A trial of a vaccine called AST-VAC2 for non small cell lung cancer

The trial showed that AST-VAC2 doesn’t cause too many side effects. It also showed that it can affect the immune system in some people.

Trial design
This was a phase 1 trial. It was for people with advanced non small cell lung cancer (NSCLC). There were no suitable standard treatments  they could have.

A total of 9 people joined this trial to begin with. They were aged between 53 and 62 years old. Two men and 7 women joined the trial.

One person died before they could start treatment. The other 8 people had AST-VAC2 injections once a week for 6 weeks. The injections were given just under the skin.

Results

Side effects
Everyone taking part had at least one side effect. They were nearly all mild or moderate. No one had to delay or stop treatment because of side effects they were having.

Non serious side effects
The most common non serious side effects were:

• 8 people (100%) had a reaction where they had the injection such as redness, swelling or itching (injection site reaction)
• 3 people (37%) had extreme tiredness (fatigue)
• 2 people (25%) had muscle aches and pains

AST-VAC2 trial results - bar chart showing percentage of people with non serious side effects

One person had a moderate allergic reaction to the vaccine. The same person had mild psoriasis, a skin reaction. These symptoms improved without needing treatment and the person was able to continue on the trial.

Serious side effects
Researchers can class a side effect as serious for a number of reasons, including if:

• the person has to go to hospital because of it
• it is particularly important for the specific treatment in the trial

No one taking part had any side effects that were classed as serious.

How well treatment worked
The trial team looked at how well the vaccine was working when people finished treatment. They found no one’s cancer had gone away or got smaller.

The cancer had:

• stayed the same for 5 people
• continued to grow for 3 people

They also looked at how many people were living 2 years after joining the trial. They found it was 3 out of 8 people (37%). This is a bit higher than you might expect with no treatment. But it’s hard to say for sure because of the small number of people in the trial.

Immune response
The trial team looked at how people’s immune system reacted to the vaccine. This is called an immune response . They tested for an immune response at various times during the trial.

They found that:

• 2 people had an immune response at more than one time point (researchers call this a durable response)
• 2 people had an immune response at a single time point
• 4 people didn’t have an immune response

Conclusion
The research team concluded that the dose of AST-VAC2 used in this trial didn’t cause too many side effects. And that 2 people had an immune response in more than one test. All the results from the trial will be useful for future research.

Other trials of AST-VAC2 in the future may show different results.

Future plans
When this summary was written there were no ongoing trials with AST-VAC2, but further trials were being considered. 

Where this information comes from    
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed ) or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.