SARS-CoV-2 Rekonvaleszentenplasma für die klinische Studie "COVIC-19": Erfahrungen mit der Sammlung von sehr hochtitrigem Plasma von superimmunisierten Personen
Simone Hoffmann (Ulm / DE), Sixten Körper (Ulm / DE), Alina Seidel (Ulm / DE), Bernd Jahrsdörfer (Ulm / DE), Carolin Ludwig (Ulm / DE), Christiane Vieweg (Ulm / DE), Henrike Hofmann (Ulm / DE), Thomas Appl (Ulm / DE), Dan Albers (Ulm / DE), Pascal von Maltitz (Ulm / DE), Rebecca Müller (Mannheim / DE), Patrick Wuchter (Mannheim / DE), Harald Klüter (Mannheim / DE), Michael Schmidt (Frankfurt a. M. / DE), Matthias Johnsen (Dresden / DE), Thomas Burkhardt (Plauen / DE), Frank Kirchhoff (Ulm / DE), Jan Münch (Ulm / DE), Hubert Schrezenmeier (Ulm / DE)
COVID-19 convalescent plasma (CCP) is a potential therapy for COVID-19. The COVIC-19 trial is building on lessons from previous studies like CAPSID, adopting a novel approach:
CCP with very high concentrations of SARS-CoV-2 antibodies (≥4,000 BAU/ml) from donors with previous SARS-CoV-2 infection and vaccinationtreatment of vulnerable persons early after symptom onsetsequencing and cross-neutralization analyses to track viral evolutionWe report the initial experience of collection of very high-titer plasma units for this COVIC-19 trial.
We recruited 691 potential donors with previous SARS-CoV-2 infection (inf) and vaccination (vax) who passed initial eligibility check. Anti-SARS-CoV-2 antibody concentrations were measured by anti-SARS-CoV-2 QuantiVac ELISA (Euroimmun) and neutralization capacity was assessed in the GenScript Surrogat and a pseudovirus neutralization assay.
We found that high antibody levels correlated with high neutralizing capacity. The average antibody concentration among willing donors was 4,298 BAU/ml. 41.1% of individuals had antibody concentrations of ≥4,000 BAU/ml and concentrations did not significantly differ by gender or ABO type, but were higher among those who had received 3 vax (median 3,746 BAU/ml) or 4 vax (median 4,166 BAU/ml). Highest S-Ab were observed in those with a breakthrough infection after 2 vax, followed by a booster (median 5,159 BAU/ml, 64% ≥4,000 BAU/ml) or breakthrough inf after 3rd or 4th vax (median 3,846; 48% ≥4,000 BAU/ml). Ultimately, 158 eligible individuals donated CCP with concentrations ranging from 4,105 BAU/ml to 22,923 BAU/ml with a median of 7,074 BAU/ml. Majority of donors donated once or twice (35.2% and 20.3%), 13.4% donated 3x, and 31.1% donated ≥4x.
Considering all eligibility criteria, 31.9% of the individuals screened met the requirements for high-titer plasma, but only 23% actually donated. Collection of very-high titer plasma from super-immunized individuals with prior infection and vaccination is feasible but requires substantial donor selection, rapid screening and prompt apheresis to capitalize on the short period of very high mAb.
COVIC-19 is supported by BMBF.
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