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SARS-COV-2 VIRUS, VARIANTS B.1.351-B.1.1.7, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HETERODIMER

Clinical trials are studying SARS-COV-2 VIRUS, VARIANTS B.1.351-B.1.1.7, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HETERODIMER in people already vaccinated against COVID-19. These studies look at safety, tolerability, and immune response, and include older adults, adolescents, and adults receiving booster doses, sometimes compared with another vaccine.

Table of contents

Trial overview

These studies investigated SARS-COV-2 VIRUS, VARIANTS B.1.351-B.1.1.7, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HETERODIMER as part of COVID-19 booster vaccination research in people who had already been vaccinated against COVID-19.[1][2][3]

The trials focused on safety, tolerability, and immunogenicity, which means how well the vaccine helps the immune system make a response.[1][2][3]

All three studies were completed and used an interventional design, meaning the researchers gave a vaccine and then measured outcomes over time.[1][2][3]

Who participated

One trial enrolled adults older than 65 years who were fully vaccinated against COVID-19 and studied coadministration with a seasonal influenza vaccine.[1]

Another trial included adults vaccinated against COVID-19 and compared a booster dose of SARS-COV-2 VIRUS, VARIANTS B.1.351-B.1.1.7, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HETERODIMER with Comirnaty Omicron XBB.1.5.[2]

The third trial studied adolescents from 12 years to less than 18 years of age who had received 2 doses of Comirnaty before getting a heterologous booster, which means a booster from a different vaccine than the first series.[3]

What was measured

Researchers measured local and systemic reactions, which are side effects at the injection site or throughout the body, through Day 7 after vaccination in the studies that reported them.[1][3]

They also tracked unsolicited adverse events, serious adverse events, and adverse events of special interest through the end of the study.[1][3]

In the booster comparison studies, the main immune test was neutralisation titre, measured by Pseudovirus Based Neutralisation Assay (PBNA), including results against Omicron BA.1 or Omicron XBB.1.16 depending on the trial.[2][3]

One study also measured medically attended adverse events and changes in safety laboratory tests, including Grade 3 and 4 changes from baseline, which means more serious changes compared with the start of the study.[2]

Trial phases and design

Two studies were Phase 2 trials, which are often used to learn more about safety and immune response in a defined group of participants.[1][3]

One study was a Phase 4 trial, which looked at a booster vaccine in adults and compared it with another approved COVID-19 vaccine.[2]

The designs included randomized, double-blind, multi-centre or multi-center, and open-label approaches. Double-blind means neither the participants nor the researchers knew who received which vaccine during the study, while open-label means the assigned vaccine was known.[1][2][3]

One trial used a non-inferiority design, which checks whether one vaccine is not worse than another by more than a set amount.[2][3]

Key trials in this set

The Phase 2 trial in adults over 65 years studied BIMERVAX with a seasonal influenza vaccine and focused on safety and tolerability when the vaccines were given together.[1]

The Phase 4 trial in adults compared a booster dose of SARS-COV-2 VIRUS, VARIANTS B.1.351-B.1.1.7, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HETERODIMER with Comirnaty Omicron XBB.1.5 and measured both safety and immune response at Baseline and Day 14.[2]

The adolescent Phase 2 trial studied BIMERVAX as a heterologous booster after 2 doses of Comirnaty and compared immune response with a young-adult booster study group, while also checking safety through the end of the study.[3]

Patient-friendly terms

  • COVID-19 booster: an extra vaccine dose given after the first vaccine series to improve protection.

  • Adjuvanted vaccine: a vaccine with an added ingredient that helps the immune system respond better.

  • Recombinant protein vaccine: a vaccine made using a lab-produced protein from the virus, not the whole virus.

  • Geometric mean titre (GMT): a way to summarize antibody test results for a group of people.

  • Baseline: the starting point before a study treatment is given.

  • Day 7, Day 14, Day 28: follow-up time points used to check reactions and immune response after vaccination.

Trial IDPhaseCondition studiedStatusEnrollment
2023-506189-29-00Phase 2SARS-CoV-2 and InfluenzaCompleted300
2023-508458-25-00Phase 4COVID-19 diseaseCompleted612
2023-504639-42-00Phase 2SARS-CoV-2 infectionCompleted300

FAQ

  • Who has been studied in these trials? The trials included adults older than 65 years, adolescents from 12 to under 18 years, and adults vaccinated against COVID-19. Some studies also looked at people who had already received a primary series and at least one booster dose.
  • What is being studied in these trials? The trials study SARS-COV-2 VIRUS, VARIANTS B.1.351-B.1.1.7, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HETERODIMER as a COVID-19 booster vaccine. They mainly check safety, tolerability, and how well the immune system responds.
  • What phases are the trials in? The studies are Phase 2 and Phase 4 trials. These phases are used to learn more about safety and immune response in larger groups of people.
  • What conditions are these trials focused on? The trials focus on SARS-CoV-2 infection, COVID-19 disease, and one study also includes influenza because the vaccine was given together with a flu vaccine. The goal is to help prevent COVID-19 in vaccinated people.
  • What outcomes do the trials measure? They measure local and systemic reactions, adverse events, serious adverse events, and special safety events. Some trials also measure neutralisation titre, which is a lab test that shows how strongly antibodies can block the virus.

Ongoing Clinical Trials on SARS-COV-2 VIRUS, VARIANTS B.1.351-B.1.1.7, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HETERODIMER

  • Study on the Safety and Immune Response of PHH-1V81 Booster for Adults Vaccinated Against COVID-19

    Not recruiting

    4 1 1 1
    Investigated drugs:
    Spain

  • Study on the Safety and Immune Response of BIMERVAX as a COVID-19 Booster in Adolescents Aged 12 to 17 Years

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Spain

  • Study on the Safety of BIMERVAX and Fluad Tetra for COVID-19 and Influenza in Adults Over 65 Who Are Fully Vaccinated Against COVID-19

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Phase 2: A mid-stage clinical trial that looks more closely at safety and how well a vaccine works in a larger group of people.
  • Phase 4: A later trial stage done after a vaccine is already in wider use, often to compare it with another vaccine or to study it in new groups.
  • Booster vaccination: An extra vaccine dose given after the first vaccine series to help strengthen or renew protection.
  • Heterologous booster: A booster dose that is different from the vaccine used in the first vaccine series.
  • Immunogenicity: How well a vaccine makes the immune system respond, usually by making antibodies.
  • Neutralisation titre: A lab result that shows how well antibodies can block a virus from infecting cells.
  • Pseudovirus Based Neutralisation Assay (PBNA): A laboratory test used to measure how strong the antibody response is against a virus-like particle.
  • Solicited reactions: Common side effects that researchers ask about in a planned way, such as pain or fever after vaccination.
  • Unsolicited adverse events: Any health problems reported after vaccination that were not specifically asked about by the researchers.
  • Serious adverse events (SAEs): Medical problems that are severe, may need hospital care, or are very important for safety monitoring.

References

  1. https://clinicaltrials.gov/study/2023-506189-29-00
  2. https://clinicaltrials.gov/study/2023-508458-25-00
  3. https://clinicaltrials.gov/study/2023-504639-42-00