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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|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.|
|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|
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
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
- Immune response as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies [ Time Frame: Day 43 ]
- Frequency and severity of solicited AES (local and systemic reactions) after each and any vaccination [ Time Frame: within 7 days ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Frequency and severity of any Adverse Event (AE) [ Time Frame: until Day 365 ]
- Frequency and severity of any unsolicited Adverse Events (AEs) [ Time Frame: until Day 43 ]
- Frequency and severity of any unsolicited vaccine-related Adverse Events (AEs) [ Time Frame: until Day 43. ]
- Frequency and severity of any serious adverse event (SAE) [ Time Frame: until Day 365 ]
- Frequency and severity of any adverse event of special interest (AESI) [ Time Frame: until Day 365 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04956224
|Contact: Valneva Clinical Development||+43 1 206 20 ext firstname.lastname@example.org|
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|Study Chair:||Valneva Clinical Deveopment||Valneva Austria GmbH|