Cuba reports 92.4% efficacy against 3-dose SOBERANA 02 COVID-19 vaccine

Coronavirus disease (COVID-19) in 2019 causes an estimated 5 million deaths worldwide and more than 248 million infections with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) It has been recorded. Rapid development of safe and effective vaccines was a top priority, with several vaccines launched at the end of 2020.

New survey published on preprint server medRxiv * Explain the safety results, Effectiveness Phase trial of the new COVID-19 vaccine from Cuba.

study: Efficacy and safety of SOBERANA 02, a COVID-19 conjugate vaccine in a combination of three heterologous doses. Image Credit: Fit Ztudio / Shutterstock.com

Investigation result

Vaccines are a high priority public health intervention. However, the success of the vaccination program depends on the speed and scope of deployment.

SOBERANA 02 is the first conjugate vaccine developed against SARS-CoV-2.The vaccine uses the viral recombinant receptor binding domain (RBD) Spike proteinIt chemically adheres to the tetanus toxoid antigen at a molar ratio of 6: 1 and adsorbs to 500 micrograms (µg) of alumina. Conversely, SOBERANA Plus contains 50 µg of dimer RBD adsorbed on 1,250 µg of alumina.Universal booster.. “

This adds SOBERANA 02 to other conjugate vaccines, such as protein-polysaccharide conjugate vaccines. Haemophilus influenzae Type b, Meningococcus, When Streptococcus pneumoniae..

Current vaccines have been shown to induce two doses Neutralizing antibodyIt secretes interferon gamma (IFN-γ), along with both memory B and T cells, and exhibits an immune T helper cell type 1 (Th1) profile.

This vaccine can also be used as a heterologous third booster dose to increase the level of neutralized anti-RBD antibody. After successful Phase 1 and 2a trials, Phase 3 trials were initiated to evaluate the efficacy and safety profile of SOBERANA’s two usage patterns, including the SOBERANA 02 double-dose regimen, with the third dose. This regimen when combined was appreciated. SOBERANA Plus.

Participants in the current study were all healthy adults from different parts of Havana, Cuba. Each participant was assigned to the vaccine and control groups in a randomized, double-blind, placebo-controlled method. The average age was 48 and the number of men and women was about the same.

One group (A) received two doses of allogeneic regimen, the second group (Group B) received a heterologous three-dose regimen, and the third group (Group C) received placebo. None of the final participants confirmed SARS-CoV-2 infection at any time.

Group A had 0.8 COVID-19 cases per 1,000 person-years (PY) and placebo 2.7 cases, which corresponded to 198 cases and 155 cases, respectively, and 71% of the efficacy of the double-dose vaccine (VE) compared to placebo. Is shown. ..

In the heterologous triple-dose regimen, VE was more than 92% compared to placebo, with an incidence of 0.1 per 1,000 PY in group B (170 and 155 in groups B and C, respectively).

Defensive power against severe COVID-19 was 63% in Group A and 100% in Group B. By comparison, VE was 59% and 100%, respectively, when considering deaths from COVID-19.

Implications

Current studies have shown that SOBERANA 02-conjugated vaccine is safe and effective in preventing severe COVID-19 in adults up to age 80 years. Over 60% of VE was expected during the period when the ancestral SARS-CoV-2 strain was circulating. However, 62% VE was achieved even during the period when the predominant strain was the beta SARS-CoV-2 mutant (VOC).

The SARS-CoV-2 beta strain accounted for 74% of the sequences isolated at the time in Havana. High VE was observed despite the presence of an E484K mutation in the serum of individuals immunized by natural infection or vaccination to confer resistance to neutralizing antibodies.

By the time the final analysis was done, DeltaVOC was the major circulating strain. However, at this point, the VE for the two doses was 71%. VE exceeded 92% in the heterologous triple-dose regimen, but remained high regardless of circulating VOCs.

Even at 2 months, the safety profile is impressive, with mild transient local reactions and no serious side effects reported. The third dose of the vaccine had few side effects.

The final VE is obtained from the edited numbers 14 days after the last immunization or 70 days after the first dose of the triple dose regimen. Although this vaccine clearly provided protection against beta and delta VOCs, further work is essential to assess immune persistence and VE of circulating VOCs.

“”In summary, SOBERANA 02 was found to be a promising vaccine that could be used in a double-dose regimen or in a heterogeneous triple-dose combination with SOBERANA Plus to combat the COVID 19 pandemic in the adult population.According to safety profile and efficacy, it is a potential vaccine for childhood age.. “

*Important Notices

medRxiv Publish preliminary scientific reports that should not be considered definitive as they are not peer-reviewed, guide clinical practice / health-related behaviors, and should not be treated as established information