A Phase 2 Study to Evaluate the Safety, Tolerability, Reactogenicity, and Immunogenicity of Baiya SARS-CoV-2 Vax 2 Vaccine as a Booster Following Vaccination for COVID-19 in Adults Between 18 and 64 Years

The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant to prevent COVID-19 disease.
This is a Phase 2, randomised, and double-blinded study to assess the safety, tolerability, reactogenicity and immunogenicity of Baiya SARS-CoV-2 Vax 2 vaccine, when used as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines.

开始日期2023-12-01

申办/合作机构

Baiya Phytopharm Co., Ltd.

NCT05197712 / Active, not recruiting临床1期

A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, and Reactogenicity of the Baiya SARS-CoV-2 Vax 2 Vaccine in Healthy Adults

The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant. The primary objective aiming to evaluate the safety, tolerability, and reactogenicity of Baiya SARS-CoV-2 Vax 2 in adults (aged between 18 to 64 years, inclusive) after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart IM, up to 28 days after the second vaccination. The secondary objective aiming to evaluate long-term safety profile (up to 1 year) and evaluate immunogenicity after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart.

开始日期2022-03-28

申办/合作机构

Baiya Phytopharm Co., Ltd.

[+1]

NCT04953078 / Completed临床1期

A Phase 1, Randomized, Open-label, Dose-Finding Study to Evaluate the Safety, Tolerability, and Reactogenicity of Escalating Doses of the Baiya SARS-CoV-2 Vax 1 Vaccine in Healthy Adults

This study is a phase 1, open-label, randomized, first-in-human clinical trial to evaluate the safety, tolerability and reactogenicity of escalating doses of Baiya SARS-CoV-2 VAX1 vaccine in participants aged 18-60 for adult groups and 61-75 for elderly groups. Each group will consist of three cohorts to evaluate different doses (low, medium, high) of Baiya SARS-CoV-2 VAX vaccine. Participants will be injected with two doses of the investigational product with a 21-day interval.

开始日期2021-09-11

申办/合作机构

Baiya Phytopharm Co., Ltd.

[+1]

100 项与 Baiya SARS CoV 2 Vax 1(Baiya Phytopharm) 相关的临床结果

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100 项与 Baiya SARS CoV 2 Vax 1(Baiya Phytopharm) 相关的转化医学

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100 项与 Baiya SARS CoV 2 Vax 1(Baiya Phytopharm) 相关的专利（医药）

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项与 Baiya SARS CoV 2 Vax 1(Baiya Phytopharm) 相关的文献（医药）

2023-04-24·Vaccine

Preclinical evaluation of immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant.

Article

作者: Jongkaewwattana, Anan ; Pichyangkul, Sathit ; Taepavarapruk, Pornnarin ; Taychakhoonavudh, Suthira ; Tomai, Mark ; Malaivijitnond, Suchinda ; Thitithanyanont, Arunee ; Srisutthisamphan, Kanjana ; Manopwisedjaroen, Suwimon ; Khorattanakulchai, Narach ; Sunyakumthorn, Piyanate ; Phoolcharoen, Waranyoo ; Fox, Christopher B. ; Shanmugaraj, Balamurugan ; Praserthsee, Wanlapa

Cost-effective, and accessible vaccines are needed for mass immunization to control the ongoing coronavirus disease 2019 (COVID-19), especially in low- and middle-income countries (LMIC).A plant-based vaccine is an attractive technology platform since the recombinant proteins can be easily produced at large scale and low cost. For the recombinant subunit-based vaccines, effective adjuvants are crucial to enhance the magnitude and breadth of immune responses elicited by the vaccine. In this study, we report a preclinical evaluation of the immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052 (TLR7/8 agonist)-Alum adjuvant. This vaccine formulation, named Baiya SARS-CoV-2 Vax 2, induced significant levels of RBD-specific IgG and neutralizing antibody responses in mice. A viral challenge study using humanized K18-hACE2 mice has shown that animals vaccinated with two doses of Baiya SARS-CoV-2 Vax 2 established immune protection against SARS-CoV-2. A study in nonhuman primates (cynomolgus monkeys) indicated that immunization with two doses of Baiya SARS-CoV-2 Vax 2 was safe, well tolerated, and induced neutralizing antibodies against the prototype virus and other viral variants (Alpha, Beta, Gamma, Delta, and Omicron subvariants). The toxicity of Baiya SARS-CoV-2 Vax 2 was further investigated in Jcl:SD rats, which demonstrated that a single dose and repeated doses of Baiya SARS-CoV-2 Vax 2 were well tolerated and no mortality or unanticipated findings were observed. Overall, these preclinical findings support further clinical development of Baiya SARS-CoV-2 Vax 2.

