SARS-CoV-2 Virus InfectionPhase 3NCT04956224
Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years
A Phase 3 study testing VLA2001 in people with SARS-CoV-2 Virus Infection, run by Valneva Austria GmbH at 8 sites in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 56 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Virus Infection
- What is being tested?
- VLA2001
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 8 sitesNew Zealand
- Study dates
- 9 Aug 2021to 18 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants must have read, understood, and signed the informed consent form (ICF).
- Participants of either gender aged 56 years or older at screening.
- 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.
- Participant has a Body Mass Index (BMI) of 18.0-35.0 kg/m2, inclusive, at screening (Visit 0).
- 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.
- 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).
- WOCBPs must have a negative pregnancy test prior to each vaccination.
Who cannot join
- Participant is pregnant or planning to become pregnant within 3 months after last study vaccine administration.
- History of allergy to any component of the vaccine.
- History of laboratory-confirmed SARS-CoV infection
- Participant had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening.
- 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.
- 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.
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- 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.
- 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.
- History of drug dependency or current use of drug of abuse or alcohol abuse at screening.
- 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.
- 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.
- Severe and uncontrolled ongoing autoimmune or inflammatory disease, history of Guillain-Barre syndrome or any other demyelinating condition.
- 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:
- 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.
- Receipt of medications and or vaccinations intended to prevent COVID-19.
- 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:
- Any member of the study team or sponsor.
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
New Zealand8 sites
Southern Clinical Trials Waitemata
Auckland, Birkenhead, 0626
Southern Clinical Trials Totara
Auckland, New Lynn, 0600
Southern Clinical Trials Remuera
Auckland, Remuera, 1050
Southern Clinical Trials Christchurch
Christchurch, 8013
Lakeland Clinical Trials Waikato
Hamilton, Nawton, 3200
Southern Clinical Trials Tasman
Nelson, Stoke, 7011
Lakeland Clinical Trials Culloden
Papamoa, Papamoa Beach, 3118
Lakeland Clinical Trials Rotorua
Rotorua, 3010
About this study
Official title: A Phase III, Open Label, Multicenter, Single Arm Study to Assess the Safety, Tolerability and Immunogenicity of VLA2001 in Volunteers Aged ≥ 56 Years.
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.
Read the detailed description
This Phase 3 study is designed as a Multicentre, Open Label, Single Arm Study to assess the Safety, Tolerability and Immunogenicity of VLA2001.
Participants aged 56 years or older and who are either generally healthy or are with a stable medical condition are enrolled.
Approximately 300 participants will be enrolled in a non-randomized manner to receive VLA2001 at the recommended dose level, 28 days apart on Days 1 and 29.
Immunogenicity and safety will be assessed up to month 12 after the first vaccination.
All participants, except those who already received a licensed COVID-19 vaccine outside of the study, will be offered a booster dose with VLA2001. All eligible and willing participants will receive a booster vaccination with VLA2001 and will have a follow-up visit 14 days after the booster dose. The participants will have 1 more follow-up visit 6 months after the booster vaccination which replaces Day 365 for those participants who received a booster dose.
This study will support the VLA2001 safety and immunogenicity database for vaccines aged ≥56 years.
- Conditions
- SARS-CoV-2 Virus Infection
- Being tested
- VLA2001
- Keywords
- VLA2001, SARS-CoV-2 Virus Infection, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLA2001Biological
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
| Study group | Role | What they receive |
|---|---|---|
| VLA2001 | Experimental | Not described Receives: Biological: VLA2001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of any Adverse Events (AE) up to Day 43 post-vaccination
Measured: Day 43
Immune response as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies
Measured: Day 43
Immune response as determined by the seroconversion rate (SCR) of SARS-CoV-2-specific neutralizing antibodies
Measured: Day 43
Secondary outcomes (23)
Frequency and severity of solicited injection site and systemic reactions after each vaccination
Measured: within 7 days
Frequency and severity of any unsolicited Adverse Event (AE)
Measured: until Day 43
Frequency and severity of any unsolicited vaccine-related Adverse Event (AE)
Measured: until Day 43
Frequency and severity of any Serious Adverse Event (SAE)
Measured: until Day 365
Frequency and severity of any Adverse Event of Special Interest (AESI)
Measured: until Day 365
Proportion of participants with Seroconversion after receipt of 2 doses of study vaccination in terms of SARS-CoV-2-specific neutralizing antibodies
Measured: on Day 29, Day 57, Day 71 and Day 208
Immune response as determined by the Geometric Mean Titer (GMT) of SARS-CoV-2-specific neutralizing antibodies
Measured: on Day 29, Day 57, Day 71 and Day 208
Proportion of participants with Seroconversion after receipt of 2 doses of study vaccination in terms of S-protein binding IgG levels
Measured: on Day 29, Day 57, Day 71 and Day 208
Immune response as determined by the Geometric Mean Titer (GMT) of IgG antibodies to SARS-CoV-2 S-protein
Measured: on Day 29, Day 57, Day 71 and Day 208
Geometric Mean Fold Increase (GMFI) of neutralizing antibody (for binding and neutralizing antibodies)
Measured: on Day 29, Day 43, Day 57, Day 71 and Day 208
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.
