NCT04969263

COVID-19 Protection After Transplant Pilot Study

Immunogenicity of a Third Dose of Either the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine in Kidney Transplant Recipients Who Failed to Respond After Two Previous Doses

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Antibodies are an important part of the body's defense against infection. Individuals who have no antibodies or very low antibody levels are considered less well protected from Coronavirus Disease 2019 (COVID-19) than those who have higher antibody levels. What level of antibodies is necessary for protection is currently unknown. Inadequate antibody response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination has been described among kidney transplant recipients. The aim of this study is to elicit an antibody response to vaccination against SARS-CoV-2 in kidney transplant recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) vaccine.

Detailed description

This is an open label, non-randomized study in kidney transplant recipients who received two doses of either mRNA COVID-19 vaccine and have a negative (\<0.8 U/mL) or low (titer \<50 U/mL) SARS-CoV-2 antibody response using the Roche Elecsys® anti-RBD assay. Eligible participants will receive a third dose of the same mRNA vaccine as the prior two doses.

Conditions

• Kidney Transplant Recipients

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2 vaccine (Pfizer/BioNTech)	30 microgram dose
BIOLOGICAL	mRNA-1273 vaccine (Moderna)	100 microgram dose

Timeline

• Start date: 2021-08-10
• Primary completion: 2022-11-10
• Completion: 2023-03-10
• First posted: 2021-07-20
• Last updated: 2025-07-30
• Results posted: 2024-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study