RecruitingPHASE1INTERVENTIONAL

A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults

This research is looking into a new COVID-19 vaccine booster called Prime-2-CoV_Beta. The main goals are to check how safe it is and how well it helps your body's defence system (immune system) fight off the virus. This is an early-stage study, meaning it's one of the first times this booster is being given to people. It's for healthy adults aged 18 to 55 who have already had COVID-19 vaccinations or infections. Participants will receive one booster injection and then be carefully monitored for six months through a series of follow-up visits and phone calls. By testing different doses, the researchers hope to find the safest and most effective amount of the booster.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

University Hospital Tuebingen

Enrolment target

Start

24 Jun 2022

Estimated completion

31 Dec 2026

COVID-19

What is this study about?

This study is about a new COVID-19 vaccine booster called Prime-2-CoV_Beta. Think of it like an extra top-up jab after your initial vaccinations. The main aim of this research is to see if this new booster is safe for people to take and how well it helps your body build up a strong defence against the COVID-19 virus. They're also trying to figure out the right amount, or 'dose', of the booster to give to get the best results without causing too many side effects.

This is an early stage of testing, often called a 'Phase 1' study. This means it's generally one of the first times a new treatment or vaccine is given to people. The study is 'open-label', which means both you and the study team will know which booster you are receiving. The researchers will be closely watching participants to understand any side effects and how their immune system reacts to the booster over several months.

Knowing how safe this new booster is and how well it makes your immune system respond is really important. This information helps scientists decide if the booster should be tested in larger groups of people and eventually, whether it could be a useful option to help protect more people from COVID-19 in the future.

Key takeaways

This study is testing a new COVID-19 booster called Prime-2-CoV_Beta.
It aims to check the booster's safety and how well it boosts your immune system.
It's for healthy adults aged 18-55 who have generally had previous COVID-19 vaccinations.
Participation involves one injection and several follow-up visits/calls over six months.
Taking part helps advance scientific understanding of new COVID-19 protections.

Who may be eligible?

This study is looking for healthy adults between 18 and 55 years old. People enrolling need to have a Body Mass Index (BMI) between 18.5 and 30, and weigh more than 50 kg (just under 8 stone). You should be generally healthy and not have any serious ongoing medical conditions.

You typically need to have already had some COVID-19 vaccinations. For most parts of the study, you'll need to have completed your main course of vaccinations (like two doses of some vaccines) or had three doses of an mRNA vaccine. The last vaccine you had must have been at least 10 weeks before starting this study. For a specific group (Cohort 7b), they are looking for people who have had fewer doses, preferably none or just one, as long as it wasn't an mRNA vaccine, and the last dose was also at least 10 weeks ago.

Women who could become pregnant must have a negative pregnancy test at the start of the study and agree to use highly effective contraception methods throughout the study period. This is to make sure you don't become pregnant while taking part. You also need to be able to understand the study information and give your written permission to take part.

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 55 years old?
Are you generally healthy with a BMI between 18.5 and 30 and weigh over 50kg?
Have you had previous COVID-19 vaccinations (or very few, for one specific group)?
If you're a woman, are you able and willing to use highly effective contraception throughout the study?
Can you understand the study information and give written permission to take part?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve several steps over about six months. First, you'll have an initial check-up to make sure you're suitable to take part. On 'Day 1' of the study, you'll receive a single injection of the Prime-2-CoV_Beta booster.

After your injection, the study team will keep in touch to monitor your health. They'll call you the next day and the day after that (Day 2 and Day 3) to ask how you're feeling and if you've had any side effects. You'll also have several in-person visits to the study clinic on Day 4, Day 8, Day 15, Day 29, and then at 3 months and 6 months after your booster injection. During these visits, the study team will check your health, ask about any symptoms, and likely take blood samples to see how your immune system is responding to the booster.

For some participants in a specific group (Cohort 7), there might be extra checks where they collect samples like urine, saliva, blood, and stool to look for something called ORFV shedding. The total duration of your active involvement in the study, from your booster injection to your final follow-up visit, will be around six months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of taking part is that you would be contributing to scientific knowledge, helping researchers understand more about potential new ways to protect people from COVID-19. You might also gain some protection from the booster, though this is not guaranteed. Potential risks could include side effects from the booster injection, similar to those you might experience with other vaccines, such as soreness at the injection site, tiredness, or a mild fever. There might also be other, unknown side effects, as this is a new booster being tested. The study team will closely monitor you for any health changes. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

University Hospital Tübingen, Institute of Tropical Medicine
Verified postcode
Tübingen, Germany· Recruiting
Bernhard-Nocht-Institut für Tropenmedizin
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is Prime-2-CoV_Beta?

It's the name of the new COVID-19 vaccine booster being tested in this study.

Do I need to have had COVID-19 vaccinations before?

For most groups, yes, you need to have had previous COVID-19 vaccinations. For one specific group, they prefer people with fewer or no COVID-19 vaccines.

How long will I be involved in the study?

From your booster injection to your final check-up, your involvement will last about six months.

Will I know if I'm getting the actual booster or a dummy dose?

In this study, everyone taking part will receive the Prime-2-CoV_Beta booster. There isn't a dummy dose (placebo) in this particular trial.

Can I leave the study if I change my mind?

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

How to find out more

University Hospital Tübingen

itmpm@med.uni-tuebingen.de +49 7071 2987179 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.