Homologous and Heterologous Boosting of the Chadox1-S1-S COVID-19 Vaccine With the SCB-2019 Vaccine Candidate: A Randomized, Controlled, Phase 2 Study

Sue Ann Costa Clemens; Eveline Pipolo Milan; Eduardo Sprinz; José Cerbino Neto; Filippo Pacciarini; Ping Li; Hui Ling Chen; Igor Smolenov; Andrew Pollard; Ralf Clemens

doi:10.1093/ofid/ofac418

Homologous and Heterologous Boosting of the Chadox1-S1-S COVID-19 Vaccine With the SCB-2019 Vaccine Candidate: A Randomized, Controlled, Phase 2 Study

Open Forum Infect Dis. 2022 Aug 16;9(8):ofac418. doi: 10.1093/ofid/ofac418. eCollection 2022 Aug.

Authors

Affiliations

¹ Oxford Vaccine Group, Department of Pediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.
² Siena University, Siena, Italy.
³ Centro de Estudos e Pesquisa em Moléstias Infecciosas Ltda. (CEPCLIN), Natal, Brazil.
⁴ Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
⁵ D'Or Institute for Research and Education, Rio de Janeiro, Brazil.
⁶ Clover Biopharmaceuticals Inc., Cambridge, Massachusetts, USA.
⁷ International Vaccine Institute, Seoul, Republic of Korea.

Abstract

Background: Ongoing outbreaks of coronavirus disease 2019 (COVID-19) are driven by waning immunity following primary immunizations and emergence of new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants that escape vaccine-induced neutralizing antibodies. It has been suggested that heterologous boosters could enhance and potentially maintain population immunity.

Methods: We assessed the immunogenicity and reactogenicity of booster doses of different formulations of aluminium hydroxide-adjuvanted SCB-2019 vaccine (9 μg of SCB-2019, with or without CpG-1018 adjuvant, or 30 μg of SCB-2019 with CpG-1018) in Brazilian adults primed with ChAdOx1-S vector vaccine. S-protein antibodies and ACE2-binding inhibition were measured by enzyme-linked immunosorbent assay (ELISA) on days 1, 15, and 29. Participants self-reported solicited adverse events and reactions.

Results: All SCB-2019 formulations increased S-protein ELISA antibodies and ACE2 binding inhibition to a greater extent than ChAdOx1-S. After 30 μg of SCB-2019 + CpG + aluminium hydroxide, titers against wild-type S-protein were significantly higher than after ChAdOx1-S on days 15 and 29, as were titers of neutralizing antibodies against the wild-type strain and Beta, Gamma, Delta, and Omicron variants. Boosting with SCB-2019 or ChAdOx1-S was well tolerated, with no vaccine-related serious or severe adverse events.

Conclusions: Boosting ChAdOx1-S-primed adults with SCB-2019 induced higher levels of antibodies against a wild-type strain and SARS-CoV-2 variants than a homologous ChAdOx1-S booster, with the highest responses being with the 30-μg SCB-2019 + CpG + aluminium hydroxide formulation.

Clinical trials registration: NCT05087368.

Keywords: COVID-19; SCB-2019; booster; chAdOx1-S; heterologous; homologous; vaccine.

Associated data

ClinicalTrials.gov/NCT05087368