Data from some studies indicate the decline in the effectiveness of the authorized COVID-19 vaccines due to antibody waning following vaccination and the emergence of different variants. These findings support the need to increase vaccination and booster campaigns to protect the adult population against infection. Valneva developed the VLA2001 vaccine, a highly purified, whole virus SARS-CoV-2 vaccine produced on Vero cells and inactivated with β-propiolactone. VLA2001 will be adjuvanted with the licensed adjuvant cytosine phospho-guanine (CpG) 1018 (produced by Dynavax, contained in HEPLISAV-B®) in combination with aluminum hydroxide. On April 14, 2022, VLA2001 was granted Conditional Marketing Authorization (CMA) by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom for primary immunization in adults 18 to 50 years of age. This follows the emergency use authorization granted by the Bahraini NHRA in March 2022. As a substantial population has received a primary vaccination series with authorized vaccines, a booster dose to extend the duration and protection may be required.This study aims to investigate the safety, tolerability, and immunogenicity of the VLA2001 vaccine as a booster dose to adults 18 years and older who were primed with another licensed inactivated COVID-19 vaccine at least 6 months prior to enrollment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
VLA2001 is a highly purified whole virus, inactivated, adjuvanted vaccine, using the manufacturing platform of Valneva's encephalitis (JE) vaccine
Centro de Estudios en Infectología Pediátrica
Cali, Valle del Cauca Department, Colombia
GMT fold-rise for neutralizing antibodies D1 and D16
GMT fold-rise for neutralizing antibodies against SARS-CoV-2 15 days after a single booster dose with VLA2001
Time frame: Day of vaccination (D1) and 15 days after vaccination (D16)
Adverse events
Frequency and severity of solicited AEs (local and systemic reactions) after the VLA2001 booster vaccination
Time frame: From the day of vaccination (D1) until 7 days after vaccination (D8)
Individual neutralizing antibody titers D1, D16, D181, M9, M12
Immune response as determined by the GMT of SARS-CoV-2-specific neutralizing antibodies
Time frame: Day of vaccination (D1), 15 days after vaccination (D16), 180 after vaccination (D181), 9 months after vaccination (M9) and 12 months after vaccination (M12)
GMT fold-rise for neutralizing antibodies D1, D181, M9, M12
GMT fold-rise for neutralizing antibodies against SARS-CoV-2 following a single booster dose with VLA2001.
Time frame: 180 after vaccination (D181), 9 months after vaccination (M9) and 12 months after vaccination (M12)
Proportion of participants achieving fold rise in neutralizing antibodies D16, D181, M9, M12
Proportion of participants achieving an at least 2-, 4-, 10- or 20-fold rise over baseline (pre-booster) in terms of neutralizing antibodies to SARS-CoV-2 S-protein
Time frame: 15 days after vaccination (D16), 180 after vaccination (D181), 9 months after vaccination (M9) and 12 months after vaccination (M12)
GMT fold-rise of IgG antibodies D1, D16, D181, M9, M12
GMT fold-rise of IgG antibodies to the SARS-CoV-2 S-protein following a single booster dose with VLA2001.
Time frame: Day of vaccination (D1), 15 days after vaccination (D16), 180 after vaccination (D181), 9 months after vaccination (M9) and 12 months after vaccination (M12)
GMT of IgG antibodies to the SARS-CoV-2 S-protein D1, D16, D181, M9, M12
Immune response as determined by the GMT of IgG antibodies to the SARS-CoV-2 S-protein
Time frame: Day of vaccination (D1), 15 days after vaccination (D16), 180 after vaccination (D181), 9 months after vaccination (M9) and 12 months after vaccination (M12)
Fold-rise IgG antibodies to SARS-CoV-2 S-protein D16, D181, M9, M12
Proportion of participants achieving an at least 2-, 4-, 10- or 20-fold rise over baseline (pre-booster) in terms of IgG antibodies to SARS-CoV-2 S-protein
Time frame: 15 months after vaccination (D16), 180 after vaccination (D181), 9 months after vaccination (M9) and 12 months after vaccination (M12)
T-cell response
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 (IFN γ) or intracellular cytokine staining (IL-2, IL-4, IL-5, IL-13, TNFα, IFN γ)
Time frame: From the day of vaccination (D1) until month 12 after vaccination day
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