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

Sponsor

Valneva Austria GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05364242

Collaborator

(none)

275

Enrollment

Locations

Arm

16.8

Anticipated Duration (Months)

68.8

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Infection	Biological: VLA2001	Phase 2/Phase 3

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 are planned to be enrolled. It is planned to enroll approximately 25% of participants who are above 65 years into the cohorts with participants above 50 years of age.

Immunogenicity and safety will be assessed up to Month 12 after the booster vaccination.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

275 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

May 9, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VLA2001	Biological: VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG)1018 in combination with aluminium hydroxide

Arm

Intervention/Treatment

Experimental: VLA2001

Biological: VLA2001

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Immune response as determined by the GMT (Geometric Mean Titer) of SARS-CoV-2-specific neutralizing antibodies [Visit 1 (Day 1), Visit 2 (Day 15), Visit 3 (Day 180), Visit 4 (Month 9) and Visit 5 (Month 12)]
GMT (Geometric Mean Titer) fold-rise for neutralising antibodies against SARS-CoV-2 following a single booster dose with VLA2001 [Day 180, Month 9 and Month 12]
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 [Day 15, Day 180, Month 9 and Month 12]
GMT (Geometric Mean Titer) fold-rise of IgG antibodies to the SARS-CoV-2 S-protein following a single booster dose with VLA2001 [Day 15, Day 180, Month 9 and Month 12]
Immune response as determined by the GMT (Geometric Mean Titer) of IgG antibodies to the SARS-CoV-2 S-protein [Day 1, Day 15, Day 180, Month 9 and Month 12]
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 [Day 15, Day 180, Month 9 and Month 12]
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 [Day 1, Day 15, Day 180, Month 9]
Frequency and Severity of any AE (Adverse Event) [up to 4 weeks after vaccination]
Frequency and Severity of unsolicited AEs (Adverse Events) [up to 4 weeks after vaccination]
Frequency and severity of any unsolicited vaccine-related AE (Adverse Event) [up to 4 weeks after vaccination]
Frequency and severity of any SAE (Serious Adverse Event) [up to 4 weeks after vaccination and up to Month 12]
Frequency and severity of any AESI (Adverse Event of Special Interest) [up to 4 weeks after vaccination and up to Month 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 had 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 had 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

Exclusion Criteria:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Practitioners Research Institute (GPRI)	Groningen		Netherlands	9713
2	European Clinical Research Alliance on Infectious Diseases (ECRAID)	Utrecht		Netherlands	3584 BA
3	Middlemore Clinical Trials	Auckland	Papatoetoe	New Zealand	2025
4	Optimal Clinical Trials	Auckland		New Zealand	1010