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SARS-COV-2 VIRUS, VARIANT LP.8.1, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HOMODIMER

Clinical trials are investigating SARS-COV-2 VIRUS, VARIANT LP.8.1, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HOMODIMER in studies of COVID-19 vaccination. These trials mainly look at immune response, safety-related study outcomes, and how well different vaccine products work in adults. The available trial data here includes a Phase 3 study in people receiving COVID-19 vaccines.

Table of Contents

Trial overview

The available clinical trial is titled COVID-19 vaccine immunology and is listed as completed.[1] It studies COVID-19 infection and looks at immune responses after vaccination with different vaccine formulations.[1]

Study design and phase

This was an interventional study, which means researchers gave vaccine products and then measured the results.[1] The trial was in Phase 3, a later stage of clinical testing that usually includes a larger number of people and checks how well a vaccine response performs.[1]

The study planned to enroll 4000 participants.[1]

Who the study involved

The trial data describes vaccine recipients in the setting of COVID-19 infection.[1] The source material does not provide a full list of eligibility rules, so only the trial-level target population can be stated here.[1]

Main outcome measured

The main outcome was the proportion of seropositive subjects with an antibody level above the target level at 6 months after two doses against the prevailing virus variant.[1] In simple terms, the researchers wanted to see how many people had antibodies in their blood and whether those antibody levels reached the planned target.[1]

Vaccines studied in the trial

The study compared several COVID-19 vaccine products, including BIMERVAX LP.8.1, Spikevax bivalent Original/Omicron BA.1, Comirnaty, Spikevax 50 micrograms, Comirnaty JN.1, Nuvaxovid, COVID-19, VIRAL VECTOR, NON-REPLICATING, Comirnaty Original/Omicron BA.4-5, Comirnaty Omicron XBB.1.5, and Comirnaty LP.8.1.[1] All were given by injection into a muscle.[1]

What the results mean for patients

This trial was designed to compare immune responses after different vaccine formulations, not to describe long-term disease treatment.[1] The key patient-focused question is whether a vaccine product can help more people reach the target antibody level after vaccination.[1] Because the study is completed, it adds evidence about how these vaccines performed in the tested group.[1]

Trial ID Phase Condition studied Status Enrollment
2024-517357-27-00 Phase 3 COVID-19 infection Completed 4000

FAQ

  • What are the trials studying? The trial is studying immune responses after COVID-19 vaccination with different vaccine formulations. It compares vaccine products and measures how many people reach a target antibody level.
  • Who can take part in these trials? The available study focuses on vaccine recipients in a COVID-19 infection study. The trial data does not give full public details on all eligibility rules.
  • What phase is the study? The study is in Phase 3. This means it is a later-stage trial that looks at how well the vaccine response performs in a larger group of people.
  • What condition is being studied? The condition listed is COVID-19 infection. The study is about vaccination in the setting of COVID-19.
  • What is the main result being measured? The main result is the proportion of seropositive subjects with an antibody level above the target level at 6 months after two doses. Seropositive means the blood test shows antibodies.

Ongoing Clinical Trials on SARS-COV-2 VIRUS, VARIANT LP.8.1, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HOMODIMER

  • Study on Immune Responses to COVID-19 Vaccines: Raxtozinameran, Bretovameran, and Drug Combination for COVID-19 Patients

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

Glossary

  • Antibody: A protein made by the immune system that helps fight infection. In these trials, antibody levels are used to see how the body responds to vaccination.
  • Antibody level: The amount of antibodies found in the blood. A higher level can suggest a stronger immune response.
  • COVID-19 infection: The illness caused by the coronavirus. This is the condition listed in the trial data.
  • Dose: A measured amount of vaccine given to a person. The trial data includes vaccines given as two doses in some study measures.
  • Emulsion for injection: A liquid vaccine form that is prepared to be injected into a muscle.
  • Interventional study: A type of clinical trial where researchers give a treatment or vaccine and then measure the results.
  • Intramuscular injection: An injection given into a muscle, usually in the arm.
  • Phase 3: A later stage of clinical testing that usually includes more people and checks how well a treatment or vaccine works.
  • Prevailing virus variant: The virus version that is most common at the time the study is done.
  • Seropositive: A blood test result showing antibodies are present.

References