View source for Medicine:ARCT-154

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{{short description|Vaccine candidate against COVID-19}}
{{Infobox drug
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| drug_name          = 
| INN                = 
| type               = vaccine
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| caption            = 
| target             = [[Biology:Severe acute respiratory syndrome coronavirus 2|SARS-CoV-2]]
| vaccine_type 	     = mRNA
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| pregnancy_AU       = <!-- A/B1/B2/B3/C/D/X -->
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| legal_AU           = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
| legal_AU_comment   = 
| legal_BR           = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F-->
| legal_BR_comment   = 
| legal_CA           = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_UK           = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM -->
| legal_US           = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_UN           = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_NZ           = <!--Class A, B, C -->
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| routes_of_administration =  [[Biology:Intramuscular injection|Intramuscular]]
<!-- Identifiers -->
| CAS_number         = 
| ATCvet             = 
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| synonyms           = LUNAR-COV19 <br /> VBC-COV19-154
}}
'''ARCT-154''', also known as '''VBC-COV19-154''' in Vietnam, is a [[Medicine:COVID-19 vaccine|COVID-19 vaccine]] candidate developed by Arcturus Therapeutics.<ref name=yahoo0208/><ref name=Bloomberg/> For its development, Arcturus collaborated with Vinbiocare, a Vietnamese company, for support with clinical trials and manufacturing.

== Medical uses ==
The vaccine requires two doses, the second one being administered 28 days after the first shot.<ref name=biopharma-reporter0208/> It is a self-amplifying mRNA vaccine.<ref name=businesswire2>{{cite news|date=2 August 2021|title=Arcturus Announces Approval of a Clinical Trial Application to Advance ARCT-154, a Next Generation STARR™ mRNA Vaccine Targeting the SARS-CoV-2 Delta Variant and Other Variants of Concern|work={{wipe|Business Wire}}|url=https://www.businesswire.com/news/home/20210802005392/en/Arcturus-Announces-Approval-of-a-Clinical-Trial-Application-to-Advance-ARCT-154-a-Next-Generation-STARR%E2%84%A2-mRNA-Vaccine-Targeting-the-SARS-CoV-2-Delta-Variant-and-Other-Variants-of-Concern}}</ref><ref name=yahoo0208>{{cite news|date=August 2, 2021|title=Vingroup collaborates with Arcturus Therapeutics to establish a manufacturing facility in Vietnam for Arcturus' mRNA Covid-19 vaccine|work=[[Software:Yahoo! Finance|Yahoo! Finance]]|url=https://finance.yahoo.com/news/vingroup-collaborates-arcturus-therapeutics-establish-153803287.html}}</ref><ref name=reuters0208/>

== Manufacturing ==
The vaccine candidate can be made in a [[Engineering:Freeze drying|lyophilized]] powder form,<ref name=yahoo0208/> allowed it to be shipped and stored between {{Convert|2|and|8|C|F|abbr=on}}.<ref>{{cite news | vauthors = Huynh M |date=2 August 2021|title=Vingroup nhận chuyển giao độc quyền công nghệ sản xuất vắc xin mRNA phòng COVID-19|work=Tuổi Trẻ | trans-title = Vingroup receives exclusive technology transfer for COVID-19 mRNA vaccines | language = Vietnamese |url=https://tuoitre.vn/vingroup-nhan-chuyen-giao-doc-quyen-cong-nghe-san-xuat-vac-xin-mrna-phong-covid-19-20210802191921769.htm}}</ref>

