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On July 20, local time, The Lancet released the latest results of two new coronavirus vaccine (COVID-19) Phase 1/2 clinical trials.
one developed by the Chinese Academy of Engineering's Chen Wei academician team and Can Biologics, and the other by Oxford University and Asricon.
from the experimental results, both vaccines can achieve an immune response to SARS-CoV-2 and induce an efficient T-cell immune response.
the clinical phase 2 trial of the non-replicated type 5 adenovirus (Ad5) new coronavirus vaccine brought by the Chen Wei academician team/Conhino Bio, a non-replicated type 5 adenovirus (Ad5) vaccine, 508 participants were given high doses (1E11 virus particles, n-253), low doses (5E10 virus particles, n?129) vaccine, and placebo (n?126) injections.
the main result of the study was to assess the immunogenicity and safety of the Ad5 vector COVID-19 vaccine and to determine the dose of the vaccine for phase 3 efficacy studies.
the average age of these participants was 39.7 years (IQR18-83), of which 266 (52%) had higher both immune systems for Ad5 carriers, while 242 (48%) had lower both aydrating.
all participants completed follow-up within 28 days of vaccination and provided blood samples on the 0th and 28th days.
follow-up results showed that from day 14, the High-Dose group and the low-dose group detected a receptor-induced receptor binding domain (RBD)-specific ELISA antibody response in the Ad5 vector COVID-19 vaccine.
on the 28th day, 244 participants in the high-dose group (96%) and 129 participants in the low-dose group (97%) showed serum transformation of RBD-specific ELISA antibodies, while the placebo group participants did not change. both the
high-dose group and the low-dose group were able to induce a significant neutralized and antibody immune response to live SARS-CoV-2, and the participants neutralized the neutralized and active geometric mean titness (GMT) of 19.5 and 18.3, respectively.
high-dose group, 148 people (59%) had a serum transformation of neutralizing antibodies to live SARS-CoV-2, while data in the low-dose group were 61 (47%).
at the same time, 227 people (90%) in the high-dose group and 129 people in the low-dose group (88%) produced specific IFN-g, indicating that the vaccine induced a T-cell response.
overall, 196 people in the high-dose group (77 percent), 98 people in the low-dose group (76 percent) and 61 people in the placebo group (48 percent) experienced one or more adverse reactions within 28 days of receiving the injection.
of these most common adverse reactions are systemic fatigue, fever, headache, and injection site pain.
notable, the researchers found that in previously highly immune and older participants, RBD-specific ELISA antibodies and neutralizing antibodies levels were correspondingly weaker, but better than the placebo group.
from the experimental results, the high dose (1E11 virus particles) would be the better dose in both doses.
, 1077 participants were given ChAdOx1 nCoV-19 (n s 543) and the control meningococcal combination vaccine CWMenAMenY (n s 534) in the 1/2 clinical trial of the AZD1222 adenovirus vector vaccine (ChAdOx1) conducted by British researchers. The average age of the
participants was 35 years (IQR 28-44 years), and more than 90% of the participants were Caucasian.
in the ChAdOx1 nCoV-19 group, anti-SARS-CoV-2 spike protein antibodies peaked on the 28th day and remained high for the 56th day after vaccination.
then, the researchers assessed the levels of neutralizing antibodies in the participants' bodies from multiple dimensions.
using the PRNT50 analysis method, the researchers conducted serum neutrality tests on 35 subjects and found that all participants received neutral izede, with a median titer of 218.
if The MNA80 method is used for testing, 91% have serum neutralized reaction after a single inoculation, while the application has 100% serum neutralized reaction.
, the researchers tested the volunteers' T-cell immune response using specific interferon-linked immunospecies and found that the volunteers were vaccinated chAdOx1-nCoV-19 on the 7th day of the cell immune response, and the 14th day of specific T response peaked (ELISPOT 856/10e6MC PB), until the 56th day remained at a high level.
adverse reactions, the researchers found that ChAdOx1-nCoV-19 participants experienced local and systemic adverse reactions, including pain at the injection site, headache, fatigue, chills, fever, discomfort, and muscle pain. No serious adverse events were reported in the
experiment.
it is understood that on the same day that The Lancet published the results of two clinical trials of the vaccine, Pfizer and BioNTech also announced further results of their new mRNA vaccine Phase 1 clinical trial on medRxiv, which states that the mRNA vaccine can induce both effective antibody response and T-cell response.
References: s1. Immunogenicity and safety of a recombinant adenovirus type-5-vectored covid-19 in healthy adults aged 18 years older or: a randomised, double blind-blind, placebo-controlled, 2 trial. Safety and immunogenicity of the ChAdOx1 nCoV-19 against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. A new crown vaccine clinical data explosion! Team Chen/Consino Bio, Oxford University/AstraZeneca, BioNTech/Pfizer announced the latest developments on the same day.