Preliminary results find COVID-19 vaccine candidate based on inactivated SARS-CoV-2 virus is safe

A Chinese COVID-19 vaccine candidate based on the inactivated whole SARS-CoV-2 virus (BBIBP-CorV) is safe and elicits an antibody response, findings from a small early-phase randomised clinical trial published today in The Lancet Infectious Diseases journal have found.

A previous clinical trial reported similar results for a different vaccine that is also based on inactivated whole SARS-CoV-2 virus, but in that study the vaccine was only tested in people aged under 60 years.

The latest study included participants aged between 18 and 80 years, and found that antibody responses were induced in all recipients. Participants aged 60 and over were slower to respond, taking 42 days before antibodies were detected in all recipients compared with 28 days for participants aged 18-59. Antibody levels were also lower in those aged 60-80 years compared with those aged 18-59 (Mean neutralising antibody titre 42 days after receiving a 8μg vaccine dose was 228.7 for people aged 18-59, and 170.9 for those aged 60-80).

The trial was not designed to assess efficacy of the vaccine, so it is not possible to say whether the antibody responses induced by the vaccine, called BBIBP-CorV, are sufficient to protect from SARS-CoV-2 infection.

Professor Xiaoming Yang, one of the authors of the study, from the Beijing Institute of Biological Products Company Limited, Beijing, China, said: “Protecting older people is a key aim of a successful COVID-19 vaccine as this age group is at greater risk of severe illness from the disease. However, vaccines are sometimes less effective in this group because the immune system weakens with age. It is therefore encouraging to see that BBIBP-CorV induces antibody responses in people aged 60 and older, and we believe this justifies further investigation.”

There are currently 42 vaccines for COVID-19 in clinical trials. These vary in type and include DNA plasmid vaccines, inactivated virus vaccines, adenovirus-vectored vaccines, RNA vaccines, protein subunit vaccines and virus-like particle vaccines. Some of these have already been shown to be safe and to elicit immune responses in early phase clinical trials.

The BBIBP-CorV vaccine used in the study reported here is based on a sample of the virus that was isolated from a patient in China. Stocks of the virus were grown in the lab using cell lines and then inactivated using a chemical called beta-proprionolactone. BBIBP-CorV includes the killed virus mixed with another component, aluminium hydroxide, which is called an adjuvant because it is known to boost immune responses.

The first phase of the study was designed to find the optimal safe dose for BBIBP-CorV. It involved 96 healthy volunteers aged between 18 and 59 years and a second group of 96 participants aged between 60 years and 80 years. Within each group, the vaccine was tested at three different dose levels (2μg, 4μg and 8μg, 24 participants per group), with two vaccinations administered on day 0 and 28. A fourth group within each age group (24 participants in each age group) were given two doses of a placebo vaccine. In total, in phase 1 of the study, 144 participants received the vaccine and 48 received the placebo.

The second phase of the study was designed to identify the optimal timing schedule for vaccination. 448 participants aged between 18 and 59 years were randomly assigned to receive either one 8?g shot of vaccine or placebo, or two shots of 4μg vaccine or placebo (at 0 and 14 days, 0 and 21 days or 0 and 28 days). In this second phase, there were 112 participants per group, with 336 receiving the vaccine, and 112 receiving the placebo.

Participants were asked to report any adverse events for the first seven days after each vaccination and these were verified by the research team. Thereafter, participants recorded any adverse events using paper cards for the following 4 weeks. During phase 1, laboratory tests were carried out after the first and second vaccinations to assess kidney function, liver function and other organ functions. Blood samples were taken to test antibody levels for SARS-CoV-2 before and after vaccination.

No serious adverse events were reported within 28 days of the final vaccination. The most common side effect was pain at the injection site (phase 1 results: 24% [34/144] of vaccine recipients, vs 6% [3/48] of placebo recipients). A small number of participants reported experiencing a fever (phase 1 results: 4% [5/144] of vaccine recipients, vs 6% [3/48] of placebo recipients). There were no instances of clinically significant changes in organ functions detected in laboratory tests in any of the groups.

The greatest antibody responses were elicited by two 4μg doses of the vaccine at either days 0 and 21 or 0 and 28 (Mean neutralising antibody titres 28 days after second vaccination were 282.7 for two 4μg injections at day 0 and 21, and 218.0 for two 4μg injections at day 0 and 28).

