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NCT05112848: COVID-19

A Study to Evaluate Safety and Immunogenicity of a COVID-19 Vaccine in People Living With HIV at Risk for SARS-CoV-2 (COVID-19)

Completed Phase 2 Last updated 16 March 2023
What this trial tests

Phase 2 trial testing NVX-CoV2373 in SARS-CoV-2 Infection in 384 participants. Completed in 30 November 2022.

Timeline
28 February 2022
Primary endpoint
23 May 2022
30 November 2022

Quick facts

Lead sponsorNovavax
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment384
Start date28 February 2022
Primary completion23 May 2022
Estimated completion30 November 2022
Sites7 locations across South Africa

Drugs / interventions tested

Conditions studied

Sponsor

Novavax — full company profile →

Who can join

Adults 18 to 65, any sex, with SARS-CoV-2 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Nanotechnology's frontier in combatting infectious and inflammatory diseases: prevention and treatment.
    Huang Y, Guo X, Wu Y, Chen X, et al · · 2024 · cited 188× · PMID 38378653 · DOI 10.1038/s41392-024-01745-z
  2. Targeted modulation of immune cells and tissues using engineered biomaterials.
    Yousefpour P, Ni K, Irvine DJ. · · 2023 · cited 105× · PMID 37772035 · DOI 10.1038/s44222-022-00016-2
  3. Advances in Pathogenesis, Progression, Potential Targets and Targeted Therapeutic Strategies in SARS-CoV-2-Induced COVID-19.
    Zhou H, Ni WJ, Huang W, Wang Z, et al · · 2022 · cited 12× · PMID 35450063 · DOI 10.3389/fimmu.2022.834942
  4. Enhancing vaccine effectiveness in the elderly to counter antibiotic resistance: The potential of adjuvants via pattern recognition receptors.
    Jung M, Kim H, Choi E, Shin MK, et al · · 2024 · cited 1× · PMID 39693178 · DOI 10.1080/21645515.2024.2317439
  5. Immunogenicity and safety of SARS-CoV-2 recombinant spike protein vaccine in South African people living with and without HIV-1 infection: A phase 2 randomised trial.
    Bennett C, Hoosain Z, Koen A, Lalloo U, et al · · 2024 · cited 1× · PMID 39343247 · DOI 10.1016/j.jinf.2024.106285

Verify or expand the search:

Other trials of NVX-CoV2373

Trials testing the same drug.

Other recruiting trials for SARS-CoV-2 Infection

Currently open trials in the same condition.

Other Novavax trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05112848.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing