China's vaccine trial shows promising results — The Lancet

Coronavirus Vaccine

In a May 15 study published on the preprint server bioRxiv, the researchers found that a single dose of ShaCoVacc resulted in an "immediate and potential immune response" against SARS-CoV-2, the virus that causes COVID-19, "in contrast to an inactivated vaccine which required at least two or three doses of injections". In other words, immunity to the common cold virus might obstruct response to the candidate vaccine. The volunteers were assigned to receive either a single injection of the new Ad5 vaccine at a low dose, middle dose, or a high dose, they said.

The study was non-randomised and did not have any controls.

The follow-up duration was really short. Most adverse reactions reported were mild or moderate in severity. One participant given the higher dose vaccine reported severe fever along with severe symptoms of fatigue, shortness of breath, and muscle pain - however these adverse reactions persisted for less than 48 hours. There were no serious adverse events.

Since January, when we began to see the COVID-19 epidemic grow in Wuhan, the scientific and pharmaceutical community has been on a quest to develop a vaccine that will end the pandemic, avert further outbreaks and prevent deaths. While significant reductions of the virus were observed after just a few minutes of simulated sunlight, the risk of exposure from contact with surfaces may not be fully eliminated, the researchers cautioned in the Journal of Infectious Diseases.

In nearly two weeks after vaccination among all dosages triggered some level of immune response by forming antibodies, some had detectable neutralising antibodies against the coronavirus.

In addition, some participants had detectable neutralizing antibodies against SARS-CoV-2: 28 percent in the low-dose group, 31 percent in the medium-dose group and 42 percent in the high-dose group, they found. The scientists also added that 50 per cent of the participants in the low- and middle-dose groups, and three-quarters of those in the high-dose group showed neutralising antibodies against SARS-CoV-2.

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In the majority of volunteers, they said the vaccine also stimulated a rapid T cell response. About 83% (30 of 36) of low-dose participants, 97% (35 of 36) of middle-dose participants and 97% (35 of 36) of high-dose participants developed T cell responses at 14 days.

Blood samples from a group of 108 vaccinated adults showed both neutralizing antibodies and T-cell responses against the novel coronavirus in most of those tested. The high pre-existing immunity might also have a negative effect on the persistence of the vaccine-elicited immune responses, they write. Recipients aged 45-60 years seemed to have lower seroconversion of neutralising antibody, compared with the younger recipients.

In the study, 44-56% of participants had high pre-existing immunity to adenovirus type-5, and had a less positive neutralising antibody and T-cell response to the vaccine, they note.

The trial did not cause any weight loss in the mice, which means the vaccine is likely not toxic to the animals.
A double-blind study with a control group has already been started as a phase trial.

In the U.S. and United Kingdom, vaccines from Moderna and Oxford University (collaborating with AstaZeneca) are in human trials, and have shown promising early results.

The study, conducted in Wuhan, China, by the Beijing Institute of Biotechnology tested different doses of the vaccine in 108 healthy adults who did not have the coronavirus.

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