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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Breast cancer
Lung cancer
Myeloma

Status:

Closed

Phase:

Other

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

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. Clinical trials testing the COVID-19 vaccines used healthy volunteers with good immune systems.

People with cancer and some chronic illnesses immune systems may not be working very well. And it isn’t known how well the COVID-19 vaccines might work for these people. 

In this study researchers are taking blood and spit (saliva) samples from these people when they have their vaccination.

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

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this study if you are at least 18 years old and have one of the following:

You may also be able to join if you have had a stem cell transplant Open a glossary item or CAR-T cell therapy

And one of the following applies.

  • You have not had your 2nd vaccine (boost). 

or

  • It has not been more than 28 days after your 2nd vaccine (boost).

Trial design

The study team need 5,000 people in total to join. Of these they need 1,000 people with cancer to take part.

There are 2 groups in this study. Your doctor chooses which group you are in.

In group 1 you give blood and spit (saliva) samples 3 to 5 times. That is:

  • before your first injection if possible. If you have already had your first vaccine and you had a sample of blood taken as part of another study the team will ask permission for some of this sample
  • the day after your first injection, this is optional you don’t have to agree to give this sample
  • before your second injection (booster)
  • 28 days after your booster injection
  • 6 months after your first injection

In group 2 you give blood samples once or twice. That is:

  • before your first injection if possible
  • 28 days after your second injection (booster)

The team will also collect information from your medical records for 6 months. This will include details about:

  • your cancer
  • your treatment
  • details of any coronavirus vaccine
  • side effects

Hospital visits

Your study doctor will arrange to take the samples. Where possible it will be when you have a clinic appointment to avoid extra visits to the hospital.

Side effects

Having blood taken may cause some discomfort, bleeding or bruising where the needle enters the body and, in rare cases, light-headedness and fainting.

Early results

In 2021 the research team published early (interim) results for the OCTAVE trial. They don’t have full results for the trial yet. 

They plan to publish more results at a later date. We hope to update this page once more results are available.

This is a summary of the results so far.

Results
The team have looked at the first 600 people in the trial to see how well their immune system responded to the COVID-19 vaccine. This included people with a number of different auto immune diseases and some people with cancer. The numbers who had cancer were: 

  • 47 who had breast cancer or lung cancer
  • 18 people who had acute myeloid leukaemia (AML) or myeloma

And people who had a stem cell transplant.

4 weeks after the 2nd vaccine injection the team found that the immune system responded in:

  • all the people (100%) who had breast cancer or lung cancer
  • just under 89 out of every 100 people (88.9%) who had AML or myeloma 
  • just over 88 out of every 100 people (88.1%) who had a stem cell transplant

The team also compared these people with the immune response of healthy volunteers. They found that for a significant number their immune response was lower than the healthy volunteers. 

Conclusion
These are early results. They can help decide whether a booster vaccine injection might be worthwhile for this group of people. 

What isn’t known is how well the vaccine can protect this group of people from getting COVID-19. 

The team say there is a need to further study those who haven’t had an immune response. 

This trial is still open and recruiting people. The team say that with more people and further analysis this will provide more answers. 

Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

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.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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