BASIS Study
Infectious Diseases
Phase II randomised open label trial of full and half dose J&J Ad26.CoV2.S and Pfizer BNT162b2 booster vaccinations after receiving the J&J Ad26.CoV2.S prime vaccine through the SISONKE phase IIIB implementation study.
Rationale
The study aims to assess the immunogenicity and effectiveness of boosting strategies for the J&J Ad26.COV2.S vaccine. It specifically addresses several key points:
- Immunogenicity in Specific Populations: It focuses on populations that may have compromised immune responses, such as people living with HIV and older individuals, to understand the effectiveness of vaccination in these groups.
- Heterologous Prime-Boost Combinations: The study investigates heterologous prime-boost combinations, particularly using the Pfizer BNT162b2 mRNA vaccine as a booster after the J&J Ad26.COV2.S prime, to assess immune response levels.
- Dosage Optimization: It evaluates the potential for reducing vaccine dosage (half-dose regimens) for cost-effectiveness and to minimize adverse effects while maintaining immunogenicity.
- Duration of Immune Response: The study aims to determine the durability of the booster immune response over time (up to 6 months) following vaccination.
Investigators
- Dr Faeezah Patel (Principal Investigator)
- Prof Lee Fairlie (Principal Investigator)
- Dr Elizea Horne (Sub Investigator)
- Dr Mrinmayee Dhar (Sub Investigator)
- Tiffany Seef (Sub Investigator)
- Othusitse Segalo (Sub Investigator)
- Dr Jeanne Coetzee (Sub Investigator)
