Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults

This research study is investigating a new vaccine designed to protect against COVID-19. It's specifically looking at a type of vaccine called a 'recombinant coronavirus-like particle' vaccine. The study has two main parts: an earlier part that confirmed the vaccine's dose and how it affects the immune system, and a main part that compares the new vaccine to a dummy injection (placebo) to see if it truly prevents COVID-19. Researchers will also keep a close eye on participants to make sure the vaccine is safe. If you join, you'll be monitored for a year after your last vaccination. We're looking for adults aged 18 and over to take part.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Medicago

Enrolment target

30,918

Start

19 Nov 2020

Estimated completion

30 Apr 2022

SARS-CoV-2 Infection

What is this study about?

This study is testing a new type of vaccine for COVID-19. This vaccine is designed to help your body learn to fight off the SARS-CoV-2 virus, which causes COVID-19. The vaccine works by showing your immune system parts of the virus that look like the actual virus but can't make you sick. This helps your body build protection without you having to get the illness first.

The study has been carefully designed in two main stages. The first stage helped researchers decide on the best dose and how the vaccine affects your immune system. The main stage, which is happening now, is comparing the new vaccine to a 'placebo' – which looks exactly like the vaccine but doesn't contain any active ingredients. This is a common and important way to see if the new vaccine really works better than no treatment at all.

Taking part would mean you would receive either the new vaccine or the placebo through injections into your muscle. Throughout the study, the research team will regularly check your health and how your body responds to the vaccine. This is to make sure it's safe and to see how well it protects against COVID-19. Your participation is really valuable as it helps us understand if this new vaccine could become available to more people in the future.

Key takeaways

Testing a new COVID-19 vaccine for safety and effectiveness.
Compares the new vaccine with a dummy injection (placebo).
Open to adults aged 18 and over who are generally healthy.
Involves injections and regular health check-ups.
Participation lasts about 12 months after the last vaccination.

Who may be eligible?

To be part of this study, you generally need to be an adult aged 18 or older. Some parts of the study specifically looked at people between 18 and 64, or those aged 65 and over, but overall, adults can participate.

It's important that you are generally in good health. If you have a long-term health condition, you might still be able to join, but only if your condition is stable and your doctor on the study team believes it won't affect your safety or the study results. Stable generally means your condition hasn't gotten worse or changed significantly recently.

For most participants, your Body Mass Index (BMI) also needs to be within a certain range (between 18.5 and under 30). If you are a woman who could become pregnant, you would need to have a negative pregnancy test at the start of the study.

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?
Are you generally in good health?
Do you have a stable long-term health condition (if applicable)?
Is your Body Mass Index (BMI) between 18.5 and under 30 (for most participants)?
Are you able to attend clinic visits and communicate with the study team for about a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first need to read and sign a consent form, making sure you understand what the study involves. You will then have an initial visit where your general health will be checked, including a physical exam and measurements like your height, weight, and blood pressure.

You will receive injections into your muscle, which will either be the new vaccine or a placebo (a dummy injection). The study staff will keep track of which one you receive, but you and your regular doctor won't know until the study is over. You'll have several visits to the study clinic, and the team will also check in with you by phone. The main purpose of these visits and calls is to monitor your health, look for any side effects, and check your immune response. After your final vaccination, you will be followed for a full year to ensure your safety and to see how well your body maintains its protection. The total duration of your involvement will therefore be around 12 months after your last injection.

Potential risks and benefits

Participating in a clinical trial can have potential benefits, such as contributing to medical knowledge and potentially receiving a new vaccine that might protect you from COVID-19. However, there are also potential risks; for example, you might experience side effects from the vaccine or the placebo, or you might not receive the active vaccine. All medical procedures carry some level of risk, and you will be closely monitored for any health changes. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (91)

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

Achieve Clinical Research, LLC dba Accel Research Sites
Verified postcode
Birmingham, United States
Fiel Family and Sports Medicine/CCT
Verified postcode
Tempe, United States
Hope Clinical Research
Verified postcode
Canoga Park, United States
CNS Network
Verified postcode
Garden Grove, United States
Long Beach Clinical Trial Services Inc.
Verified postcode
Long Beach, United States
Pharmacology Research Institute
Verified postcode
Newport Beach, United States
Wr-McCr, Llc
Verified postcode
San Diego, United States
Ascension Providence Health System
Verified postcode
Washington D.C., United States
Alliance for Multispecialty Research
Verified postcode
Coral Gables, United States
Research Centers of America
Verified postcode
Hollywood, United States
AppleMed Research Inc
Verified postcode
Miami, United States
Elixia COVID-19
Verified postcode
Palm Beach, United States

Common questions

What is a 'recombinant coronavirus-like particle' vaccine?

It's a type of vaccine that uses tiny structures that look like the coronavirus but don't contain any real virus, so they can't make you sick. These 'particles' help your body's immune system learn to recognise and fight off the actual virus.

What does 'placebo-controlled' mean?

It means some participants will receive the new vaccine, while others will receive a dummy injection (a placebo) that doesn't contain any active ingredients. This helps researchers fairly compare the effects of the new vaccine.

What does being 'observer blinded' mean?

It means that the people giving you the injections and those assessing your health during the study won't know whether you received the actual vaccine or the placebo. This helps prevent any bias in the study results.

Will I know if I received the actual vaccine or the placebo?

No, you won't know during the study. This is to keep the study results as accurate as possible. Usually, this information is shared with participants after the study is completed.

How long will I be involved in the study?

You'll be monitored for 12 months after your final vaccination, which means your total involvement in the study will be for about a year following your last injection.