A Prospective, Multi-centre, Open-labelled, Randomized, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability and Immunogenicity of GEMCOVAC-OM as a booster in Subjects 18 years of age and older

开始日期2022-10-17

申办/合作机构

Gennova Biopharmaceuticals Ltd.

100 项与 GEMCOVAC-OM 相关的临床结果

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100 项与 GEMCOVAC-OM 相关的转化医学

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100 项与 GEMCOVAC-OM 相关的专利（医药）

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项与 GEMCOVAC-OM 相关的文献（医药）

2024-05-01·Nature medicine

An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial

Article

作者: Savergave, Laxman ; Karmalkar, Abhishek ; Singh, Ajay ; Lahoti, Manoj ; Borthakur, Swapnav ; Bulle, Ajay ; Saraf, Amit ; Giri, Krishna ; Agarwal, Praveen ; Vikhe, Vikram ; Rao, A. Venkateshwar ; Kumar, Durgesh ; Kaviraj, Swarnendu ; Baranwal, Ekta ; Jain, Manish Kumar ; Siddiqui, Md. Sabah ; Das, Manoja Kumar ; Shukla, Dhaiwat ; Shende, Prakash ; Barge, Vijaykumar ; Krishnan, Jayashri ; Raghuwanshi, Arjun ; Supe, Pravin Dinkar ; Pophale, Himanshu ; Yadav, Anjali ; Kulkarni, Ruta ; Deshpande, Shrikant ; Bhardwaj, Pankaj ; Gurjar, Rohan ; Kulkarni, Aishwarya ; Virkar, Rashmi ; Deshmukh, Bhaskar ; Shinde, Ravindra Baban ; Tummuru, V. Reddy ; Singh, Sanjay

Abstract:

Here we conducted a multicenter open-label, randomized phase 2 and 3 study to assess the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron-specific (BA.1/B.1.1.529), monovalent, thermostable, self-amplifying mRNA vaccine, GEMCOVAC-OM, when administered intradermally as a booster in healthy adults who had received two doses of BBV152 or ChAdOx1 nCoV-19. GEMCOVAC-OM was well tolerated with no related serious adverse events in both phase 2 and phase 3. In phase 2, the safety and immunogenicity of GEMCOVAC-OM was compared with our prototype mRNA vaccine GEMCOVAC-19 (D614G variant-specific) in 140 participants. At day 29 after vaccination, there was a significant rise in anti-spike (BA.1) IgG antibodies with GEMCOVAC-OM (P < 0.0001) and GEMCOVAC-19 (P < 0.0001). However, the IgG titers (primary endpoint) and seroconversion were higher with GEMCOVAC-OM (P < 0.0001). In phase 3, GEMCOVAC-OM was compared with ChAdOx1 nCoV-19 in 3,140 participants (safety cohort), which included an immunogenicity cohort of 420 participants. At day 29, neutralizing antibody titers against the BA.1 variant of SARS-CoV-2 were significantly higher than baseline in the GEMCOVAC-OM arm (P < 0.0001), but not in the ChAdOx1 nCoV-19 arm (P = 0.1490). GEMCOVAC-OM was noninferior (primary endpoint) and superior to ChAdOx1 nCoV-19 in terms of neutralizing antibody titers and seroconversion rate (lower bound 95% confidence interval of least square geometric mean ratio >1 and difference in seroconversion >0% for superiority). At day 29, anti-spike IgG antibodies and seroconversion (secondary endpoints) were significantly higher with GEMCOVAC-OM (P < 0.0001). These results demonstrate that GEMCOVAC-OM is safe and boosts immune responses against the B.1.1.529 variant. Clinical Trial Registry India identifier: CTRI/2022/10/046475.

2024-03-01·Vaccine

Leveraging the immunoinformatics approach for designing the SARS-CoV-2 omicron-specific antigenic cassette of mRNA vaccine

Article

作者: Wadapurkar, Rucha ; Singh, Sanjay ; Singh, Ajay

Emergence of SARS-CoV-2 Omicron variant has presented a significant challenge to global health, demanding rapid development of mRNA-based vaccines. The mRNA-guided vaccine platforms offer various advantages over traditional vaccine platforms. The mRNA by nature is a short-lived molecule that guides the cells to manufacture antigenic proteins. In the present work, we have created an omicron spike antigenic protein sequence characterized by base composition analysis, modeling, and docking with the ACE-2 receptor. Further, we predicted the B-cell and T-cell epitopes followed by antigenicity, toxicity, and allergenicity. Finally, the protein was reverse translated, codon-optimized, and encoding mRNA sequence was checked for its stability by predicting the secondary structures. A comprehensive examination of in-silico data revealed 628.2 as a potent antigenic candidate that was finally used in Gemcovac®-OM, a heterologous booster mRNA vaccine for COVID-19.

2023-11-01·Biochemical and biophysical research communications

Evaluation of self-amplifying mRNA platform for protein expression and genetic stability: Implication for mRNA therapies

Article

作者: Mahudkar, Siddhi ; Deo, Swarda ; Srivastava, Shalini ; Patare, Aishwarya ; Wadapurkar, Rucha ; Sathe, Madhura ; Rade, Saniya ; Desai, Kaushik ; Prasanna, Pragya ; Singh, Ajay

The consecutive launch of mRNA vaccines like mRNA-1273, BNT 162b2, and GEMCOVAC®-19 against COVID-19 has triggered the debate of long-term expression, safety, and genomic integration of the mRNA vaccine platforms. In the present study, we examined the longevity of antigenic protein expression of mRNA-614 and mRNA-S1LC based on self-amplifying mRNA (SAM) in Expi-293F™, HEK-293 T, and ARPE-19 cells. The protein expression was checked by sandwich-ELISA, FACS, luciferase activity assay, and Western blot. The transcribed antigenic mRNA was sequenced and found to be un-mutated. Additionally, no genomic integration of the reverse transcribed mRNA was observed even up to 7 days post-transfection as verified by PCR. Furthermore, we have generated high-quality 3D structures of non-structural proteins (nsPs) in silico and the genes encoding for the nsPs were cloned and expressed using the T7 system. Findings from the current study have strengthened the fact that the alphavirus-based SAM platform has the potential to become a modality in the upcoming years.

项与 GEMCOVAC-OM 相关的新闻（医药）

2024-04-24

·BioSpace

Nature Publication Highlights the Benefits of Tropis® Intradermal When Used to Administer a First-in-Class Self-Amplifying mRNA Vaccine

