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COVID-19Phase 3NCT05545683

Safety and Immunogenicity of Inactivated Heterologous Booster Vaccination

A Phase 3 study testing VLA 2001 in people with COVID-19, run by Centro de Estudios en Infectogía Pediatrica at 1 site in Colombia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Data from some studies indicate the decline in the effectiveness of the authorized COVID-19 vaccines due to antibody waning following vaccination and the emergence of different variants. These findings support the need to increase vaccination and booster campaigns to protect the adult population against infection. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
VLA 2001
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteColombia
Study dates
1 Dec 2022to 30 Jun 2024
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants of either gender aged 18 years and older at screening
  • Participants who have received two doses of an inactivated Covid vaccine and no booster. Primary series with an inactivated vaccine had to be completed at least 6 months prior to enrollment.
  • Participants must have read, understood, and signed the informed consent form (ICF)
  • 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.
  • A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to the expected day of booster vaccination.
  • Participant has a Body Mass Index (BMI) of 18.0-30.0 kg/m2, inclusive, at screening (Visit 0).
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  • 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 receiving the booster vaccine.
  • A female participant is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile.
  • Note: Participants not of childbearing potential are not required to use any other forms of contraception during the study. Non-childbearing potential is defined as participant confirmed:
  • Surgical sterilization for ≥3 months prior to Visit 1 (e.g., bilateral oophorectomy, bilateral salpingectomy, bilateral occlusion by cautery, hysterectomy, or tubal ligation).
  • Postmenopausal (defined as permanent cessation of menstruation for at least 12 consecutive months prior to screening).
  • WOCBPs must have a negative pregnancy test prior to the booster vaccination.
  • Has received a second dose of licensed inactivated COVID-19 vaccine 6 to 15 months before study vaccination.

Who cannot join

  • Known history of natural SARS-CoV-2 infection (based on medical history and/or confirmed either by PCR or rapid antigen test) less than four months prior to the planned booster vaccination..
  • 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 > 100 °F (> 37.8 °C) within 48 hours before vaccination.
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  • Positive SARS-CoV-2 rapid Antigen test result during screening (Visit 0) 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).
  • Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent ≥ 0.05 mg/kg/day within 4 weeks prior to the expected day of first vaccination (visit 1), radiation therapy or immunosuppressive cytotoxic drugs/ monoclonal antibodies in the previous 3 years; topical and inhaled steroids are allowed.
  • Participants with chronic HIV unless: HIV disease with documented viral load <50 copies/ml and CD4 count >200 cells/mm3 for at least 6 months before first vaccination, and stable antiretroviral therapy for the last 6 months.
  • 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. A history of hematologic malignancy is a permanent exclusion. Participants with a history of skin cancer must not be vaccinated at the previous tumor site.
  • 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 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.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Centro de Estudios en Infectología Pediátrica

    Cali, Valle del Cauca Department, 12345

Other trials in Colombia

About this study

Official title: Open-Label Phase 3 Clinical Study to Investigate Safety and Immunogenicity of a Single VLA2001 Booster Vaccination in Volunteers Aged ≥18 Years, After Priming With Another Inactivated COVID-19 Vaccine

Data from some studies indicate the decline in the effectiveness of the authorized COVID-19 vaccines due to antibody waning following vaccination and the emergence of different variants. These findings support the need to increase vaccination and booster campaigns to protect the adult population against infection. Valneva developed the VLA2001 vaccine, a highly purified, whole virus SARS-CoV-2 vaccine produced on Vero cells and inactivated with β-propiolactone. VLA2001 will be adjuvanted with the licensed adjuvant cytosine phospho-guanine (CpG) 1018 (produced by Dynavax, contained in HEPLISAV-B®) in combination with aluminum hydroxide. On April 14, 2022, VLA2001 was granted Conditional Marketing Authorization (CMA) by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom for primary immunization in adults 18 to 50 years of age. This follows the emergency use authorization granted by the Bahraini NHRA in March 2022. As a substantial population has received a primary vaccination series with authorized vaccines, a booster dose to extend the duration and protection may be required.This study aims to investigate the safety, tolerability, and immunogenicity of the VLA2001 vaccine as a booster dose to adults 18 years and older who were primed with another licensed inactivated COVID-19 vaccine at least 6 months prior to enrollment.

