A novel coronavirus SARS-CoV-2 causing Coronavirus disease 2019 (COVID-19) has entered the human population and has spread rapidly around the world in the first half of 2020 causing a global pandemic. The virus uses its spike glycoprotein receptor-binding domain to interact with host cell angiotensin-converting enzyme 2 (ACE2) sites to initiate a cascade of events that culminate in severe acute respiratory syndrome in some individuals. In efforts to curtail viral spread, authorities initiated far-reaching lockdowns that have disrupted global economies. The scientific and medical communities are mounting serious efforts to limit this pandemic and subsequent waves of viral spread by developing preventative vaccines and repurposing existing drugs as potential therapies. In this review, we focus on the latest developments in COVID-19 vaccine development, including results of the first Phase I clinical trials and describe a number of the early candidates that are emerging in the field. We seek to provide a balanced coverage of the seven main platforms used in vaccine development that will lead to a desired target product profile for the "ideal" vaccine. Using tales of past vaccine discovery efforts that have taken many years or that have failed, we temper over exuberant enthusiasm with cautious optimism that the global medical community will reach the elusive target to treat COVID-19 and end the pandemic.

To determine the prevalence of antibody to Chlamydia heat-shock protein 60 (C-hsp60) in women with tubal infertility, an ELISA using purified recombinant C-hsp60 was developed. Antibody to C. trachomatis was present in 32 (72.7%) of 44 women with tubal infertility compared with 9 (32.1%) of 28 with other causes of infertility and 55 (28.9%) of 190 pregnant women (P < .001). Among the seropositive women, antibody to C-hsp60 was present in 26 (81.3%) of 32 women with tubal infertility compared with 0 of 9 with other causes of infertility and 9 (16.4%) of 55 pregnant women (P < .001). The C-hsp60 ELISA detected Chlamydia-associated tubal infertility in infertile women with a sensitivity of 81.3% and a specificity of 97.5%. There is a strong association between antibody response to the C-hsp60 and the development of Chlamydia-associated tubal infertility. Thus, a C-hsp60 ELISA may be useful as a predictor for poor fertility outcome.

The 13-valent pneumococcal conjugate vaccine (PCV13) is the only licensed PCV with serotype 3 polysaccharide in its formulation. Postlicensure PCV13 effectiveness studies against serotype 3 invasive pneumococcal disease (IPD) in children have shown inconsistent results.  We performed a systematic review and meta-analysis of observational studies to assess PCV13 vaccine effectiveness (VE) for serotype 3 IPD in children. We systematically searched PubMed, Embase, and the Cochrane library for studies published before 14 August 2017. We identified 4 published studies and 2 conference posters that provided PCV13 VE estimates stratified by serotype. The pooled PCV13 VE against serotype 3 IPD from the random-effects meta-analysis was 63.5% (95% confidence interval [CI], 37.3%–89.7%). A sensitivity analysis including conference posters gave a pooled VE estimate of 72.4% (95% CI, 56.7%–88.0%). The pooled data from case-control studies with similar methodologies and high quality support direct PCV13 protection against serotype 3 IPD in children.

Opsonophagocytosis is a correlate of protection that measures the functional activity of vaccine-induced antibodies. A standardized opsonophagocytosis assay (OPA) should be used as part of the evaluation of current and future pneumococcal (Pnc) polysaccharide (Ps)-based vaccines. We enrolled five laboratories to evaluate a previously standardized viability OPA. Each laboratory was provided with a detailed OPA protocol, seven target Pnc strains (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F), two quality control sera and 12 paired sera (blinded) from adult donors who received one dose of the 23-valent Pnc Ps vaccine. Laboratories sent their results to the Centers for Disease Control and Prevention for analysis. Sera were tested in duplicate (single run), and the results were averaged to yield a single OPA titer (>50% killing) for each serum sample. The percentage of sera within one or two dilutions of the calculated median OPA titer was determined for each laboratory and for each serotype. In general, laboratories were capable of detecting OPA titers within one or two dilutions of the median for at least 75 and 88%, respectively, of the sera tested. The level of agreement with the median OPA titers varied depending on the participating laboratory (overall agreement ‫؍‬ 0.8 [99% confidence interval ‫؍‬ 0.75 to 0.85]). All OPA median titers reported for quality control sera were within one dilution of the expected titer. We conclude that this OPA can be done in multiple laboratories with a high degree of interlaboratory reproducibility.Vaccine-induced protection to Streptococcus pneumoniae (pneumococcus) has been determined through vaccine efficacy trials for both polysaccharide (Ps) vaccines (1, 4, 22) and Psprotein conjugate vaccines (2,5,8). Trials of these pneumococcal (Pnc) vaccine formulations have shown various efficacies for protection depending on the end point being measured and the population being studied. These trials are costly and difficult to perform given the large sample size. In addition, pneumococcus has 90 different capsular serotypes, with the majority of disease being caused by about 30 of these 90 serotypes. Distribution of these serotypes also varies with the geographical region, making the estimation of the burden of disease and the impact of vaccination rather difficult (3, 9, 10).Efforts have been made for the identification and standardization of laboratory correlates of protection that can aid vaccine efficacy trials in the estimation of vaccine-induced protection. Currently, a highly standardized enzyme-linked immunosorbent assay (ELISA) is available (www.vaccine.uab.edu) for the evaluation of infant sera. Several modifications to the protocol described by Quartaert et al. (20) allowed for the measurement of Ps-specific antibodies in children and adults (6,19,18). Adults can have cross-reactive antibodies, which confound the measurements of immunoglobulin G (IgG) antibodies by ELISA, especially if absorption with a nonrelevant serotype is not performed prior to testing (6,7,26). These c...

The coronavirus SARS-CoV-2, which causes Coronavirus disease 2019 (COVID-19), has infected more than 100 million people globally and caused over 2.5 million deaths in just over one year since its discovery in Wuhan, China in December 2019. The pandemic has evoked widespread collateral damage to societies and economies, and has destabilized mental health and well-being. Early in 2020, unprecedented efforts went into the development of vaccines that generate effective antibodies to the SARS-CoV-2 virus. Teams developing twelve candidate vaccines, based on four platforms (messenger RNA, non-replicating viral vector, protein/virus-like particle, and inactivated virus) had initiated or announced the Phase III clinical trial stage by early November 2020, with several having received emergency use authorization in less than a year. Vaccine rollout has proceeded around the globe. Previously, we and others had proposed a target product profile (TPP) for ideal/optimal and acceptable/minimal COVID-19 vaccines. How well do these candidate vaccines stack up to a harmonized TPP? Here, we perform a comparative analysis in several categories of these candidate vaccines based on the latest available trial data and highlight the early successes as well as the hurdles and barriers yet to be overcome for ending the global COVID-19 pandemic.

No abstract

No abstract

No abstract