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Updated: Aug 11, 2026

Protocol for Recombinant RBD-based SARS Vaccines: Protein Preparation, Animal Vaccination and Neutralization Detection
Published on: May 2, 2011
Protection efficacy of mRNA-based SARS-CoV-2 variant vaccine in non-human primates
Dongrong Yi1, Yongxin Zhang1, Jing Wang1
1Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences, Beijing 100050, China.
Abstract:
The rapid emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants that evade immunity elicited by vaccination has posed a global challenge to the control of the coronavirus disease 2019 (COVID-19) pandemic. Therefore, developing countermeasures that broadly protect against SARS-CoV-2 and related sarbecoviruses is essential. Herein, we have developed a lipid nanoparticle (LNP)-encapsulated mRNA (mRNA-LNP) encoding the full-length Spike (S) glycoprotein of SARS-CoV-2 (termed RG001), which confers complete protection in a non-human primate model. Intramuscular immunization of two doses of RG001 in Rhesus monkey elicited robust neutralizing antibodies and cellular response against SARS-CoV-2 variants, resulting in significantly protected SARS-CoV-2-infected animals from acute lung lesions and complete inhibition of viral replication in all animals immunized with low or high doses of RG001. More importantly, the third dose of RG001 vaccination elicited effective neutralizing antibodies against current epidemic XBB and JN.1 strains and similar cellular response against SARS-CoV-2 Omicron variants (BA.1, XBB.1.16, and JN.1) were observed in immunized mice. All these results together strongly support the great potential of RG001 in preventing the infection of SARS-CoV-2 variants of concern (VOCs).
Insights
A novel mRNA vaccine (RG001) provides complete protection against SARS-CoV-2 variants in primates. This vaccine candidate shows broad efficacy against multiple variants, including Omicron sublineages, offering hope for controlling COVID-19.
Area of Science:
- Virology
- Immunology
- Vaccine Development
Background:
- Emergence of SARS-CoV-2 variants poses a global challenge to COVID-19 control.
- Existing vaccines show reduced efficacy against immune-evasive variants.
- Need for broad-spectrum countermeasures against SARS-CoV-2 and related sarbecoviruses.
Purpose of the Study:
- To develop and evaluate a novel mRNA vaccine (RG001) encoding the full-length Spike glycoprotein of SARS-CoV-2.
- To assess the protective efficacy of RG001 against SARS-CoV-2 variants in a non-human primate model.
- To investigate the neutralizing antibody and cellular immune responses elicited by RG001.
Main Methods:
- Development of a lipid nanoparticle (LNP)-encapsulated mRNA vaccine (mRNA-LNP) encoding the full-length Spike (S) glycoprotein of SARS-CoV-2 (RG001).
- Intramuscular immunization of Rhesus monkeys with two doses of RG001.
- Assessment of neutralizing antibodies, cellular responses, viral replication, and lung lesions in immunized animals post-challenge.
- Evaluation of a third dose of RG001 in mice against Omicron variants (BA.1, XBB.1.16, JN.1).
Main Results:
- Two doses of RG001 conferred complete protection in Rhesus monkeys, preventing acute lung lesions and viral replication.
- RG001 elicited robust neutralizing antibodies and cellular responses against SARS-CoV-2 variants.
- A third dose of RG001 demonstrated effective neutralizing antibodies against epidemic strains XBB and JN.1.
- Similar cellular responses were observed against SARS-CoV-2 Omicron variants in immunized mice.
Conclusions:
- RG001, an mRNA-LNP vaccine, shows significant potential for broad protection against SARS-CoV-2 and its variants.
- The vaccine candidate effectively induces humoral and cellular immunity, crucial for combating immune-evasive strains.
- RG001 represents a promising countermeasure for controlling the ongoing COVID-19 pandemic.
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