Covid human challenge trial: World’s first study to deliberately expose people to coronavirus to begin in UK

The first-of-its-kind study has been approved by the UK’s clinical trials ethics body.

ITV News www.itv.com 

The world’s first study which will deliberately expose volunteers to coronavirus to establish the smallest amount of virus needed to cause infection will take place in the UK.

Starting in the next few weeks, the human challenge trial will involve up to 90 carefully selected, healthy adult volunteers being deliberately exposed to Covid-19 in a safe and controlled environment.

The first-of-its-kind study has been approved by the UK’s clinical trials ethics body.

It will give doctors a greater understanding of Covid-19 and help support the pandemic response by aiding vaccine and treatment development.

Because the safety of volunteers is paramount, this virus characterisation study will initially use the version of the virus that has been circulating in the UK since March 2020.

This variant has been shown to be of low risk in young healthy adults.

Medics and scientists will closely monitor the effect of the virus on volunteers and will be on hand to look after them 24 hours a day.

The researchers are working closely with the Royal Free Hospital and the North Central London (NCL) Adult Critical Care Network to ensure the study will not affect the NHS’s ability to care for patients during the pandemic.

The study will not begin without their go-ahead, the Department for Business, Energy and Industrial Strategy (Beis) has announced.

Interim chairman of the Vaccines Taskforce, Clive Dix, said: “We have secured a number of safe and effective vaccines for the UK, but it is essential that we continue to develop new vaccines and treatments for Covid-19.

“We expect these studies to offer unique insights into how the virus works and help us understand which promising vaccines offer the best chance of preventing the infection.”

After the initial study has taken place, vaccine candidates proven to be safe in clinical trials could be given to small numbers of volunteers who are then exposed to coronavirus.

This will help identify the most effective vaccines and accelerate their development.

People aged between 18 and 30 years old, who are at the lowest risk of complications resulting from coronavirus, are being encouraged to volunteer for this vital study.

Volunteers will be compensated for the time they spend in the study.

They will receive around £4,500 to participate in the study which will involve some 17 days of quarantine and follow-ups over 12 months.

Professor Sir Terence Stephenson, chairman of the Health Research Authority (HRA), said: “People are rewarded for being in those studies, or compensated.

“The sum is about £4,500 but that covers the initial stay and follow-up.”

He added: “The initial stay involves quite an imposition on a young person – 17 days in quarantine and you cannot be visited by any member of your family or friend or relative.

“For the first £1,500 for 17 days we’ve got something like £88 a day, which I don’t think anyone would sense was a ridiculous coercion or inducement.”

In the past, human challenge studies have played important roles in accelerating the development of treatments for diseases including malaria, typhoid, cholera, norovirus and flu.

The trials have also helped researchers establish which possible vaccine is most likely to succeed in phase three clinical trials that would follow, usually involving thousands of volunteers.

This study, backed by a £33.6 million UK Government investment, will also help doctors understand how the immune system reacts to coronavirus and identify factors that influence how the virus is transmitted.

This includes how a person who is infected with Covid-19 virus transmits infectious virus particles into the environment.

The human challenge study is being delivered by a partnership between the Government’s Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and the industry-leading clinical company hVIVO, which has pioneered viral human challenge models.

The Royal Free Hospital’s specialist and secure clinical research facilities in London are specifically designed to contain the virus.

Highly trained medics and scientists will be on hand to carefully examine how the virus behaves in the body and to ensure the safety of volunteers.

The virus being used in the characterisation study has been produced by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, in collaboration with hVIVO with support from virologists at Imperial College London.

The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are the UK’s regulators responsible for providing ethics and regulatory approval, respectively for all human clinical trials.

Research Ethics Committees (RECs) are formed by the HRA as part of the approval process.

A specially-appointed independent REC has approved the study, and after reviewing the protocol, the MHRA concluded the virus characterisation study did not require its approval because the study does not involve an investigational medicinal product.


Let neighbours vote to redesign their streets, urges think tank

“Three Homes” Jenrick welcomes a report proposing suburban home-owners vote to demolish their street and rebuild in the Georgian style.

Could Exmouth become the new Sidmouth? – Owl

By Tony Diver, Political Correspondent www.telegraph.co.uk 

Homeowners in streets of bungalows or detached houses should be allowed to vote to turn their roads into Georgian-style terraces, a new report has argued.

The paper, from the Policy Exchange think tank, calls for local planning decisions to be devolved to individual streets, allowing residents to redesign their homes alongside their neighbours.

