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The Oxford adenovirus COVID-19 vaccine is safe and elicits significant immune responses in study volunteers, according to research published in The Lancet.

Oxford COVID-19 vaccine — Will the Oxford vaccine turn the tide of the pandemic?

Image credit: Steve Parsons / POOL / AFP

Among the myriad of vaccine candidates that researchers across the globe are developing to stop the spread of the new coronavirus, SARS-CoV-2, the Oxford vaccine has already garnered significant attention.

The vaccine, which the researchers call ChAdOx1 nCoV-19 but many refer to as the Oxford vaccine, uses a weakened adenovirus from chimpanzees.

Together with colleagues across the United Kingdom and Europe, the researchers from the University of Oxford in the U.K. previously demonstrated that the vaccine could protect rhesus macaques on subsequent exposure to the new coronavirus. This research has not been through full peer review yet.

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A further study, which has also not undergone peer review yet, indicated that pigs were able to produce neutralizing antibodies to SARS-CoV-2, in addition to showing T cell responses. A second booster shot led to an enhanced antibody response, the authors write.

The latest results in The Lancet show that the vaccine is safe in humans and that it also produces a measurable immune response. Experts have reacted with cautious enthusiasm to the preliminary findings.

For their study, the researchers recruited 1,077 volunteers at five study sites across the U.K., half of whom received the Oxford vaccine while the other half received a meningitis vaccine, which served as the control.

The average age of the study participants was 35, the gender split was roughly equal, and 90.9% were white.

Side effects in response to the Oxford vaccine were common but generally mild. They included fatigue, headaches, pain at the injection site, and flu-like symptoms. Prophylactic acetaminophen, which a subset of volunteers received, was effective in reducing these symptoms.

The quantity of antibodies that the team measured peaked 28 days after injection and remained elevated at 56 days.

The 10 participants who received a booster shot of the Oxford vaccine had an increased number of antibodies at 56 days.

When the researchers specifically looked for neutralizing antibodies, which can stop the virus from infecting host cells, they found that the majority of people had developed these.

The team used several different laboratory assays to screen for these antibodies, showing that all of the people who had received the booster had neutralizing activity. Depending on the assay, 62–100% of people who had received just one dose had neutralizing antibodies.

However, antibodies are not the only way in which people can fight off pathogens. T cells, which are a type of white blood cell, can attack cells that are infected with a virus.

The team was able to measure T cell responses within 7 days of vaccination. These peaked at 14 days and were still measurable at 56 days. Delivering a second booster shot had no effect on T cell responses.

While these results certainly are encouraging, the study authors highlight some limitations. These include the short follow-up time and the fact that most of the study participants were young, white, and in good health.

“Further studies are required to assess the vaccine in various population groups, including older age groups, those with comorbidities, and in ethnically and geographically diverse populations.”

Phase III trials are currently underway.

Reactions to the results have been positive, but experts do urge caution.

“We are still in the early days of understanding what constitutes an effective long-term immune response against SARS-CoV-2,” says Dr. Doug Brown, Chief Executive of the British Society for Immunology. “This paper shows that the Oxford vaccine elicited both neutralizing antibodies and T cell immune response against SARS-CoV-2 in the majority of patients after a single dose — this is a good first sign, but we still have yet to understand whether these immune responses will have an effect if those individuals encounter the SARS-CoV-2 virus in the future.”

“It has encouraging results, but it is not the end of the road, far from it, but a vital, necessary step toward an effective vaccine without significant harms,” comments Prof. Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine in the U.K.

“The key elements required to proceed to a phase III trial are all there. The responses measured in the blood and the absence of serious harms indicate there is a possibility of an effective vaccine against COVID-19,” he continues. “It does not yet show that the disease is reduced or prevented, and this will not be easy to show until phase III trials have been completed in settings where the SARS-CoV-2 virus is circulating at a high rate, and people are getting clinical and severe disease.”

The authors also take a cautionary approach to their conclusions. “Further clinical studies, including in older adults, should be done with this vaccine,” they write about the implications of the evidence of their work.

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COVID-19 vaccine trial shows promising results

COVID-19 vaccine trial shows promising result…

03:29

A senior British official has called the latest news on an Oxford University team’s potential coronavirus vaccine “extremely encouraging.” The results of the Phase I/II trial of the vaccine being developed by Oxford’s Jenner Institute, in conjunction with pharmaceutical giant AstraZeneca, showed that it is safe and “produced strong immune results,” according to the research published on Monday in The Lancet medical journal.

The vaccine caused a 2-pronged immune response, a news release from the Jenner Institute at Oxford said. First, within 14 days, it triggered a T cell response, generating white blood cells that can attack infected cells. Second, within 28 days, it provoked an antibody response. Antibodies are able to prevent the virus from infecting cells when it is initially contracted, according to the release.

A photo provided by the COVID-19 Vaccine Team at the University of Oxford’s Vaccine Centre in England shows a researcher working on the manufacture of a potential vaccine for the disease caused by the new coronavirus.

Sean Elias/Oxford Vaccine Centre

The U.K. Phase I/II trial began in April and involved more than 1,000 healthy volunteers who were between 18 and 55 years old. Some of those volunteers received a second, booster dose of the vaccine, and they appeared to benefit most.

“We saw the strongest immune response in the 10 participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination,” Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University and co-author of the study, said.

Oxford is working with AstraZeneca to develop, manufacture, and produce a coronavirus vaccine on a large scale. The unprecedented effort aims to make some 2 billion doses of the vaccine available globally, through partnerships with manufacturers in several countries, by early next year.

Coronavirus vaccine tests begin in South Afri…

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While the latest results are encouraging, they show the candidate vaccine creates the reaction in the body that should create immunity to the disease. The Phase III trials, to prove it actually gives people that immunity, are already ongoing, involving a far larger sample of people, in the U.K., the United States, Brazil, and South Africa.

“While there is more work to be done, today’s data increases our confidence that the vaccine will work and allows us to continue our plans to manufacture the vaccine at scale for broad and equitable access around the world,” Mene Pangalos, Executive Vice President of BioPharmaceuticals Research and Development at AstraZeneca, said.

The U.S. government has invested a whopping $1 billion in Oxford’s trial vaccine already, gambling on it being a success to secure millions of doses as soon as possible.

Britain has also poured about $90 million into the work by Oxford’s Jenner Institute for vaccine research. On Monday, British government Business Secretary Alok Sharma called the latest trial results “extremely encouraging, taking us one step closer to finding a successful vaccine to protect millions in the U.K. and across the world.”

The Oxford vaccine has been out in front of about 15 serious global competitors for months, but a few others are hot on the team’s heels.

Moderna advances potential COVID-19 vaccine

03:48

Just last week, officials announced similarly hopeful results from Phase I trialing of a vaccine being developed by the National Institutes of Health and Moderna Inc. The experimental vaccine will move to its most important step around the end of July: A 30,000-person study to prove the shots are effective at stopping coronavirus infection.

The U.K. vaccine news was published Monday in The Lancet along with another study on a Chinese vaccine trial. That vaccine also showed promise, creating a strong antibody and T cell response in more than 90 percent of those given the injection after 28 days.

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