Active not recruitingPHASE1INTERVENTIONAL

COVID-19 Omicron BA.5 Subvariant Dose Finding Infection Study

This study looks at how much of the Omicron BA.5 COVID-19 virus it takes to cause an infection in healthy volunteers. These volunteers have already had COVID-19 vaccines or have been infected with the virus before. The main goal is to find a safe way to study COVID-19 infection closely in a controlled setting. This type of study, sometimes called a human challenge study, helps scientists learn how the virus works and quickly test new medicines. Participants will stay in a special isolation unit. Medical teams will carefully monitor them for safety and to see how the virus behaves. The information gained will help develop better ways to fight new COVID-19 variants and protect public health.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

University of Oxford

Enrolment target

Start

08 Aug 2024

Estimated completion

31 Oct 2028

SARS-CoV-2 Infection

What is this study about?

This research is looking into a specific type of COVID-19, called the Omicron BA.5 subvariant. Scientists want to understand how easily this virus can cause an infection in people who have already been vaccinated against COVID-19 or have had COVID-19 before. Think of it like trying to find the 'tipping point' for infection.

The main aim is to develop a safe way to study COVID-19 where volunteers are given a very controlled amount of the virus. This kind of study is really important because it helps researchers learn quickly about new versions of the virus and test potential new treatments. By understanding exactly how the virus infects people, and at what 'dose', they can then test new medicines to see if they can stop the infection or reduce its effects more effectively and safely.

Volunteers will be closely looked after in special isolation rooms. This allows the medical team to monitor them very carefully. If a participant starts to feel unwell or shows signs of infection beyond a mild cold, they will be given treatments like Paxlovid. The information gathered from this study will help us create better ways to fight future COVID-19 variants and protect everyone's health.

Key takeaways

Tests how much Omicron BA.5 virus causes infection.
For healthy people aged 18-40, vaccinated or previously infected.
Participants stay in isolation for at least 11-14 days.
Close monitoring and treatment if needed.
Helps develop new COVID-19 treatments and understanding.

Who may be eligible?

To join this study, you need to be a healthy person between 18 and 40 years old. It's important that you have already received at least one COVID-19 vaccine, with your last jab being at least three months ago. You also need to show that you've either had a COVID-19 infection in the past or that you have antibodies against the virus, meaning your body has already fought it off.

There are also some health requirements: your Body Mass Index (BMI) needs to be within a healthy range (between 18.5 and 28, though in some cases up to 30 for very fit people). You should be generally in good health with no serious medical conditions that could make taking part unsafe. The study team will do checks like blood tests, an ECG (heart trace), and a chest X-ray to make sure you're suitable.

Finally, you must be willing to give your permission to join, allow doctors to speak to your GP, and agree to not donate blood during the study. If you could become pregnant, you must agree to use effective contraception before and during your time in the study and have negative pregnancy tests.

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 between 18 and 40 years old?
Have you had at least one COVID-19 vaccine, with the last dose over 3 months ago?
Do you have proof of a past COVID-19 infection or antibodies against the virus?
Do you have a general good health, with no significant ongoing medical problems?
If you could become pregnant, are you willing to use effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through screening tests to ensure you're eligible and healthy enough. If you qualify, you'll be given a small amount of the Omicron BA.5 virus through your nose. Then, you'll need to stay in a special isolation room within the study unit.

You'll be very closely monitored by the medical team. They will check for signs of infection and take regular samples to see how the virus is behaving and if it's decreasing. You'll stay in isolation for at least 11 to 14 days, and until tests show the virus is no longer active and your viral load is reducing. If you show any signs of more than mild COVID-19, you will be given anti-viral medication like Paxlovid.

During this time, you won't be able to leave the unit, and there will be strict rules for your safety and the safety of others. Details on follow-up appointments after you leave isolation will be provided, but the isolation period is the main part of your active participation.

Potential risks and benefits

Participating in this study could offer some potential benefits, perhaps gaining a better understanding of how your body responds to the virus and helping scientists develop new ways to fight COVID-19. However, there are risks, including getting infected with the Omicron BA.5 subvariant. While you will be very closely monitored and treated if needed, there's always a chance of unpleasant symptoms or, in rare cases, unexpected reactions. Your safety is a top priority, and the research team will take every precaution. You will have full information about potential risks before joining, and you are free to withdraw from the study at any time without giving a reason.

Locations (1)

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

Centre for Clinical Vaccinology and Tropical Medicine
Verified postcode
Oxford, United Kingdom

Common questions

What kind of virus will I be given?

You'll be given a controlled amount of the Omicron BA.5 subvariant of the COVID-19 virus.

Why is this study needed?

This study helps scientists understand how COVID-19 Omicron BA.5 infects people and how well new treatments work against it, helping to develop better ways to fight future variants.

Will I get sick if I join?

The goal is to understand infection at different controlled levels. You might experience mild COVID-like symptoms, and you will be treated if your symptoms are more than mild.

How long will I have to stay in isolation?

You'll stay in isolation for at least 11 to 14 days, and until tests show the virus is no longer active in your system.

What happens if I get very unwell?

You will be very closely monitored. If you develop symptoms beyond mild illness, you will be given antiviral treatments like Paxlovid or Remdesivir, depending on availability.