Abstract
Objective: To assess the immunogenicity and safety of a booster vaccination with an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. Methods: The phase Ⅱ trial of an inactivated SARS-CoV-2 vaccine was conducted by Jiangsu Provincial Center for Disease Control and Prevention (CDC) since October 2020. The subjects were healthy adults aged 18-59 years, excluding pregnant, and not breastfeeding women. The primary vaccination schedule groups were 0-14 d 5 μg, 0-14 d 10 μg, 0-28 d 5 μg and 0-28 d 10 μg, respectively. And 50 participants in each group, a total of 200, who have received 2-doses primary vaccination were selected in ascending order of the study number and vaccinated with a booster dose (same dosage as primary vaccination) at the 6th months after post the primary vaccination (30-day window period). Blood samples were collected before and after boosting and tested for the geometric mean titers (GMT) and seroconversion of live virus neutralizing antibody, pseudovirus neutralizing antibody and receptor-binding-domain (RBD) IgG antibody. Adverse events (AE) were collected and assessed within 28 days after boosting. Results: The ages of subjects in group 0-14 d 5 μg, 0-14 d 10 μg, 0-28 d 5 μg and 0-28 d 10 μg were (43.98±9.58), (43.46±9.34), (42.56±9.08) and (43.94±11.05) years old, respectively (P=0.877). Sex ratios were balanced among the 4 groups (P=0.331). The live virus neutralizing antibody GMT (95%CI) in group 0-14 d 5 μg, 0-14 d 10 μg, 0-28 d 5 μg and 0-28 d 10 μg increased from 4.07 (3.30-5.04), 3.75 (3.08-4.55), 8.33 (7.01-11.11) and 7.69 (6.19-9.57) before the booster vaccination to 284.84 (215.28-376.86), 233.05 (178.61-304.08), 274.81 (223.64-337.68) and 280.77 (234.59-336.04) in 28 days after the booster vaccination, respectively. The rates of live virus neutralizing antibody seroconversion were all 100% in the 4 groups. The AE incidences following booster vaccination were 18.0% (9 cases), 4.0% (2 cases), 12% (6 cases), and 12% (6 cases) in the 4 groups(P=0.182). No AE was graded as level 3 or worse. No serious AE was reported. Conclusion: One booster vaccination of an inactivated SARS-CoV-2 vaccine administered 6 months after primary vaccination showed good immunogenicity and safety.
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