COVID-19 Corona virus infection COVID-19
Conditions
Interventions
A single COVID-19 booster vaccination
Sponsors
Valneva Austria GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants must meet all inclusion criteria to be eligible for the study. ALL PARTICIPANTS: 1. Participants of either gender aged 18 years and older at screening 2. Participants must have read, understood, and signed the informed consent form (ICF) 3. Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up. 4. Participant has a Body Mass Index (BMI) of 18.0-30.0 kg/m2, inclusive, at screening (Visit 0). 5. Must be able to attend all visits of the study and comply with all study procedures, including daily completion of the e-diary for 7 days following each vaccination. 6. Women of childbearing potential (WOCBP), who are sexually active with a man, must be able and willing to use at least 1 highly effective method of contraception (i.e. implant contraceptive, intra-uterine device (IUD) containing either copper or levonorgestrel, male sterilization [vasectomy], female sterilization, injectable contraceptive, oral contraceptive pill, vaginal contraceptive ring, barrier type of birth control measure) from study start until a minimum of 3 months after receiving the booster vaccine. 7. WOCBPs must have a negative pregnancy test prior to the booster vaccination. Cohort Specifics: Cohort 1A (>/= 18 years): 2 doses of mRNA, no infection Cohort 1B (18-50 years): 3 doses of mRNA, no infection Cohort 1C (18-50 years): 2 doses of mRNA, PCR or antigen confirmed SARS-CoV-2 infection Cohort 1D (18-50 years): 3 doses of mRNA, PCR or antigen confirmed SARS-CoV-2 infection Cohort 2A (> 50 years): 2 doses of mRNA, no infection Cohort 2B (> 50 years): 3 doses of mRNA, no infection Cohort 2C (> 50 years): 2 doses of mRNA, PCR or antigen confirmed SARS-CoV-2 infection Cohort 2D (> 50 years): 3 doses of mRNA, PCR or antigen confirmed SARS-CoV-2 infection Cohort 3 (>/= 18 years): PCR or antigen confirmed SARS-CoV-2 infection, but not vaccinated Note: Rapid antigen test results can be considered as proof of previous Covid-19 infection but only if the antigen test results have been officially documented or registered in an official system - as for the PCR test results, in all cases, a paper document must be available/printable to be considered sufficient proof of a previous infection prior to enrollment (in the relevant Cohorts).
Exclusion criteria
Exclusion criteria: Participants will not be eligible for the study if they meet any of the exclusion criteria. 1. Participant is pregnant or planning to become pregnant within 3 months after booster administration 2. History of allergy to any component of the vaccine 3. Participant had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening (Visit 0) 4. Participant has participated in a clinical study involving an investigational SARS-CoV-2 vaccine or has received or plans to receive a licensed SARS-CoV-2 vaccine during the duration of the study 5. Significant infection or other acute illness, including fever > 37.8 °C within 48 hours before vaccination 6. Positive SARS-CoV-2 rapid Antigen test result during screening (Visit 0) or Visit 1 7. Participant has a known or suspected defect of the immune system, such as participants with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno-suppressive therapy within 4 weeks prior to the expected day of vaccination (Visit 1). 8. 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 9. History of drug dependency or current use of drug of abuse or alcohol abuse at screening 10. Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to the expected day of first vaccination (Visit 1) 11. History of clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture 12. Severe and uncontrolled ongoing autoimmune or inflammatory disease, History of Guillain-Barre syndrome or any other demyelinating condition 13. Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study Prior/concomitant therapy: 14. Receipt of immunoglobulin or another blood product within the 3 months before expected day of vaccination (Visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study 15. Receipt of medications to treat or prevent COVID-19 (except licensed mRNA vaccine for participants of Cohort 1 and 2) 16. Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine or for medical emergencies such as tetanus or rabies exposure, within 28 days prior to the expected day of first vaccination (Visit 1) Others: 17. Any member of the study team or sponsor 18. An immediate family member or household member of the study*s personnel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity: - GMT fold-rise for neutralising antibodies against SARS-CoV-2 at Day 15 following a single booster dose with VLA2001 Safety: - Frequency and severity of solicited AEs (local and systemic reactions) within 7 days after the VLA2001 booster vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity: - Immune response as determined by the GMT of SARS-CoV-2-specific neutralizing antibodies at Visit 1 (pre-booster, Day 1) and Visit 2 (Day 15). - Proportion of participants achieving an at least 2-, 4-, 10- or 20-fold rise over baseline (pre-booster) in terms of neutralizing antibodies to SARS-CoV-2 S-protein at Visit 2 (Day 15). - GMT fold-rise of IgG antibodies to the SARS-CoV-2 S-protein at Day 15. - Immune response as determined by the GMT of IgG antibodies to the SARS-CoV-2 S-protein at Visit 1 (pre-booster, Day 1) and Visit 2 (Day 15). - Proportion of participants achieving an at least 2-, 4-, 10- or 20-fold rise over baseline (pre-booster) in terms of IgG antibodies to SARS-CoV-2 S-protein at Visit 2 (Day 15). - Assessment of T-cell responses from PBMCs after in vitro stimulation with SARS-CoV-2 antigens using e.g., ELISpot (IFN) or intracellular cytokine staining (IL-2, IL-4, IL-5, IL-13, TNF, IFN) at Day 1 and Day 15. Safety: - Frequency and severity of any AE up to 4 weeks after vaccination - Frequency and severity of unsolicited AEs up to 4 weeks after vaccination - Frequency and severity of any unsolicited vaccine-related AE up to 4 weeks after vaccination - Frequency and severity of any serious adverse event (SAE) up to 4 weeks after vaccination and up to Day 180. - Frequency and severity of any adverse event of special interest (AESI) up to 4 weeks after vaccination and up to Day 180. | — |
Countries
Netherlands
Outcome results
None listed