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Also known as Inactivated SARS-CoV-2 Vaccine (Vero Cells) - Sinovac, High-dosage SARS-CoV-2 vaccine, Medium-dosage SARS-CoV-2 vaccine, Inactivated COVID-19 Vaccine, Experimental Group, SARS-CoV-2 Inactivated Vaccine
CoronaVac · 1 trial · 2 indications
Differences in the humoral immunogenicity (GMT ratio \>1) of the neutralizing antibodies against the Delta and Omicron variants in response to a booster dose of the trivalent vaccine compared to CoronaVac® in adults who have initially received two doses of CoronaVac® and two booster doses with vaccines against SARS-CoV-2 different from CoronaVac® (mRNA or viral vectors (heterologous group)) will be evaluated.
Differences in the humoral immunogenicity (GMT ratio \>1) of the neutralizing antibodies against the Omicron variant generated in response to a booster dose with the Omicron vaccine when compared with CoronaVac® in adults who have initially received two doses of CoronaVac® and two booster doses with vaccines against SARS-CoV-2 different from CoronaVac® (mRNA or viral vectors (heterologous group)) will be evaluated.
Evaluation of the non-inferiority (seroconversion rate ≥5%) of neutralizing antibodies against the Omicron and Delta variants generated by a booster dose of trivalent vaccine when compared to CoronaVac® in adults who have initially received two doses of CoronaVac® and two booster doses with vaccines from other platforms (mRNA or viral vectors (heterologous group)).
Evaluation of the non-inferiority (seroconversion rate ≥5%) of neutralizing antibodies against the Omicron variant generated by a booster dose with Omicron vaccine when compared with CoronaVac® in adults who have two doses of CoronaVac® and two booster doses with vaccines from other platforms (mRNA or viral vectors (heterologous group)).
| Arm | Type | Description |
|---|---|---|
| Heterologous group receiving CoronaVac® | ACTIVE_COMPARATOR | General population that received two doses of CoronaVac® as a primary schedule of vaccination and two booster doses as part of the national vaccination schedule with mRNA or viral vector-based vaccines; and who receive a booster dose of CoronaVac® |
| Heterologous group receiving Omicron vaccine | EXPERIMENTAL | General population that received two doses of CoronaVac® as a primary schedule of vaccination and two booster doses as part of the national vaccination schedule with mRNA or viral vector-based vaccines; and who receive a booster dose of Omicron vaccine |
| Heterologous group receiving a trivalent vaccine | EXPERIMENTAL | General population that received two doses of CoronaVac® as a primary schedule of vaccination and two booster doses as part of the national vaccination schedule with mRNA or viral vector-based vaccines; and who receive a booster dose of trivalent vaccine |
| Homologous group receiving Omicron vaccine | EXPERIMENTAL | Participants of the CoronaVac03CL study who have received the primary regimen and two booster doses with CoronaVac® vaccine; and who receive a booster dose of Omicron vaccine |
| Homologous group receiving a trivalent vaccine | EXPERIMENTAL | Participants of the CoronaVac03CL study who have received the primary regimen and two booster doses with CoronaVac® vaccine and who receive a booster dose of trivalent vaccine |
| Name | Type | Description |
|---|---|---|
| CoronaVac® | BIOLOGICAL | The active ingredient is the SARS-CoV-2 virus (CZ02 strain, ancestral) grown in Vero cells and inactivated, in aluminum hydroxide. The vaccine is preservative-free, and it is packed in pre-load syringes (0.5 mL) with 600 SU/0.5mL of inactivated SARS-CoV-2. |
| Omicron Vaccine | BIOLOGICAL | An experimental intervention consisting of a booster dose of an inactivated Omicron variant vaccine. The active ingredient is the SARS-CoV-2 virus (Omicron variant) grown in Vero cells and inactivated, in aluminum hydroxide. The vaccine is preservative-free, packed in a pre-load syringe, and contains one dose (0.5mL) of 1200 SU of inactivated SARS-CoV-2 Omicron variant. |
| Trivalent Vaccine | BIOLOGICAL | An experimental intervention consisting of a booster dose of an inactivated trivalent (CZ02 strain, ancestral, Delta, and Omicron variants) variant vaccine. The active ingredient is the SARS-CoV-2 virus (CZ02 strain, ancestral, Delta, and Omicron variants) grown in Vero cells and inactivated, in aluminum hydroxide. The vaccine is preservative-free, and it is packed in a pre-load syringe containing one dose (0.5mL) (1200 SU of inactivated SARS-CoV-2 WT, 1200 SU of inactivated SARS-CoV-2 Delta variant, and 1200 SU of inactivated SARS-CoV-2 Omicron variant). |
Inclusion Criteria: * Adults, male or female, over 18 years of age; * Fully vaccinated against SARS-CoV-2 with two initial doses of CoronaVac® vaccine and that have received two booster doses of a different vaccine (heterologous group) or with CoronaVac® (homologous group) at least 5 months before ...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
CoronaVac is an investigational COVID-19 product developed by Sinovac Biotech, Ltd for the prevention of COVID-19. It is being studied in the infectious disease therapeutic area. Its clinical development has reached Phase 2, and it has been evaluated in a completed randomized, double-blind, active-controlled trial.
CoronaVac is being developed for COVID-19, the disease caused by SARS-CoV-2. Its clinical program has focused on immunogenicity against COVID-19, including evaluation of an Omicron variant-based vaccine and a trivalent vaccine in adults. The completed Phase 2 study enrolled 551 participants in Chile.
CoronaVac is developed by Sinovac Biotech, Ltd, which trades under the ticker SVA. The company is the sponsor behind the clinical program for this COVID-19 candidate.
CoronaVac is in Phase 2 clinical development. It is an investigational product and is not described as approved. One Phase 2 trial has been completed, and no trials are currently listed as active.
CoronaVac has been studied in the Phase 2 trial NCT05593042, titled Immunogenicity Evaluation of Omicron Variant-based Vaccine and a Trivalent Vaccine in Adults Against COVID-19 in Chile. That trial is completed, enrolled 551 participants, was randomized, double-blind, and active-controlled, and included healthy volunteers aged 18 years and older in Chile.
Yes, CoronaVac and CoronaVac® refer to the same COVID-19 product from Sinovac Biotech, Ltd. The registered trademark symbol is simply a stylized form of the same name, so searches for either term point to the same investigational candidate.