Safety and immunogenicity of homologous versus heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901 SARS-CoV-2 vaccines in adults: An observer-blinded, multi-center, phase 2 randomized trial

Lila Estephan; Ying-Chin Lin; Yi-Tsung Lin; Yen-Hsu Chen; Sung-Ching Pan; Szu-Min Hsieh; Paal Fure Torkehagen; Yi-Jen Weng; Hao-Yuan Cheng; Josue Antonio Estrada; Alexander Waits; Charles Chen; Chia En Lien

doi:10.1016/j.vaccine.2023.04.029

Safety and immunogenicity of homologous versus heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901 SARS-CoV-2 vaccines in adults: An observer-blinded, multi-center, phase 2 randomized trial

Vaccine. 2023 May 26;41(23):3497-3505. doi: 10.1016/j.vaccine.2023.04.029. Epub 2023 Apr 12.

Authors

Affiliations

¹ Medigen Vaccine Biologics Corporation, Taipei, Taiwan.
² Department of Family Medicine, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan; Department of Family Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
³ Division of Infectious Diseases, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Emergency and Critical Care Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
⁴ Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; School of Medicine, College of Medicine, National Sun Yat-Sen University, Kaohsiung, Taiwan.
⁵ Department of Internal Medicine, Division of Infectious Diseases, National Taiwan University Hospital, Taipei City, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan.
⁶ Medigen Vaccine Biologics Corporation, Taipei, Taiwan; Institute of Public Health, National Yang Ming Chiao Tung University, Taipei, Taiwan.
⁷ Medigen Vaccine Biologics Corporation, Taipei, Taiwan; Temple University, Philadelphia, PA 19122, USA.
⁸ Medigen Vaccine Biologics Corporation, Taipei, Taiwan; Institute of Public Health, National Yang Ming Chiao Tung University, Taipei, Taiwan. Electronic address: allenlien@medigenvac.com.

Abstract

Objectives: To report the safety and immunogenicity profile of a protein subunit vaccine (MVC-COV1901) compared to AZD1222 and mRNA-1273 when given as a third (booster) dose to individuals who have completed different primary vaccine regimens.

Methods: Individuals were classified according to their primary vaccine regimens, including two-dose MVC-COV1901, AZD1222, or mRNA-1273. A third dose of either half-dose MVC-COV1901, full-dose MVC-COV1901, standard-dose AZD1222, half-dose mRNA-1273 was administered in a 1:1:1:1 treatment ratio to individuals with an interval range of 84-365 days after the second dose. Endpoints included safety, humoral immunogenicity, and cell-mediated immune response on trial days 15 and 29. Exploratory endpoint included testing against variants of concern (Omicron).

Results: Overall, 803 participants were randomized and boosted - 201 received half-dose MVC-COV1901, 196 received full-dose MVC-COV1901, 203 received AZD1222, and 203 received half-dose mRNA-1273. Reactogenicity was mild to moderate, and less in the MVC-COV1901 booster group. Heterologous boosting provided the best immunogenic response. Boosting with mRNA-1273 in MVC-COV1901 primed individuals induced the highest antibody titers, even against Omicron, and cell-mediated immune response.

Conclusions: Overall, MVC-COV1901 as a booster showed the best safety profiles. MVC-COV1901 as a primary series, with either homologous or heterologous booster, elicited the highest immunogenic response.

Clinicaltrials: gov registration NCT05197153.

Keywords: Booster; COVID-19; MVC-COV1901; Omicron strain; SARS-CoV-2 vaccine; Subunit vaccine.

Publication types

Clinical Trial, Phase II
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

2019-nCoV Vaccine mRNA-1273
Adult
Antibodies, Neutralizing
Antibodies, Viral
COVID-19 Vaccines* / adverse effects
COVID-19* / prevention & control
ChAdOx1 nCoV-19
Humans
Immunogenicity, Vaccine
SARS-CoV-2

Substances

2019-nCoV Vaccine mRNA-1273
Antibodies, Neutralizing
Antibodies, Viral
ChAdOx1 nCoV-19
COVID-19 Vaccines

Associated data

ClinicalTrials.gov/NCT05197153