COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
About 3000 participants aged 30 years and above will be randomized via an Interactive Response System (IRS) in a 2:1 ratio to receive two intramuscular recommended doses of either VLA2001 (n=2000) or
Sponsors
Valneva (Austria)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must have read, understood, and signed the informed consent form (ICF) 2. Participants of either gender aged 18 years and older at screening 3. Medically stable 4. Must be able to attend all visits of the study and comply with all study procedures 5. Women of childbearing potential (WOCBPs) must be able and willing to use at least one highly effective method of contraception for a minimum of 3 months after the last dose of study vaccine 6. WOCBPs must have a negative pregnancy test prior to each vaccination
Exclusion criteria
Exclusion criteria: 1. Participant is pregnant or planning to become pregnant within 3 months after study vaccine administration 2. History of allergy to any component of the vaccine 3. Significant infection (e.g. positive SARS-CoV-2 RT-PCR) or other acute illness, including fever >100 °F (>37.8 °C) 48 hours before vaccination 4. Participant has a known or suspected defect of the immune system 5. Participant has a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome 6. Participant has a history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the participant may be enrolled. A history of hematologic malignancy is a permanent exclusion. Participants with a history of skin cancer must not be vaccinated at the previous tumour site 7. History of drug dependency or current use of drug abuse or alcohol abuse at screening 8. Significant blood loss (> 450 ml) or has donated one or more units of blood or plasma within 6 weeks prior to the expected day of randomization (Visit 1) 9. History of clinically significant bleeding disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture 10. Severe and uncontrolled ongoing autoimmune or inflammatory disease History of Guillain-Barre syndrome or any other demyelinating condition 11. Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the volunteer Prior/concomitant therapy: 12. Receipt of immunoglobulin or another blood product within the 3 months before expected day of randomization (visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study 13. Receipt of medications and or vaccinations intended to prevent COVID-19 14. Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (Visit 1) Others: 15. Any member of the study team or sponsor 16. An immediate family member or household member of the study’s personnel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity: 1. Immune response after completion of a two-dose immunization schedule, as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies measured using a neutralization assay on Day 43 Safety: 2. Frequency and severity of any Adverse Events (AE) collected during study visits up to Day 43 post-vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity: 1. Proportion of participants with seroconversion measured using a neutralization assay on Day 8 (age 55+ only), Day 29, Day 43, Day 71, Day 208 and Day 365 2. Immune response, as determined by the GMT of SARS-CoV-2-specific neutralizing antibodies measured using a neutralization assay on Day 8 (age 55+ only), Day 29, Day 71, Day 208 and Day 365 3. Immune response, as determined by the GMT of IgG antibodies to SARS-CoV-2 S-protein measured using an Enzyme-Linked Immunosorbent Assay (ELISA) on Day 8 (age 55+ only), Day 29, Day 43, Day 71, Day 208 and Day 365 4. T-cell responses assessed using T-spot assay and/or intracellular cytokine staining at selected timepoints (yet to be defined) in a subset of participants Safety: 5. Frequency and severity of solicited injection site and systemic reactions captured using electronic diaries within 7 days after each and after any vaccination 6. Frequency and severity of any AE collected during study visits during the entire study period 7. Frequency and severity of any unsolicited AE collected during study visits until Day 43 8. Frequency and severity of any unsolicited vaccine-related AE collected during study visits until Day 43 9. Frequency and severity of any serious adverse event (SAE) collected during study visits during the entire study period 10. Frequency and severity of any adverse event of special interest (AESI) collected during study visits during the entire study period | — |
Countries
United Kingdom
Outcome results
None listed