Scholarlink

Background <p>Use of fungal mycelium as a vaccination adjunct may constitute a novel antiviral strategy to address newly emerging viruses. We evaluated safety and feasibility of a fungal mycelium-based natural product (<i>Fomitopsis officinalis</i> and <i>Trametes versicolor</i>, FoTv) as an adjunct to human COVID-19 vaccination, as well as its impact on vaccine side-effects and anti-SARS-CoV-2 antibodies (Abs).</p> Methods <p>Randomized, double-blind, placebo-controlled clinical trial involving adjunctive treatment with FoTv or visually-identical Placebo (dosage: eight 500-mg capsules TID orally for four days) in combination with COVID-19 vaccination. Main outcomes included: Safety (adverse events, renal and hepatic function [Days 1–14]); Feasibility (completion rate and treatment adherence); Side-effects (number and severity, self-reported on days 1 [vaccination] to 5); and anti-SARS-CoV-2 Ab levels (receptor-binding domain and Spike, collected from blood drawn on days 1, 3, 14, and 28/42, and at 6 months).</p> Results <p>Ninety participants receiving COVID-19 vaccination were randomized to either FoTv (<i>N</i> = 52) or Placebo (<i>N</i> = 38) groups. There were no adverse events and the groups had overlapping 95% confidence intervals for the percentage of participants transitioning from normal to abnormal renal/hepatic function when comparing Days 1 and 14. All participants (100%) completed the study and treatment adherence was greater than 95%. Participants with detectable anti-SARS-CoV-2 Abs (from prior COVID antigen exposure) were classified as “COVID-Exposed” and those with undetectable anti-SARS-CoV-2 Abs as “COVID-Naive.” FoTv, versus Placebo, significantly reduced side-effects in COVID-Naive individuals, specifically on days 3 and 5, but not in COVID-Exposed individuals. In the COVID-Naive FoTv group, Ab responses were preserved across 6 months (and possibly increased), an effect not observed among other groups.</p> Conclusions <p>After COVID-19 vaccination, adjunctive FoTv was safe, feasible, and reduced vaccine side-effects without compromising (and possibly increasing) Ab levels up to 6 months in participants without previous SARS-CoV-2 exposure. Use of fungal mycelia was successfully tested as a unique approach to prevent a novel pandemic virus (SARS-CoV-2), with potential application to H5N1/Bird Flu and other emerging viruses.</p> Trial registration <p>Trial registered on ClinicalTrials.gov NCT04951336 on June 30, 2021.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Polypore mushroom mycelia as an adjunct to COVID-19 vaccination: a randomized clinical trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月31日

查看全文
  • Gordon Saxe,
  • Christine N. Smith,
  • Shahrokh Golshan,
  • Tatyana Shekhtman,
  • Zolton J. Bair,
  • Chase Beathard,
  • Renee A. Davis,
  • Lauray MacElhern,
  • Andrew Shubov,
  • Daniel Slater,
  • Lan K. Kao,
  • Phoebe Senowitz,
  • Stephen Wilson

摘要

Background

Use of fungal mycelium as a vaccination adjunct may constitute a novel antiviral strategy to address newly emerging viruses. We evaluated safety and feasibility of a fungal mycelium-based natural product (Fomitopsis officinalis and Trametes versicolor, FoTv) as an adjunct to human COVID-19 vaccination, as well as its impact on vaccine side-effects and anti-SARS-CoV-2 antibodies (Abs).

Methods

Randomized, double-blind, placebo-controlled clinical trial involving adjunctive treatment with FoTv or visually-identical Placebo (dosage: eight 500-mg capsules TID orally for four days) in combination with COVID-19 vaccination. Main outcomes included: Safety (adverse events, renal and hepatic function [Days 1–14]); Feasibility (completion rate and treatment adherence); Side-effects (number and severity, self-reported on days 1 [vaccination] to 5); and anti-SARS-CoV-2 Ab levels (receptor-binding domain and Spike, collected from blood drawn on days 1, 3, 14, and 28/42, and at 6 months).

Results

Ninety participants receiving COVID-19 vaccination were randomized to either FoTv (N = 52) or Placebo (N = 38) groups. There were no adverse events and the groups had overlapping 95% confidence intervals for the percentage of participants transitioning from normal to abnormal renal/hepatic function when comparing Days 1 and 14. All participants (100%) completed the study and treatment adherence was greater than 95%. Participants with detectable anti-SARS-CoV-2 Abs (from prior COVID antigen exposure) were classified as “COVID-Exposed” and those with undetectable anti-SARS-CoV-2 Abs as “COVID-Naive.” FoTv, versus Placebo, significantly reduced side-effects in COVID-Naive individuals, specifically on days 3 and 5, but not in COVID-Exposed individuals. In the COVID-Naive FoTv group, Ab responses were preserved across 6 months (and possibly increased), an effect not observed among other groups.

Conclusions

After COVID-19 vaccination, adjunctive FoTv was safe, feasible, and reduced vaccine side-effects without compromising (and possibly increasing) Ab levels up to 6 months in participants without previous SARS-CoV-2 exposure. Use of fungal mycelia was successfully tested as a unique approach to prevent a novel pandemic virus (SARS-CoV-2), with potential application to H5N1/Bird Flu and other emerging viruses.

Trial registration

Trial registered on ClinicalTrials.gov NCT04951336 on June 30, 2021.