A Phase 2b Study to Assess the Effect of Dose Interval on the Effectiveness of a Protein-based Covid-19 Vaccine (Spikogen® Vaccine)

C19-P2/3B

A study to assess the effect of varying the time interval between doses on the immunogenicity of an adjuvanted recombinant spike protein Covid-19 vaccine (Spikogen/Covax-19)

2022-03-01

2023-02-23

2024-06-30

Active (not recruiting)

Early phase I

200

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomised into 4 groups, where the only difference will be the time between vaccine doses (3, 4, 5 or 6 weeks)', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-04-09