Covid-19 Living Data

Trial NCT05054621
Publication Chen C, Nat Commun, 2022
Dates: 2021-10-01 to 2022-02-01
Funding: Mixed (Ministry of Health and Welfare of Taiwan ; Chang Gung Memorial Hospital ; Ministry of Science and Technology of Taiwan ; Medigen Vaccine Biologics Corp)
Conflict of interest: no COI

Methods
	RCT
	Location : Single center / Taiwan Follow-up duration (months): 0.9
	ChAdOx1/ChAdOx1 (n =50 ) ChAdOx1/MVC-COV1901 (n = 50)
Inclusion criteria	Healthy adults without severe disorders age of 20–70 years had their first dose of the ChAdOx1 vaccine For female participants, they must be either of non-childbearing potential (i.e., surgically sterilized or one year post-menopausal) or, if of childbearing potential, be abstinent or agree to use medically effective contraception on enrollment continuously until 90 days after boost immunization of study intervention. A negative pregnancy test was required before enrollment.
Exclusion criteria	Previous receipt of two or more COVID-19 vaccine doses 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). This includes latex and polyethylene glycol/macrogol (PEG) Pregnancy, lactation or willingness/intention to become pregnant within 3 months post boost vaccine Malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for treatment of solid organ cancer/hematological malignancy within the 6 months prior to enrolment Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture Suspected or known current alcohol or drug dependency 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 Insufficient level of language to undertake all study requirements in opinion of the Investigators Known HIV antibody positive.
Interventions
	Intervention 1 IM dose of 2.5×10^8 InfU ChAdOx1 and 1 IM dose of 15 mcg MVC-COV1901, 28-70 days apart
	Control 2 IM doses of 2.5×10^8 InfU ChAdOx1, 28-70 days apart
Participants
	Randomized 100 participants
	Characteristics of participants Type of participants: Healthy adults N=100 50 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 22-59
	Description of participants Healthy adults, HIV-negative and without severe disorders, who had received their initial ChAdOx1 dose at a single center in Taiwan.
Primary outcome
	In the register Immunogenicity: Neutralizing antibody against SARS-CoV-2 [ Time Frame: Day 28 after booster dose ] To determine if the immune response to heterologous prime-boost immunization with ChAdOx1 nCOV-19 (AZD1222) and MVC-COV1901 is non-inferior to homologous prime-boost immunization with ChAdOx1 nCOV-19, in enrolled adult participants
	In the report Immune response by neutralizing antibody titer at day 28 after the booster vaccination.
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes, Immediately after publication Data accessibility: The data associated with this study are available within the article, its supplementary information and Source Data file for tables and figures at https://www.nature.com/articles/s41467-022-33146-7#Sec25 Correspondence to Chung-Guei Huang or Kuan-Ying A. Huang (joyce@cgmh.org.tw; arthur1726@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 published article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The article reports preliminary results in a trial in which follow up was continuing at time of reporting. The primary outcomes in the article reflect included, but added to, the primary outcome in the registry. The trial (n = 100) achieved its target sample size (n = 100).