2023-03-01·Biotechnology Reports

Immunogenicity and efficacy of recombinant subunit SARS-CoV-2 vaccine candidate in the Syrian hamster model

Article

作者: Shanmugaraj, Balamurugan ; Akkhawattanangkul, Yada ; Paungpin, Weena ; Phoolcharoen, Waranyoo ; Thitithanyanont, Arunee ; Manopwisedjaroen, Suwimon ; Khorattanakulchai, Narach

SARS-CoV-2 causes devastating impact on the human population and has become a major public health concern. The frequent emergence of SARS-CoV-2 variants of concern urges the development of safe and efficacious vaccine against SARS-CoV-2 variants. We developed a candidate vaccine Baiya SARS-CoV-2 Vax 1, based on SARS-CoV-2 receptor-binding domain (RBD) by fusing with the Fc region of human IgG. The RBD-Fc fusion was produced in Nicotiana benthamiana. Previously, we reported that this plant-produced vaccine is effective in inducing immune response in both mice and non-human primates. Here, the efficacy of our vaccine candidate was tested in Syrian hamster challenge model. Hamsters immunized with two intramuscular doses of Baiya SARS-CoV-2 Vax 1 induced neutralizing antibodies against SARS-CoV-2 and protected from SARS-CoV-2 challenge with reduced viral load in the lungs. These preliminary results demonstrate the ability of plant-produced subunit vaccine Baiya SARS-CoV-2 Vax 1 to provide protection against SARS-CoV-2 infection in hamsters.

2022-07-01·Vaccine

Preclinical evaluation of a plant-derived SARS-CoV-2 subunit vaccine: Protective efficacy, immunogenicity, safety, and toxicity

Article

作者: Malaivijitnond, Suchinda ; Thitithanyanont, Arunee ; Inthawong, Manutsanun ; Shanmugaraj, Balamurugan ; Srimangkornkaew, Passaraporn ; Klungthong, Chonticha ; Malla, Ashwini ; Suttisan, Nutchanat ; Phoolcharoen, Waranyoo ; Taychakhoonavudh, Suthira ; Reed, Matthew C ; Klinkhamhom, Aekkarin ; Sunyakumthorn, Piyanate ; Hunsawong, Taweewun ; Manopwisedjaroen, Suwimon ; Im-Erbsin, Rawiwan ; Khorattanakulchai, Narach ; Panapitakkul, Chalisa ; Kemthong, Taratorn

Coronavirus disease 2019 (COVID-19) is an acute respiratory illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The prevention of SARS-CoV-2 transmission has become a global priority. Previously, we showed that a protein subunit vaccine that was developed based on the fusion of the SARS-CoV-2 receptor-binding domain (RBD) to the Fc portion of human IgG1 (RBD-Fc), produced in Nicotiana benthamiana, and adjuvanted with alum, namely, Baiya SARS-CoV-2 Vax 1, induced potent immunological responses in both mice and cynomolgus monkeys. Hence, this study evaluated the protective efficacy, safety, and toxicity of Baiya SARS-CoV-2 Vax 1 in K18-hACE2 mice, monkeys and Wistar rats. Two doses of vaccine were administered three weeks apart on Days 0 and 21. The administration of the vaccine to K18-hACE2 mice reduced viral loads in the lungs and brains of the vaccinated animals and protected the mice against challenge with SARS-CoV-2. In monkeys, the results of safety pharmacology tests, general clinical observations, and a core battery of studies of three vital systems, namely, the central nervous, cardiovascular, and respiratory systems, did not reveal any safety concerns. The toxicology study of the vaccine in rats showed no vaccine-related pathological changes, and all the animals remained healthy under the conditions of this study. Furthermore, the vaccine did not cause any abnormal toxicity in rats and was clinically tolerated even at the highest tested concentration. In addition, general health status, body temperature, local toxicity at the administration site, hematology, and blood chemistry parameters were also monitored. Overall, this work presents the results of the first systematic study of the safety profile of a plant-derived vaccine, Baiya SARS-CoV-2 Vax 1; this approach can be considered a viable strategy for the development of vaccines against COVID-19.

100 项与 Baiya SARS CoV 2 Vax 1(Baiya Phytopharm) 相关的药物交易

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