhang J, Zhou L, Yang Y, Peng W, Wang W, Chen X. Therapeutic and triage strategies for 2019 novel coronavirus disease in fever clinics. Lancet Respir Med. 2020 Mar;8(3):e11-e12. doi: 10.1016/S2213-2600(20)30071-0. Epub 2020 Feb 13. No abstract available.

Reference Type: BACKGROUND

PMID: 32061335 (View on PubMed)

Chou R, Dana T, Buckley DI, Selph S, Fu R, Totten AM. Epidemiology of and Risk Factors for Coronavirus Infection in Health Care Workers: A Living Rapid Review. Ann Intern Med. 2020 Jul 21;173(2):120-136. doi: 10.7326/M20-1632. Epub 2020 May 5.

Reference Type: BACKGROUND

PMID: 32369541 (View on PubMed)

Rivett L, Sridhar S, Sparkes D, Routledge M, Jones NK, Forrest S, Young J, Pereira-Dias J, Hamilton WL, Ferris M, Torok ME, Meredith L; CITIID-NIHR COVID-19 BioResource Collaboration; Curran MD, Fuller S, Chaudhry A, Shaw A, Samworth RJ, Bradley JR, Dougan G, Smith KG, Lehner PJ, Matheson NJ, Wright G, Goodfellow IG, Baker S, Weekes MP. Screening of healthcare workers for SARS-CoV-2 highlights the role of asymptomatic carriage in COVID-19 transmission. Elife. 2020 May 11;9:e58728. doi: 10.7554/eLife.58728.

Reference Type: BACKGROUND

PMID: 32392129 (View on PubMed)

CDC COVID-19 Response Team. Characteristics of Health Care Personnel with COVID-19 - United States, February 12-April 9, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):477-481. doi: 10.15585/mmwr.mm6915e6.

Reference Type: BACKGROUND

PMID: 32298247 (View on PubMed)

Nguyen LH, Drew DA, Graham MS, Joshi AD, Guo CG, Ma W, Mehta RS, Warner ET, Sikavi DR, Lo CH, Kwon S, Song M, Mucci LA, Stampfer MJ, Willett WC, Eliassen AH, Hart JE, Chavarro JE, Rich-Edwards JW, Davies R, Capdevila J, Lee KA, Lochlainn MN, Varsavsky T, Sudre CH, Cardoso MJ, Wolf J, Spector TD, Ourselin S, Steves CJ, Chan AT; COronavirus Pandemic Epidemiology Consortium. Risk of COVID-19 among front-line health-care workers and the general community: a prospective cohort study. Lancet Public Health. 2020 Sep;5(9):e475-e483. doi: 10.1016/S2468-2667(20)30164-X. Epub 2020 Jul 31.

Reference Type: BACKGROUND

PMID: 32745512 (View on PubMed)

Wang X, Ferro EG, Zhou G, Hashimoto D, Bhatt DL. Association Between Universal Masking in a Health Care System and SARS-CoV-2 Positivity Among Health Care Workers. JAMA. 2020 Aug 18;324(7):703-704. doi: 10.1001/jama.2020.12897.

Reference Type: BACKGROUND

PMID: 32663246 (View on PubMed)

Ritz N, Hanekom WA, Robins-Browne R, Britton WJ, Curtis N. Influence of BCG vaccine strain on the immune response and protection against tuberculosis. FEMS Microbiol Rev. 2008 Aug;32(5):821-41. doi: 10.1111/j.1574-6976.2008.00118.x. Epub 2008 Jul 9.

Reference Type: BACKGROUND

PMID: 18616602 (View on PubMed)

Abubakar I, Pimpin L, Ariti C, Beynon R, Mangtani P, Sterne JA, Fine PE, Smith PG, Lipman M, Elliman D, Watson JM, Drumright LN, Whiting PF, Vynnycky E, Rodrigues LC. Systematic review and meta-analysis of the current evidence on the duration of protection by bacillus Calmette-Guerin vaccination against tuberculosis. Health Technol Assess. 2013 Sep;17(37):1-372, v-vi. doi: 10.3310/hta17370.