It argues that to solve the housing crisis the Government should increase housing density by allowing local people to choose to replace sparsely-built homes with terraced properties, which could be built in popular Victorian or Georgian styles.

The report’s authors say the democratic “street plan” proposal would also increase the value of residents’ homes.

Street plans would also allow local residents to agree on parking, contributions to local authorities and building heights, while the think tank said increased building work would provide a boost to the economy as the coronavirus pandemic comes to an end.

New planning rules for the street could be imposed if more than 60 per cent of residents voted for them, the think tank suggested.

The report’s findings were cautiously welcomed by Robert Jenrick, the Housing Secretary, who said the Government “supports enabling communities to set their own rules for what developments in their area should look like” and “ensuring that they reflect and enhance their surroundings and preserve our cherished local heritage”.

The Government’s own White Paper for planning reform raised the prospect of “very small areas” like individual streets having their own planning rules.

Calculations suggest that the average homeowner who took up the scheme and remodelled their street could make hundreds of thousands of pounds, because the new properties would be more valuable.

Today’s report says the areas most likely to increase the value of homes with such a scheme are London suburbs, including Barnet, Harrow, Croydon and Bromley.

St Albans and Brighton and Hove could also benefit from the plans, Policy Exchange said.

Christopher Boyle, Chairman of the Georgian Group, a charity promoting Georgian architecture, said: “This is an excellent proposal, which could make an immense contribution to resolving the housing shortage. 

“When land values rose during the Georgian era, they built up, bequeathing us many of our most prized streets. 

“This powerful and sophisticated proposal offers a way of doing this again, letting us create beautiful streets that we treasure for centuries.”

Community buildings to benefit from £17,500 funding

Five valued East Devon community buildings will benefit from more than £17,500 of funding from East Devon District Council.

Tim Dixon www.midweekherald.co.uk

They are the latest projects to win cash from the authority’s Community Buildings Fund.

Beer Albion Football Club will receive £3,500 to help pay for a viewing area for sports activities, community events and for private hire events.

Colyford Memorial Hall was granted £4,611 to help replace its floor, which is beyond further repair.

Exton Village Hall will receive £2,567 to help provide its sound system with a hearing loop, which users of the hall have asked for.

Newton Poppleford Pavilion was granted £2,000 to pay towards replacing windows, doors and other woodwork, some of which is rotten. This project will help make the hall more energy efficient and secure.

West Hill Royal British Legion Hall will receive £5,000 to help create a new kitchen. This will enable the Legion, groups that meet there regularly and other hirers to prepare and cook food on the premises, which isn’t currently possible.

The Community Building Fund has been running for more than 14 years. It supports village halls, community buildings and community shops by offering grants of anything up to £5,000.

The scheme’s purpose is to help rural community buildings and community shops all around East Devon with funding for projects such as new or improved toilet facilities, kitchen facilities, roof repairs, heating and new door fixtures.

The closing date for the next raft of applications is 9am on Monday, March 15.

The council explained that it had a maximum of £2,187 left to give out. Councillor Jack Rowland, East Devon District Council chair of the community grants panel, said: “On behalf of the East Devon District Council Community Grants Panel, we were pleased to support these applications as they all demonstrated exactly the reasons why these grants were made available.

“In these particularly difficult times it is vitally important that facilities such as these are maintained and improved in readiness for the time when the communities can make full use of them again.”

71 new homes for West Clyst

Plans for up to 71 homes on the edge of Exeter – half of which will be affordable – have been approved.

Daniel Clark, local democracy reporter www.radioexe.co.uk 

And a toucan crossing too!

East Devon District Council’s planning committee has unanimously backed the Johnstone Land (South West) Ltd scheme for land north of Moonhill Copse in West Clyst.

Their outline application was recommended for approval, despite being a departure from the Local Plan, as officers said the housing development was in a highly sustainable area and the 50 per cent affordable housing outweighed any harm caused.

The plans were due to be discussed last Wednesday but were deferred following a Devon County Council request for a contribution of £3,250 from the developer to alleviate some of the traffic issues the development could cause.

Councillors on Monday morning heard the developer had agreed. The money will first go towards putting a toucan crossing on the B3181.

Cllr Philip Skinner proposed that the scheme be approved, but asked if there was any way in which the crossing could come forward as quickly as possible.

Cllr Steve Gazzard added: “This seems a well thought out application,” while Cllr Olly Davey added: “It makes a lot of sense to bring the land into use and this seems a well-designed plan in a sustainable location with good provision for cycling and walking.”

