- Participants will receive either Pfizer, Moderna or Novavax as a third dose of vaccine
- The government-funded study follows the results of the OCTAVE trial showing that 89% of immunocompromised or immunocompromised people generate antibodies and 60% generate a strong antibody response after two doses.
A new clinical trial to determine whether a third dose of the vaccine will improve the immune response of people with weakened immune systems has been launched in the UK.
The study, OCTAVE DUO, will offer immunocompromised or immunocompromised people a Pfizer, Moderna or Novavax vaccine to determine if it will give an immune response stronger than two doses.
The £ 2.2million study will build on the OCTAVE trial, led by the University of Glasgow and coordinated by the Cancer Research UK Clinical Trials Unit at the University of Birmingham.
The OCTAVE trial today released preliminary data showing that 89% of immunocompromised or immunocompromised people generate antibodies after vaccination, and 60% generate a strong antibody response after two doses of a vaccine.
However, 40% of people in these groups exhibited a weak or undetectable immune response after two doses, and the level of antibody response varied between the groups studied.
The level of antibodies required for protection against COVID-19 is still not known, and it is likely that T cells also play an important role in protecting people from the virus. These results therefore do not provide a conclusive assessment of the protection that vaccines offer to people with weakened immune systems.
Up to 1,200 patients already involved in the OCTAVE study or those with other risky conditions involved in parallel studies will be recruited for the OCTAVE DUO trial.
The OCTAVE DUO study, co-funded by the government’s Vaccines Taskforce and UK Research and Innovation (UKRI) and led by the University of Glasgow and the University of Birmingham, will analyze in detail the immune response of this group to the vaccine and sustainability of this protection. It will also use health records to determine if any participants are later diagnosed with COVID-19.
The first results are expected later this year to inform the deployment of the COVID-19 vaccine in the UK in these specific risk groups. The trial will follow patients until mid-2022 and will offer more detailed information at this point on the immune responses that develop in these groups.
The government is carefully reviewing the results of the OCTAVE trial and will also consider any other appropriate advice – including from the Independent Joint Committee on Immunization and Immunization (JCVI) – for people with compromised immunity in the course of testing. regular updates on the latest data and evidence. on the effectiveness and efficacy of vaccines.
Health and Social Affairs Secretary Sajid Javid said
Vaccines have built a strong wall of defense in the UK, allowing most of us to learn how to live safely with COVID-19.
We know that some people may be less protected than others by the vaccine, so we are planning a booster program in the fall, prioritizing those most at risk.
This new study will play an important role in helping to shape the deployment of future vaccine doses for these specific risk groups.
A separate study from Public Health England in July that looked at the antibody response and vaccine effectiveness against symptomatic infection also showed that those who were immunocompromised had weaker antibody responses.
He also found that the protection against COVID (vaccine effectiveness against symptomatic diseases) for those who are immunocompromised of all ages after one dose was 4%, but after two doses it was 74%, providing similar protection. to those who are not in a group at risk. Again, the effectiveness of the vaccine may vary depending on the specific condition and the severity of that condition.
Patients included in the OCTAVE DUO study are people with lymphoid malignancies, immune-mediated inflammatory diseases (including rheumatoid arthritis, psoriatic arthritis, vasculitis and inflammatory bowel disease), kidney disease, solid tumors (including breast and lung cancer), hematopoietic stem cell transplantation. , liver and intestinal diseases and primary immune deficiency.
Professor Iain McInnes, Director of the College of Medical, Veterinary and Life Sciences at the University of Glasgow, who leads the OCTAVE and OCTAVE DUO studies, said:
It is extremely important for us to urgently understand the effectiveness of COVID-19 vaccines in people with immune-mediated inflammatory diseases, cancer, and kidney or liver disease.
Our first study to answer this question is the OCTAVE study which showed that there is a group of patients who may not develop a sufficient immune response.
We are pleased to now launch the OCTAVE DUO trial, to study the effects of a third dose on this particular group of patients who have shown an undetectable or weak vaccine response. We hope to provide answers to this very important unanswered question.
Professor Pam Kearns, Director of the Cancer Clinical Trials Unit at the University of Birmingham in the UK, which coordinates both OCTAVE and OCTAVE DUO, said:
The pandemic has been of particular concern to millions of people in the UK who suffer from long-term conditions or illnesses that put them at increased risk of serious illness and death from COVID-19.
Along with our preliminary results from OCTAVE, this new study will help inform about how best to vaccinate patients with chronic illnesses and protect them against COVID-19 infection in the future.
Dr Rob Buckle, chief scientist of the Medical Research Council, part of UKRI, which co-funded the trial, said:
While most of us are relieved to be vaccinated to protect ourselves and those around us, today’s findings investigating outcomes for people with immunosuppression will concern the subset for which the vaccine does not. did not elicit a significant protective response.
This new study of giving this group a third blow is critical research that we hope will demonstrate much needed immunity boost or identify those who may benefit from other interventions.
One of the real strengths of the UK’s scientific response to the pandemic has been the way we have brought together teams of experts to conduct cutting-edge studies like this, to inform our vaccine deployment and real-time government decision-making.
Over 89 million people have been vaccinated in the UK, including over 47 million people with a first dose (87.7%) and over 41 million people with a second dose (76.9%).
Data from Public Health England (PHE) shows that COVID-19 vaccines are highly effective against hospitalization of the Delta variant (B.1.617.2), the dominant strain in the UK. Analysis shows that in all adults, Pfizer-BioNTech vaccine is 96% effective and Oxford-AstraZeneca vaccine is 92% effective against hospitalization after 2 doses.
COVID-19 vaccines have saved around 95,200 lives and prevented 82,100 hospitalizations and 23.9 million infections in England alone, according to the latest data from Public Health England and the University of Cambridge.
Notes to Editors:
- Further advice on vaccination, including whether to give a third dose to immunocompromised people, is not dependent on OCTAVE DUO, whose results are expected later this year.
- Recruitment for the OCTAVE DUO study will only be from the cohort of individuals involved in the initial OCTAVE study and similar studies.
- Hospital study sites that recruited patients for OCTAVE: QEH Birmingham, Glasgow, St James Leeds, Imperial London (Hammersmith), Oxford, Addenbrookes, Southampton, King’s College London, Sheffield, St Georges London, Freeman Hospital.
Context of the immunization program:
- The latest UK-wide vaccination statistics are published here and NHS England publishes vaccination statistics for England here.
- The latest PHE analysis on the effectiveness of COVID-19 vaccines is available here. Their latest study on the number of cases averted and lives saved with vaccines is here.
- PHE has published data here on the effectiveness of COVID-19 vaccines for groups at risk.
- Visit the NHS website for advice on how to book or manage a COVID-19 vaccination appointment.