Professor Xiaoming Yang said: “Our findings indicate that a booster shot is necessary to achieve the greatest antibody responses against SARS-CoV-2 and could be important for protection. This provides useful information for a phase 3 trial.”

The authors noted some limitations with the study, including the short duration of follow up at just 42 days. They also highlighted that the study did not include children and adolescents aged under 18. Trials with these groups will be carried out when the full analysis of data from adult groups is completed, the researchers say.

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Analysis shows high level of SARS-CoV-2 contamination in patient toilets, staff and public areas in hosptials

A systematic review of evidence being presented at this week’s ESCMID Conference on Coronavirus Disease shows that air around patients with COVID-19, as well as patients toilets, and staff and public areas in hospitals are all show significant levels of contamination with SARS-CoV-2. The study is by Dr. Gabriel Birgand, University Hosptial Centre Nantes, France, and colleagues.

Controversy remains worldwide regarding the transmission mode of SARS-CoV-2 virus in hospital settings. In this study, the authors reviewed the current evidence on the air contamination with SARS-CoV-2 in hospital settings, the viral load and the particle size, and the factors associated to the contamination.

The authors searched the MEDLINE, Embase, Web of Science databases for original English-language articles detailing COVID-19 air contamination in hospital settings between 1 December 2019 and 21 July 2020.

The positivity rate of SARS-CoV-2 viral RNA and culture were described and compared according to the setting, clinical context, air ventilation system, and distance from patient. The SARS-CoV-2 RNA concentrations in copies per m3 of air were pooled and their distribution were described by hospital areas.

Among 2,034 records identified, 17 articles were deemed eligible and included in the review. Overall, 27.5% (68/247) of air sampled from close patients’ environment were positive for SARS-CoV-2 RNA, with no difference between settings (ICU: 27/97, 27.8%; non-ICU: 41/150, 27.3%). Just 1/67 (1.5%) of samples in the air less than 1 metre from the patient tested positive for SARS-CoV-2, and just 4/67 (6%) of samples 1-5 metres away. (see results in abstract and poster)

In other areas, the positivity rate was 23.8% (5/21) in patient toilets, 9.5% (20/221) in clinical areas, 12.4% (15/121) in staff areas, and 34.1% (14/41) in public areas (see table in abstract). A total of 78 viral cultures were performed, and 3 (4%) were positives (meaning the virus was viable and capable of reproduction), all from close patients’ environment (3/39, 7.7%) in non-ICU settings.

The median SARS-CoV-2 RNA concentrations were found to be 10 times higher in patient toilets than in the patients’ rooms.

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Coronavirus: is the Effect of temperature on SARS-CoV-2? – Naturopathy Naturopathy Specialist Portal

Study: Thus, the temperature acts on the Coronavirus Transmission

It is known that the novel Coronavirus SARS-CoV-2 of human-to-human transferable, wherein the Transfer seems to be done mainly by droplet infection. However, the transfer surfaces are not excluded. Researchers have now investigated how long the pathogen on surfaces at different temperatures remains infectious.

Although some professionals in infection with the novel Coronavirus SARS-CoV-2 on surfaces as unlikely, but this infection is not exclude risk. Therefore, it is important to know how long the pathogen on surfaces, remains infectious. And also, whether and how the temperature affects the Virus.

Transfers via surfaces are not excluded

The infection with the novel Coronavirus probably happens mainly through droplets. Also aerosols in the breathing air seem to play a role. In addition, Transfers via surfaces are not excluded, especially in hospitals.

According to a statement of Ruhr-University Bochum (RUB) has investigated a Swiss-German research team, how long dried SARS-CoV-2-particles on surfaces at different temperatures remain infectious.

“Surprisingly, it is irrelevant whether it is very cold or very hot,” explains Prof. Dr. Stephanie Pfänder of the Department of Molecular and Medical Virology of the RUB. The study was published in the journal “Journal of Infection”.

The risk of infection drops in the first hour of strong

According to the report, the infectivity of the viruses decreased in the course of drying on metal plates within the first hour of the 100-fold.

In the following four to eight hours, the number of infectious particles decreased initially and then slowly more, but almost independent of the temperature.

The researchers found 180 hours, so about a week after the Application of the viruses, infectious particles to the metal samples.

