Strong immunogenicity & protection in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a functional polymer.

DNA- based vaccines have demonstrated the potential as a safe and effective modality. PlaCCine, a DNA-based vaccine approach described subsequently relies on a synthetic DNA delivery system and is independent of virus or device. The synthetic functionalized polymer combined with DNA demonstrated stability over 12 months at 4C and for one month at 25C. Transfection efficiency compared to naked DNA increased by 5-15-fold in murine skeletal muscle. Studies of DNA vaccines expressing spike proteins from variants D614G (pVAC15), Delta (pVAC16), or a D614G + Delta combination (pVAC17) were conducted. Mice immunized intramuscular injection (IM) with pVAC15, pVAC16 or pVAC17 formulated with functionalized polymer and adjuvant resulted in induction of spike-specific humoral and cellular responses. Antibody responses were observed after one immunization. And endpoint IgG titers increased to greater than 1x 105 two weeks after the second injection. Neutralizing antibodies as determined by a pseudovirus competition assay were observed following vaccination with pVAC15, pVAC16 or pVAC17. Spike specific T cell immune responses were also observed following vaccination and flow cytometry analysis demonstrated the cellular immune responses included both CD4 and CD8 spike specific T cells. The immune responses in vaccinated mice were maintained for up to 14 months after vaccination. In an immunization and challenge study of K18 hACE2 transgenic mice pVAC15, pVAC16 and pVAC17 induced immune responses lead to decreased lung viral loads by greater than 90 % along with improved clinical score. These findings suggest that PlaCCine DNA vaccines are effective and stable and further development against emerging SARS-CoV-2 variants is warranted.

Comparison of response rates on invitation mode of a web-based survey on influenza vaccine adverse events among healthcare workers: a pilot study.

BACKGROUND: Web-based surveys have become increasingly popular but response rates are low and may be prone to selection bias. How people are invited to participate may impact response rates and needs further study as previous evidence is contradictory. The purpose of this study was to determine whether response to a web-based survey of healthcare workers would be higher with a posted or an emailed invitation. We also report results of the pilot study, which aims to estimate the percentage of adults vaccinated against influenza who report recurrent systemic adverse events (the same systemic adverse event occurring successively following receipt of influenza vaccines). METHODS: The pilot study was conducted in November 2016 in Toronto, Canada. Members of a registry of adults (18 years and older and predominantly healthcare workers) who volunteered to receive information regarding future studies about influenza were randomly assigned to receive either an email or postal invitation to complete a web-based survey regarding influenza vaccinations. Non-respondents received one reminder using the same mode of contact as their original invitation. RESULTS: The overall response rate was higher for those sent the invitation by email (34.8%) than by post (25.8%; p < 0.001) and for older versus younger participants (ptrend < 0.001). Of those who responded, 387/401 had been vaccinated against influenza at least once since adulthood. Of those responding to the question, 70/386 (18.1%) reported a systemic adverse event after their most recent influenza vaccine including 22 (5.7%) who reported a recurring systemic event. Systemic adverse events were reported more often by males 18-49 years old than by other groups (p = 0.01). Recurrent systemic adverse events were similar by age and sex with muscle ache being the most commonly reported recurrent reaction. More respondents who reported only a local adverse event (93.1%) planned to be vaccinated again next year than those with a systemic adverse event (69.7%; p = 0.04). CONCLUSIONS: In this convenience sample of registry volunteers, response rates were generally low, but were higher for the emailed than posted invitations and for older than younger adults.