Covid-19 Living Data

Trial NCT05132855
Publication Chuang C-H, J Clin Virol, 2022
Dates: 2021-11-29 to 2021-12-14
Funding: Mixed (Medigen Vaccine Biologics Corporation and Chang Gung Memorial Hospital (both to CHC), the Research Center for Epidemic Prevention Science, Chang Gung University and Chang Gung Memorial Hospital (to CHC and Shih SR). All vaccines were acquired from Taiwan CDC.)
Conflict of interest: no COI

Methods
	RCT
	Location : Single center / Taiwan Follow-up duration (months): 5.9
	Booster (after prime by ChAdOx1 nCov-19) 30 mcg BNT162b2 (n = 85) 50 mcg mRNA-1273 (n = 85) 100 mcg mRNA-1273 (n = 85) 15 mcg MVC-COV1901 (n = 85)
Inclusion criteria	Health care worker between 20 to 65 years of age had received 2 doses of ChAdOx1 nCoV-19 vaccine for more than 90 days (after the second dose) before enrollment willing to give written informed consent in the trial.
Exclusion criteria	History of laboratory confirmed COVID-19 Fever or evidence of upper respiratory tract infections Confirmed COVID-19 cases (PCR-confirmed infection or detectable anti-nucleocapsid protein IgG) History of anaphylaxis, severe allergic disease or reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the listed ingredients of any study vaccine) Malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for treatment of solid organ cancer/hematological malignancy within the 6 months prior to enrollment Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture Has received vaccines other than COVID-19 vaccine within one month Pregnancy or willingness/intention to become pregnant within 3 months post booster vaccine Aged < 20 years or unable to sign informed consent Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data or insufficient level of language to undertake all study requirements in opinion of the Investigators Blood or liver dysfunction determined by blood tests at the 1st visit, including CBC/DC and AST、ALT, determined by infectious disease physician Female subjects aged 20-40 years old with positive hCG pregnancy test (human chorionic gonadotropin urine test) If the anti-N antibody test is positive from the blood test at the 1st visit, the case will be excluded from the analysis of immunogenicity effectiveness in the follow-up.
Interventions
	Intervention 2 IM prime doses 8 weeks apart (ChAdOx1 nCov-19), >90 days before 1 IM booster of 50 mcg mRNA-1273 2 IM prime doses 8 weeks apart (ChAdOx1 nCov-19), >90 days before 1 IM booster of 100 mcg mRNA-1273 2 IM prime doses 8 weeks apart (ChAdOx1 nCov-19), >90 days before 1 IM booster of 15 mcg MVC-COV1901
	Control 2 IM prime doses 8 weeks apart (ChAdOx1 nCov-19), >90 days before 1 IM booster of 30 mcg BNT162b2
Participants
	Randomized 340 participants
	Characteristics of participants Type of participants: Healthcare workers N=340 110 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Health care worker with no history of COVID-19 who had received 2 prime doses of ChAdOx1 nCoV-19 in a single centre in Taiwan.
Primary outcome
	In the register 1. The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination [ Time Frame: Day 28 after third dose boost ] Immunogenicity studies include SARS-CoV-2 anti-spike IgG, the 50% neutralizing antibody titer (NT50) and IFN - secreting T cells specific to whole spike protein. 2. The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination [ Time Frame: Day 180 after third dose boost ]Immunogenicity studies include SARS-CoV-2 anti-spike IgG, the 50% neutralizing antibody titer (NT50) and IFN - secreting T cells specific to whole spike protein. 3. The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination [ Time Frame: Day 360 after third dose boost ] Immunogenicity studies include SARS-CoV-2 anti-spike IgG, the 50% neutralizing antibody titer (NT50) and IFN - secreting T cells specific to whole spike protein.
	In the report Immunogenicity assessed 28 days after booster vaccination, including serum SARS-CoV-2 anti-spike IgG concentration, the 50% neutralizing antibody titers (NT50) against wild-type, alpha, delta and omicron variants, and IFN-γ secreting T cells specific to whole spike protein of the wild type.
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes Data accessibility: Corresponding author Cheng-Hsun Chiu: chchiu@adm.cgmh.org.tw
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the pre-print and its supplement, the study registry was used in data extraction and risk of bias assessment. The target sample size specified in the registry was achieved. Some outcomes were reported at an earlier follow-up timepoint than pre-specified in the registry. There is no change from the trial registration in the population, procedures, or interventions. This trial was updated on December 12th 2022, after publication of study report.