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BNT162b2 versus mRNA-1273 Third Dose COVID-19 Vaccine in Patients with CKD and Maintenance Dialysis Patients
Kevin Yau1,2,3, Paul Tam4, Christopher T Chan2,3
1Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Background:
There is a lack of randomized controlled trial data regarding differences in immunogenicity of varying coronavirus disease 2019 (COVID-19) mRNA vaccine regimens in CKD populations.
Methods:
We conducted a randomized controlled trial at three kidney centers in Toronto, Ontario, Canada, evaluating the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody response after third dose vaccination. Participants ( n =273) with CKD not on dialysis or receiving dialysis were randomized 1:1 to third dose 30- µ g BNT162b2 (Pfizer-BioNTech) or 100- µ g mRNA-1273 (Moderna). The primary outcome of this study was SARS-CoV-2 IgG-binding antibodies to the receptor-binding domain (anti-RBD). Spike protein (antispike), nucleocapsid protein, and vaccine reactogenicity were also evaluated. Serology was measured before third dose and 1, 3, and 6 months after third dose. A subset of participants ( n =100) were randomly selected to assess viral pseudovirus neutralization against wild-type D614G, B.1.617.2 (Delta), and B.1.1.529 (Omicron BA.1).
Results:
Among 273 participants randomized, 94% were receiving maintenance dialysis and 59% received BNT162b2 for initial two dose COVID-19 vaccination. Third dose of mRNA-1273 was associated with higher mean anti-RBD levels (1871 binding antibody units [BAU]/ml; 95% confidence interval [CI], 829 to 2988) over a 6-month period in comparison with third dose BNT162b2 (1332 BAU/ml; 95% CI, 367 to 2402) with a difference of 539 BAU/ml (95% CI, 139 to 910; P = 0.009). Neither antispike levels nor neutralizing antibodies to wild-type, Delta, and Omicron BA.1 pseudoviruses were statistically different. COVID-19 infection occurred in 10% of participants: 15 (11%) receiving mRNA-1273 and 11 (8%) receiving BNT162b2. Third dose BNT162b2 was not associated with a significant different risk for COVID-19 in comparison with mRNA-1273 (hazard ratio, 0.78; 95% CI, 0.27 to 2.2; P = 0.63).
Conclusions:
In patients with CKD, third dose COVID-19 mRNA vaccination with mRNA-1273 elicited higher SARS-CoV-2 anti-RBD levels in comparison with BNT162b2 over a 6-month period.
Clinical Trial Registry Name And Registration Number:
COVID-19 Vaccine Boosters in Patients With CKD (BOOST KIDNEY), NCT05022329 .
Insights
In patients with chronic kidney disease (CKD), a third dose of the Moderna (mRNA-1273) COVID-19 vaccine generated higher SARS-CoV-2 antibody levels compared to the Pfizer-BioNTech (BNT162b2) vaccine over six months.
Area of Science:
- Immunology
- Nephrology
- Vaccinology
Background:
- Limited randomized controlled trial data exists on the immunogenicity of different coronavirus disease 2019 (COVID-19) mRNA vaccine regimens in patients with chronic kidney disease (CKD).
- CKD populations may exhibit altered immune responses to vaccination, necessitating specific research.
Purpose of the Study:
- To compare the immunogenicity of third-dose mRNA-1273 (Moderna) versus BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines in patients with CKD.
- To evaluate antibody responses and vaccine reactogenicity following a third mRNA COVID-19 vaccine dose in this vulnerable population.
Main Methods:
- A randomized controlled trial involving 273 participants with CKD (dialysis or non-dialysis) was conducted.
- Participants received either a 30-µg dose of BNT162b2 or a 100-µg dose of mRNA-1273 as their third COVID-19 vaccine dose.
- The primary outcome was SARS-CoV-2 IgG-binding antibodies to the receptor-binding domain (anti-RBD), with secondary outcomes including antispike levels, neutralizing antibodies, and reactogenicity over six months.
Main Results:
- Third-dose mRNA-1273 was associated with significantly higher mean anti-RBD levels compared to BNT162b2 over six months (1871 vs. 1332 BAU/ml).
- No statistically significant differences were observed in antispike levels or neutralizing antibodies against wild-type, Delta, or Omicron BA.1 variants.
- COVID-19 infection occurred in 10% of participants, with no significant difference in risk between the vaccine groups.
Conclusions:
- In patients with CKD, a third dose of mRNA-1273 elicited superior SARS-CoV-2 anti-RBD antibody levels compared to BNT162b2 over a six-month period.
- Both mRNA vaccines demonstrate potential for boosting immune response in CKD patients, though mRNA-1273 showed a stronger antibody response.
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