Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (Covid-19), have spread to millions of persons worldw...

https://www.nejm.org/doi/pdf/10.1056/NEJMoa2027906

Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates.

In March 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1, a pandemic. With rapidly accumulating numbers of cases and deaths reported globally2, a vaccine is urgently needed. Here we report the available safety, tolerability and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose-escalation study (ClinicalTrials.gov identifier NCT04368728) among 45 healthy adults (18–55 years of age), who were randomized to receive 2 doses—separated by 21 days—of 10 μg, 30 μg or 100 μg of BNT162b1. BNT162b1 is a lipid-nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes the trimerized receptor-binding domain (RBD) of the spike glycoprotein of SARS-CoV-2. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 μg was not administered because of the increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared with the 30-μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titres in sera increased with dose level and after a second dose. Geometric mean neutralizing titres reached 1.9–4.6-fold that of a panel of COVID-19 convalescent human sera, which were obtained at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate. In a dose-escalation study of the COVID-19 RNA vaccine BNT162b1 in 45 healthy adults, RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titres in sera increased with dose level and after a second vaccine dose.

/pdf/phase-i-ii-study-of-covid-19-rna-vaccine-bnt162b1-in-adults-2rnilo82hw.pdf

Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults.

CpG Oligonucleotides (ODN) are immunomodulatory synthetic oligonucleotides designed to specifically agonize Toll-like receptor 9. Here, we review recent progress in understanding the mechanism of action of CpG ODN and provide an overview of human clinical trial results using CpG ODN to improve the vaccines for cancer, allergy and infectious disease.

/pdf/recent-progress-concerning-cpg-dna-and-its-use-as-a-vaccine-k1vx1jncqn.pdf

Recent progress concerning CpG DNA and its use as a vaccine adjuvant.

Background: Severe acute respiratory syndrome coronavirus 2 (SARS−CoV−2) infections and the resulting disease, coronavirus disease 2019 (COVID−19), have spread to millions of people globally. Multiple vaccine candidates are under development, but no vaccine is currently available. 
Methods: Healthy adults 18−55 and 65−85 years of age were randomized in an ongoing, placebo−controlled, observer−blinded dose−escalation study to receive 2 doses at 21−day intervals of placebo or either of 2 lipid nanoparticle−formulated, nucleoside−modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS−CoV−2 receptor-binding domain, or BNT162b2, which encodes a prefusion stabilized membrane-anchored SARS−CoV−2 full-length spike. In each of 13 groups of 15 participants, 12 received vaccine and 3 received placebo. Groups were distinguished by vaccine candidate, age of participant, and vaccine dose level. Interim safety and immunogenicity data of BNT162b1 in younger adults have been reported previously from US and German trials. We now present additional safety and immunogenicity data from the US Phase 1 trial that supported selection of the vaccine candidate advanced to a pivotal Phase 2/3 safety and efficacy evaluation. 
Results: In both younger and older adults, the 2 vaccine candidates elicited similar dose-dependent SARS−CoV−2−neutralizing geometric mean titers (GMTs), comparable to or higher than the GMT of a panel of SARS−CoV−2 convalescent sera. BNT162b2 was associated with less systemic reactogenicity, particularly in older adults. 
Conclusion: These results support selection of the BNT162b2 vaccine candidate for Phase 2/3 large−scale safety and efficacy evaluation, currently underway.

https://www.medrxiv.org/content/medrxiv/early/2020/08/20/2020.08.17.20176651.full.pdf

RNA-based COVID-19 vaccine BNT162b2 selected for a pivotal efficacy study

https://www.mdpi.com/2076-393X/2/2/323/pdf

Immune Adjuvant Effect of Molecularly-defined Toll-Like Receptor Ligands.

Randomized, double-blind, placebo-controlled, safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers

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Randomized, double-blind, placebo-controlled, safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers