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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.
Estephan, Lila; Lin, Ying-Chin; Lin, Yi-Tsung; Chen, Yen-Hsu; Pan, Sung-Ching; Hsieh, Szu-Min; Torkehagen, Paal Fure; Weng, Yi-Jen; Cheng, Hao-Yuan; Estrada, Josue Antonio; Waits, Alexander; Chen, Charles; Lien, Chia En.
  • Estephan L; Medigen Vaccine Biologics Corporation, Taipei, Taiwan.
  • Lin YC; 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.
  • Lin YT; 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.
  • Chen YH; Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; School of Medicine, College of Medicine, National Sun Yat-Sen University, Kaohsiung, Taiwan.
  • Pan SC; Department of Internal Medicine, Division of Infectious Diseases, National Taiwan University Hospital, Taipei City, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan.
  • Hsieh SM; Department of Internal Medicine, Division of Infectious Diseases, National Taiwan University Hospital, Taipei City, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan.
  • Torkehagen PF; Medigen Vaccine Biologics Corporation, Taipei, Taiwan.
  • Weng YJ; Medigen Vaccine Biologics Corporation, Taipei, Taiwan.
  • Cheng HY; Medigen Vaccine Biologics Corporation, Taipei, Taiwan.
  • Estrada JA; Medigen Vaccine Biologics Corporation, Taipei, Taiwan.
  • Waits A; Medigen Vaccine Biologics Corporation, Taipei, Taiwan; Institute of Public Health, National Yang Ming Chiao Tung University, Taipei, Taiwan.
  • Chen C; Medigen Vaccine Biologics Corporation, Taipei, Taiwan; Temple University, Philadelphia, PA 19122, USA.
  • Lien CE; Medigen Vaccine Biologics Corporation, Taipei, Taiwan; Institute of Public Health, National Yang Ming Chiao Tung University, Taipei, Taiwan. Electronic address: allenlien@medigenvac.com.
Vaccine ; 41(23): 3497-3505, 2023 05 26.
Article in English | MEDLINE | ID: covidwho-2294781
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 1111 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans Language: English Journal: Vaccine Year: 2023 Document Type: Article Affiliation country: J.vaccine.2023.04.029

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans Language: English Journal: Vaccine Year: 2023 Document Type: Article Affiliation country: J.vaccine.2023.04.029