In August 2021, Arcturus Therapeutics entered a partnership with Vinbiocare, a unit of Vingroup to conduct clinical trials of ARCT-154 COVID-19 vaccine, developed created using Arcturus’ STARR mRNA technology, in Vietnam and establish a manufacturing facility a factory in Hòa Lạc Hi-tech Park, Hanoi, which requires an estimated investment of $200 million and has the capacity to make 200 million doses per year.<ref name=yahoo0208/><ref name=businesswire0208>{{cite news|date=2 August 2021|title=Arcturus Therapeutics Collaborates with Vingroup to Establish Manufacturing Facility in Vietnam for Arcturus' Investigational mRNA Vaccines for COVID-19|work={{wipe|Business Wire}}|url=https://www.businesswire.com/news/home/20210802005320/en/Arcturus-Therapeutics-Collaborates-with-Vingroup-to-Establish-Manufacturing-Facility-in-Vietnam-for-Arcturus%E2%80%99-Investigational-mRNA-Vaccines-for-COVID-19}}</ref><ref name=vnexpress0208/><ref name=Bloomberg>{{cite news | vauthors = Giang NK |date=2 August 2021|title=Arcturus Allows Vietnam's Vingroup to Make Covid Vaccines|work={{wipe|Bloomberg News}}|url=https://www.bloomberg.com/news/articles/2021-08-02/arcturus-agrees-to-let-vietnam-s-vingroup-produce-its-vaccines}}</ref> It is expected that Vingroup will produce its first batches of the vaccine in early 2022.<ref>{{cite news | vauthors = Châu L |date=2 August 2021|title=Vingroup tiếp nhận công nghệ sản xuất vắc xin Covid-19 chống lại các biến chủng mới | trans-title = Vingroup receives Covid-19 vaccine technology transfer to fight against new variants | language = Vietnamese |work=Thanh Niên |url= https://thanhnien.vn/vingroup-tiep-nhan-cong-nghe-san-xuat-vac-xin-covid-19-chong-lai-cac-bien-chung-moi-post1096296.html}}</ref> Arcturus will provide to Vinbiocare access to "proprietary technologies and processes for the manufacture" of its vaccines, as well as an exclusive license to manufacture them solely for sales and use in Vietnam.<ref name=biopharma-reporter0208/><ref name=yahoo0208/><ref name=reuters0208/> This includes all of Arcturus’ other Covid-19 vaccines such as [[Medicine:ARCT-021|ARCT-021]] and other vaccines in the future for disease prevention in Vietnam.<ref name=vnexpress0208/> Vinbiocare will pay $40m upfront, be responsible for technology transfer costs, and "pay for mRNA drug substance supplied by Arcturus and royalties on vaccines produced at the facility".<ref name=biopharma-reporter0208/><ref name=businesswire0208/>


==Clinical trials==

Preclinical research showed that it elicits neutralizing antibodies in non-human primates against COVID-19 variants of concern, including the SARS-CoV-2 Alpha variant, Beta variant, Delta variant, and Gamma variant.<ref name=biopharma-reporter0208/><ref name=reuters0208/><ref name=yahoo0308>{{cite news|date=3 August 2021|title=Arcturus Announces Approval of Singapore Clinical Trial Application to Advance ARCT-154 and ARCT-165, Next Generation STARR™ mRNA Vaccines Targeting SARS-CoV-2 Variants of Concern, in a Phase 1/2 Study|work=[[Software:Yahoo! Finance|Yahoo! Finance]]|url=https://finance.yahoo.com/news/arcturus-announces-approval-singapore-clinical-110000958.html}}</ref>

===In Singapore===
On 3 August, Arcturus Therapeutics confirmed that the company had received approval for a clinical trial of ARCT-154 and another vaccine called ARCT-165 in Singapore. The Phase I-II clinical trial will evaluate the vaccines as a primary vaccination series and a booster following first dose with [[Medicine:Pfizer–BioNTech COVID-19 vaccine|Pfizer–BioNTech COVID-19 vaccine]]. The study is being partially funded by a grant from the Singapore Government.<ref name=yahoo0308/><ref>{{cite news|date=3 August 2021|title=Why Arcturus Therapeutics Stock Is Soaring Today|work=The Motley Fool|url=https://www.fool.com/investing/2021/08/03/why-arcturus-therapeutics-stock-is-soaring-today/}}</ref>

===In Vietnam===
The clinical trials of the vaccine in Vietnam are completely sponsored and funded by Vinbiocare, a Vingroup subsidiary.<ref name=reuters0208/><ref name=biopharma-reporter0208>{{cite news | vauthors = Arthur R |date=2 August 2021|title=Arcturus Therapeutics lines up Phase 1/2/3 trial for next-generation mRNA COVID-19 vaccine|work=Biopharma Reporter|url=https://www.biopharma-reporter.com/Article/2021/08/02/Arcturus-Therapeutics-lines-up-clinical-trials-for-next-generation-mRNA-vaccine}}</ref>

