Lancet's paper is detailed! The future of chAdOx1's new crown candidate vaccine is bright.

!--Webeditor:page title"--29 July 2020 /--- In a new study, a Phase 1/2 clinical trial of a candidate vaccine for SARS-CoV-2 in the United Kingdom, which causes COVID-19, reported promising early results.
related findings were published online July 20, 2020 in the journal Lancet, with the title "Safety and Immunogenicity of the ChAdOx1 nCoV-19 Against SARS-CoV-2: a preliminary report of a phase 1/2, blind-blind, randomis controlled trial".
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this early clinical trial, the candidate vaccine has found that the vaccine is safe, causes few side effects and induces a strong immune response -- a T-cell response within 14 days of vaccination (i.e., a cell immune response, which can find and attack infected cells), and an antibody response within 28 days of vaccination (i.e., an immune reaction in the bodily fluid, when the virus circulates in the blood or lymphatic system, it can find and attack the virus).
the ideal SARS-CoV-2 vaccine should be effective once or twice, apply to target populations, including the elderly and people with other health conditions, for at least six months of protection and reduce the spread of the virus to contacts.
the early stages of clinical trials are still in the early stages, it is not possible to confirm whether the new vaccine meets these requirements, but the UK, Brazil and South Africa are conducting their Phase 2 (UK only) and Phase 3 clinical trials to determine whether it is effective in preventing SARS-CoV-2 infection. Explaining how the vaccine works, professor Andrew Pollard, of the University of
, said: "This new vaccine is a chimpanzee adenovirus vector (ChAdOx1) vaccine that expresses SARS-CoV-2 stingprotein.
it uses the common cold virus (adenovirus) infected with chimpanzees, weakens it from causing any disease in humans, and genetically modifies it to encode human SARS-CoV-2 virus stingproteins.
this means that when the adenovirus enters the cells of vaccinated people, it also delivers the genetic code of the stingprotein.
this will cause these people's cells to produce stinging proteins and help teach the immune system to recognize the SARS-CoV-2 virus.
," he continued, "the immune system has two ways to find and attack pathogens--- antibodies and T-cell responses."
the vaccine is designed to induce both, so it can attack viruses circulating in the body or infected cells.
We hope this means that the immune system remembers the virus so that our vaccine can protect people in the long run.
However, more research is needed to determine whether the vaccine is effective in protecting people from SARS-CoV-2 infection and how long it will last.
" The new clinical trial, which involved 1,077 healthy adults aged 18 to 55 with no history of COVID-19, was conducted in five hospitals in the UK between 23 April and 21 May 2020.
the data contained in this paper covers the first 56 days of the clinical trial and is still in progress.
these participants received either the new COVID-19 vaccine (543 persons) or the meningococcal combination vaccine (534 people as a control).
113 participants (56 from the vaccination group and 57 from the control group) were also asked to take paracetamol before and within 24 hours of vaccination to help reduce vaccine-related reactions (because the high dose of the COVID-19 vaccine can help induce a strong immune response).
all participants provided additional blood samples and conducted clinical evaluations to determine whether the new COVID-19 vaccine was safe and triggered an immune response.
participants were also asked to record any adverse events that occurred throughout the clinical trial.
the participants were divided into four groups.
group 1 (88 people) conducted additional safety monitoring to form phase 1 of the clinical trial and evaluated their antibody and T-cell responses.
group 2 (412 persons) received additional blood collection to evaluate antibody and T-cell reactions, and group 4 (567 persons) received serum harvesting for the purpose of evaluating antibody responses only.
in group 1, group 2 and 4, half of the participants were vaccinated against COVID-19 and half were given the control vaccine.
group 3 (10 people) only received the COVID-19 vaccine and an additional dose of the vaccine on the 28th day after the first dose of vaccination to determine safety and whether it promotes antibody and T-cell responses.
clinical findings show that the vaccine is safe and without serious adverse events.
fatigue and headaches were the most frequently reported reactions (about 70 per cent of all participants who were given THE COVID-19 vaccine reported fatigue, 68 per cent reported headaches, and about 48 per cent of the participants reported fatigue and 41 per cent of the 195/477 in the control group, respectively, with fatigue and 41 per cent of the 195/477). other common side effects
include pain at the injection site, muscle soreness, weakness, chills, fever and high fever.
participants who took paracetamol before and after vaccination reduced pain, chills, fever, muscle pain, headache, and discomfort within two days of vaccination.
in addition, the second dose had fewer side effects after vaccination in 10 people who received an additional dose of the COVID-19 vaccine.
the researchers found that the vaccine produced a strong antibody and T-cell response.
significantly increased the T-cell response of THE SARS-CoV-2 sting protein (in 43 subjects), peaked at the 14th day after vaccination (the median of 856 speckled cells per million peripheral blood cells), and by the 56th day of the experiment, this level decreased slightly (the median number of speckled cells per million peripheral blood mononucleosome cells was 424).
