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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)
Phase 2 trial testing NVX-CoV2373 in SARS-CoV-2 Infection in 384 participants. Completed in 30 November 2022.
23 May 2022
Quick facts
| Lead sponsor | Novavax |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 384 |
| Start date | 28 February 2022 |
| Primary completion | 23 May 2022 |
| Estimated completion | 30 November 2022 |
| Sites | 7 locations across South Africa |
Drugs / interventions tested
- NVX-CoV2373 — full drug profile →
Conditions studied
- SARS-CoV-2 Infection — all drugs for SARS-CoV-2 Infection →
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT05112848
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of NVX-CoV2373
Trials testing the same drug.
- NCT05875701 — Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA Vaccines · Phase 3 · completed
- NCT05249816 — Phase 3 Boosting Study for the SARS-CoV-2 rS Vaccine · Phase 3 · completed
- NCT04834869 — COVID-19 Vaccines Safety Tracking (CoVaST) · recruiting
Other recruiting trials for SARS-CoV-2 Infection
Currently open trials in the same condition.
- NCT07079670 — Safety and Immunogenicity of NVX-CoV2705 · Phase 3 · active not recruiting
- NCT05697068 — Intervention to Prevent Household and Community Spread of COVID-19 Among Latinos · NA · active not recruiting
- NCT05172011 — Understanding the Long-term Impact of COVID on Children and Families · active not recruiting
- NCT05141058 — T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients · Phase 1 · recruiting
- NCT05046470 — SARS-CoV-2 Transmission in Belgian Primary Schools of the Federation Wallonia - Brussels: An Epidemiological Pilot Study · active not recruiting
Other Novavax trials
Trials by the same sponsor.
- NCT07086222 — Efficacy and Safety of NVX-CoV2705 · Phase 4 · not yet recruiting
- NCT06482359 — Lot Consistency Study of COVID-19 and Influenza Combination Vaccine · Phase 2, PHASE3 · withdrawn
- NCT06291857 — A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine · Phase 3 · active not recruiting
- NCT06409663 — A Strain Change Study for SARS-CoV-2 rS Vaccines · Phase 3 · completed
- NCT06633835 — Impact of Reactogenicity of the 2024-2025 COVID-19 Vaccines on Health Care Workers and First Responders in the United St · Phase 4 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05112848 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novavax
- Last refreshed: 16 March 2023
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