Cllr Geoff Pook added: “So often we see applications on a larger scale skinning down the affordable housing to single digits, so this developer has shown a responsible way to deliver it and address all the concerns. This is a good and responsible development.”

Recommending approval, Chris Rose, East Devon District Council’s development manager, said: “The site has very good public transport links to the city of Exeter and further afield settlements including train and bus connection to the rest of the country. A recently constructed primary school lies within easy walking distance of the site and a convenience shop has recently opened on the opposite side of the B3181.

“These are significant considerations when considering the location of development to seek to minimise the use of the private motor vehicle and weigh significantly in favour on the proposed development. On the basis that houses have been consented surrounding the site having been found to be sustainably located, the same conclusion should be reached in relation to this site.

“The benefits of the proposal through providing housing development in a highly sustainable area with good linkages and nearby infrastructure to support daily living without reliance on the private motor vehicle, and provision of a high proportion of affordable housing to address the needs of the district, are considered to outweigh any harm caused by the proposal and outweighs the fact that the proposal represents a departure from local plan policy.”

Contact tracing alone has little impact on curbing Covid spread, report finds

Contact tracing alone has a marginal impact on Covid transmission, curbing the spread of the disease by just 2% to 5%, official estimates show.

Natalie Grover www.theguardian.com 

The figures come after Dido Harding, who heads the government’s £22bn test-and-trace programme in England, suggested it was set to substantially reduce the spread of coronavirus this spring.

Newly published data behind that assertion shows the vast majority of the impact of test and trace is down to people self-isolating. An army of contact tracers has been hired to track down close contacts of those who test positive for Covid, and ask them to self-isolate. The contact tracers also remind people of the need to quarantine after a positive test.

Earlier this month, Harding told MPs that thanks to test and trace, the R (reproduction) number for the virus was expected to fall by between 0.6 and 0.8 at the end of March, an improvement on a drop of between 0.3 and 0.6 achieved in October. Greg Clark, the chair of the science and technology committee, pressed Harding for the source of the claim.

Published last week, the official report behind the claim said a combination of testing, tracing and self-isolation in an environment similar to last October’s resulted in an R reduction of 18% to 33% when compared with a scenario involving only social distancing restrictions and no self-isolation. This corresponded to a reduction in the R number of 0.3 to 0.6.

Contact tracing alone reduced the R number by just 2% to 5%, the modellers estimated in the report, with testing and self-isolation accounting for the remaining 16% to 28%. “Hence, the majority of transmission reduction is due to isolation on symptoms,” it said.

If all test and trace targets were met – and circumstances otherwise were similar to those in October – the model estimates that transmission would reduce by 33% to 42%, including a contact-tracing impact of 7% to 10%. That translates to an R reduction of 0.5 to 0.8, Harding wrote in a letter to Clark.

Prof Sir David Spiegelhalter, chair of the Winton Centre for Risk and Evidence Communication at the University of Cambridge, noted on Tuesday that the report stresses the R reduction estimate is in comparison to a scenario with only social distancing restrictions and no self-isolation.

However, advice to self-isolate upon developing symptoms was already in place before NHS Test and Trace was set up in May, together with some testing capacity.

Spiegelhalter told the Guardian: “It’s unfortunate but understandable that they felt unable to estimate the influence of TTI [test, trace and isolate] over and above other strategies to encourage self-isolation.”

The R number reflects how many people an infected person can spread the disease to – and it must be below 1 for the epidemic to wane. As of Friday, scientists estimate the UK-wide R number is between 0.7 to 0.9.

Harding’s projection of a 0.6 to 0.8 reduction by the end of March is optimistic, suggested Prof Rowland Kao, who studies infectious disease dynamics at the University of Edinburgh.

“The potential for test and trace to work effectively is there – a large proportion of transmission is believed to occur before people are symptomatic, so if you can get people to isolate, thereby reducing contact, then it can eliminate this element of the spread – and 0.6 to 0.8 impact on R is not necessarily out of line,” Kao said. “So, the potential is there but unless people self-isolate … then all the test and trace isn’t going to help.”

Dr Kit Yates, a senior lecturer in the department of mathematical sciences at the University of Bath, indicated the considerable resources set aside for NHS Test and Trace could be put to better use by focusing on isolation.

“One can’t help thinking that some of the £22bn – the figure widely quoted as having been earmarked for the operation thus far – might be better spent on providing support for isolation, which is likely to have a significant impact reducing transmission,” said Yates.

About 20,000 people a day who are contacted by test and trace are not fully isolating, Harding has said. The estimate suggests 20% to 40% of people cannot or do not comply with the rules. Research suggests a majority of people who apply for a one-off £500 payment for isolation are rejected.

Plans for Poltimore homes rejected ‘with sadness’ by East Devon council

‘Unsustainable’ proposals for eight new homes in Poltimore have been turned down by East Devon planning chiefs. 

Daniel Clark eastdevonnews.co.uk

Councillors made the decision ‘with sadness’ after the scheme for land west of Kilmore House  – which featured six ‘affordable’ dwellings – was considered by the authority on Monday (February 15).

Applicant Martin Reeves told the committee that the project was about keeping communities together in small village areas.

He added: “This is a must and, if you take the youth away, the village will die, as the properties are way too expensive for 99 per cent of people.

“People have a right to live in the village they have grown up in.

“There are schools in walking distance, a village shop, hall, pub, and the church, and we will have a play park in the development.

“We are trying to build a community and not dissect one. It is vital more than ever to keep the community together so the community can thrive.”

But recommending refusal, East Devon District Council (EDDC) development manager Chris Rose cited five reasons why the application should be turned down.

The mooted development site on land west of Kilmore House in Poltimore. Image shown to East Devon District Council's Planning Committee

The mooted development site on land west of Kilmore House in Poltimore. Image shown to East Devon District Council’s Planning Committee

He said: “While the proposal would address the housing need numbers for affordable housing in this immediate locality… it remains the case that insufficient justification has been provided to satisfy the policy requirements in terms of unit types and location.

“The site lies in an unsustainable location with insufficient services and facilities to meet the needs of potential occupiers resulting in an unsustainable form of development reliant on private modes of transport, and the proposed development, by virtue of the number and scale of dwellings, would introduce a form of development which would present a harsh urban form within the open countryside.

“The heritage impact of the proposed development on the adjacent Grade II listed building Poltimore House is not considered to be acceptable and it is not considered that any benefits of the proposed development would be sufficient to outweigh this harm.

“In addition, it has not been demonstrated how the development would achieve the valley park specific objectives for people and wildlife for the Clyst Valley Regional Park, or that there would be no adverse effect on the County Wildlife Site within which the site is located.”

Councillor Philip Skinner said: “I don’t want to be coming here and not supporting applications for affordable housing, but there is no support from officers, the parish council, and no support from the ward member.

“So on that basis, and the many reasons why we shouldn’t support, I have to move for refusal and the recommendation of officers.“

Cllr Olly Davey added: “There is just not enough support from officers for this one.

“It is in the Clyst Valley Regional Park, it’s too close to Poltimore House, and there are just too many objections, as sad as I am to refuse this.”

EDDC’s Planning Committee voted by nine to none, with three abstentions, to refuse the application.

Chunk of Exmouth cliff ‘on brink of collapse’

A huge chunk of cliff near Orcombe Point appears to be on the brink of collapsing into the sea.

Chloe Parkman www.devonlive.com

The rock located between Orcombe Point in Exmouth and Devon Cliffs Holiday Park can be seen balancing 180 feet high at the coastal spot.

It comes just two weeks after there was an enormous cliff collapse in Exmouth which saw massive rocks crashing onto the popular beach.

A spokesperson for East Devon District Council (EDDC) said: ”Cliff falls are a natural and unpredictable occurrence along the East Devon coast, this is because the rock from which the cliffs are formed is soft and therefore prone to rock falls and landslides, which can happen at any time, although heavy rainfall can trigger incidences.”

Last week, Devon Live reported on all of the properties in Devon most at risk of toppling into the sea.

Following the recent landslide in Exmouth, a spokesperson for National Trust said: ”Orcombe Point is cared for by the National Trust.

”Cliff falls are a regular occurrence around the SW coast and there’s nothing we can do to prevent this.

The chunks appear to be on the brink of collapse

”Following heavy rainfall an increase in cliff falls are also quite likely.

”In this area, as with any of our outdoor sites and particularly coastal sites, we strongly encourage our visitors to heed any information signs, keep to the designated paths and not to gather at the foot of cliffs.”

Less than a year ago, Devon Live reported that three cliffs collapsed in Sidmouth within just 24-hours of one another.

With regards to the ‘suspended’ chunks of the cliff face near Orcombe Point, a spokesperson for EDDC said: “The land in question belongs to the National Trust.

”Should anyone want to report hazards on this land, they can call their local ranger team on 01297 680507.

“In terms of reporting cliff falls if there is an immediate risk to life people should call 999 and ask for the coastguard.”