Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients.
Hall, V. G., et al.New England Journal of Medicine 2021; 385(13): 1244-1246.
Aims
This study aimed to investigate the effect of a third dose of the mRNA1273 (Moderna) vaccine in solid organ transplant (SOT) recipients.
Interventions
Participants were randomised to receive either a third dose of mRNA1273 vaccine or saline placebo.
Participants
120 adult solid organ transplant recipients.
Outcomes
The primary endpoint was a serologic response. Secondary endpoints included the percent neutralization, and the polyfunctional T-cell response.
Follow-up
4 months
CET Conclusions
Published as a correspondence letter in the NEJM, this study randomised transplant recipients to a third coronavirus vaccine dose (moderna) or to placebo. 120 transplant recipients were included, with median age 66 years and median time after transplant to third vaccine dose of 3 years. Making use of the supplemental appendix and protocol, we can see that this study was conducted in an adequately blinded and randomised fashion, with allocation concealment. Four months after the third injection, 55% in the study group and 18% in the placebo group had antibody levels over the threshold of 100U/ml for anti-receptor-binding domain antibodies. There was also a significant improvement in virus neutralisation in the study group (71% versus 13%). The third moderna vaccine dose showed a significantly higher immunogenicity than placebo in this patient group, but the authors acknowledge that the study was not powered to, nor had long enough follow up, to assess clinical outcomes.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT04885907