Safety and efficacy of FINLAY-FR-2/1A, a novel protein-based COVID-19 vaccine

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of the coronavirus disease 2019 (COVID-19) pandemic, has claimed more than 6.92 million lives and infected more than 765 million. rice field.Most COVID-19 vaccines target the SARS-CoV-2 spike glycoprotein A receptor-binding domain (RBD) to prevent SARS-CoV-2 from binding to host angiotensin-converting enzyme 2 (ACE-2) receptors.

study: Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial. Image credit: Tatevosian Yana / Shutterstock.com

Background

Preclinical study on protein FINLAY-FR-2 (Soverana 02) subunit vaccine It binds to a tetanus toxoid carrier protein and has been shown to be effective, with similar results in Phase I, II and III clinical trials. These studies demonstrate that the unbound RBD dimer, FINLAY-FR-1A (Soberana Plus), increased the neutralizing capacity of individuals recovering from COVID-19. Moreover, introduction of this protein-based vaccine as his third dose of her FINLAY-FR-2 induced the production of anti-RBD immunoglobulin G (IgG) antibodies.

Several countries, including Iran, Cuba, Venezuela, Belarus, Mexico, and Nicaragua, have approved FINLAY-FR-2 and FINLAY-FR-1A vaccines for emergency use. These vaccines were developed at the Finlay Vaccine Institute in Cuba and manufactured by the Pasteur Institute in Iran and branded as Pastokovac and Pastokovac Plus.

The recently launched safe and effective COVID-19 vaccine is raising hopes for millions of people living in low-income countries. Previously, many governments around the world faced challenges due to the high cost of vaccines and building adequate infrastructure to store and transport these vaccines at cold temperatures.

Two key advantages of RBD-based vaccines are rapid production and affordability. Additionally, these vaccines are temperature stable in the range of 2°C to 8°C.

About research

Recent JAMA network open This study evaluated the safety profile, immunogenicity, and effectiveness of Iranian FINLAY-FR-1A. To this end, cohort 1 was used to evaluate his 2-dose regimen of FINLAY-FR-2 (25 μg) and cohort 2 received a 2-dose regimen of FINLAY-FR-2 plus his FINLAY- A third dose of FR was administered. -1A (50 μg).

In this study, participants were recruited from eight different cities. Cohort 1 included 17,319 participants from 6 cities and cohort 2 included 5,521 volunteers from 2 cities.

All participants were adults aged 18 to 80 with no history of SARS-CoV-2 infection or COVID-19 vaccination. In addition, no candidate had congenital or uncontrolled he-type 2 diabetes, chronic liver disease, hypertension, and chronic kidney disease.

FINLAY-FR-2 was administered intramuscularly twice 28 days apart. Cohort 2 introduced his FINLAY-FR-1A on day 56 as his third dose. An enzyme-linked immunosorbent assay (ELISA) was performed to measure anti-S1 IgG levels.

Investigation result

The mean age of participants was 39.3 years in cohort 1 and 39.7 years in cohort 2. No significant age difference was observed between the vaccinated and placebo groups.

Two doses of FINLAY-FR-2 in Cohort 1 effectively prevented COVID-19. Vaccine efficacy (VE) for cohort 1 was estimated at 49.7% for symptomatic SARS-CoV-2 infection, 76.8% for severe infection, and 77.7% for infection-related hospitalization.

In cohort 2, VE was significantly higher after the third vaccination. More specifically, this vaccine regimen was associated with 64.9% VE for preventing symptomatic infection and 96.6% VE for severe infection and hospitalization.

The VE of the current trial is lower compared to that of a phase III randomized trial conducted in Cuba, which may be due to differences in infection intensity and comorbidities in the study cohorts. Notably, the VE estimated in this study was among the Delta variant predominance.

Conclusion

An effective protein-based COVID-19 vaccine may have greater potential due to its stability and ease of distribution. Similarly, the findings indicate that FINLAY-FR-2 can be used as his third COVID-19 vaccine that is affordable and effective in resource-limited settings.

Two of the main strengths of this study are the large sample size and the geographical diversity of the participants. Nevertheless, the current study has some limitations, such as the selection of participants with controlled underlying diseases that may affect VE.

The authors also were unable to perform serological analysis of all participants at baseline due to limited resources. This may reduce the generalizability of the findings, as mass vaccination for COVID-19 prioritized the elderly group and previously vaccinated individuals were excluded from this trial.

Despite these limitations, the FINLAY-FR-2 vaccine and FINLAY-FR-1A as a booster dose were effective against SARS-CoV-2 infection. Both FINLAY-FR-2 and FINLAY-FR-1A were well tolerated among participants and demonstrated excellent safety profiles.