On 2 August, Vinbiocare received regulatory approval to start a clinical trial of its COVID-19 vaccine candidate in Vietnam.<ref name=reuters0208>{{cite news|date=2 August 2021|title=Arcturus to start clinical trial of COVID-19 vaccine in Vietnam|work={{wipe|Reuters}}|url=https://www.reuters.com/business/healthcare-pharmaceuticals/arcturus-start-clinical-trial-covid-19-vaccine-vietnam-2021-08-02/}}</ref><ref name=vnexpress0208>{{cite news|date=2 August 2021|title=Sắp thử nghiệm vaccine Covid-19 thứ ba của Việt Nam | trans-title = Vietnam set to start third Covid-19 vaccine trial | language = Vietnamese |work=VnExpress|url=https://vnexpress.net/sap-thu-nghiem-vaccine-covid-19-thu-ba-cua-viet-nam-4334630.html}}</ref> The company will coordinate with the Ministry of Health to carry out Phase I-III clinical trials of VBC-COV19-154 vaccine on 21,000 adults in three phases in August 2021.<ref name=reuters0208/><ref name=yahoo0208/> The clinical trial Phase 1 will recruit 100 volunteers to evaluate the safety, tolerability, and initial assessment of immunogenicity of the vaccine. The clinical trial Phase 2 enrolled 300 volunteers at designated medical facilities in multiple provinces, while the third phase of human trials is expected to involve 20,600 volunteers, including phase 3a (600 volunteers) and 3b (20,000 volunteers).<ref name=vnexpress0208/><ref>{{cite news | vauthors = Lin T |date=2 August 2021|title=Cho phép thử nghiệm lâm sàng vaccine COVID-19 mua công nghệ mRNA của Mỹ | trans-title = American mRNA Covid-19 vaccine candidate gets green light for trial | language = Vietnamese |work=Lao Động|url=https://laodong.vn/y-te/cho-phep-thu-nghiem-lam-sang-vaccine-covid-19-mua-cong-nghe-mrna-cua-my-937583.ldo}}</ref> Those receiving placebo will receive active vaccine after 6 months, while all participants will be followed up for 1 year.<ref name=businesswire2/> 

In December 2021, the company plans to complete and submit procedures to the Ministry of Health, applying for an emergency authorization in Vietnam.<ref name=vnexpress0208/><ref name=yahoo0208/>

==== Phase I ====
The clinical trial Phase I began on 15-16 August at Hanoi Medical University. Phase I was conducted on 100 healthy volunteers randomly assigned in a ratio of 3:1, i.e. 75% of them received the ARCT-154 vaccine and 25% received a placebo. The primary objective of the phase one trial was to assess safety and immunogenicity of the vaccine. Volunteers will receive 2 doses of ARCT-154 vaccine or placebo, 28 days apart. Data of the volunteers from the first dose (day 1) to 7 days after the second dose (day 36), will be evaluated by the research team.<ref>{{cite news | vauthors = |date=14 August 2021|title=100 người đầu tiên sắp tiêm thử vaccine Covid thứ ba của Việt Nam | trans-title = | language = Vietnamese |work=VnExpress|url=https://vnexpress.net/100-nguoi-dau-tien-sap-tiem-thu-vaccine-covid-thu-ba-cua-viet-nam-4340438.html}}</ref> Phase I report on the safety of the ARCT-154 vaccine was approved by the Ethics Committee on September 20, 2021. Preliminary results show that the ARCT-154 vaccine is safe in healthy volunteers.<ref>{{Cite news|date=29 September 2021|title=Kết quả bước đầu của vaccine ARCT-154|work=Vietnam Government Portal|url=https://baochinhphu.vn/Suc-khoe/Ket-qua-buoc-dau-cua-vaccine-ARCT154/448093.vgp}}</ref><ref name=vnexpress2909/>

==== Phase II and III ====
Phase II and IIIa trials of the vaccine were carried out at the same time in Bắc Ninh, [[Place:Hanoi|Hanoi]] and Long An with a total of 1,000 volunteers. The trial work in the northern localities is carried out by Hanoi Medical University and Pasteur Institute in Ho Chi Minh City in the south. In Bắc Ninh, from 20 to 23 September, the research team started recruiting volunteers and selected 338 people aged 18-65, who received the first dose from 27 to 29 September. In Long An and Hanoi, the Ministry of Health also implemented the first dose for volunteers.<ref name=vnexpress2909>{{cite web|url=https://vnexpress.net/thu-nghiem-vaccine-arct-154-giai-doan-2-va-3a-4364151.html|title=Thử nghiệm vaccine ARCT-154 giai đoạn 2 và 3a|publisher=VnExpress|date=29 September 2021|access-date=29 September 2021|language=vi}}</ref> The phase IIIa trial is expected to end on November 24, and the research team will report the results of the trial to the Ministry of Health on December 30.<ref name=vnexpress2909/>

== References ==
{{reflist}}
{{Vaccines}}

[[Category:Clinical trials]]

{{Sourceattribution|ARCT-154|1}}