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Clinical Trial
. 2023 Mar 24;41(13):2253-2260.
doi: 10.1016/j.vaccine.2023.02.018. Epub 2023 Feb 10.

Six-month safety follow-up of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in adults: A phase 2/3, double-blind, randomized study

Romana Hosain  1 , Peter Aquino  2 , Carmen Baccarini  2 , Igor Smolenov  2 , Ping Li  2 , Haijing Qin  2 , Carole Verhoeven  2 , Branda Hu  2 , Yung Huang  2 , Pilar Rubio  2 ; SPECTRA Study Group  2
Affiliations
Clinical Trial

Six-month safety follow-up of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in adults: A phase 2/3, double-blind, randomized study

Romana Hosain et al. Vaccine. .

Abstract

Background: We evaluated the safety of SCB-2019, a protein subunit vaccine candidate containing a recombinant SARS-CoV-2 spike (S) trimer fusion protein, combined with CpG-1018/alum adjuvants.

Methods: This ongoing phase 2/3, double-blind, placebo-controlled, randomized trial is being conducted in Belgium, Brazil, Colombia, the Philippines, and South Africa in participants ≥ 12 years of age. Participants were randomly assigned to receive 2 doses of SCB-2019 or placebo administered intramuscularly 21 days apart. Here, we present the safety results of SCB-2019 over the 6-month period following 2-dose primary vaccination series in all adult participants (≥18 years of age).

Results: A total of 30,137 adult participants received at least one dose of study vaccine (n = 15,070) or placebo (n = 15,067) between 24 March 2021 and 01 December 2021. Unsolicited adverse events, medically-attended adverse events, adverse events of special interest, and serious adverse events were reported in similar frequencies in both study arms over the 6-month follow-up period. Vaccine-related SAEs were reported by 4 of 15,070 SCB-2019 recipients (hypersensitivity reactions in two participants, Bell's palsy, and spontaneous abortion) and 2 of 15,067 placebo recipients (COVID-19, pneumonia, and acute respiratory distress syndrome in one participant and spontaneous abortion in the other one). No signs of vaccine-associated enhanced disease were observed.

Conclusions: SCB-2019 administered as a 2-dose series has an acceptable safety profile. No safety concerns were identified during the 6-month follow-up after the primary vaccination.

Clinical trials registration: NCT04672395; EudraCT: 2020-004272-17.

Keywords: COVID-19; Recombinant; SARS-CoV-2; SCB-2019; Safety; Vaccine.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: RH, PA, IS, PL, HQ, CV, BH, and YH are employees of Clover Biopharmaceuticals and may own stocks in the company. CB is an employee of Clover Biopharmaceuticals and owns stocks in Clover Biopharmaceuticals, GSK, and Sanofi. PR was an employee of Clover Biopharmaceuticals at the time of the study conduct and owns stocks in the company.

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