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CompletedNCT04956224Updated Sep 1, 2023

Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years

A Phase 3 interventional study of VLA2001 in SARS-CoV-2 Virus Infection, sponsored by Valneva Austria GmbH. Completed at 8 sites in New Zealand. Open to participants aged 56 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by Valneva Austria GmbH · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
306
Allocation
Not applicable
Ages
56 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • SARS-CoV-2 Virus Infection

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Keywords

  • VLA2001
  • SARS-CoV-2 Virus Infection
  • COVID-19
03

In context

Virus Diseases

914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.

This study's enrollment of 306 is above the median of 102 across 604 interventional studies indexed under Virus Diseases.

Browse Virus Diseases studies →

Lead sponsor

Valneva Austria GmbH is the lead sponsor of 44 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
56 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
306 participants (actual)

Study arms

  • Experimental
    VLA2001

    Biological: VLA2001

Interventions

  • BiologicalVLA2001

    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

06

What researchers measure

Primary outcomes

  1. Frequency and severity of any Adverse Events (AE) up to Day 43 post-vaccination

    Time frame: Day 43

  2. Immune response as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies

    Time frame: Day 43

  3. Immune response as determined by the seroconversion rate (SCR) of SARS-CoV-2-specific neutralizing antibodies

    Time frame: Day 43

Secondary outcomes

  1. Frequency and severity of solicited injection site and systemic reactions after each vaccination

    Time frame: within 7 days

  2. Frequency and severity of any unsolicited Adverse Event (AE)

    Time frame: until Day 43

  3. Frequency and severity of any unsolicited vaccine-related Adverse Event (AE)

    Time frame: until Day 43

  4. Frequency and severity of any Serious Adverse Event (SAE)

    Time frame: until Day 365

  5. Frequency and severity of any Adverse Event of Special Interest (AESI)

    Time frame: until Day 365

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Frequency and severity of solicited injection site and systemic reactions

    Time frame: within 7 days after booster vaccination

  13. Frequency and severity of any unsolicited AE (Adverse Event)

    Time frame: up to 6 months after booster vaccination

  14. Frequency and severity of any vaccine-related unsolicited AE (Adverse Event)

    Time frame: up to 6 months after booster vaccination

  15. Frequency and severity of any SAE (Serious Adverse Event)

    Time frame: up to 6 months after booster vaccination

  16. Frequency and severity of any AESI (Adverse Event of Special Interest)

    Time frame: up to 6 months after booster vaccination

  17. 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

  18. 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

  19. 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

  20. Geometric mean fold rise (GMFR) with regards to S-protein binding antibodies

    Time frame: from day of booster vaccination up to 14 days after

  21. 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

  22. 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

  23. 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

07

Study locations

8 sites
  • Southern Clinical Trials Waitemata
    Auckland, Birkenhead 0626, New Zealand
  • Lakeland Clinical Trials Waikato
    Hamilton, Nawton 3200, New Zealand
  • Southern Clinical Trials Totara
    Auckland, New Lynn 0600, New Zealand
  • Lakeland Clinical Trials Culloden
    Papamoa, Papamoa Beach 3118, New Zealand
  • Southern Clinical Trials Remuera
    Auckland, Remuera 1050, New Zealand
  • Southern Clinical Trials Tasman
    Nelson, Stoke 7011, New Zealand
  • Southern Clinical Trials Christchurch
    Christchurch, 8013, New Zealand
  • Lakeland Clinical Trials Rotorua
    Rotorua, 3010, New Zealand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04956224
Lead sponsor
Valneva Austria GmbH
Responsible party
Sponsor
First posted
Jul 9, 2021
Start date
Aug 9, 2021
Primary completion
Nov 10, 2021
Completion
Nov 18, 2022
Last update
Sep 1, 2023

Study contacts

Valneva Clinical Deveopment
study chair · Valneva Austria GmbH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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