Australian Phase 2b Study to Assess Effect of Dose Interval on Spikogen Covid-19 Vaccine

Launched by VAXINE PTY LTD · Dec 3, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how the time between doses of the Spikogen Covid-19 vaccine affects how well the vaccine works in the body. The Spikogen vaccine is designed to help protect against Covid-19 by teaching the immune system to recognize and fight the virus. The trial is currently active but not recruiting new participants, and it includes individuals aged 65 to 74, regardless of gender.

To participate, individuals must not have received any previous Covid-19 vaccinations and must be able to commit to all study visits. Women who could become pregnant need to use reliable birth control for a period before and after receiving the vaccine. Participants will need to provide written consent before starting and cannot have a history of severe allergic reactions to vaccines. Throughout the study, participants can expect to receive the vaccine at specific intervals and will be monitored to see how their immune response develops. This research is important for understanding the best way to use the Spikogen vaccine to protect against Covid-19.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provide written informed consent prior to initiation of any study procedures.
• • No history of previous Covid-19 vaccinations
• • Women of childbearing potential must use an acceptable contraception method from at least 28 days before study vaccination until 14 days after last study vaccination.
• • Understand and comply with planned study procedures and be available for all study visits.
• Exclusion Criteria:
• • Have a history of severe systemic reactions (anaphylaxis, breathing difficulties, severe rash) following previous immunization with licensed or unlicensed vaccines.
• • Received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period.
• • Intend to receive another Covid-19 vaccine during the time of the study