T-cell response did not increase as a result of the second dose of vaccination, which is consistent with other similar vaccines.
!--/ewebeditor:!--ewebeditor: !--ewebeditor" -- The antibody response peaked on the 28th day (the median of 157 ELISA units among the 127 participants in the study) and remained high on the 56th day of the clinical trial (the median of 119 LISA E Units was among the 43 participants in the study).
this antibody response can be reinforced by a second dose of vaccination (the median of the 10 participants at day 56 was 639 ELISA units).
neutralizing antibody reaction against SARS-CoV-2 was detected in 32 people (91%) after 28 days of vaccination in 35 participants who received a single dose of COVID-19 vaccination, and neutralizing antibody reactions against SARS-CoV-2 in all participants.
these reactions were present in all participants who received the booster vaccine (in the 42-day MNA80 and assays, in nine participants, they all produced neutralizing antibody reactions, and in the 56th marburg VN assay, they all produced neutralizing antibody responses in 10 participants).
the researchers found that taking paracetamol did not affect the immunogenicity of the COVID-19 vaccine. "There is still a lot of research to be done before we confirm whether our vaccine will help control the COVID-19 pandemic, but these early results are promising," said professor Sarah Gilbert of the University of Oxford, co-author of the
paper.
in addition to continuing to test our vaccine in phase 3 trials, we need to learn more about the virus, for example, we still don't know how strong an immune response is needed to effectively fight SARS-CoV-2 infection.
If our vaccine is effective, it is a promising treatment option because this type of vaccine can be produced on a large scale.
successful SARS-CoV-2 vaccine prevents infection, disease and death in all populations, and high-risk groups such as hospital workers and the elderly are given priority vaccination.
" the researchers pointed to some of the limitations of the study, including the need for more research to confirm their findings in different populations, including older people, people with other health conditions, and people of different races and geographies.
noted that these populations are being recruited in Phase 2 and Phase 3 clinical trials of the new vaccine in the UK, Brazil and South Africa.
in the current clinical trial, 91 percent (979/1,077) of participants were white, with an average age of 35.
they also noted that, given the recent absence of potential participants with 19 SYMPTOMs of COVID-19 or a positive HISTORy of SARS-CoV-2 PCR testing, a small number of participants had a detectable neutralizing antibody and T-cell reaction against SARS-CoV-2 stingproteins prior to vaccination, most likely due to past asymptomatic infections.
the researchers say participants recruited in the study will be followed for at least a year to continue studying the vaccine's safety and its induced immune response. "This Phase 1/2 clinical trial is very much anticipated," wrote Naor Bar-Zeev, an assistant professor at the International Center for Vaccine Acquisition at the Bloomberg School of Public Health at Johns Hopkins University in the United States, in a review-type article published in the Lancet journal.

its clinical results bode well for Phase 3 clinical trials, in which the vaccine must be tested in a larger population of participants to assess its effectiveness and safety... This Phase 1/2 clinical trial uses adenovirus vectors to deliver and study the COVID-19 vaccine, an innovative and effective tool for developing vaccines during pandemics.
the potential of adenovirus vector vaccines is significant given the ability to produce body fluid, cellular and congenital immune responses.
", however, he cautioned that the candidate vaccine is still in its early stages.
continued, "This platform, the adenovirus vector vaccine, has only been approved by the European Commission for the Ebola vaccine on 1 July 2020.
the candidate vaccine and other COVID-19 vaccines being developed still have many unknowns, including the persistence and immunogenicity of responses in older people or other specific groups, such as those who are often excluded from clinical trials, or ethnic or racial groups more severely affected by COVID-19.
" (Bioon.com) References: 1. Pedro M Folegatti et al. Safety and Immunogenicity of the ChAdOx1 nCoV-19 vaccine againstSARS-CoV-2: a preliminary report of a phase 1/2, single blind-, randomis controlled di. Lancet, 2020, doi:10.1016/S0140-6736 (20)31604-4. 2. UK's vaccine against SARS-CoV-2 is safe and dats an immune reaction.