ABSTRACT
Several severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are being deployed, but the global need greatly exceeds the supply, and different formulations might be required for specific populations. Here we report Day 42 interim safety and immunogenicity data from an observer-blinded, dose escalation, randomized controlled study of a virus-like particle vaccine candidate produced in plants that displays the SARS-CoV-2 spike glycoprotein (CoVLP: NCT04450004 ). The co-primary outcomes were the short-term tolerability/safety and immunogenicity of CoVLP formulations assessed by neutralizing antibody (NAb) and cellular responses. Secondary outcomes in this ongoing study include safety and immunogenicity assessments up to 12 months after vaccination. Adults (18-55 years, n = 180) were randomized at two sites in Quebec, Canada, to receive two intramuscular doses of CoVLP (3.75 µg, 7.5 µg, and 15 µg) 21 d apart, alone or adjuvanted with AS03 or CpG1018. All formulations were well tolerated, and adverse events after vaccination were generally mild to moderate, transient and highest in the adjuvanted groups. There was no CoVLP dose effect on serum NAbs, but titers increased significantly with both adjuvants. After the second dose, NAbs in the CoVLP + AS03 groups were more than tenfold higher than titers in Coronavirus 2019 convalescent sera. Both spike protein-specific interferon-γ and interleukin-4 cellular responses were also induced. This pre-specified interim analysis supports further evaluation of the CoVLP vaccine candidate.
Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Drug-Related Side Effects and Adverse Reactions/prevention & control , Vaccines, Virus-Like Particle/administration & dosage , Adolescent , Adult , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , COVID-19/genetics , COVID-19/immunology , COVID-19/therapy , COVID-19/virology , COVID-19 Vaccines/adverse effects , Canada , Drug-Related Side Effects and Adverse Reactions/immunology , Drug-Related Side Effects and Adverse Reactions/virology , Female , Humans , Immunization, Passive , Immunogenicity, Vaccine , Male , Middle Aged , SARS-CoV-2/drug effects , SARS-CoV-2/pathogenicity , Spike Glycoprotein, Coronavirus , Vaccines, Virus-Like Particle/adverse effects , Young Adult , COVID-19 SerotherapyABSTRACT
The newly developed Dissoziations-Spannungs-Skala (Dissociation Tension Scale; DSS) is a self-rating instrument for the assessment of psychological and somatoform dissociative features (ranging from normal up to pathological) as well as aversive inner tension occurring within the past 7 days. The DSS contains 21 items assessing dissociative symptoms and 1 additional item assessing aversive inner tension. Ratings are made on a time-oriented scale ranging from 0% (never) to 100% (constantly). We measured the psychometric qualities of the DSS in a total of 294 patients and healthy controls. Internal consistency of the DSS was high (Cronbach's alpha = .92; Gutmann's split-half r = .92). We found good support for convergent, discriminant, and differential validity. There was clear evidence for the DSS being a sensitive instrument for the assessment of changing symptomatology. Assessment of dissociation and other psychopathological features over the same period of time are now possible.
