{"id":40549,"date":"2021-05-03T07:24:02","date_gmt":"2021-05-03T07:24:02","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=40549"},"modified":"2021-05-03T21:58:00","modified_gmt":"2021-05-03T21:58:00","slug":"three-new-covid-19-vaccine-studies-enrolling-in-the-uk","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/40549","title":{"rendered":"Three new COVID-19 vaccine studies enrolling in the UK"},"content":{"rendered":"
\n

<\/span>Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n

\n

The following studies are either ongoing or due to start shortly.<\/span><\/strong><\/p>\n<\/div>\n

\n

COVID-19 heterologous prime boost study (Com-Cov)<\/h2>\n

This two-stage study was publicised in February as a \u00a37 million independent study that will initially use a factorial design with eight arms to study two vaccines and two dosing schedules. [1]<\/p>\n<\/div>\n

\n

In Stage 1, each arm will either alternative between the Oxford\/AstraZenica and Pfizer vaccines, or vice versa with either a 4 week or 12 week schedule with control arm still using single vaccines. It is a non-inferiority to compare switched dosing to the approved single dosing. Additional vaccines might be added later.<\/p>\n<\/div>\n

\n

This randomised single-blind study, run by the Oxford Vaccine Group, plans to enrol 820 vaccine-na\u00efve adults >50 years old. [2]<\/p>\n<\/div>\n

\n

Stage 1 is not currently recruiting.<\/p>\n<\/div>\n

\n

Stage 2 uses a similar design but will enrol 1050 adults who have already had one vaccine, and who will be randomised for the second dose. Stage 2 also includes the Moderna and Novavax vaccines.[3]<\/p>\n<\/div>\n

\n

Further information about both stages, including the study protocols are online. [4]<\/p>\n<\/div>\n

\n

Potential participants can register online for this study.
\n<\/span>https:\/\/www.nhs.uk\/conditions\/coronavirus-covid-19\/research\/coronavirus-vaccine-research<\/a><\/p>\n

OCTAVE study to study responses to COVID-19 vaccines in people with reduced immunity<\/h2>\n

A UK study plans to enroll up to 5000 people adults with reduced immune function due to health complications. These include peo<\/span>ple with cancer, inflammatory arthritis, kidney or liver disease or transplant recipients who could be at increased risk of severe complications of COVID-19 infection. [5]<\/p>\n<\/div>\n

\n

\n<\/p><\/div>\n

\n

The OCTAVE study is funded by the\u00a0<\/span>Medical Research Council (MRC)<\/a>, and is a collaborative research project involving groups in the Universities of Glasgow, Birmingham, Oxford, Liverpool, Imperial College London and Leeds Teaching Hospitals NHS Trust.<\/span><\/p>\n<\/div>\n

The study will look at immune responses compared to people without these health complications.<\/span><\/p>\n

Phase 3 immunogenecity study comparing Valneva candidate to Oxford\/AZ vaccine opens in the UK<\/h2>\n

On 21 April 2021, Valneva announced the UK launch of the p<\/span>hase 3 Cov-Compare immunogenecity study that will compare vaccine candidate, VLA2001 (Vaxzevria) against the Oxford\/AstraZeneca vaccine. [6]<\/p>\n

The study will randomise approximately 4,000 adults to receive two doses of either vaccine.<\/p>\n

\n

The primary endpoint of Cov-Compare will be to immune responses two weeks after the second vaccine.<\/p>\n<\/div>\n

\n

It is supported by the National Institute for Health Research (NIHR).<\/p>\n<\/div>\n

\n

Top-line phase 1\/2 results from the candidate vaccine were also released by company press release on 6 April 2021. [7]<\/p>\n<\/div>\n

\n

References<\/span><\/p>\n<\/div>\n

\n
    \n
  1. UK NIHR. World’s first COVID-19 vaccine alternating dose study launches in UK. (2 February 2021).
    \n<\/span>    https:\/\/www.nihr.ac.uk\/news\/worlds-first-covid-19-vaccine-alternating-dose-study-launches-in-uk\/26773<\/a><\/li>\n
  2. A single-blind, randomised, phase II UK multi-centre study to determine reactogenicity and immunogenicity of heterologous prime\/boost COVID-19 vaccine schedules – Stage 1. <\/span>EudraCT Number: 2020-005085-33.
    \n    https:\/\/comcovstudy.org.uk\/files\/com-covprotocolv4014-apr-2021pdf<\/a> (protocol PDF)<\/li>\n
  3. A single-blind, randomised, phase II UK multi-centre study to determine reactogenicity and immunogenicity of heterologous prime\/boost COVID-19 vaccine schedules – Stage 2. <\/span>EudraCT Number: 2021-001275-16.
    \n    https:\/\/comcovstudy.org.uk\/files\/com-cov2protocolv2123-apr-2021cleanpdf<\/a> (protocol PDF)<\/li>\n
  4. Com-Cov website.
    \n    https:\/\/comcovstudy.org.uk<\/a><\/li>\n
  5. ICL press release. COVID-19 vaccine response in patients with impaired immune systems – new study. (4 March 2021).
    \n    https:\/\/www.imperial.ac.uk\/news\/216393\/covid-19-vaccine-response-patients-with-impaired<\/a><\/li>\n
  6. Valneva press release. Valneva initiates phase 3 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. (21 April 2021).
    \n    https:\/\/valneva.com\/press-release\/valneva-initiates-phase-3-clinical-trial-for-its-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001<\/a><\/li>\n
  7. Valneva press release. Valneva reports positive phase 1\/2 data for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. (6 April 2021).
    \n    https:\/\/valneva.com\/press-release\/valneva-reports-positive-phase-1-2-data-for-its-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001<\/a><\/li>\n<\/ol>\n<\/div>\n
    \n

    \u00a0<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base The following studies are either ongoing or due to start shortly. COVID-19 heterologous prime boost study (Com-Cov) This two-stage study was publicised in February as a \u00a37 million independent study that will initially use a factorial …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[292,288,278],"tags":[],"class_list":["post-40549","post","type-post","status-publish","format-standard","hentry","category-covid-19-vaccine","category-covid-19-research-studies","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/40549","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=40549"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/40549\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=40549"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=40549"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=40549"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}