Conditions
COVID-19
Being tested
VLA 2001
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VLA 2001Biological

    VLA2001 is a highly purified whole virus, inactivated, adjuvanted vaccine, using the manufacturing platform of Valneva's encephalitis (JE) vaccine

Study groups in NCT05545683
Study groupRoleWhat they receive
VLA 2001ExperimentalOne dose (0.5 mL) contains no less than 25 Antigen Units (AU) of inactivated SARS-CoV-2. Highly purified whole virus SARS-CoV-2 antigen, inactivated and adjuvanted with CpG 1018 in combination with aluminum hydroxide.
Receives: Biological: VLA 2001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. GMT fold-rise for neutralizing antibodies D1 and D16

    GMT fold-rise for neutralizing antibodies against SARS-CoV-2 15 days after a single booster dose with VLA2001

    Measured: Day of vaccination (D1) and 15 days after vaccination (D16)

  2. Adverse events

    Frequency and severity of solicited AEs (local and systemic reactions) after the VLA2001 booster vaccination

    Measured: From the day of vaccination (D1) until 7 days after vaccination (D8)

Secondary outcomes (7)

  1. Individual neutralizing antibody titers D1, D16, D181, M9, M12

    Immune response as determined by the GMT of SARS-CoV-2-specific neutralizing antibodies

    Measured: Day of vaccination (D1), 15 days after vaccination (D16), 180 after vaccination (D181), 9 months after vaccination (M9) and 12 months after vaccination (M12)

  2. GMT fold-rise for neutralizing antibodies D1, D181, M9, M12

    GMT fold-rise for neutralizing antibodies against SARS-CoV-2 following a single booster dose with VLA2001.

    Measured: 180 after vaccination (D181), 9 months after vaccination (M9) and 12 months after vaccination (M12)

  3. Proportion of participants achieving fold rise in neutralizing antibodies D16, D181, M9, M12

    Proportion of participants achieving an at least 2-, 4-, 10- or 20-fold rise over baseline (pre-booster) in terms of neutralizing antibodies to SARS-CoV-2 S-protein

    Measured: 15 days after vaccination (D16), 180 after vaccination (D181), 9 months after vaccination (M9) and 12 months after vaccination (M12)

  4. GMT fold-rise of IgG antibodies D1, D16, D181, M9, M12

    GMT fold-rise of IgG antibodies to the SARS-CoV-2 S-protein following a single booster dose with VLA2001.

    Measured: Day of vaccination (D1), 15 days after vaccination (D16), 180 after vaccination (D181), 9 months after vaccination (M9) and 12 months after vaccination (M12)

  5. GMT of IgG antibodies to the SARS-CoV-2 S-protein D1, D16, D181, M9, M12

    Immune response as determined by the GMT of IgG antibodies to the SARS-CoV-2 S-protein

    Measured: Day of vaccination (D1), 15 days after vaccination (D16), 180 after vaccination (D181), 9 months after vaccination (M9) and 12 months after vaccination (M12)

  6. Fold-rise IgG antibodies to SARS-CoV-2 S-protein D16, D181, M9, M12

    Proportion of participants achieving an at least 2-, 4-, 10- or 20-fold rise over baseline (pre-booster) in terms of IgG antibodies to SARS-CoV-2 S-protein

    Measured: 15 months after vaccination (D16), 180 after vaccination (D181), 9 months after vaccination (M9) and 12 months after vaccination (M12)

  7. T-cell response

    Assessment of T-cell responses from PBMCs in a subset of participants after in vitro stimulation with SARS-CoV-2 antigens using e.g. ELISpot (IFN γ) or intracellular cytokine staining (IL-2, IL-4, IL-5, IL-13, TNFα, IFN γ)

    Measured: From the day of vaccination (D1) until month 12 after vaccination day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completion30 Mar 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Why it stopped: funding was suspended

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05545683
Sponsor's protocol ID
IIT-VAL-LOP-COV-001
Status last verified
Feb 2023
First submitted
6 Sep 2022
Last updated
9 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VLA 2001 in people with COVID-19, run by Centro de Estudios en Infectogía Pediatrica at 1 site in Colombia.

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 14 inclusion and 16 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: withdrawn, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. 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 was withdrawn before enrolling participants, so there are no results.

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 fold-rise for neutralizing antibodies D1 and D16 (time frame: Day of vaccination (D1) and 15 days after vaccination (D16)). 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?

On the ClinicalTrials.gov record for NCT05545683.

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 9 Feb 2023.

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