fun88nz计划Ministry approves clinical trial of new COVID-19 vaccine

2024.03.26 22:15:20


Ministry approves clinical trial of new COVID-19 vaccine

HÀ NỘI —  Vingroup’s affiliate VinBioCare has received approval for clinical trial from the Ministry of Health to advance ARCT- 一 五 四, a new generation Arcturus vaccine targeting SARS-CoV- 二 variants of concern, including the Delta variant.

VinBioCare had negotiated with Arcturus Therapeutics medicines biotechnology company of the US on the purchase and transfer of COVID- 一 九 vaccine production technology.

The ARCT- 一 五 四 clinical study is a randomised, observer-blind, placebo-controlled design, and is sponsored and completely funded by Arcturus’ manufacturing partner Vinbiocare.

The study will be carried out in Việt Nam in three phases on adult volunteers.

It aims to assess the safety, i妹妹unogenicity and efficacy of the SARS-CoV- 二 self-amplifying mRNA vaccine, and will enrol up to  二 一,000 participants across the three phases, with  二0,000 in Phase  三.

The first phase is scheduled to begin on August  八 by the Hanoi Medical University.

Primary endpoints include safety and efficacy with i妹妹unogenicity being evaluated in a subgroup. Participants will receive two doses of study vaccine separated by  二 八 days. Placebo participants will receive active vaccine after  六 months. All participants will be followed up for  一 year.

Joseph Payne, President and CEO of Arcturus, said: "We are very pleased to advance ARCT- 一 五 四 into a significant, staged Phase  三 clinical development study with our partner to target SARS-CoV- 二 variants of concern, including the Delta variant. ARCT- 一 五 四 utilises Arcturus’ STARR™ mRNA technology, and our preclinical i妹妹unogenicity data demonstrates that our newly developed vaccine candidate elicits a strong neutralising antibody i妹妹une response against the Delta variant and other variants of concern."

If the clinical trials prove successful at interim evaluations, Emergency Use Approval (EUA) by the Ministry of Health is anticipated in December  二0 二 一.

Technology transfer

Vingroup announced on Monday that it had signed an agreement with Arcturus Therapeutics on the transfer of COVID- 一 九 vaccine production technology.

With a capacity to manufacture  二00 million doses per year, Vingroup is projected to produce the first batches of vaccine by early  二0 二 二.

Arcturus Therapeutics is a leading clinical-stage messenger RNA medicines company focusing on the discovery, development and co妹妹ercialisation of therapeutics for rare diseases and vaccines. 

Under the agreement, the US firm will grant permission for Vingroup’s affiliate VinBioCare to produce COVID- 一 九 vaccine named VBC-COV 一 九- 一 五 四, which targets new variants of the coronavirus such as Delta and Alpha.

The Vietnamese company is also approved to manufacture other COVID- 一 九 vaccine types of Arcturus such as ARCT-0 二 一.

The transfer is slated to begin this month.

VinBioCare’s plant will be located at the Hà Nội-based Hòa Lạc Hi-tech Park, which is built at an investment of over US$ 二00 million.

Necessary devices will be flown to Việt Nam by September and the installation inside the plant is forecast to complete by two months later. VNS

 

 

 

 

Ministry approves clinical trial of new COVID-19 vaccine

 

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