Reference Type: BACKGROUND

PMID: 24021245 (View on PubMed)

Walk J, de Bree LCJ, Graumans W, Stoter R, van Gemert GJ, van de Vegte-Bolmer M, Teelen K, Hermsen CC, Arts RJW, Behet MC, Keramati F, Moorlag SJCFM, Yang ASP, van Crevel R, Aaby P, de Mast Q, van der Ven AJAM, Stabell Benn C, Netea MG, Sauerwein RW. Outcomes of controlled human malaria infection after BCG vaccination. Nat Commun. 2019 Feb 20;10(1):874. doi: 10.1038/s41467-019-08659-3.

Reference Type: BACKGROUND

PMID: 30787276 (View on PubMed)

Koeken VACM, Verrall AJ, Netea MG, Hill PC, van Crevel R. Trained innate immunity and resistance to Mycobacterium tuberculosis infection. Clin Microbiol Infect. 2019 Dec;25(12):1468-1472. doi: 10.1016/j.cmi.2019.02.015. Epub 2019 Feb 23.

Reference Type: BACKGROUND

PMID: 30807849 (View on PubMed)

Suliman S, Geldenhuys H, Johnson JL, Hughes JE, Smit E, Murphy M, Toefy A, Lerumo L, Hopley C, Pienaar B, Chheng P, Nemes E, Hoft DF, Hanekom WA, Boom WH, Hatherill M, Scriba TJ. Bacillus Calmette-Guerin (BCG) Revaccination of Adults with Latent Mycobacterium tuberculosis Infection Induces Long-Lived BCG-Reactive NK Cell Responses. J Immunol. 2016 Aug 15;197(4):1100-1110. doi: 10.4049/jimmunol.1501996. Epub 2016 Jul 13.

Reference Type: BACKGROUND

PMID: 27412415 (View on PubMed)

Nemes E, Geldenhuys H, Rozot V, Rutkowski KT, Ratangee F, Bilek N, Mabwe S, Makhethe L, Erasmus M, Toefy A, Mulenga H, Hanekom WA, Self SG, Bekker LG, Ryall R, Gurunathan S, DiazGranados CA, Andersen P, Kromann I, Evans T, Ellis RD, Landry B, Hokey DA, Hopkins R, Ginsberg AM, Scriba TJ, Hatherill M; C-040-404 Study Team. Prevention of M. tuberculosis Infection with H4:IC31 Vaccine or BCG Revaccination. N Engl J Med. 2018 Jul 12;379(2):138-149. doi: 10.1056/NEJMoa1714021.

Reference Type: BACKGROUND

PMID: 29996082 (View on PubMed)

World Health Organization. Clinical Management of Severe acute respiratory infection when COVID-19 is suspected. (2020). Accessed on April 1, 2020 at: https://apps.who.int/iris/bitstream/handle /10665/331446/WHO-2019-nCoV-clinical-2020.4- eng.pdf.

Reference Type: BACKGROUND

O'Neill LAJ, Netea MG. BCG-induced trained immunity: can it offer protection against COVID-19? Nat Rev Immunol. 2020 Jun;20(6):335-337. doi: 10.1038/s41577-020-0337-y.

Reference Type: BACKGROUND

PMID: 32393823 (View on PubMed)

Kleinnijenhuis J, Quintin J, Preijers F, Joosten LA, Ifrim DC, Saeed S, Jacobs C, van Loenhout J, de Jong D, Stunnenberg HG, Xavier RJ, van der Meer JW, van Crevel R, Netea MG. Bacille Calmette-Guerin induces NOD2-dependent nonspecific protection from reinfection via epigenetic reprogramming of monocytes. Proc Natl Acad Sci U S A. 2012 Oct 23;109(43):17537-42. doi: 10.1073/pnas.1202870109. Epub 2012 Sep 17.

Reference Type: BACKGROUND

PMID: 22988082 (View on PubMed)

Spencer JC, Ganguly R, Waldman RH. Nonspecific protection of mice against influenza virus infection by local or systemic immunization with Bacille Calmette-Guerin. J Infect Dis. 1977 Aug;136(2):171-5. doi: 10.1093/infdis/136.2.171.

Reference Type: BACKGROUND

PMID: 894076 (View on PubMed)

Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21.