Delivery of a novel self-amplifying mRNA (samRNA)-based vaccine with Tropis ID System directly into the dermis significantly boosts immune responses. This study shows that intradermal (ID) delivery of a samRNA vaccine with liquid nano-emulsion is safe and well-tolerated. GEMCOVAC®-OM samRNA vaccine is a low dose, room temperature stable mRNA vaccine that was licensed under emergency use authorization in 2023. GOLDEN, Colo.--(BUSINESS WIRE)-- PharmaJet®, a company that strives to improve the performance and outcomes of medicines with its innovative delivery systems, today announced the Nature publication1 of Gennova Biopharmaceutical’s Phase 2/3 clinical trial conducted to evaluate the safety and immunogenicity of its novel samRNA-based Covid-19 vaccine booster. The results demonstrated that GEMCOVAC-OM, administered exclusively with Tropis, is well-tolerated with no related serious adverse events and significantly boosts immune responses against the Omicron variant. Furthermore, the publication cited that the self-amplifying, thermostable mRNA platform delivered intradermally with Tropis provides a framework for next-generation vaccines that can improve accessibility and global equity. This press release features multimedia. View the full release here: The PharmaJet pioneering technology unlocks the rich potential of the human dermis, paving the way for enhanced immune responses. (Graphic: Business Wire) ID delivery is known to have the potential to improve the performance of vaccines, but this study is the first time a samRNA vaccine has been developed with a lipid nano-emulsion, and the data show that ID administration of this vaccine is safe and well-tolerated. Tropis unlocks the rich potential of the human dermis, paving the way for enhanced immune responses. Vaccine delivery directly into the dermis enables access to the immune system, with benefits on durability and breadth of immune response, and mucosal immunity. Tropis also enables access to immune cell populations more directly thus creating the potential for dose sparing. PharmaJet has partnered with Gennova to improve the performance and outcomes of their samRNA platform with PharmaJet’s breakthrough ID delivery technology. The outcome of this collaboration is a needle-free self-amplifying vaccine with advantages over the other mRNA vaccines approved for COVID-19: GEMCOVAC-OM is a lyophilized vaccine, stable at 2-8°C, which means it can be distributed through the existing refrigeration supply chain. The booster vaccine is exclusively administered intradermally with Tropis. Tropis leverages the rich network of dendritic cells, macrophages, and T cells in the dermal layer providing a more potent and broader immunogenic response than vaccinating into the muscle. Tropis is prequalified by the WHO and approved by numerous regulatory bodies globally. As a needle-free delivery System, Tropis eliminates the need for sharps disposal and needle-stick injuries, as well as increases coverage due to its high acceptability among caregivers and healthcare workers. “We congratulate our partner Gennova for their compelling data published in this prestigious journal,” said Chris Cappello, President, and Chief Executive Officer, PharmaJet. “This new data adds to the evidence base indicating Tropis needle-free ID administration is an enabler for vaccine platforms.” Tropis ID (for intradermal administration) and Stratis® SC/IM (for intramuscular and subcutaneous administration) are the only commercially scaled needle-free technologies that enhance the performance of several vaccines and therapeutics. PharmaJet has over 80 global development partners and Tropis has been used to perform over 10 million vaccinations in several countries. For more information about PharmaJet visit . Refer to Instructions for Use to ensure safe injections and to review risks. 1 An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial | Nature Medicine About PharmaJet The PharmaJet mission is to improve the performance and outcomes of medicines with our innovative delivery systems that better activate the immune system. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Precision Delivery Systems™ can improve increased vaccine effectiveness, allow for a preferred patient and caregiver experience, and offer a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections. They are both commercially available for global immunization programs. For more information or if you are interested in partnering with PharmaJet to improve the impact of your novel development program, visit or contact PharmaJet here. Follow us on LinkedIn. View source version on businesswire.com: Contacts Nancy Lillie Nancy.Lillie@pharmajet.com 1-888-900-4321 Option 3 Source: PharmaJet Smart Multimedia Gallery Photo The PharmaJet pioneering technology unlocks the rich potential of the human dermis, paving the way for enhanced immune responses. (Graphic: Business Wire) Logo View this news release and multimedia online at:

疫苗信使RNA免疫疗法

2023-04-04

·Pharmaceutical Technology

Gennova applies for Covid-19 booster emergency use authorisation in India

Gennova’s Covid-19 booster has been designed for treating the Omicron variant. Credit: Viktor Forgacs on Unsplash. Gennova Biopharmaceuticals has applied for an emergency use authorisation (EUA) from the Drug Controller General of India (DCGI) for its mRNA-based Omicron-specific Covid-19 booster vaccine. The firm, which is a partner of PharmaJet, has submitted interim safety and immunogenicity endpoints data from the Phase II/III trial to the Indian regulator to secure the EUA. The move follows a rise in the incidence of Covid-19 in India. Pharmajet stated that Gennova’s booster is the first in India for treating the Omicron variant. Dubbed GEMCOVAC-OM, the needle-free vaccine will be delivered intradermally with the PharmaJet Tropis Precision Delivery System (PDS). The lyophilised vaccine remains stable at 2°C-8°C and can be distributed using the current refrigeration supply chain across India, along with other low and middle-income countries (LMICs). Unlike other approved mRNA vaccines, GEMCOVAC-OM need not be stored in ultra-low temperature environments. The vaccine was evaluated for its safety and immunogenicity as a booster in subjects who received two doses of Covishield and Covaxin, the two major Covid-19 vaccines administered in the country. Gennova Biopharmaceuticals CEO Sanjay Singh said: “We are seeing encouraging results with precise intradermal delivery of our vaccine using the PharmaJet Tropis needle-free solution. “After launching this Omicron booster, we are eager to grow the partnership with PharmaJet to leverage all the benefits of needle-free delivery and our lyophilised mRNA platform.” Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Optimise your cell therapy process: a guide to cell thawing Typically carried out at the point of care, errors in cell therapy thawing could compromise treatment efficacy, leading to significant patient impact as well as high costs and a compromised reputation for the product’s developer. This guide addresses how cell thawing has historically developed into the new techniques used today, along with the physical and biological implications of key metrics and components such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy