In short
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.
Key points
- Clinical trials of SARS-COV-2 VIRUS, VARIANTS B.1.351-B.1.1.7, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HETERODIMER focus on COVID-19 booster use in people already vaccinated against COVID-19. The studies include older adults, adolescents, and adults, and they are mainly Phase 2 and Phase 4 trials. Researchers are looking at safety, tolerability, and immune response. One trial also compares this vaccine with another COVID-19 vaccine, and one study includes coadministration with an influenza vaccine. The main measurements include local and systemic reactions, adverse events, serious adverse events, and antibody response tests.
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.
The trials focused on safety, tolerability, and immunogenicity, which means how well the vaccine helps the immune system make a response.
All three studies were completed and used an interventional design, meaning the researchers gave a vaccine and then measured outcomes over time.
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.
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.
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.
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.
They also tracked unsolicited adverse events, serious adverse events, and adverse events of special interest through the end of the study.
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.
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.
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.
One study was a Phase 4 trial, which looked at a booster vaccine in adults and compared it with another approved COVID-19 vaccine.
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.
One trial used a non-inferiority design, which checks whether one vaccine is not worse than another by more than a set amount.
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.
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.
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.
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.