Reference Type: BACKGROUND

PMID: 27102489 (View on PubMed)

Netea MG, Giamarellos-Bourboulis EJ, Dominguez-Andres J, Curtis N, van Crevel R, van de Veerdonk FL, Bonten M. Trained Immunity: a Tool for Reducing Susceptibility to and the Severity of SARS-CoV-2 Infection. Cell. 2020 May 28;181(5):969-977. doi: 10.1016/j.cell.2020.04.042. Epub 2020 May 4.

Reference Type: BACKGROUND

PMID: 32437659 (View on PubMed)

Arts RJW, Moorlag SJCFM, Novakovic B, Li Y, Wang SY, Oosting M, Kumar V, Xavier RJ, Wijmenga C, Joosten LAB, Reusken CBEM, Benn CS, Aaby P, Koopmans MP, Stunnenberg HG, van Crevel R, Netea MG. BCG Vaccination Protects against Experimental Viral Infection in Humans through the Induction of Cytokines Associated with Trained Immunity. Cell Host Microbe. 2018 Jan 10;23(1):89-100.e5. doi: 10.1016/j.chom.2017.12.010.

Reference Type: BACKGROUND

PMID: 29324233 (View on PubMed)

Netea MG, van Crevel R. BCG-induced protection: effects on innate immune memory. Semin Immunol. 2014 Dec;26(6):512-7. doi: 10.1016/j.smim.2014.09.006. Epub 2014 Oct 23.

Reference Type: BACKGROUND

PMID: 25444548 (View on PubMed)

Kleinnijenhuis J, van Crevel R, Netea MG. Trained immunity: consequences for the heterologous effects of BCG vaccination. Trans R Soc Trop Med Hyg. 2015 Jan;109(1):29-35. doi: 10.1093/trstmh/tru168.

Reference Type: BACKGROUND

PMID: 25573107 (View on PubMed)

Higgins JP, Soares-Weiser K, Lopez-Lopez JA, Kakourou A, Chaplin K, Christensen H, Martin NK, Sterne JA, Reingold AL. Association of BCG, DTP, and measles containing vaccines with childhood mortality: systematic review. BMJ. 2016 Oct 13;355:i5170. doi: 10.1136/bmj.i5170.

Reference Type: BACKGROUND

PMID: 27737834 (View on PubMed)

Wardhana, Datau EA, Sultana A, Mandang VV, Jim E. The efficacy of Bacillus Calmette-Guerin vaccinations for the prevention of acute upper respiratory tract infection in the elderly. Acta Med Indones. 2011 Jul;43(3):185-90.

Reference Type: BACKGROUND

PMID: 21979284 (View on PubMed)

Han RF, Pan JG. Can intravesical bacillus Calmette-Guerin reduce recurrence in patients with superficial bladder cancer? A meta-analysis of randomized trials. Urology. 2006 Jun;67(6):1216-23. doi: 10.1016/j.urology.2005.12.014.

Reference Type: BACKGROUND

PMID: 16765182 (View on PubMed)

Leentjens J, Kox M, Stokman R, Gerretsen J, Diavatopoulos DA, van Crevel R, Rimmelzwaan GF, Pickkers P, Netea MG. BCG Vaccination Enhances the Immunogenicity of Subsequent Influenza Vaccination in Healthy Volunteers: A Randomized, Placebo-Controlled Pilot Study. J Infect Dis. 2015 Dec 15;212(12):1930-8. doi: 10.1093/infdis/jiv332. Epub 2015 Jun 12.

Reference Type: BACKGROUND

PMID: 26071565 (View on PubMed)

World Health Organization. Expert committee on biological standardization: Recommendations to assure the quality, safety and efficacy of BCG vaccines. (2011). Accessed on April 1, 2020 at: https://www.who.int/biologicals/BCG_DB_HK_23_April_2012.pdf

Reference Type: BACKGROUND

Hatherill M, Geldenhuys H, Pienaar B, Suliman S, Chheng P, Debanne SM, Hoft DF, Boom WH, Hanekom WA, Johnson JL. Safety and reactogenicity of BCG revaccination with isoniazid pretreatment in TST positive adults. Vaccine. 2014 Jun 30;32(31):3982-8. doi: 10.1016/j.vaccine.2014.04.084. Epub 2014 May 9.

