Fengcai Zhu’s team revealed the safety and immunogenicity results of the recombinant new crown vaccine in healthy people aged 18 years or older: safe and reliable

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In addition to the "first wave" of COVID-19 vaccines, iNature also has many candidate vaccines under development, whose efficacy has not yet been determined, especially vaccines from the protein subunit technology platform (which has accounted for more than 30%)
.

In addition, recombinant subunit vaccines target a wider range of people, are safer for people with relatively low immunity, the elderly and children, and are easy to store and distribute
.

Protein subunit vaccines are promising in the development of COVID-19 vaccines
.

COVID-19 vaccines from multiple manufacturers are needed to deal with the shortage of supplies
.

On July 15, 2021, Fengcai Zhu’s team from the Jiangsu Provincial Center for Disease Control and Prevention published an online publication titled “Safety and immunogenicity of a recombinant COVID-19 vaccine (Sf9 cells) in healthy population aged 18 in Signal Transduction and Targeted Therapy (IF=18.
19).
years or older: two single-center, randomised, double-blind, placebo-controlled, phase 1 and phase 2 trials" research paper, the study conducted two single-center, randomized, double-blind, placebo-controlled phase 1 And Phase 2 trials to evaluate the safety, tolerability and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells) in healthy Chinese people aged 18 years or older
.

Include eligible participants, the ratio of candidate vaccine to placebo in each dose group is 3:1 (Phase 1) or 5:1 (Phase 2)
.

Starting from August 28, 2020, 168 participants will be enrolled and randomly assigned to receive low-dose vaccine, high-dose vaccine or placebo.
The timetable for the phase 1 trial is 0, 28 days or 0, 14, 28 days
.

Starting from November 18, 2020, 960 participants will be randomly assigned to receive low-dose vaccine, high-dose vaccine or placebo, with a schedule of 0, 21 days or 0, 14, 28 days in the phase 2 trial
.

The most common injection site adverse reaction within 7 days in both trials was pain
.

The most common systemic adverse reactions within 7 days are fatigue, cough, sore throat, fever and headache
.

ELISA antibodies and neutralizing antibodies increased on the 14th day, and peaked at 28 days (stage 1) or 30 days (stage 2) after the last dose of vaccination
.

At 28 or 30 days after the last vaccination, the GMT of neutralizing antibodies against live SARS-CoV-2 was the highest in the adult high-dose group (0, 14, 28 days), at 102.
9 (95% CI 61.
9-171.
2) ), which was 102.
6 (95% CI 75.
2-140.
1) in phase 1 and phase 2 trials, respectively
.

The specific T cell response peaked 14 days after the last vaccination in the phase 1 trial
.

This vaccine is safe and will cause a significant immune response after three doses of the vaccine
.

In the past 20 years, following the outbreaks of SARS-CoV and MERS-CoV, SARS-CoV-2 is the third highly pathogenic coronavirus that has appeared in humans
.

SARS-CoV-2 infection has accelerated worldwide, leading to an increase in morbidity and mortality
.

As of June 16, 2021, more than 170 million confirmed cases of COVID-19 have been reported to the World Health Organization (WHO), of which nearly 4 million have died
.

Currently, according to the World Health Organization's survey, there are more than 280 COVID-19 vaccines in development worldwide
.

Among them, 102 vaccines have been approved for clinical trials, including protein subunits (n = 32, accounting for 31%), viral vectors (n = 21, accounting for 21%), and inactivated vaccines (n = 16, accounting for 16%) , DNA or RNA vaccines (n = 26, accounting for 25%), VLP vaccines (n = 5, accounting for 5%) and live attenuated vaccines (n = 2, accounting for 2%)
.

As of now, 25 COVID-19 vaccines are in phase 3 clinical trials, and the "first wave" of 8 COVID-19 vaccines have announced preliminary results, including mRNA vaccines, non-replicating viral vector vaccines, and protein subunits.
The effectiveness of vaccines and inactivated vaccines is between 50% and 95%
.

In addition to the "first wave" of COVID-19 vaccines, there are many candidate vaccines under development, whose efficacy has not yet been determined, especially vaccines from the protein subunit technology platform (which have accounted for more than 30%)
.

In addition, recombinant subunit vaccines target a wider range of people, are safer for people with relatively low immunity, the elderly and children, and are easy to store and distribute
.

Protein subunit vaccines are promising in the development of COVID-19 vaccines
.

The recombinant COVID-19 vaccine in this study uses baculovirus as a vector to express the RBD region of the SARS-CoV-2 spike protein receptor binding domain in Sf9 cells.
This region is isolated and purified and adjuvants are added to prevent COVID-19
.

Here, the study reports the results of the first analysis 28 days (Phase 1) or 30 days (Phase 2) after full-dose vaccination to evaluate the effects of recombinant COVID-19 vaccine (Sf9 cells) in 18-year-old healthy people.
Safety and immunogenicity
.

The study conducted two single-center, randomized, double-blind, placebo-controlled phase 1 and phase 2 trials to evaluate the safety and tolerance of recombinant COVID-19 vaccine (Sf9 cells) in healthy Chinese people aged 18 years or older.
Receptivity and immunogenicity
.

Include eligible participants, the ratio of candidate vaccine to placebo in each dose group is 3:1 (Phase 1) or 5:1 (Phase 2)
.

From August 28, 2020, 168 participants will be enrolled in order and randomly assigned to receive low-dose vaccine, high-dose vaccine or placebo.
The timetable for the phase 1 trial is 0, 28 days or 0, 14, 28 days
.

Starting from November 18, 2020, 960 participants will be randomly assigned to receive low-dose vaccine, high-dose vaccine or placebo, with a schedule of 0, 21 days or 0, 14, 28 days in the phase 2 trial
.

The most common injection site adverse reaction within 7 days in both trials was pain
.

The most common systemic adverse reactions within 7 days are fatigue, cough, sore throat, fever and headache
.

ELISA antibodies and neutralizing antibodies increased on the 14th day, and peaked at 28 days (stage 1) or 30 days (stage 2) after the last dose of vaccination
.

At 28 or 30 days after the last vaccination, the GMT of neutralizing antibodies against live SARS-CoV-2 was the highest in the adult high-dose group (0, 14, 28 days), at 102.
9 (95% CI 61.
9-171.
2) ), which was 102.
6 (95% CI 75.
2-140.
1) in phase 1 and phase 2 trials, respectively
.

The specific T cell response peaked 14 days after the last vaccination in the phase 1 trial
.

This vaccine is safe and will cause a significant immune response after three doses of the vaccine
.

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