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Immunogenicity of VLA2101 Compared to VLA2001.

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ClinicalTrials.gov Identifier: NCT04956224
Recruitment Status : Recruiting
First Posted : July 9, 2021
Last Update Posted : August 19, 2021
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Brief Summary:

This is a Multicentre, Randomized, Observer-blind, Active-Controlled, Non-inferiority Study to compare the immunogenicity of VLA2101 to VLA2001.

Participants aged 12 years or older and who are either generally healthy or are with a stable medical condition will be enrolled.

In Cohort 1, approximately 150 participants aged 56 years or older will be enrolled in a non-randomized manner to receive VLA2001 at the recommended dose level, 28 days apart, on Days 1 and 29.

In Cohort 2, approximately 600 participants 12 years of age or older will be randomized in a 1:1 ratio to receive 2 intramuscular doses of either VLA2001 (n=300) or VLA2101 (n=300), 28 days apart, on Days 1 and 29.

Randomization of 56 year olds in Cohort 2 will be started once Cohort 1 has been fully recruited.


Condition or disease Intervention/treatment Phase
Sars-Cov-2 Virus Infection Biological: VLA2001 Biological: VLA2101 Phase 3

Detailed Description:

This Phase 3 study is designed as a randomized, observer-blind, active-controlled, stratified study, in order to demonstrate the non-inferiority of the immunogenicity of VLA2101 vaccine to VLA2001 vaccine.

This study will serve two purposes. On the one hand, safety and immunogenicity data in volunteers aged 56 years and older will be generated (Cohort 1) to strengthen the database for this age group. On the other hand, immuno-bridging of Valneva's VLA2101 vaccine to VLA2001 will be performed, complemented by the respective safety comparison (Cohort 2).

Participants enrolled for Cohort 1 will receive the study treatment in an open-label manner to confirm the safety and immunogenicity of VLA2001.

For the study population enrolled in Cohort 2 the study will be observer blinded to the Investigators and study team. However, the pharmacists/ nurses who prepare the vaccination will not be blinded since the packaging of the 2 vaccines is different. Observers (i.e. investigators and study team performing any study related assessments) remain blinded to minimize possibility of a safety bias by the participants and/or Investigator's or staff performing medical safety assessments.

The dose level tested in this study was selected based on the results of the Phase 1/2 study VLA2001-201 of 150 participants aged 18 to 55 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: For the study population enrolled in Cohort 2 the study will be observer blinded to the Investigators and study team. However, the pharmacists/ nurses who prepare the vaccination will not be blinded since the packaging of the 2 vaccines is different. Observers (i.e. investigators and study team performing any study related assessments) remain blinded to minimize possibility of a safety bias by the participants and/or Investigator's or staff performing medical safety assessments.
Primary Purpose: Prevention
Official Title: A Randomized, Observer-Blind, Controlled, Non-Inferiority Study To Compare The Immunogenicity Against COVID-19, Of VLA2101 Vaccine To VLA2001 Vaccine, In Volunteers Aged ≥12 Years.
Actual Study Start Date : August 9, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
Experimental: VLA2001 Biological: VLA2001

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

2 vaccinations 28 days apart


Experimental: VLA2101 Biological: VLA2101

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

2 vaccinations 28 days apart





Primary Outcome Measures :
  1. Immune response as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies [ Time Frame: Day 43 ]
  2. Frequency and severity of solicited AES (local and systemic reactions) after each and any vaccination [ Time Frame: within 7 days ]

Secondary Outcome Measures :
  1. Proportion of participants with seroconversion defined as ≥ 4-fold increase in SARS-CoV-2 neutralizing antibody titer and S-protein binding IgG levels between Day 1 and post-vaccination timepoints. [ Time Frame: on Day 29, Day 43, Day 57, Day 71, Day 208 and Day 365 ]
  2. Immune response as determined by the GMT of SARS-CoV-2-specific neutralizing antibodies. [ Time Frame: on Day 29, Day 57, Day 71, Day 208 and Day 365 ]
  3. Immune response as determined by the GMT of IgG antibodies to SARS-CoV-2 S-protein. [ Time Frame: on Day 29, Day 43, Day 57, Day 71, Day 208 and Day 365 ]
  4. 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 or intracellular cytokine staining [ Time Frame: on Day 1, Day 43, Day 208 and Day 365 ]
  5. Frequency and severity of any Adverse Event (AE) [ Time Frame: until Day 365 ]
  6. Frequency and severity of any unsolicited Adverse Events (AEs) [ Time Frame: until Day 43 ]
  7. Frequency and severity of any unsolicited vaccine-related Adverse Events (AEs) [ Time Frame: until Day 43. ]
  8. Frequency and severity of any serious adverse event (SAE) [ Time Frame: until Day 365 ]
  9. Frequency and severity of any adverse event of special interest (AESI) [ Time Frame: until Day 365 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Parent(s)/legal representative(s) and participants who have an understanding of the study and its procedures as explained by the investigator and agree to its provisions:
  2. Cohort 1: Participants of either gender aged 56 years or older at screening. Cohort 2: Participants of either gender aged 12 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.
  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 from study start until a minimum of 3 months after the last dose of study vaccine.
  7. WOCBPs must have a negative pregnancy test prior to each vaccination.

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 randomization.
  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 randomization (visit 1) 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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04956224


Contacts
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Contact: Valneva Clinical Development +43 1 206 20 ext 0 office@valneva.com

Locations
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New Zealand
Southern Clinical Trials Waitemata Recruiting
Auckland, Birkenhead, New Zealand, 0626
Lakeland Clinical Trials Waikato Recruiting
Hamilton, Nawton, New Zealand, 3200
Southern Clinical Trials Totara Not yet recruiting
Auckland, New Lynn, New Zealand, 0600
Lakeland Clinical Trials Culloden Recruiting
Papamoa, Papamoa Beach, New Zealand, 3118
Southern Clinical Trials Remuera Not yet recruiting
Auckland, Remuera, New Zealand, 1050
Southern Clinical Trials Tasman Recruiting
Nelson, Stoke, New Zealand, 7011
Southern Clinical Trials Christchurch Recruiting
Christchurch, New Zealand, 8013
Lakeland Clinical Trials Rotorua Recruiting
Rotorua, New Zealand, 3010
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
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Study Chair: Valneva Clinical Deveopment Valneva Austria GmbH
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Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT04956224    
Other Study ID Numbers: VLA2001-304
First Posted: July 9, 2021    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Valneva Austria GmbH:
VLA2001
Sars-Cov-2 Virus Infection
Covid-19
VLA2101
Additional relevant MeSH terms:
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COVID-19
Virus Diseases
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases