Antibody response in immunocompromised patients after the administration of SARS-CoV-2 vaccine BNT162b2 or mRNA-1273: A randomised controlled trial. Clinical Infectious Diseases.
Speich et al. compared the antibody response between the two available SARS-CoV-2 mRNA vaccines BNT162b2 (by Pfizer-BioNTech) and mRNA-1273 (Spikevax, by Moderna) in people living with HIV (PLWH) and solid organ transplant (SOT) recipients.
A trial platform was implemented within the Swiss HIV Cohort Study (SHCS) and the Swiss Transplant Cohort Study (STCS), and participants from the cohort centers in Bern, Basel and Zürich were randomly allocated 1:1 to 2 doses of BNT162b2 or mRNA-1273. Between April and June 2021, vaccines were administered in 2 doses on days 0 and 28 in both groups. The primary outcome in this non-inferiority trial was antibody response to SARS-CoV-2 spike protein (S1) defined as ≥ 0.8 units/mL assessed at 4 weeks after the second injection (non-inferiority margin of 10%). At the same time point, serum neutralization activity against SARS-CoV-2 was assessed using a cut-off of 17 in the ABCORA2 sum S1 algorithm.
Of the 430 randomized individuals, 142 patients were included in the intention-to-treat analysis. The median age was 53 years (IQR 43-61), 76% were men, 82% were PLWH and 18% were SOT recipients (53% lung transplants, 47% kidney transplants). Overall, antibody response was sufficient in 92.1% who received mRNA-1273, and 94.3% in those who received BNT162b2 (difference -2.2%, 95% CI -7.1 to 2.7), confirming non-inferiority of mRNA-1279 compared to BNT162b2. Neutralizing antibodies were present in 84.7% of individuals who received mRNA-1273 and in 82.4% of those who received BNT162b2. Importantly, whereas antibody response was observed in all PLWH, sufficient antibodies were detectable in only 60.6%, and neutralizing antibody activity was present in only 21.1% of SOT recipients.
In summary, the present head-to-head comparison of the two available SARS-CoV-2 mRNA vaccines among PLWH and SOT recipients demonstrated the non-inferiority of mRNA-1273 compared to BNT162b2. Whereas the two doses were followed by a good immune response among PLWH, the vaccines were less efficient among immunocompromised SOT recipients, warranting further doses in those individuals. This elegant study highlights the great potential of the collaboration between SHCS and STCS, and shows nicely how randomized controlled trials can efficiently be implemented within cohorts.