November 4, 2020
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November 17, 2020
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March 26, 2021
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December 7, 2020
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March 23, 2021 (Final data collection date for primary outcome measure)
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Incidence of symptomatic rt-PCR-confirmed SARS-CoV-2 infection [ Time Frame: 6 months ] The primary outcome measure is the development of symptomatic COVID 19 infections. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the incidence of rt-PCR-confirmed symptomatic SARS-CoV-2 infection following BCG vaccination compared to that following placebo, starting from 3 days post-vaccination through 6 months.
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Same as current
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- incidence of Serology-confirmed infection with SARS-CoV-2 [ Time Frame: 6 months ]
The secondary outcome measure is the development of Serology-confirmed infection with SARS-CoV-2. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the incidence of serology-confirmed SARS-CoV-2 following BCG vaccination compared to that following placebo, starting from 3 days post vaccination through 6 months.
- severity of COVID-19 disease [ Time Frame: 6 months ]
In individuals who test positive for COVID-19, the proportion with severe disease following BCG vaccination compared to placebo, as defined by the following necessary care levels: non- hospital care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died.Additional WHO severity indicators of severe pneumonia, respiratory failure, sepsis, septic shock will also be included.
- symptomatic respiratory infection [ Time Frame: 6 months ]
Incidence of self-reported symptomatic respiratory infections following BCG vaccination compared to that following placebo, starting from 3 days post-vaccination through 6 months.
- effect of prior adult immunization with other vaccines associated with trained immunity [ Time Frame: 6 months ]
rates of 1) all cause respiratory infection 2) symptomatic COVID- 19, 3) serology-confirmed SARS-CoV-2 infection in health care workers.
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Same as current
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Not Provided
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Not Provided
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BCG Vaccination to Prevent COVID-19
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Novel Use of an Existing Vaccine (BCG) Alliance: The NUEVA Trial
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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.
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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.
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Interventional
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Phase 3
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention
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COVID-19
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- Drug: 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.
- 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.
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- Active Comparator: 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.
Intervention: Drug: Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine
- Placebo Comparator: 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.
Intervention: Drug: Preservative-free saline
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- 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. Review.
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- Netea MG, Giamarellos-Bourboulis EJ, Domínguez-Andrés 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. Review.
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- 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. Review.
- 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. Review.
- Higgins JP, Soares-Weiser K, López-López 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. Review. Erratum in: BMJ. 2017 Mar 8;356:j1241.
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- Giamarellos-Bourboulis EJ, Tsilika M, Moorlag S, Antonakos N, Kotsaki A, Domínguez-Andrés 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.
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Withdrawn
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0
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550
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March 23, 2021
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March 23, 2021 (Final data collection date for primary outcome measure)
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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:
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Sexes Eligible for Study: |
All |
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18 Years to 64 Years (Adult)
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Yes
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Contact information is only displayed when the study is recruiting subjects
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Not Provided
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United States
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NCT04632537
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USUHS.2020-062
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Yes
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
Product Manufactured in and Exported from the U.S.: |
Yes |
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Henry M. Jackson Foundation for the Advancement of Military Medicine
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Same as current
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Henry M. Jackson Foundation for the Advancement of Military Medicine
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Same as current
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- Harvard Medical School (HMS and HSDM)
- Uniformed Services University of the Health Sciences
- United States Department of Defense
- Immunization HealthCare Division, Defense Health Agency
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Principal Investigator: |
Jeffrey R Livezey, MD |
Uniformed Services University of the Health Sciences |
Study Chair: |
Naomi E Aronson |
Uniformed Services University of the Health Sciences |
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Henry M. Jackson Foundation for the Advancement of Military Medicine
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March 2021
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