SARS-CoV-2 InfectionPhase 2/3NCT05364242
VLA2001 Booster in Adult Participants After Priming With mRNA COVID-19 Vaccine and/or Natural SARS-CoV-2 Infection
A Phase 2/3 study testing VLA2001 in people with SARS-CoV-2 Infection, run by Valneva Austria GmbH at 4 sites in 2 countries.
Trial summary
This is a clinical study to investigate the safety, tolerability and immunogenicity of a VLA2001 booster vaccination in participants aged 18 years and older. In total approximately 275 participants are planned to be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- VLA2001
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 9 May 2022to 22 May 2023
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ALL PARTICIPANTS:
- Participants of either gender aged 18 years and older at screening
- Participants must have read, understood, and signed the informed consent form (ICF)
- Medically stable
- Participant has a Body Mass Index (BMI) of 18.0-30.0 kg/m2
- Must be able to attend all visits of the study and comply with all study procedures
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- Women of childbearing potential (WOCBP) must be able and willing to use at least 1 highly effective method of contraception
- 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
Who cannot join
- ALL PARTICIPANTS:
- Participant is pregnant or planning to become pregnant within 3 months after booster administration
- History of allergy to any component of the vaccine
- 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 or has received or plans to receive a licensed SARS-CoV-2 vaccine during the duration of the study
- Significant infection or other acute illness, including fever > 37.8 °C within 48 hours before vaccination
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- Positive SARS-CoV-2 rapid Antigen test result during screening or Visit 1
- 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).
- 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 (Visit 1)
- 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
- 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 vaccination (Visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study
- Receipt of medications to treat or prevent COVID-19 (except licensed mRNA vaccine for participants of cohort 1 and 2)
- 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:
- Any member of the study team or sponsor
- An immediate family member or household member of the study's personnel
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Netherlands2 sites
General Practitioners Research Institute (GPRI)
Groningen, 9713
European Clinical Research Alliance on Infectious Diseases (ECRAID)
Utrecht, 3584 BA
New Zealand2 sites
Middlemore Clinical Trials
Auckland, Papatoetoe, 2025
Optimal Clinical Trials
Auckland, 1010
About this study
Official 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
This is a clinical study to investigate the safety, tolerability and immunogenicity of a VLA2001 booster vaccination in participants aged 18 years and older. In total approximately 275 participants are planned to be enrolled.
Read the detailed description
This is a multicentric, open-label, phase 2/3 study to investigate the safety, tolerability and immunogenicity of a VLA2001 booster vaccination standard dose in adults aged ≥18 to ≤50 years or double dose in volunteers aged >50 years.
Volunteers who are either generally healthy or are with a stable medical condition will be enrolled. In total approximately 275 participants were planned to be enrolled. It was planned to enroll approximately 25% of participants who are above 65 years into the cohorts with participants above 50 years of age.
Cohorts 1B, 1C, 1D, 2B and 2D have been fully recruited. Recruitment for Cohorts 1A, 2A, 2C, and 3, has been stopped in December 2022 due to very low recruitment rates in these cohorts.
The revised study design ensures a safety follow-up of at least 6 months after the VLA2001 vaccination for all enrolled study participants.
Immunogenicity will be assessed at Visits 1 (pre-booster, Day 1) and Visit 2 (Day 15, 14 days after the booster vaccination).
Safety will be assessed up to Visit 3a (Day 180) or up to an End of Study Visit for participants who have already had their Day 180 visit before the current study amendment.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- VLA2001
- Keywords
- VLA2001, SARS-CoV-2 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
| 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.
GMT (Geometric Mean Titer) fold-rise for neutralising antibodies against SARS-CoV-2 following a single booster dose with VLA2001
Measured: Day 15
Frequency and severity of solicited AEs (Adverse Events) (local and systemic reactions) after the VLA2001 booster vaccination
Measured: until Day 7
Secondary outcomes (11)
Immune response as determined by the GMT (Geometric Mean Titer) of SARS-CoV-2-specific neutralizing antibodies
Measured: Visit 1 (Day 1) and Visit 2 (Day 15)
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
Measured: Visit 2 (Day 15)
GMT (Geometric Mean Titer) fold-rise of IgG antibodies to the SARS-CoV-2 S-protein following a single booster dose with VLA2001
Measured: Visit 2 (Day 15)
Immune response as determined by the GMT (Geometric Mean Titer) of IgG antibodies to the SARS-CoV-2 S-protein
Measured: Visit 1 (Day 1) and Visit 2 (Day 15)
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
Measured: Visit 2 (Day 15)
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
Measured: Visit 1 (Day 1) and Visit 2 (Day 15)
Frequency and Severity of any AE (Adverse Event)
Measured: up to 4 weeks after vaccination
Frequency and Severity of unsolicited AEs (Adverse Events)
Measured: up to 4 weeks after vaccination
Frequency and severity of any unsolicited vaccine-related AE (Adverse Event)
Measured: up to 4 weeks after vaccination
Frequency and severity of any SAE (Serious Adverse Event)
Measured: up to Day 180
Frequency and severity of any AESI (Adverse Event of Special Interest)
Measured: up to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start9 May 2022
- Primary completion22 Sep 2022
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 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 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valneva Clinical Development, Study chair, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364242
- Sponsor's protocol ID
- VLA2001-307
- Status last verified
- Jun 2023
- First submitted
- 4 May 2022
- Last updated
- 7 Jun 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 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05364242
- Acronym / sponsor ID
- VLA2001-307
- Conditions
- SARS-CoV-2 Infection
- Keywords
- VLA2001, SARS-CoV-2 Infection, COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 6 May 2022 (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 clinical study to investigate the safety, tolerability and immunogenicity of a VLA2001 booster vaccination in participants aged 18 years and older. In total approximately 275 participants are planned to be enrolled.
