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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05364242




Registration number
NCT05364242
Ethics application status
Date submitted
4/05/2022
Date registered
6/05/2022

Titles & IDs
Public title
VLA2001 Booster in Adult Participants After Priming With mRNA COVID-19 Vaccine and/or Natural SARS-CoV-2 Infection
Scientific title
Open-Label Phase 2/3 Clinical Study to Investigate Safety and Immunogenicity of a Single VLA2001 Booster Vaccination in Adult Volunteers, After Receipt of Nationally Rolled Out mRNA COVID-19 Vaccines and/or Natural SARS-CoV-2 Infection
Secondary ID [1] 0 0
VLA2001-307
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - VLA2001

Experimental: VLA2001 -


Treatment: Other: VLA2001
whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG)1018 in combination with aluminium hydroxide
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
GMT (Geometric Mean Titer) fold-rise for neutralising antibodies against SARS-CoV-2 following a single booster dose with VLA2001
Timepoint [1] 0 0
Day 15
Primary outcome [2] 0 0
Frequency and severity of solicited AEs (Adverse Events) (local and systemic reactions) after the VLA2001 booster vaccination
Timepoint [2] 0 0
until Day 7
Secondary outcome [1] 0 0
Immune response as determined by the GMT (Geometric Mean Titer) of SARS-CoV-2-specific neutralizing antibodies
Timepoint [1] 0 0
Visit 1 (Day 1) and Visit 2 (Day 15)
Secondary outcome [2] 0 0
Proportion of participants achieving an at least 2-, 4-, 10- or 20-fold rise over baseline in terms of neutralizing antibodies to SARS-CoV-2 S-protein neutralizing antibodies
Timepoint [2] 0 0
Visit 2 (Day 15)
Secondary outcome [3] 0 0
GMT (Geometric Mean Titer) fold-rise of IgG antibodies to the SARS-CoV-2 S-protein following a single booster dose with VLA2001
Timepoint [3] 0 0
Visit 2 (Day 15)
Secondary outcome [4] 0 0
Immune response as determined by the GMT (Geometric Mean Titer) of IgG antibodies to the SARS-CoV-2 S-protein
Timepoint [4] 0 0
Visit 1 (Day 1) and Visit 2 (Day 15)
Secondary outcome [5] 0 0
Proportion of participants achieving an at least 2-, 4-, 10- or 20-fold rise over baseline in terms of IgG antibodies to SARS-CoV-2 S-protein antibodies
Timepoint [5] 0 0
Visit 2 (Day 15)
Secondary outcome [6] 0 0
Assessment of T-cell responses from PBMCs (Peripheral Blood Mononuclear Cell) after in vitro stimulation with SARS-CoV-2 antigens using e.g. ELISpot or intracellular cytokine staining
Timepoint [6] 0 0
Visit 1 (Day 1) and Visit 2 (Day 15)
Secondary outcome [7] 0 0
Frequency and Severity of any AE (Adverse Event)
Timepoint [7] 0 0
up to 4 weeks after vaccination
Secondary outcome [8] 0 0
Frequency and Severity of unsolicited AEs (Adverse Events)
Timepoint [8] 0 0
up to 4 weeks after vaccination
Secondary outcome [9] 0 0
Frequency and severity of any unsolicited vaccine-related AE (Adverse Event)
Timepoint [9] 0 0
up to 4 weeks after vaccination
Secondary outcome [10] 0 0
Frequency and severity of any SAE (Serious Adverse Event)
Timepoint [10] 0 0
up to Day 180
Secondary outcome [11] 0 0
Frequency and severity of any AESI (Adverse Event of Special Interest)
Timepoint [11] 0 0
up to Day 180

Eligibility
Key inclusion criteria
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
4. Participant has a Body Mass Index (BMI) of 18.0-30.0 kg/m2
5. Must be able to attend all visits of the study and comply with all study procedures
6. Women of childbearing potential (WOCBP) must be able and willing to use at least 1 highly effective method of contraception
7. WOCBPs must have a negative pregnancy test prior to the booster vaccination.

Cohort 1:

Will receive a standard dose of VLA2001 (0.5 mL), if:

* Aged between 18 years and 50 years and
* Have received two or three doses of mRNA SARS-CoV-2 vaccines and have never experienced a natural SARS-CoV-2 infection, or
* Have received two or three doses of mRNA SARS-CoV-2 vaccines and have experienced a natural SARS-CoV-2 infection.

Cohort 2:

Will receive a double dose of VLA2001 (1.0 mL), if:

* older than 50 years and
* Have received two or three doses of mRNA SARS-CoV-2 vaccines and have never experienced a natural SARS-CoV-2 infection, or
* Have received two or three doses of mRNA SARS-CoV-2 vaccines and have experienced a natural SARS-CoV-2 infection.

Cohort 3:

Will receive a standard dose of VLA2001 (0.5 mL), if:

* Aged between 18 years and 50 years and
* Have never received any SARS-CoV-2 vaccine and
* Have experienced a natural SARS-CoV-2 infection

Will receive a double dose of VLA2001 (1.0 mL), if:

* Older than 50 years and
* Have never received any SARS-CoV-2 vaccine and
* Have experienced a natural SARS-CoV-2 infection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
ALL PARTICIPANTS:

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 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.
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/05/2023
Sample size
Target
Accrual to date
Final
178
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Netherlands
State/province [1] 0 0
Groningen
Country [2] 0 0
Netherlands
State/province [2] 0 0
Utrecht
Country [3] 0 0
New Zealand
State/province [3] 0 0
Papatoetoe
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Valneva Austria GmbH
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Valneva Clinical Development
Address 0 0
Valneva Austria GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05364242