A randomized, double-blind, placebo-controlled phase I clinical trial of rotavirus inactivated vaccine (Vero cell) in a healthy adult population aged 18-49 years to assess safety and preliminary observation of immunogenicity.

We conducted a phase I, randomized, double-blind, placebo-controlled trial including healthy adults in Sui County, Henan Province, China. Ninety-six adults were randomly assigned to one of three groups (high-dose, medium-dose, and low-dose) at a 3:1 ratio to receive one vaccine dose or placebo. Adverse events up to 28 days after each dose and serious adverse events up to 6 months after all doses were reported.

Safety, tolerability, and immunogenicity of a CpG/Alum adjuvanted SARS-CoV-2 recombinant protein vaccine (ZR202-CoV) in healthy adults: Preliminary report of a phase 1, randomized, double-blind, placebo-controlled, dose-escalation trial.

This was a phase 1 dose-escalation study of ZR202-CoV, a recombinant protein vaccine candidate containing a pre-fusion format of the spike (S)-protein (S-trimer) combined with the dual-adjuvant system of Alum/CpG. A total of 230 participants were screened and 72 healthy adults aged 18-59 years were enrolled and randomized to receive two doses at a 28-day interval of three different ZR202-CoV formulations or normal saline. We assessed the safety for 28 days after each vaccination and collected blood samples for immunogenicity evaluation.

Design of a mutation-integrated trimeric RBD with broad protection against SARS-CoV-2.

The continuous emergence of SARS-CoV-2 variants highlights the need of developing vaccines with broad protection. Here, according to the immune-escape capability and evolutionary convergence, the representative SARS-CoV-2 strains carrying the hotspot mutations were selected. Then, guided by structural and computational analyses, we present a mutation-integrated trimeric form of spike receptor-binding domain (mutI-tri-RBD) as a broadly protective vaccine candidate, which combined heterologous RBDs from different representative strains into a hybrid immunogen and integrated immune-escape hotspots into a single antigen.

Immunogenicity and safety of a recombinant fusion protein vaccine (V-01) against coronavirus disease 2019 in healthy adults: a randomized, double-blind, placebo-controlled, phase II trial.

Background: Innovative coronavirus disease 2019 (COVID-19) vaccines, with elevated global manufacturing capacity, enhanced safety and efficacy, simplified dosing regimens, and distribution that is less cold chain-dependent, are still global imperatives for tackling the ongoing pandemic. A previous phase I trial indicated that the recombinant COVID-19 vaccine (V-01), which contains a fusion protein (IFN-PADRE-RBD-Fc dimer) as its antigen, is safe and well tolerated, capable of inducing rapid and robust immune responses, and warranted further testing in additional clinical trials. Herein, we aimed to assess the immunogenicity and safety of V-01, providing rationales of appropriate dose regimen for further efficacy study.

[Effects of temperature on the growth, development and reproduction of Dysmicoccus neobrevipes Beardsley (Hemiptera: Pseudococcidae).].

In recent years, Dysmicoccus neobrevipes Beardsley (Hemiptera: Pseudococcidae) is found as one of important alien species in China. For the alien pest, temperature always is a crucial factor on constructing stable population. In this study, the development and reproduction of D.

[Comparison of the kinesis of immune responses in mice vaccinated by different kinds of recombinant hepatitis B vaccines].

Objective: To evaluate the kinesis of cellular and humoral immune responses to different kinds of recombinant hepatitis B(rHB) vaccines in the immunized mice.

Methods: At serial time points, the levels of IFN-gamma and IL-2 secreted by spleens mononuclear cells (MNC) of the vaccinated mice were detected by enzyme-linked immunospot methods (ELISPOT) after stimulation in vitro with HBsAg MHC class I peptide S28-39 or HBsAg. The lymphocytotoxicity of the immunized mice were also detected (CTL) by a specific lysis assay and the levels of anti-HBs were measured by the Abbott IMX kit.

[Cellular immune responses of recombinant hepatitis B (rHB) vaccine and HBsAG derived from Hansenula polymorpha cells].

Objective: To study the kinetics of immune response in mice and human immunized with rHB vaccine or rHBsAg derived from yeast cells (Hansenula polymorpha).

Methods: With different doses,the level of IFN-gamma secreted by spleen mononuclear cells (MNC) including CD8+ T cells by MACs of mice were detected by enzyme-linked immunospot (ELISPOT) methods after stimulation in vitro with HBsAg MHC class I peptide S28-39, respectively. At serial time points, the immunized mice were detected for IFN-gamma by ELISPOT as above and for the lymphocytotoxicity test (CTL) by specific lysis assay.

[Study on the kinesis of cellular immunity in adults vaccinated with recombinant hepatitis B vaccine].

Objective: To evaluate the kinesis of cellular immunity in adults who were vaccinated with yeast recombinant hepatitis B(rHB) vaccine and the correlation between cellular and humoral immune responses induced by the vaccine.

Methods: Eight adults were vaccinated with rHB vaccine according to 0, 1,2 month schedule. The peripheral blood mononuclear cells(PBMCs) were collected at the 3, 8, 21, 34 and 65 days after the first dose.

[Studies on the status of immune memory after completion of hepatitis B vaccination].

Objective: To study the immune memory in vaccinees after the completion of a full schedule hepatitis B immunization.

Methods: One thousand and two hundred one infants born in 1987 -1989 were immunized with 3 doses of plasma derived hepatitis B vaccine, while 2484 newborn babies during 1996-1999 were injected with 3 doses of the yeast recombinant hepatitis B vaccine. All of the infants under observation were tested for HBsAg, anti-HBs and anti-HBc, in 2005.