Status:
COMPLETED
Dose Finding Study to Evaluate The Safety, Tolerability and Immunogenicity of an Inactiviated, Adjuvanted SARS-CoV-2 Virus Vaccine Candidate Against Covid-19 in Healthy Subjects
Lead Sponsor:
Valneva Austria GmbH
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
SARS-CoV-2 Virus Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
A multicenter, 3-arm randomized dose finding study in the UK to evaluate safety, tolerability and immunogenicity of a vaccine candidate against Covid-19. 150 healthy volunteers will be enrolled and re...
Detailed Description
The multicenter, dose finding Phase 1/2 study starts off with an open-label, dose-escalation part, thereafter, during the double-blind part of study, participants will be randomized 1:1:1 to receive t...
Eligibility Criteria
Inclusion
- Inclusion Criteria - Subjects who meet ALL of the following criteria are eligible for the study:
- Participant is 18 to 55 years of age
- Participant who has a smart phone and is willing and able to install and use the eDiary.
- Participant 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.
- Participant is generally healthy as determined by the Investigator
- Participant has a Body Mass Index (BMI) of 18.0-30.0 kg/m2
- If subject is of childbearing potential:
- Participant has practiced an adequate method of contraception during the 30 days before screening (Visit 0).
- Participant has a negative serum or urine pregnancy test at screening (Visit 0) or Visit 1, respectively.
- Participant agrees to employ adequate birth control measures up to Day 106 (Visit 5).
- Inclusion Criteria for Booster Phase - Subjects who meet ALL of the following criteria are eligible for the Booster phase:
- B1. Participant has received complete VLA2001 primary immunization (two vaccinations according to the protocol)
- B2. Participant who has a smart phone and is willing and able to install and use the e-Diary.
- B3. Participant 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.
- B4. Participant is generally healthy as determined by the Investigator's clinical judgement
- B5. If a participant is of childbearing potential:
- Participant has a negative urine pregnancy test at Visit 7 prior to booster vaccination.
- Participant agrees to employ adequate birth control measures up to 3 months after the Booster vaccination.
- Exclusion criteria - Participants who meet ANY of the following criteria are NOT eligible for this study:
- Clinically significant infection or other acute illness, including fever ≥ 38°C within 24 hours prior to the planned study vaccination.
- History of laboratory-confirmed SARS-CoV-2 infection.
- Participant had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening (Visit 0).
- Participant has participated in a clinical study involving an investigational SARS-CoV-2 vaccine.
- Participant has an acute or recent infection not due to SARS-CoV-2
- Participant has a history of SARS-CoV-1 or MERS infection (self-reported)
- Participant tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Participant has received any vaccine within 30 days prior Visit 1 other than the study intervention, with the exception of the seasonal influenza vaccination.
- Participant has abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator.
- Participants 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.
- Participants with underlying diseases with a high risk of developing severe COVID-19 symptoms if infected
- 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 subject 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.
- Participant has a known or suspected defect of the immune system, such as Participants with congenital or acquired immune deficiency
- Participant received immuno-suppressive therapy within 4 weeks prior to Visit 1 or receipt of immunosuppressive therapy is expected during the study.
- Participant has a history of any vaccine related contraindicating event
- Participant presents with clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- Participant is pregnant, has plans to become pregnant up to Day 106 of the study or lactating at the time of enrolment.
- Participant 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.
- Participant 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 venepuncture.
- Participant has a rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating.
- Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator.
- Participant has any condition that, in the opinion of the Investigator, may compromise the Participant's well-being, might interfere with evaluation of study endpoints, or would limit the Participant's ability to complete the study.
- Participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).
- Participant has participated in another clinical study involving an investigational medicinal product (IMP) or device within 4 weeks prior to Visit 0 (screening) or is scheduled to participate in another clinical study involving an IMP, or device during the course of this study.
- Participant is a member of the team conducting the study or in a dependent relationship with one of the study team members.
- Exclusion Criteria for Booster Phase - Participants who meet ANY of the following criteria are NOT eligible for Booster phase:
- B1. Clinically significant infection or other acute illness, including fever ≥ 38°C within 48 hours prior to the planned Booster vaccination.
- B2. Participant has an acute or recent infection not due to SARS-CoV-2 and is not symptom-free in the week prior to the Booster vaccination (Visit 7).
- B3. Participant has received any vaccine within 30 days prior Visit 7, with the exception of the seasonal influenza vaccination. Participants will be encouraged to receive this vaccination at least 7 days after their Booster vaccine.
- B4. Participant has abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) that is considered clinically relevant by the Investigator.
- B5. Participant has received immuno-suppressive therapy within 4 weeks prior to Visit 7 or is expected to receive immunosuppressive therapy during the study. Immunosuppressive therapy is defined as administration of chronic (longer than 2 weeks) prednisone or equivalent ≥ 0.05 mg/kg/day within 4 weeks prior to Visit 7 (topical and inhaled steroids are allowed), radiation therapy or immunosuppressive cytotoxic drugs or monoclonal antibodies in the previous 3 years.
- B6. Participant has clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- B7. Participant is pregnant (positive urine pregnancy test at Visit 7, respectively), has plans to become pregnant up to 3 months after the Booster vaccination.
- B8. Participant has a rash, dermatological condition that would, in the opinion of the Investigator, interfere with injection site reaction rating.
- B9. Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator.
- B10. Participant has any condition that, in the opinion of the Investigator, may compromise the Participant's well-being, might interfere with evaluation of study endpoints, or would limit the Participant's ability to complete the study.
- B11. Participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).
- B12. Participant has participated in another clinical study involving an investigational medicinal product (IMP) or device within 4 weeks prior to Visit 7 or is scheduled to participate in another clinical study involving an IMP, or device during the course of this study.
Exclusion
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04671017
Start Date
December 16 2020
End Date
April 6 2022
Last Update
April 22 2022
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
2
University Hospital Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom, BS1 3NU
3
Newcastle University Medical School
Newcastle, United Kingdom, NE7 7DN
4
Southampton NIHR Clinical Research Facility
Southampton, United Kingdom, SO16 6YD