Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VLA2001 · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| VLA2001 | EXPERIMENTAL | - |
| AZD1222 | ACTIVE_COMPARATOR | \<30 years will receive VLA2001; participants aged ≥30 years will be randomised 2:1 to receive VLA2001 or AZD1222 |
| VLA2001 - adolescent part | EXPERIMENTAL | ≥12 to \< 18 years will be randomized 1:1 to receive VLA2001 or Placebo |
| Placebo | PLACEBO_COMPARATOR | ≥12 to \< 18 years will be randomized 1:1 to receive VLA2001 or Placebo |
| Low Dose: VLA2001 | EXPERIMENTAL | - |
| Medium Dose: VLA2001 | EXPERIMENTAL | - |
| High Dose: VLA2001 | EXPERIMENTAL | - |
| Booster: High Dose: VLA2001 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| VLA2001 | BIOLOGICAL | whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxide (Wuhan strain) 2 vaccinations 28 days apart Booster Vaccination on Visit B1 |
| AZD1222 | BIOLOGICAL | 2 vaccinations 28 days apart AZD1222 is a recombinant, replication-defective chimpanzee adenovirus expressing the SARS-CoV-2 S surface glycoprotein. |
| VLA2001 - adolescent part | BIOLOGICAL | whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxid 2 vaccinations 28 days apart and with a booster vaccination on day 208. Placebo group will receive VLA2001 on day 208 and following second vaccination 28 days later. |
| Placebo | BIOLOGICAL | 2 vaccinations 28 days apart with placebo (PBS buffer based on Dulbecco's PBS media formulation without Calcium and Magnesium ) |
Inclusion Criteria: 1. All participants must have read, understood, and signed the informed consent form (ICF). 2. Participants of either gender aged 56 years or older at screening. 3. Medically stable such that, according to the judgment of the investigator, hospitalization within the study period...
VLA2001 is an investigational vaccine being developed for the prevention of SARS-CoV-2 virus infection and SARS-CoV-2 infection, the illnesses caused by the virus that leads to COVID-19. It is intended for use in healthy individuals, including adults and adolescents aged 12 years and older.
VLA2001 is being developed by Valneva SE, a biopharmaceutical company. Valneva's stock is traded under the ticker symbol VALN on the stock market.
VLA2001 is in Phase 2 clinical development. It has completed Phase 1 and Phase 3 trials, but it is not yet approved by regulatory authorities. The drug remains investigational and is still undergoing clinical evaluation to assess its safety and immunogenicity.
VLA2001 has been studied in several completed clinical trials, including NCT04671017 (a Phase 1 dose-finding study), NCT04864561 (a Phase 3 trial comparing VLA2001 to AZD1222), NCT04956224 (a Phase 3 trial in adults aged 56 years and older), and NCT05364242 (a Phase 2 booster study).
No, VLA2001 is not the same as AZD1222. AZD1222 is a different COVID-19 vaccine developed by AstraZeneca. In one clinical trial, VLA2001 was compared directly against AZD1222 to evaluate its immunogenicity, but they are distinct vaccine candidates.