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

  • STATUS
    Recruiting
  • End date
    Oct 11, 2023
  • participants needed
    275
  • sponsor
    Valneva Austria GmbH
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Updated on 4 October 2022
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Accepts healthy volunteers

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.

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.

Details
Condition SARS-CoV-2 Infection
Treatment VLA2001
Clinical Study IdentifierNCT05364242
SponsorValneva Austria GmbH
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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
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 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
Significant infection or other acute illness, including fever > 37.8 °C within 48 hours before vaccination
Any member of the study team or sponsor
An immediate family member or household member of the study's personnel
Receipt of medications to treat or prevent COVID-19 (except licensed mRNA vaccine for participants of cohort 1 and 2)
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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