At four degrees Celsius, the number of infectious virus particles was halved after about 13 hours, at room temperature after about nine hours and at 30 degrees Celsius to about 18 hours.

Potentially lower rate of infection in the summer

“So far, we had assumed that the temperature contributes to the fact that Sars-Cov-2 transfers in the summer, less good,” says Stephanie Pfänder.

“At least on the surface, the stability of the virus seems to be due to the different temperatures but is not affected.”

A potentially lower infection rate in the summer, but could be based on other factors such as UV radiation and humidity. (ad)

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Coronavirus: Almost every second SARS-CoV-2 infection is without symptoms, Natural medicine naturopathic specialist portal

45 percent of the SARS-CoV-2 infections are asymptomatic

Infection by the Coronavirus SARS-CoV-2 can be completely run without complaints, as several studies have already shown. How high this percentage is, it has been speculated only. A research team evaluated the data of over 40,000 COVID-19-Concerned. This showed that around 45 percent of all SARS-CoV-2 infections are without symptoms.

Researchers from the Scripps Research Institute substantiate the suspicion that a considerable part of the SARS-CoV-2 running to the infections are asymptomatic. The analysis included data from 16 groups of COVID-19-Concerned. The silent bearers could have a significant impact on the spread of the disease, or have had. The results were recently presented in the prestigious scientific journal “Annals of Internal Medicine”.

The silence spread

An exceptionally high percentage of people infected with the Virus SARS-CoV-2, show no symptoms of the disease COVID-19, the results of the current analysis. “The silent spread of the Virus makes it all the more difficult to keep it under control,” says Professor Eric Topol, Director of Scripps Research Institute.

Early spread by asymptomatic cases worn

The results suggest that asymptomatic infections may account for up to 45 percent of all COVID-19-cases, and a significant role in early and ongoing dissemination of COVID-19 play. The report underlines the need for extensive testing and contact tracing, to stem the pandemic.

In the prison of the asymptomatic proportion was 96 per cent

The analysis included data gathered from individuals from several countries and from different areas of life, including, for example, residents of nursing homes, cruise ship passengers, prison inmates, and various other groups. “What was practically common to all, was that a very large part of the Infected had no symptoms,” adds behavior researcher Daniel Oran.

In some groups, the proportion of asymptomatic cases was significantly higher. “Among more than 3,000 inmates in four American States that have tested positive for the Coronavirus, the proportion was astronomically high,” says Oran. In this group, 96 percent of those Infected showed no symptoms.

Asymptomatic cases are the drivers of the disease?

The Review suggests further that asymptomatic individuals are able to transmit the Virus over a longer period of time, perhaps longer than 14 days. The viral loads in people with or without symptoms are very similar, but it remains unclear whether their infectiousness is of the same order of magnitude as in the case of persons who show symptoms. This issue had to be examined in further studies. (vb)

Also read: “silent” infections: blood-giving on Coronavirus antibodies tested.

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Biomedical sciences researchers provide methods to inactivate and safely study SARS-CoV-2

Detailed methods on how to perform research on SARS-CoV-2, the virus that causes COVID-19, including procedures that effectively inactivate the virus to enable safe study of infected cells have been identified by virologists in the Institute for Biomedical Sciences at Georgia State University.

The peer-reviewed paper on the novel coronavirus, published in the journal Viruses, is a resource for newcomers in the field.

“Importantly, the study defines specific methods that fully inactivate the virus, that is make it non-infectious, in ways compatible with further scientific analysis,” said Dr. Christopher Basler, professor in the Institute for Biomedical Sciences, director of the Center for Microbial Pathogenesis and a Georgia Research Alliance Eminent Scholar in Microbial Pathogenesis.

“This allows researchers to study the proteins and genes of the virus and how the infected host responds to infection outside of high containment. Confirming that such analyses can be done safely, with no risk of infection, will increase the rate of discovery about the virus and COVID-19.”

When the disease COVID-19 appeared in humans, virologists in Basler’s lab, who study emerging pathogens, wanted to contribute to the effort to understand SARS-CoV-2 and develop medical countermeasures for the virus. Because the new pathogen causes serious disease for which there are no definitive treatments, biosafety level 3 (BSL3) facilities are required. It was also necessary to handle the virus with extra care because so little was known about it.

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