A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-Mâ„¢Adjuvant in People Living with HIV.


Novavax, Inc. is developing recombinant vaccines adjuvanted with the saponin-based Matrix-M adjuvant for the prevention of disease caused by SARS-CoV-2. Both nonclinical and clinical data to date support continued clinical development of SARS-CoV-2 recombinant (r) spike (S) protein nanoparticle vaccines (SARS-CoV-2 rS) combined with Matrix-M adjuvant as potential vaccines against SARS-CoV-2. Reports from the United Kingdom (UK), Brazil, South Africa, and India revealed the emergence of the B.1.1.7 (Alpha), P.1 (Gamma), B.1.351 (Beta), and B.1.617.2 (Delta) variants of SARS-CoV-2, respectively, with confirmed acquisition of mutations in key antigenic sites in the receptor binding domain (RBD) and N-terminal domain of the S protein. For the prototype SARS-CoV-2 rS with Matrix-M adjuvant, clinical efficacy results are available from studies run in the UK and South Africa where some of these variants have circulated.

The purpose of this safety and immunogenicity study is to determine an optimal regimen/dosing interval for PLWH aged 18 to 65 years across a spectrum of baseline control of HIV-infection as indicated by baseline level of control of HIV infection. Stratification by level of control of HIV viral infection will be used to achieve balance in the treatment groups.


  • Dr Faeezah Patel, Principal Investigator
  • Dr Elizea Horne
  • Dr Mrinmayee Dhar
  • Dr Robert Kieser
  • Tiffany Seef
  • Othusitse Segalo

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September 2023

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