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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04956224




Registration number
NCT04956224
Ethics application status
Date submitted
21/06/2021
Date registered
9/07/2021
Date last updated
1/09/2023

Titles & IDs
Public title
Safety and Immunogenicity of VLA2001 Adults Aged =56 Years
Scientific title
A Phase III, Open Label, Multicenter, Single Arm Study to Assess the Safety, Tolerability and Immunogenicity of VLA2001 in Volunteers Aged = 56 Years.
Secondary ID [1] 0 0
VLA2001-304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 Virus Infection 0 0
Condition category
Condition code

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 (Wuhan strain)

2 vaccinations 28 days apart

Booster Vaccination on Visit B1
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and severity of any Adverse Events (AE) up to Day 43 post-vaccination
Timepoint [1] 0 0
Day 43
Primary outcome [2] 0 0
Immune response as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies
Timepoint [2] 0 0
Day 43
Primary outcome [3] 0 0
Immune response as determined by the seroconversion rate (SCR) of SARS-CoV-2-specific neutralizing antibodies
Timepoint [3] 0 0
Day 43
Secondary outcome [1] 0 0
Frequency and severity of solicited injection site and systemic reactions after each vaccination
Timepoint [1] 0 0
within 7 days
Secondary outcome [2] 0 0
Frequency and severity of any unsolicited Adverse Event (AE)
Timepoint [2] 0 0
until Day 43
Secondary outcome [3] 0 0
Frequency and severity of any unsolicited vaccine-related Adverse Event (AE)
Timepoint [3] 0 0
until Day 43
Secondary outcome [4] 0 0
Frequency and severity of any Serious Adverse Event (SAE)
Timepoint [4] 0 0
until Day 365
Secondary outcome [5] 0 0
Frequency and severity of any Adverse Event of Special Interest (AESI)
Timepoint [5] 0 0
until Day 365
Secondary outcome [6] 0 0
Proportion of participants with Seroconversion after receipt of 2 doses of study vaccination in terms of SARS-CoV-2-specific neutralizing antibodies
Timepoint [6] 0 0
on Day 29, Day 57, Day 71 and Day 208
Secondary outcome [7] 0 0
Immune response as determined by the Geometric Mean Titer (GMT) of SARS-CoV-2-specific neutralizing antibodies
Timepoint [7] 0 0
on Day 29, Day 57, Day 71 and Day 208
Secondary outcome [8] 0 0
Proportion of participants with Seroconversion after receipt of 2 doses of study vaccination in terms of S-protein binding IgG levels
Timepoint [8] 0 0
on Day 29, Day 57, Day 71 and Day 208
Secondary outcome [9] 0 0
Immune response as determined by the Geometric Mean Titer (GMT) of IgG antibodies to SARS-CoV-2 S-protein
Timepoint [9] 0 0
on Day 29, Day 57, Day 71 and Day 208
Secondary outcome [10] 0 0
Geometric Mean Fold Increase (GMFI) of neutralizing antibody (for binding and neutralizing antibodies)
Timepoint [10] 0 0
on Day 29, Day 43, Day 57, Day 71 and Day 208
Secondary outcome [11] 0 0
Assessment of T-cell responses from Peripheral Blood Mononuclear Cell (PBMCs) in a subset of participants after in vitro stimulation with SARS-CoV-2 antigens using e.g. ELISpot or intracellular cytokine staining.
Timepoint [11] 0 0
on Day 1, Day 43, Day 208, Day 365
Secondary outcome [12] 0 0
Frequency and severity of solicited injection site and systemic reactions
Timepoint [12] 0 0
within 7 days after booster vaccination
Secondary outcome [13] 0 0
Frequency and severity of any unsolicited AE (Adverse Event)
Timepoint [13] 0 0
up to 6 months after booster vaccination
Secondary outcome [14] 0 0
Frequency and severity of any vaccine-related unsolicited AE (Adverse Event)
Timepoint [14] 0 0
up to 6 months after booster vaccination
Secondary outcome [15] 0 0
Frequency and severity of any SAE (Serious Adverse Event)
Timepoint [15] 0 0
up to 6 months after booster vaccination
Secondary outcome [16] 0 0
Frequency and severity of any AESI (Adverse Event of Special Interest)
Timepoint [16] 0 0
up to 6 months after booster vaccination
Secondary outcome [17] 0 0
Geometric mean fold rise (GMFR) with regards to SARS-CoV-2-specific neutralizing antibodies
Timepoint [17] 0 0
from day of booster vaccination up to 14 days after
Secondary outcome [18] 0 0
Geometric Mean Titer (GMT) of SARS-CoV-2 specific neutralizing antibodies including formal non-inferiority testing on the GMT ratio for the booster subgroup who had received 2 doses of VLA2001 for primary immunization
Timepoint [18] 0 0
on Day 43 and 14 days after booster vaccination
Secondary outcome [19] 0 0
Proportion of participants with 4-fold increase with regards to SARS-CoV-2-specific neutralizing antibodies
Timepoint [19] 0 0
from day of booster vaccination up to 14 days after
Secondary outcome [20] 0 0
Geometric mean fold rise (GMFR) with regards to S-protein binding antibodies
Timepoint [20] 0 0
from day of booster vaccination up to 14 days after
Secondary outcome [21] 0 0
Proportion of participants with 4-fold increase with regards to S-protein binding antibodies
Timepoint [21] 0 0
from day of booster vaccination up to 14 days after
Secondary outcome [22] 0 0
Geometric Mean Titer (GMT) measured as IgG antibodies against SARS-CoV-2 as determined by ELISA
Timepoint [22] 0 0
from day of booster vaccination up to 6 months after
Secondary outcome [23] 0 0
Assessment of T-cell responses from Peripheral Blood Mononuclear Cell (PBMCs) in participants after in vitro stimulation with SARS-CoV-2 antigens using ELISpot
Timepoint [23] 0 0
from day of booster vaccination up to 6 months after

Eligibility
Key inclusion criteria
1. All participants must have read, understood, and signed the informed consent form (ICF).
2. Participants of either gender aged 56 years or older at screening.
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 18.0-35.0 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 the last dose of study vaccine (i.e. 3 months after second dose or 3 months after booster dose).
7. WOCBPs must have a negative pregnancy test prior to each vaccination.
Minimum age
56 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participant is pregnant or planning to become pregnant within 3 months after last study vaccine administration.
2. History of allergy to any component of the vaccine.
3. History of laboratory-confirmed SARS-CoV infection
4. Participant had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening.
5. 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.
6. Significant infection (e.g. positive SARS-CoV-2 RT-PCR) or other acute illness, including fever > 100 °F (> 37.8 °C) 48 hours before vaccination.
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 randomization.
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 or the booster administration.
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 venipuncture.
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 first vaccination or the booster administration in this study or those who expect to receive immunoglobulin or another blood product during this study.
15. Receipt of medications and or vaccinations intended to prevent COVID-19.
16. Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine or for medical emergencies such as tetanus or rabies exporsure, within 28 days prior to the expected day of randomization.

Others:
17. Any member of the study team or sponsor.
18. An immediate family member or household member of the study's personnel.

Booster Vaccination in participants 56 years and older:

In addition to the above described eligibility criteria, the following criteria must be met:

1. Participant has not received a licensed COVID-19 vaccine during his/her participation in the study.

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 3
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
9/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/11/2022
Sample size
Target
Accrual to date
Final
306
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Birkenhead
Country [2] 0 0
New Zealand
State/province [2] 0 0
Nawton
Country [3] 0 0
New Zealand
State/province [3] 0 0
New Lynn
Country [4] 0 0
New Zealand
State/province [4] 0 0
Papamoa Beach
Country [5] 0 0
New Zealand
State/province [5] 0 0
Remuera
Country [6] 0 0
New Zealand
State/province [6] 0 0
Stoke
Country [7] 0 0
New Zealand
State/province [7] 0 0
Christchurch
Country [8] 0 0
New Zealand
State/province [8] 0 0
Rotorua

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a A Phase III, Open label, Multicenter, Single Arm Study to assess the Safety, Tolerability and Immunogenicity of VLA2001 in volunteers aged = 56 years. Approximately 300 participants are enrolled in a non-randomized manner.
Trial website
https://clinicaltrials.gov/study/NCT04956224
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Valneva Clinical Deveopment
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04956224