Randomized, controlled, blinded clinical trial to evaluate the safety, immunogenicity and efficacy of the self-amplifying RNA vaccine ARCT-154 for prevention of SARS-CoV-2 infection in adults

Overview

During the complex and evolving COVID-19 pandemic, many vaccines worldwide were granted emergency use authorization to control the outbreak. However, in Vietnam, vaccine supply was initially limited, restricting the country’s ability to proactively protect public health and end the pandemic.
Following directives from the Prime Minister and the Ministry of Health on COVID-19 vaccine technology transfer to rapidly secure domestic vaccine supply, Vingroup, through its subsidiary VinBioCare Biotechnology Joint Stock Company, engaged in discussions with Arcturus Therapeutics, Inc. (USA) to introduce the technology and conduct clinical trials of an mRNA COVID-19 vaccine (ARCT-154) in Vietnam.
This vaccine uses self-amplifying mRNA (sa-mRNA) technology, developed with the aim of inducing stronger, longer-lasting, and broader immune responses than traditional mRNA vaccines. This platform allows for lower doses, reduced production costs, and improved storage characteristics.
The ARCT-154 clinical trial was designed as a multicenter, randomized, double-blind, controlled trial with placebo-controlled phases (Phase 1, 2, 3a, 3b) and an active-controlled Phase 3c comparing ARCT-154 with the ChAdOx1 nCoV-19 vaccine from AstraZeneca.

Inclusion Criteria

Men and women aged ≥18 years (or 18 to <60 years for Phase 1), who had not previously received any COVID-19 vaccine
Participants in Phases 1 and 2 needed to be able to access and use an electronic diary

Exclusion Criteria

Ongoing acute illness or severe infection
Pregnant or breastfeeding women, or women unwilling to use appropriate contraception for 2 months after vaccination
History of COVID-19 infection or close contact with a confirmed case within 7 days prior to screening
History of anaphylaxis, bleeding disorders, or immunodeficiency/immunosuppression
Planned vaccination with any COVID-19 vaccine outside this study

PI

Prof, PhD Ta Thanh Van
Assoc. Prof, PhD Pham Thi Van Anh
Hanoi Medical University (responsible for sites in Hanoi, Bac Ninh, and Thanh Hoa)

PhD, MD Nguyen Vu Thuong
Pasteur Institute Ho Chi Minh City (responsible for sites in Tien Giang, Dong Thap, Vinh Long)

Assoc. Prof, PhD Pham Ngoc Hung
Assoc. Prof, PhD Chu Van Men
Military Medical Academy (responsible for sites in Hung Yen)

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