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Immunomodulatory Effect of Probiotics on the Immunogenicity of Anti-SARS-CoV-2 Vaccines

CompletedNA

Sponsor: Grape King Bio Ltd.

Conditions: COVID-19, Immune Response

Interventions: Probiotics, Placebo

Countries: Taiwan

This study aims to evaluate whether oral probiotic supplementation can modulate the immune response induced by COVID-19 vaccination. Specifically, the study will assess the effects of probiotics on vaccine-induced antibody responses and cellular immune responses, and explore whether probiotics may enhance or accelerate immunity and reduce vaccine-related adverse effects. A total of 140 participants are planned to be enrolled.

Eligibility overview

Sex: ALL

Age: 20 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Male or female subject ≥ 20 to ≤ 65 years of age at the time signing informed consent form.
2. Body weight ≥50 kgs
3. Must be scheduling to receive a BNT162b2 mRNA COVID-19 vaccine
4. Being able to comply with the study protocol
5. Being able to independently provide written informed consent

Exclusion Criteria:

1. Taking antibiotic at enrollment
2. Taking immunomodulatory (e.g., steroid) or anti-histamine drugs
3. Took pre- or probiotics within the past 30 days
4. Being to expected to take other probiotic supplement during the study period
5. Being expected to take antibiotic during the study period
6. A history of hypersensitivity or severe allergic reaction to any components of the probiotics or placebo supplement
7. Pregnant or breastfeeding
8. Having a severe immunocompromised disorder (e.g. HIV infection)
9. Solid organ or bone marrow transplant recipients
10. Major gastrointestinal surgery within 3 months before enrollment
11. Having severe active gastrointestinal conditions, including inflammatory bowel disease or diverticulitis
12. No self-reported symptoms of an upper airway infection with the past 2 weeks
13. A history of SARS-CoV-2 infection
14. Previously participated in investigational study involving SARS-CoV-2 vaccines or therapies

Locations (1)

Taipei, Taiwan