VLA2001 Booster in Adult Participants After Priming With mRNA COVID-19 Vaccine and/or Natural SARS-CoV-2 Infection

NCT05364242 | Completed Phase 2 DMC

• 1 other identifier: VLA2001-307
• Study Type: interventional
• Target: 178
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

SARS-CoV-2 Infection

Keywords

VLA2001; SARS-CoV-2 Infection; COVID-19

Outcome Measures

Primary Outcomes (2)

• GMT (Geometric Mean Titer) fold-rise for neutralising antibodies against SARS-CoV-2 following a single booster dose with VLA2001

  Day 15

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

  until Day 7

Secondary Outcomes (11)

• Immune response as determined by the GMT (Geometric Mean Titer) of SARS-CoV-2-specific neutralizing antibodies

  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

  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

  Visit 2 (Day 15)

• Immune response as determined by the GMT (Geometric Mean Titer) of IgG antibodies to the SARS-CoV-2 S-protein

  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

  Visit 2 (Day 15)

Study Arms (1)

VLA2001

EXPERIMENTAL

Biological: VLA2001

Interventions

VLA2001 BIOLOGICAL

whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG)1018 in combination with aluminium hydroxide

VLA2001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• Valneva Austria GmbH: lead

Study Sites (4)

General Practitioners Research Institute (GPRI)

Groningen, 9713, Netherlands

Location

European Clinical Research Alliance on Infectious Diseases (ECRAID)

Utrecht, 3584 BA, Netherlands

Location

Middlemore Clinical Trials

Auckland, Papatoetoe, 2025, New Zealand

Location

Optimal Clinical Trials

Auckland, 1010, New Zealand

Location

MeSH Terms

Conditions

COVID-19

Interventions

VLA2001 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Valneva Clinical Development

  Valneva Austria GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 6, 2022
• Study Start: May 9, 2022
• Primary Completion: September 22, 2022
• Study Completion: May 22, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); NL (2)