Table 2.
Overview of the clinical trials of VLPs vaccines against COVID-19 as of November 1, 2022 (https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines).
| Developers/Study identifier | Study phase | Type of candidate vaccine | Via | Subjects | Number of subjects | Study location | Project title |
|---|---|---|---|---|---|---|---|
| Radboud University/NCT05329220 | Phase 3 | ABNCoV2 capsid virus-like particle (cVLP) +/- adjuvant MF59 | IM |
Adults (18 Years and older) | 4000 | United States, Georgia | Evaluation of the Immunogenicity, Safety, and Tolerability of a Single Dose of ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2: a Phase 3 Trial in Two Parts-Randomized, Double-blind, Active Controlled and Open-label, Single-arm |
| Medicago Inc./NCT05040789 | Phase 3 | Coronavirus-Like Particle COVID-19 (CoVLP) MT-2766 Other Name: CoVLP, AS03 adjuvant |
IM | Adults (18–49 years old) (Not yet recruiting) |
900 | Canada, Ontario | A Randomized, Observer-Blind, Multicenter Study to Evaluate the Lot Consistency of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Healthy Adults |
| The Scientific and Technological Research Council of Turkey/NCT04962893 | Phase 2 | SARS-CoV-2 VLP: Vaccine/Vaccine-Wuhan; Vaccine-Alpha variant; Vaccine-Wuhan + Alpha variant | SC | Adults (18–59 years old) | 349 | Turkey | Assess the Safety, Efficacy, and Immunogenicity of Authentic SARS-CoV-2 or Alpha Variant Spike Containing VLP Vaccines and Their Combination for the Prevention of COVID-19 in Healthy Adult Volunteers (SAVE STUDY) |
| VBI Vaccines Inc./NCT04773665 | Phase 1/2 | VBI-2902a. An enveloped virus-like particle (eVLP) of SARS-CoV-2 spike (S)/glycoprotein and aluminum phosphate adjuvant | IM |
Adults (18–54 years old) | 114 | Canada, Nova Scotia | A Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the COVID-19 (SARS-CoV-2) Vaccine Candidates VBI-2902a and VBI-2905a in Healthy Adults |
| Serum Institute of India + Accelagen Pty + SpyBiotech/ACTRN12620000817943/ACTRN12620001308987 | Phase 1/2 | RBD SARS-CoV-2 HBsAg VLP/RBD SARS-CoV-2 HBsAg VLP (Adjuvanted with Alum + CpG 1018/Alum alone) | IM/ IM |
Adults (18–79 years old)/Adults (18–79 years old)(Not yet recruiting) | 280/255 | Australia/Australia (Not yet recruiting) | A randomized, placebo-controlled, multi-centre study to evaluate the safety and immunogenicity of COVID-19 Vaccine in Healthy Adults/ A randomized, placebo-controlled, multi-centre study to evaluate the safety and immunogenicity of a novel Receptor Binding Domain (RBD) COVID-19 Vaccine in Healthy Adults |
| Yantai Patronus Biotech Co., Ltd./NCT05125926 | Phase 1 | SARS-CoV-2 Vaccine LYB001, a receptor-binding domain (RBD) from SARS-CoV-2 and virus-like particle (VLP) vector, adjuvanted with aluminum hydroxide. | IM | Adults(18 Years and older) (Not yet recruiting) | 100 | Not yet recruiting |
Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Vaccine LYB001 in Healthy Adults: a Randomized, Double Blinded, Placebo-controlled Phase Ⅰ Trial |
IM, intramuscular; SC, subcutaneous injection.