Measured: on Day 1, Day 43, Day 208, Day 365
Frequency and severity of solicited injection site and systemic reactions
Measured: within 7 days after booster vaccination
Frequency and severity of any unsolicited AE (Adverse Event)
Measured: up to 6 months after booster vaccination
Frequency and severity of any vaccine-related unsolicited AE (Adverse Event)
Measured: up to 6 months after booster vaccination
Frequency and severity of any SAE (Serious Adverse Event)
Measured: up to 6 months after booster vaccination
Frequency and severity of any AESI (Adverse Event of Special Interest)
Measured: up to 6 months after booster vaccination
Geometric mean fold rise (GMFR) with regards to SARS-CoV-2-specific neutralizing antibodies
Measured: from day of booster vaccination up to 14 days after
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
Measured: on Day 43 and 14 days after booster vaccination
Proportion of participants with 4-fold increase with regards to SARS-CoV-2-specific neutralizing antibodies
Measured: from day of booster vaccination up to 14 days after
Geometric mean fold rise (GMFR) with regards to S-protein binding antibodies
Measured: from day of booster vaccination up to 14 days after
Proportion of participants with 4-fold increase with regards to S-protein binding antibodies
Measured: from day of booster vaccination up to 14 days after
Geometric Mean Titer (GMT) measured as IgG antibodies against SARS-CoV-2 as determined by ELISA
Measured: from day of booster vaccination up to 6 months after
Assessment of T-cell responses from Peripheral Blood Mononuclear Cell (PBMCs) in participants after in vitro stimulation with SARS-CoV-2 antigens using ELISpot
Measured: from day of booster vaccination up to 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start9 Aug 2021
- Primary completion10 Nov 2021
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valneva Clinical Deveopment, Study chair, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956224
- Sponsor's protocol ID
- VLA2001-304
- Status last verified
- Aug 2023
- First submitted
- 21 Jun 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open Label, Multicenter, Single Arm Study to Assess the Safety, Tolerability and Immunogenicity of VLA2001 in Volunteers Aged ≥ 56 Years.
- ClinicalTrials.gov ID
- NCT04956224
- Acronym / sponsor ID
- VLA2001-304
- Conditions
- SARS-CoV-2 Virus Infection
- Keywords
- VLA2001, SARS-CoV-2 Virus Infection, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This Phase 3 study is designed as a Multicentre, Open Label, Single Arm Study to assess the Safety, Tolerability and Immunogenicity of VLA2001.
Participants aged 56 years or older and who are either generally healthy or are with a stable medical condition are enrolled.
Approximately 300 participants will be enrolled in a non-randomized manner to receive VLA2001 at the recommended dose level, 28 days apart on Days 1 and 29.
Immunogenicity and safety will be assessed up to month 12 after the first vaccination.
All participants, except those who already received a licensed COVID-19 vaccine outside of the study, will be offered a booster dose with VLA2001. All eligible and willing participants will receive a booster vaccination with VLA2001 and will have a follow-up visit 14 days after the booster dose. The participants will have 1 more follow-up visit 6 months after the booster vaccination which replaces Day 365 for those participants who received a booster dose.
This study will support the VLA2001 safety and immunogenicity database for vaccines aged ≥56 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VLA2001 | Experimental | Biological: VLA2001 |
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All participants must have read, understood, and signed the informed consent form (ICF).