Reference Type: BACKGROUND

PMID: 24814553 (View on PubMed)

McKee AS, Munks MW, Marrack P. How do adjuvants work? Important considerations for new generation adjuvants. Immunity. 2007 Nov;27(5):687-90. doi: 10.1016/j.immuni.2007.11.003.

Reference Type: BACKGROUND

PMID: 18031690 (View on PubMed)

Mangtani P, Abubakar I, Ariti C, Beynon R, Pimpin L, Fine PE, Rodrigues LC, Smith PG, Lipman M, Whiting PF, Sterne JA. Protection by BCG vaccine against tuberculosis: a systematic review of randomized controlled trials. Clin Infect Dis. 2014 Feb;58(4):470-80. doi: 10.1093/cid/cit790. Epub 2013 Dec 13.

Reference Type: BACKGROUND

PMID: 24336911 (View on PubMed)

Kemp EB, Belshe RB, Hoft DF. Immune responses stimulated by percutaneous and intradermal bacille Calmette-Guerin. J Infect Dis. 1996 Jul;174(1):113-9. doi: 10.1093/infdis/174.1.113.

Reference Type: BACKGROUND

PMID: 8655980 (View on PubMed)

Pizzi M, Albertoni L, Stefanizzi L, Mescoli C, Rugge M. Gastrointestinal Crohn-like disease following BCG therapy. Int J Colorectal Dis. 2015 Dec;30(12):1745-6. doi: 10.1007/s00384-015-2157-2. Epub 2015 Feb 18. No abstract available.

Reference Type: BACKGROUND

PMID: 25690704 (View on PubMed)

Queiro R, Ballina J, Weruaga A, Fernandez JA, Riestra JL, Torre JC, Rodriguez A. Psoriatic arthropathy after BCG immunotherapy for bladder carcinoma. Br J Rheumatol. 1995 Nov;34(11):1097. doi: 10.1093/rheumatology/34.11.1097. No abstract available.

Reference Type: BACKGROUND

PMID: 8542217 (View on PubMed)

Dudelzak J, Curtis AR, Sheehan DJ, Lesher JL Jr. New-onset psoriasis and psoriatic arthritis in a patient treated with Bacillus Calmette-Guerin (BCG) immunotherapy. J Drugs Dermatol. 2008 Jul;7(7):684. No abstract available.

Reference Type: BACKGROUND

PMID: 18664162 (View on PubMed)

Randomised controlled trial of single BCG, repeated BCG, or combined BCG and killed Mycobacterium leprae vaccine for prevention of leprosy and tuberculosis in Malawi. Karonga Prevention Trial Group. Lancet. 1996 Jul 6;348(9019):17-24.

Reference Type: BACKGROUND

PMID: 8691924 (View on PubMed)

To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.

Reference Type: BACKGROUND

PMID: 32213337 (View on PubMed)

Chen Y, Li L. SARS-CoV-2: virus dynamics and host response. Lancet Infect Dis. 2020 May;20(5):515-516. doi: 10.1016/S1473-3099(20)30235-8. Epub 2020 Mar 23. No abstract available.

Reference Type: BACKGROUND

PMID: 32213336 (View on PubMed)

Hoft DF, Leonardi C, Milligan T, Nahass GT, Kemp B, Cook S, Tennant J, Carey M. Clinical reactogenicity of intradermal bacille Calmette-Guerin vaccination. Clin Infect Dis. 1999 Apr;28(4):785-90. doi: 10.1086/515201.

Reference Type: BACKGROUND

PMID: 10825039 (View on PubMed)

Giamarellos-Bourboulis EJ, Tsilika M, Moorlag S, Antonakos N, Kotsaki A, Dominguez-Andres J, Kyriazopoulou E, Gkavogianni T, Adami ME, Damoraki G, Koufargyris P, Karageorgos A, Bolanou A, Koenen H, van Crevel R, Droggiti DI, Renieris G, Papadopoulos A, Netea MG. Activate: Randomized Clinical Trial of BCG Vaccination against Infection in the Elderly. Cell. 2020 Oct 15;183(2):315-323.e9. doi: 10.1016/j.cell.2020.08.051. Epub 2020 Sep 1.

Reference Type: BACKGROUND

PMID: 32941801 (View on PubMed)

Other Identifiers

USUHS.2020-062

Identifier Type: -

Identifier Source: org_study_id