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Clinical Trial Summary

This is a Phase 2, randomized, observer-blinded study evaluating the safety and immunogenicity of SARS-CoV-2 with Matrix-M™ Adjuvant in people living with human immunodeficiency virus (HIV) (PLWH) and HIV- negative adults, seronegative to SARS-CoV-2 at baseline.

Clinical Trial Description

The investigational product will be a monovalent Serum Institute of India (SII) severe respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2-rS) at a dose of 5 µg antigen adjuvanted with 50 µg Matrix-M (referred hereafter as NVX-CoV2373). A total of 270 PLWH, 18 to 65 years of age, inclusive, will be randomly assigned 1:1:1 to receive NVX-CoV2373 in either a two-dose regimen on Day 0 and Day 21 or Day 0 and Day 70 or a three-dose regimen on Days 0, 21, and 70. Randomization of PLWH will be stratified by level of control of HIV infection to distribute well-controlled and less-well-controlled participants approximately evenly among all the 3 PLWH treatment groups. Approximately 90 HIV-negative participants, 18 to 65 years of age, inclusive, will be randomly assigned 1:1 to receive NVX-CoV2373 in a two-dose regimen on Day 0 and Day 21 or Day 0 and Day 70. All HIV-negative participants will be baseline seronegative (for SARS-CoV-2). Placebo (normal saline solution) will be administered to participants who receive a two-dose regimen of NVX-CoV2373 to maintain overall blinding. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05112848
Study type Interventional
Source Novavax
Contact Chijioke Bennett, MD
Phone +1 (240) 661-8140
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date November 2021
Completion date July 2022

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