A study to see how the COVID-19 vaccination affects how the body fights infection (OCTAVE)

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers
Breast cancer
Leukaemia
Lung cancer
Myeloma

Status:

Results

Phase:

Other

This study looked at how the COVID-19 vaccines affect the immune system Open a glossary item of people with cancer and chronic illnesses.

The study was open for people to join between February and October 2021. The team published the results in 2023.

More about this trial

Vaccines for COVID-19 work by helping the immune system make antibodies Open a glossary item that can fight the virus if you get it. The people taking part in the earlier clinical trials testing the COVID-19 vaccines were healthy volunteers with good immune systems.

The immune systems of people with cancer and some chronic illnesses may not work as well. And it wasn’t known how well the COVID-19 vaccines might work for these people. 

In this study researchers took blood and spit (saliva) samples from these people after they had their COVID-19 vaccination.

The aim of the study was to find out how well the immune system of people with cancer and chronic illnesses responds to the COVID-19 vaccines.

Summary of results

The team looked at the blood and spit samples of 2,686 people. This included people with a number of different autoimmune diseases Open a glossary item and some people with cancer. 

Those who had cancer were:

The team included people who had a stem cell transplant. They were:

They also included:

How well the immune system responded
Four weeks after the 2nd vaccine injection the team found that the immune system responded in:

  • everyone (100%) who had breast cancer or lung cancer
  • everyone (100%) who had AML or myeloma 
  • 85 out of every 100 people (85%) who had an autologous stem cell transplant
  • 86 out of every 100 people (86%) who had an allogeneic stem cell transplant
  • half the people (50%) who had CAR T-cell therapy
  • 28 out of every 100 people (28%) who had rituximab

Predicting how well the immune system responds 
The team found that the immune system of people with certain diseases or having particular treatments were more likely to have a low to moderate response to the vaccine. This means that they would be less able to fight COVID-19. This included people with:

  • inflammatory arthritis
  • kidney problems
  • Crohn’s disease

It also included people who had:

  • an allogeneic stem cell transplant
  • corticosteroids
  • some types of chemotherapy
  • certain drugs that affected the immune system 

COVID-19 infection and how bad it was
The team looked at how many people had COVID-19 up to a year after their 2nd vaccine. They had the results of 1,648 people. Of these, there were 474 people with COVID-19. For just over 90 in every 100 people (90.2%) it was a mild infection.

Most infections happened in people who had:

  • a kidney transplant
  • Crohn’s disease
  • inflammatory arthritis

They also found that for some people who had an autologous stem cell transplant or CAR T-cell treatment the infection rate of COVID-19 was low. But the people who had COVID-19 had a severe infection. 

Side effects
The majority of people had side effects after the vaccine. For over 97 out of every 100 people (97%) they were mild or moderate. 

The most common side effects included:

  • a reaction where they had the injection
  • headache
  • chills
  • sore muscles
  • high temperature (fever)

Conclusion
The trial team concluded that the immune system of these people had a moderate response after 2 vaccines. And if they did have COVID-19 after the vaccine it would be most likely be mild.

More detailed information
There is more information about this research in the references below. 

Please note, the information we links to here is not in plain English. It has been written for healthcare professionals and researchers.

SARS-CoV-2-specific immune responses and clinical outcomes after COVID-19 vaccination in patients with immune-suppressive disease
E Barnes and others
Nature Medicine, 2023. Volume 29, pages 1760 to 17740.

Examining the Immunological Effects of COVID-19 Vaccination in Patients with Conditions Potentially Leading to Diminished Immune Response Capacity – The OCTAVE Trial
P Kearns and others
Preprint with The Lancet

Where this information comes from    
We have based this summary on the information in the articles above. These have been reviewed by independent specialists (peer reviewed Open a glossary item) and published in medical journals. We have not analysed the data ourselves. As far as we are aware, the links we list above are active and the articles are free and available to view.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Iain McInnes

Supported by

Imperial College London
Medical Research Council (MRC)
University of Birmingham
University of Glasgow
University of Oxford
Cancer Research UK Clinical Trials Unit, Birmingham

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17321

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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