A multicenter, 3-arm randomized dose finding study in the UK to evaluate safety, tolerability and immunogenicity of a vaccine candidate against Covid-19. 150 healthy volunteers will be enrolled and receive two shots of the vaccine candidate. All participants who receive two doses of the vaccine candidate will be invited to participate in the Booster phase.
The multicenter, dose finding Phase 1/2 study starts off with an open-label, dose-escalation part, thereafter, during the double-blind part of study, participants will be randomized 1:1:1 to receive the low, medium or high dose of the vaccine (VLA2001). All participants will received a total of two vaccinations intramuscularly, on day 1 and day 22. The first 5 participants in each dose group will receive VLA2001 open label, starting with the low dose of VLA2001. If no safety concerns are identified, the next 5 subjects will receive the medium dose of the vaccine. Again, if no safety issues are identified, 5 participants will be vaccinated with the high dose of the vaccine. A Data Safety and Monitoring Board (DSMB) will review accrued safety data before randomization of the remaining 135 subjects across all sites will be initiated. All study participants will be followed up for safety and immunogenicity up to approximately 6 months after receiving their second vaccination. This study was extended to investigate the tolerability, safety and immungenicity of a booster vaccination with VLA2001. All study participants, in the Booster phase, will be followed up for safety and immunogenicity up to 6 months after receiving their Booster vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
153
whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxide
Queen Elizabeth Hospital
Birmingham, United Kingdom
University Hospital Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
Newcastle University Medical School
Newcastle, United Kingdom
Southampton NIHR Clinical Research Facility
Southampton, United Kingdom
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Time frame: within 7 days after any vaccination
Geometric Mean Titre (GMT) for Neutralizing Antibodies Against SARS-CoV-2 Determined by Wild-type Virus Neutralizing Assay
Time frame: Day 36
Frequency of Any Unsolicited AE
Time frame: until Day 36
Frequency of Any Vaccine-related AE
Time frame: until Day 36
Frequency and Severity of Any AE
Time frame: until Day 208
Frequency and Severity of Any Vaccine-related AE
Time frame: until Day 208
Frequency of Any SAE
All Adverse Events of Special Interest (AESIs) were treated as important medical event and were therefore be treated as SAE according to protocol.
Time frame: until Day 36
Frequency of Any AESI
Time frame: until Day 36
Frequency and Severity of Any SAE
Time frame: until Day 208
Frequency and Severity of an AESI
Time frame: until Day 208
Frequency and Severy of Solicited AEs (Local and Systemic Reactions) After the Booster Vaccination
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Time frame: until Visit 7 plus 6 days
Frequency and Severity of Any Unsolicited AE
Time frame: until Visit 9
Frequency and Severity of Any Vaccine-related AE
Time frame: until Visit 9
Frequency and Severity of Any SAE
Time frame: until Visit 10
Frequency and Severity of Any AESI
Time frame: until Visit 10
Immune Response as Measured by Neutralizing Antibody Titres Against SARS-CoV-2
Time frame: until Day 208
Proportion of Participants With Seroconversion in Terms of Neutralizing Antibodies
Time frame: until Day 208
Fold Increase of SARS-CoV-2 Neutralizing Antibody Titres Compared With Baseline
Time frame: until Day 208
GMTs for IgG Antibodies Against SARS-CoV-2 Determined by ELISA
Time frame: until Day 208
Proportion of Participants With Seroconversion in Terms of IgG Antibodies Against SARS-CoV-2, as Determined by ELISA in Participants Negative for SARS-CoV-2 at Screening
Time frame: until Day 208
Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to Neutralizing Antibodies
Time frame: until Visit 8
Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to Neutralizing Antibodies
Time frame: until Visit 9
Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to Neutralizing Antibodies
Time frame: until Visit 8
Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to Neutralizing Antibodies
Time frame: until Visit 9
Geometric Mean Titres (GMT) Measured as Neutralizing Antibody Titres Against SARSCoV-2
Time frame: until Visit 9
Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to S-protein Binding Antibodies (ELISA)
Time frame: until Visit 8
Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to S-protein Binding Antibodies (ELISA)
Time frame: until Visit 9
Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose in Regards to S-protein Binding Antibodies (ELISA)
Time frame: until Visit 8
Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose in Regards to S-protein Binding Antibodies (ELISA)
Time frame: until Visit 9
Geometric Mean Titres (GMT) Measured as IgG Antibodies Against SARS-CoV-2 (ELISA
Time frame: until Visit 9