- Participants of either gender aged 56 years or older at screening.
- 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.
- Participant has a Body Mass Index (BMI) of 18.0-35.0 kg/m2, inclusive, at screening (Visit 0).
- 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.
Key exclusion criteria (23 listed)
- Participant is pregnant or planning to become pregnant within 3 months after last study vaccine administration.
- History of allergy to any component of the vaccine.
- History of laboratory-confirmed SARS-CoV infection
- Participant had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLA2001whole 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 | Biological | VLA2001 |
Primary outcome
Frequency and severity of any Adverse Events (AE) up to Day 43 post-vaccination
Time frame: Day 43
Immune response as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies
Time frame: Day 43
Immune response as determined by the seroconversion rate (SCR) of SARS-CoV-2-specific neutralizing antibodies
Time frame: Day 43
23 secondary outcomes
Frequency and severity of solicited injection site and systemic reactions after each vaccination
Time frame: within 7 days
Frequency and severity of any unsolicited Adverse Event (AE)
Time frame: until Day 43
Frequency and severity of any unsolicited vaccine-related Adverse Event (AE)
Time frame: until Day 43
Frequency and severity of any Serious Adverse Event (SAE)
Time frame: until Day 365
Frequency and severity of any Adverse Event of Special Interest (AESI)
Time frame: until Day 365
Proportion of participants with Seroconversion after receipt of 2 doses of study vaccination in terms of SARS-CoV-2-specific neutralizing antibodies
Time frame: on Day 29, Day 57, Day 71 and Day 208
Immune response as determined by the Geometric Mean Titer (GMT) of SARS-CoV-2-specific neutralizing antibodies
Time frame: on Day 29, Day 57, Day 71 and Day 208
Proportion of participants with Seroconversion after receipt of 2 doses of study vaccination in terms of S-protein binding IgG levels
Time frame: on Day 29, Day 57, Day 71 and Day 208
Immune response as determined by the Geometric Mean Titer (GMT) of IgG antibodies to SARS-CoV-2 S-protein
Time frame: on Day 29, Day 57, Day 71 and Day 208
Geometric Mean Fold Increase (GMFI) of neutralizing antibody (for binding and neutralizing antibodies)
Time frame: on Day 29, Day 43, Day 57, Day 71 and Day 208
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.
Time frame: on Day 1, Day 43, Day 208, Day 365
Frequency and severity of solicited injection site and systemic reactions
Time frame: within 7 days after booster vaccination
Frequency and severity of any unsolicited AE (Adverse Event)
Time frame: up to 6 months after booster vaccination
Frequency and severity of any vaccine-related unsolicited AE (Adverse Event)
Time frame: up to 6 months after booster vaccination
Frequency and severity of any SAE (Serious Adverse Event)
Time frame: up to 6 months after booster vaccination
Frequency and severity of any AESI (Adverse Event of Special Interest)
Time frame: up to 6 months after booster vaccination
Geometric mean fold rise (GMFR) with regards to SARS-CoV-2-specific neutralizing antibodies
Time frame: from day of booster vaccination up to 14 days after
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
Time frame: on Day 43 and 14 days after booster vaccination
Proportion of participants with 4-fold increase with regards to SARS-CoV-2-specific neutralizing antibodies
Time frame: from day of booster vaccination up to 14 days after
Geometric mean fold rise (GMFR) with regards to S-protein binding antibodies
Time frame: from day of booster vaccination up to 14 days after
Proportion of participants with 4-fold increase with regards to S-protein binding antibodies
Time frame: from day of booster vaccination up to 14 days after
Geometric Mean Titer (GMT) measured as IgG antibodies against SARS-CoV-2 as determined by ELISA
Time frame: from day of booster vaccination up to 6 months after
Assessment of T-cell responses from Peripheral Blood Mononuclear Cell (PBMCs) in participants after in vitro stimulation with SARS-CoV-2 antigens using ELISpot
Time frame: from day of booster vaccination up to 6 months after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valneva Clinical Deveopment study chair
Valneva Austria GmbH
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VLA2001 in people with SARS-CoV-2 Virus Infection, run by Valneva Austria GmbH at 8 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of any Adverse Events (AE) up to Day 43 post-vaccination (time frame: Day 43). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.