Detailed description
This is a multicentric, open-label, phase 2/3 study to investigate the safety, tolerability and immunogenicity of a VLA2001 booster vaccination standard dose in adults aged ≥18 to ≤50 years or double dose in volunteers aged >50 years.
Volunteers who are either generally healthy or are with a stable medical condition will be enrolled. In total approximately 275 participants were planned to be enrolled. It was planned to enroll approximately 25% of participants who are above 65 years into the cohorts with participants above 50 years of age.
Cohorts 1B, 1C, 1D, 2B and 2D have been fully recruited. Recruitment for Cohorts 1A, 2A, 2C, and 3, has been stopped in December 2022 due to very low recruitment rates in these cohorts.
The revised study design ensures a safety follow-up of at least 6 months after the VLA2001 vaccination for all enrolled study participants.
Immunogenicity will be assessed at Visits 1 (pre-booster, Day 1) and Visit 2 (Day 15, 14 days after the booster vaccination).
Safety will be assessed up to Visit 3a (Day 180) or up to an End of Study Visit for participants who have already had their Day 180 visit before the current study amendment.
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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Participants of either gender aged 18 years and older at screening
- Participants must have read, understood, and signed the informed consent form (ICF)
- Medically stable
- Participant has a Body Mass Index (BMI) of 18.0-30.0 kg/m2
- Must be able to attend all visits of the study and comply with all study procedures
Key exclusion criteria (21 listed)
- Participant is pregnant or planning to become pregnant within 3 months after booster administration
- History of allergy to any component of the vaccine
- 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 or has received or plans to receive a licensed SARS-CoV-2 vaccine during the duration of the study
- Significant infection or other acute illness, including fever > 37.8 °C within 48 hours before vaccination
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 | Biological | VLA2001 |
Primary outcome
GMT (Geometric Mean Titer) fold-rise for neutralising antibodies against SARS-CoV-2 following a single booster dose with VLA2001
Time frame: Day 15
Frequency and severity of solicited AEs (Adverse Events) (local and systemic reactions) after the VLA2001 booster vaccination
Time frame: until Day 7
11 secondary outcomes
Immune response as determined by the GMT (Geometric Mean Titer) of SARS-CoV-2-specific neutralizing antibodies
Time frame: Visit 1 (Day 1) and Visit 2 (Day 15)
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
Time frame: Visit 2 (Day 15)
GMT (Geometric Mean Titer) fold-rise of IgG antibodies to the SARS-CoV-2 S-protein following a single booster dose with VLA2001
Time frame: Visit 2 (Day 15)
Immune response as determined by the GMT (Geometric Mean Titer) of IgG antibodies to the SARS-CoV-2 S-protein
Time frame: Visit 1 (Day 1) and Visit 2 (Day 15)
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
Time frame: Visit 2 (Day 15)
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
Time frame: Visit 1 (Day 1) and Visit 2 (Day 15)
Frequency and Severity of any AE (Adverse Event)
Time frame: up to 4 weeks after vaccination
Frequency and Severity of unsolicited AEs (Adverse Events)
Time frame: up to 4 weeks after vaccination
Frequency and severity of any unsolicited vaccine-related AE (Adverse Event)
Time frame: up to 4 weeks after vaccination
Frequency and severity of any SAE (Serious Adverse Event)
Time frame: up to Day 180
Frequency and severity of any AESI (Adverse Event of Special Interest)
Time frame: up to Day 180
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 7 Jun 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 Development study chair
Valneva Austria GmbH
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VLA2001 in people with SARS-CoV-2 Infection, run by Valneva Austria GmbH at 4 sites in 2 countries.
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 27 inclusion and 21 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 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
GMT (Geometric Mean Titer) fold-rise for neutralising antibodies against SARS-CoV-2 following a single booster dose with VLA2001 (time frame: Day 15). The study lists 2 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 7 Jun 2023.