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.
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 were planned to be enrolled. It was planned to enroll approximately 25% of participants who are above 65 years into the cohorts with participants above 50 years of age. Cohorts 1B, 1C, 1D, 2B and 2D have been fully recruited. Recruitment for Cohorts 1A, 2A, 2C, and 3, has been stopped in December 2022 due to very low recruitment rates in these cohorts. The revised study design ensures a safety follow-up of at least 6 months after the VLA2001 vaccination for all enrolled study participants. Immunogenicity will be assessed at Visits 1 (pre-booster, Day 1) and Visit 2 (Day 15, 14 days after the booster vaccination). Safety will be assessed up to Visit 3a (Day 180) or up to an End of Study Visit for participants who have already had their Day 180 visit before the current study amendment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
178
whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG)1018 in combination with aluminium hydroxide
General Practitioners Research Institute (GPRI)
Groningen, Netherlands
European Clinical Research Alliance on Infectious Diseases (ECRAID)
Utrecht, Netherlands
Middlemore Clinical Trials
Auckland, Papatoetoe, New Zealand
Optimal Clinical Trials
Auckland, New Zealand
GMT (Geometric Mean Titer) fold-rise for neutralising antibodies against SARS-CoV-2 following a single booster dose with VLA2001
Time frame: Day 15
Frequency and severity of solicited AEs (Adverse Events) (local and systemic reactions) after the VLA2001 booster vaccination
Time frame: until Day 7
Immune response as determined by the GMT (Geometric Mean Titer) of SARS-CoV-2-specific neutralizing antibodies
Time frame: Visit 1 (Day 1) and Visit 2 (Day 15)
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
Time frame: Visit 2 (Day 15)
GMT (Geometric Mean Titer) fold-rise of IgG antibodies to the SARS-CoV-2 S-protein following a single booster dose with VLA2001
Time frame: Visit 2 (Day 15)
Immune response as determined by the GMT (Geometric Mean Titer) of IgG antibodies to the SARS-CoV-2 S-protein
Time frame: Visit 1 (Day 1) and Visit 2 (Day 15)
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
Time frame: Visit 2 (Day 15)
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
Time frame: Visit 1 (Day 1) and Visit 2 (Day 15)
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Frequency and Severity of any AE (Adverse Event)
Time frame: up to 4 weeks after vaccination
Frequency and Severity of unsolicited AEs (Adverse Events)
Time frame: up to 4 weeks after vaccination
Frequency and severity of any unsolicited vaccine-related AE (Adverse Event)
Time frame: up to 4 weeks after vaccination
Frequency and severity of any SAE (Serious Adverse Event)
Time frame: up to Day 180
Frequency and severity of any AESI (Adverse Event of Special Interest)
Time frame: up to Day 180