A phase I/II study to evaluate the safety of and immunological response to a vaccine candidate (VLA2001) against COVID-19
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN82411169
- Lead Sponsor
- Valneva (Austria)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 150
1. Subject is 18 to 55 years of age
2. Subject who has a smart phone and is willing and able to install and use an eDiary
3. Subject has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures
4. Subject is generally healthy as determined by the Investigator
5. Subject has a Body Mass Index (BMI) of 18.0-30.0 kg/m²
6. If the subject is of childbearing potential:
6.1. Subject has practiced an adequate method of contraception during the 30 days before screening (Visit 0)
6.2. Subject has a negative serum or urine pregnancy test at screening (Visit 0) or Visit 1, respectively
6.3. Subject agrees to employ adequate birth control measures up to Day 106 (Visit 5)
1. Clinically significant infection or other acute illness, including fever =38°C within 24 hours prior to the planned study vaccination
2. History of laboratory-confirmed SARS-CoV-2 infection
3. Subject had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening (Visit 0)
4. Subject has participated in a clinical study involving an investigational SARS-CoV-2 vaccine
5. Subject has an acute or recent infection not due to SARS-CoV-2
6. Subject has a history of SARS-CoV-1 or MERS infection (self-reported)
7. Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
8. Subject has received any vaccine within 30 days prior Visit 1 other than the study intervention, with the exception of the seasonal influenza vaccination
9. Subject has abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator
10. Subjects with either medical history of or present acute or progressive, unstable or uncontrolled clinical conditions that pose a risk for participation or completion of the study, based on Investigator’s clinical judgement
11. Subjects with underlying diseases with a high risk of developing severe COVID-19 symptoms if infected
12. Subject 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 subject may be enrolled. A history of hematologic malignancy is a permanent exclusion. Subjects with a history of skin cancer must not be vaccinated at the previous tumor site
13. Subject has a known or suspected defect of the immune system, such as subjects with congenital or acquired immune deficiency
14. Subject received immuno-suppressive therapy within 4 weeks prior to Visit 1 or receipt of immunosuppressive therapy is expected during the study.
15. Subject has a history of any vaccine related contraindicating event
16. Subject presents with clinical conditions representing a contraindication to intramuscular vaccination and blood draws
17. Subject is pregnant, has plans to become pregnant up to Day 106 of the study or lactating at the time of enrolment
18. Subject has donated blood, blood fractions or plasma within 4 weeks prior to Visit 1 or received blood-derived products (e.g. plasma) within 12 weeks prior to Visit 1 in this study or plans to donate blood or use blood products during the study
19. Subject with clinically significant bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following IM injections or venipuncture
20. Subject has a rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating
21. Subject has a known or suspected problem with alcohol or drug abuse as determined by the Investigator
22. Subject has any condition that, in the opinion of the Inves
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method