AstraZeneca’s COVID-19 Vaccine Enters Phase 2/3 Clinical Trial |

From the Website FierceBiotech comes some good news in the battle against COVID-19


Researchers at the University of Oxford have begun enrolling subjects in a phase 2/3 clinical trial of AstraZeneca-partnered COVID-19 vaccine AZD1222. The next stage of the program, which follows a 1,000-subject phase 1, is set to enroll 10,260 people in the U.K. to generate results to support the first shipments to customers in September.AZD1222, the recombinant adenovirus vaccine that originated in Oxford, entered the clinic shortly after Moderna’s candidate. The initiation of the phase 1 trial marked the start of a large, significantly truncated development program plotted out by researchers at the University of Oxford, who have talked up the prospect of making the vaccine available in September.Work toward that goal is advancing apace on multiple fronts. On the R&D side, the University of Oxford said Friday that it has begun enrolling participants in the phase 2 portion of the program.The phase 2 will relax the exclusion criteria used in the phase 1, notably by enrolling a small number of children aged 5 to 12 years and adults aged 56 years and older. One cohort will enroll adults aged over 70 years, a demographic that is particularly at risk from the coronavirus. By expanding the age range, the researchers aim to understand how immune response varies across demographics.Once the vaccine moves into phase 3, the researchers will limit enrollment to people age 18 years and older. Adult participants in the phase 2 and 3 trials will be randomized to receive one or two doses of AZD1222 or a vaccine against meningococcal bacteria that will serve as the control. The use of an active vaccine as a control is intended to ensure participants are unable to tell whether they received AZD1222 based on side effects such as soreness at the injection site. In the absence of such effects across both groups, participants could determine whether they had received the vaccine and make behavioral changes that skew the results of the study. Investigators plan to administer the vaccines to participants in the next stage of the study across May and June. Subjects will then attend follow-up visits to provide blood samples that will show whether their immune system has responded to the virus. The researchers will also ask some participants to log any symptoms they feel in the week after vaccination.Those measures will provide an early look at the safety and immunogenicity of the vaccine, but it will take longer to gauge whether the shot can prevent people from becoming infected with the coronavirus. The researchers are trying to accelerate that process by enrolling healthcare workers and other people who are more likely to be exposed to the virus. Depending on the extent to which SARS-CoV-2 is present in the U.K., it is expected to take two to six months for enough infections to happen to show whether the vaccine is working.Neither the university nor AstraZeneca are hanging around to see if that is the case before preparing for widespread use of the vaccine. The phase 2/3 trial is getting underway despite the university being yet to share phase 1 data, and AstraZeneca is already racing to equip itself to ship 1 billion doses.

Source: AstraZeneca’s COVID-19 vaccine enters phase 2/3 clinical trial | FierceBiotech

I’ve got my fingers crossed that it will be effective and safe and we could potentially have a vaccine by September.

Skeptically (but occasionally optimistically) Yours

-ACP

14 thoughts on “AstraZeneca’s COVID-19 Vaccine Enters Phase 2/3 Clinical Trial |”

  1. I thought I read something not too many days ago that the UK was finding it hard to find enough people to enroll in the studies.

    1. You are correct. The Guardian reported a few days ago that

      Figures released last week suggest about 7% of the UK population may have already been infected with Covid-19 virus, a relatively low level of infection that poses problems for testing vaccines. A sufficient number of volunteers has to be exposed to the virus to see if a vaccine protects them or not. But if their chances of being in contact with an infected person are low, it will take a long time to demonstrate the efficacy of a vaccine candidate

      Therefore they are discussing intentionally infecting volunteers, something that raises ethical concerns.

      1. Question: My understanding is that the virus lives no more than 3 seconds under ultraviolet light. So, if I am outside during the day, should there be virus floating in the air, they would be dead unless you were very close to the shedder of them. If you inhale a dead virus, could that result in developing an immunity similar to a vaccine? Would your body react in a similar manner? If inhaled, would they move within the body such that an immune response could result?

  2. I know they are working on many vaccines all at once. My general understanding of vaccines previously was that the inject a dead or weakened part of the virus so that you build antibodies in advance of catching the virus. Is this how all of the vaccines being made now work? If so why would there be so many different attempts?

  3. Like Victor Meldrew, advancing age brings forth to me a host of tribulations that were unnoticed in younger years.

    I find that this style of text extract is incomprehensible. A faint text, in italics, with one very long paragraph, no line breaks or white space, defies my eyes and comprehension.

    A regret for me, as it seems a very interesting article.

    This style of small faint print in very long paragraphs seems to be spreading, much to my detriment.

    So I have a mini crusade, politely and courteously pointing out my problem, hoping improvements might follow.

    UK and Australian readers will know Victor Meldrew was an elderly curmudgeon in the comedy BBC TV series “One Foot in The Grave”.

    His protests were vehemently vengeful and extreme, leading to comedic scenarios.

  4. “Potentially have a vaccine in September “

    After 5 to 7 months of Covid-19 “experience” we are still hearing about new symptoms, including some long-term or perhaps permanent, and having decided to leave “bleeding edge tech” to younger folk, is my “wait for gen 2 of everything” skepticism of all the vaccines’ safety unreasonable?

  5. I’ve noticed the results of a recent (Gates funded?) “HCQ” RCT have been published, with ‘HCQ’ failng to work in a post-exposure environment.
    Another disappointment, as we await a Vaccine.

    Just as a matter of interest, what was the ‘placebo in this trial ?

    1. Placebo folate tablets, which were similar in appearance to the hydroxychloroquine tablets, were prescribed as an identical regimen for the control group.

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