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Dose Finding Study to Evaluate Safety, Tolerability and Immunogenicity of an Inactiviated Adjuvanted Sars-Cov-2 Virus Vaccine Candidate Against Covid-19 in Healthy Adults

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ClinicalTrials.gov Identifier: NCT04671017
Recruitment Status : Active, not recruiting
First Posted : December 17, 2020
Last Update Posted : March 9, 2021
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Valneva Austria GmbH

Tracking Information
First Submitted Date  ICMJE December 15, 2020
First Posted Date  ICMJE December 17, 2020
Last Update Posted Date March 9, 2021
Actual Study Start Date  ICMJE December 16, 2020
Actual Primary Completion Date February 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2020)
  • Frequency and severity of solicited AEs (local and systemic reactions) within 7 days after any vaccination [ Time Frame: until Day 29 ]
  • Geometric mean titre (GMT) for neutralizing antibodies against SARS-CoV-2 [ Time Frame: Day 36 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2020)
  • Frequency and severity of any unsolicited AE [ Time Frame: until Day 36 ]
  • Frequency and severity of any vaccine-related AE [ Time Frame: until Day 36 ]
  • Frequency and severity of any AE [ Time Frame: until Day 208 ]
  • Frequency and severity of any vaccine-related AE [ Time Frame: until Day 208 ]
  • Frequency and severity of any SAE [ Time Frame: until Day 36 ]
  • Frequency and severity of any AESI [ Time Frame: until Day 36 ]
  • Frequency and severity of any SAE [ Time Frame: until Day 208 ]
  • Frequency and severity of an AESI [ Time Frame: until Day 208 ]
  • Immune response as measured by neutralizing antibody titres against SARS-CoV-2 [ Time Frame: until Day 208 ]
  • Proportion of subjects with seroconversion in terms of neutralizing antibodies [ Time Frame: until Day 208 ]
  • Fold increase of SARS-CoV-2 neutralizing antibody titres compared with baseline [ Time Frame: until Day 208 ]
  • GMTs for IgG antibodies against SARS-CoV-2 [ Time Frame: until Day 208 ]
  • Proportion of subjects with seroconversion in terms of IgG antibodies against SARS-CoV-2 in subjects negative for SARS-CoV-2 at screening [ Time Frame: until Day 208 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Finding Study to Evaluate Safety, Tolerability and Immunogenicity of an Inactiviated Adjuvanted Sars-Cov-2 Virus Vaccine Candidate Against Covid-19 in Healthy Adults
Official Title  ICMJE A Phase I/II Randomized, Two Parts, Dose-Finding Study To Evaluate The Safety, Tolerability and Immunogenicity Of An Inactivated, Adjuvanted Sars-Cov-2 Virus Vaccine Candidate (VLA2001), Against Covid-19 In Healthy Subjects
Brief Summary A multicenter, 3-arm randomized dose finding study in UK to evaluate safety, tolerability and immunogenicity of a vaccine candidate against Covid-19. 150 healthy volunteers will be enrolled and receive two shots of the vaccine candidate.
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 the low, medium or high dose of the vaccine (VLA2001). All participants will received a total of two vaccinations intramuscularly, on day 1 and day 22.

The first 5 participants in each dose group will receive VLA2001 open label, starting with the low dose of VLA2001. If no safety concerns are identified, the next 5 subjects will receive the medium dose of the vaccine. Again, if no safety issues are identified, 5 participants will be vaccinated with the high dose vaccine. A Data Safety and Monitoring Board (DSMB) will review accrued safety data before randomization of the remaining 135 subjects across all sites will be initiated.

All study participants will be followed up for safety and immunogenicity up to approximately 6 months after receiving their second vaccination.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
  1. st phase Sequential (open-label randomized phase)
  2. nd phase Parallel Assignment (double-blinded randomized phase )
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
  1. st phase is open-label randomized
  2. nd phase is double-blind randomized (Participant, Investigator )
Primary Purpose: Prevention
Condition  ICMJE Sars-Cov-2 Virus Infection
Intervention  ICMJE Biological: VLA2001
whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phosphor-guanine (CpG) 1018 in combination with aluminium hydroxide
Study Arms  ICMJE
  • Experimental: Low Dose: VLA2001
    Intervention: Biological: VLA2001
  • Experimental: Medium Dose: VLA2001
    Intervention: Biological: VLA2001
  • Experimental: High Dose: VLA2001
    Intervention: Biological: VLA2001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 29, 2021)
153
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2020)
150
Estimated Study Completion Date  ICMJE August 28, 2021
Actual Primary Completion Date February 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria - Subjects who meet ALL of the following criteria are eligible for the study:

  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 the 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 subject is of childbearing potential:

    1. Subject has practiced an adequate method of contraception during the 30 days before screening (Visit 0).
    2. Subject has a negative serum or urine pregnancy test at screening (Visit 0) or Visit 1, respectively.
    3. Subject agrees to employ adequate birth control measures up to Day 106 (Visit 5).

Exclusion criteria - Subjects who meet ANY of the following criteria are NOT eligible for this study:

  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 tumour 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 venepuncture.
  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 Investigator, may compromise the subject's well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study.
  23. Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).
  24. Subject 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.
  25. Subject is a member of the team conducting the study or in a dependent relationship with one of the study team members.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04671017
Other Study ID Numbers  ICMJE VLA2001-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Valneva Austria GmbH
Study Sponsor  ICMJE Valneva Austria GmbH
Collaborators  ICMJE National Institute for Health Research, United Kingdom
Investigators  ICMJE
Study Chair: Valneva Clinical Development Valneva Austria GmbH
PRS Account Valneva Austria GmbH
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP