Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A Phase IIb/III, Double-Blind, Randomised, Active-Controlled, Multi-Center, Non-Inferiority Clinical Trial, to assess the safety and immunogenicity of a booster vaccination with an adapted recombinant protein RBD fusion homodimer candidate (PHH-1V81) against SARS-CoV-2, in adults vaccinated against COVID-19.

This research study is looking into a new booster vaccine for COVID-19 called PHH-1V81. We want to find out how safe this new booster is and how well it helps your immune system protect you against the virus. The study will compare PHH-1V81 with a booster vaccine that's already in use. People taking part will have already received a COVID-19 vaccine. We'll be carefully watching for any side effects and checking how their bodies respond to the vaccine by looking at their immune response. The main goal is to make sure the new booster is safe and works at least as well as the existing one in protecting against current variants of COVID-19.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Hipra Scientific S.L., Hipra Scientific S.L.

Enrolment target

612

Start

13 Nov 2023

COVID-19 disease

What is this study about?

This study is focused on developing new ways to protect against COVID-19. As the virus changes, like with the Omicron variants, vaccine makers need to update vaccines to keep them effective. This research is testing a new booster vaccine, called PHH-1V81, which is designed to specifically target these newer versions of the virus. It's a type of vaccine that uses a piece of the virus's spike protein to teach your immune system how to fight it.

The study has two main goals. First, it wants to make sure this new booster vaccine is safe. Researchers will closely monitor for any side effects that people experience. Second, it aims to see how well the new booster helps your body create strong protection against the virus. This protection is measured by checking your immune response, specifically by looking at how well your body creates antibodies that can neutralise the virus.

To make sure the new booster is effective, it's being compared to an existing COVID-19 booster vaccine. This comparison will help researchers understand if PHH-1V81 is at least as good, or even better, than what's currently available. By doing this research, scientists hope to provide more effective options for boosting protection against COVID-19, helping to keep people safer as the virus continues to evolve.

Key takeaways

This study tests a new COVID-19 booster vaccine (PHH-1V81).
It aims to check the booster's safety and how well it boosts your immune system.
The new booster is compared to an existing COVID-19 booster.
Participants must be adults (18+) who have already had a COVID-19 vaccine.
Close monitoring for side effects and immune response will happen over several months.

Who may be eligible?

This study is looking for adult volunteers, aged 18 and over, who have already had at least one COVID-19 vaccine in the past. Both men and women are welcome to take part.

There might be some other criteria that mean you can or cannot join the study, even if you meet the age and previous vaccination requirements. These could include certain health conditions, medications you take, or if you've recently had COVID-19. The study team will check all these details with you if you're interested in participating.

It's important that you discuss your full medical history with the study doctors to make sure this is the right study for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you already received at least one COVID-19 vaccine?
Are you generally in good health?
Are you able to attend several clinic visits for check-ups and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the new experimental booster vaccine (PHH-1V81) or an approved COVID-19 booster vaccine. It's a 'double-blind' study, meaning neither you nor the study team will know which treatment you are receiving.

You'll have several visits to the study clinic over several months. During these visits, the team will check your health, ask about any side effects, and take blood samples. These blood samples help the researchers see how well your immune system is responding to the vaccine. You'll also be asked to keep track of any local reactions (like pain at the injection site) or general body reactions (like fever or headache) for a week after your vaccination. The study could last for many months, and the team will keep in touch to monitor your well-being throughout this period.

Potential risks and benefits

Taking part in a clinical trial could offer a potential benefit of receiving a new experimental vaccine that might offer strong protection against COVID-19. However, like all vaccines, there's always a possibility of side effects, which vary from mild (like soreness at the injection site or feeling tired) to less common, more serious reactions. The study team will explain all known or potential risks to you before you decide to join. It is very important to remember that participating in a clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is the new booster vaccine being tested?

The new booster vaccine is called PHH-1V81, and it's designed to protect against newer versions of the COVID-19 virus, like Omicron.

Will I know if I'm getting the new vaccine or the standard one?

No, this is a 'double-blind' study, meaning neither you nor the study team will know which booster you receive. This helps ensure the results are fair.

What kind of immune response are they looking for?

Researchers will take blood samples to measure how well your body makes antibodies that can fight off the different COVID-19 variants.

How long will I need to be involved in the study?

Your participation in the study, including follow-up visits and checks, could last for several months to make sure your health and immune response are properly monitored.

What happens if I change my mind about participating?

You are free to leave the study at any time, for any reason, without it affecting your usual medical care.