Osteogenic potential of apical papilla stem cells mediated by platelet-rich fibrin and low-level laser.

To evaluate the osteogenic potential of platelet-rich fibrin (PRF) and low-level laser therapy (LLLT) on human stem cells from the apical papilla (SCAP) we isolated, characterized, and then cultured in an osteogenic medium cells with PRF and/or LLLT (660 nm, 6 J/m2-irradiation). Osteogenic differentiation was assessed by bone nodule formation and expression of bone morphogenetic proteins (BMP-2 and BMP-4), whereas the molecular mechanisms were achieved by qRT-PCR and RNA-seq analysis. Statistical analysis was performed by ANOVA and Tukey's post hoc tests (p < 0.05* and p < 0.01**). Although PRF and LLLT increased bone nodule formation after 7 days and peaked at 21 days, the combination of PRF + LLLT led to the uppermost nodule formation. This was supported by increased levels of BMP-2 and -4 osteogenic proteins (p < 0.005). Furthermore, the PRF + LLLT relative expression of specific genes involved in osteogenesis, such as osteocalcin, was 2.4- (p = 0.03) and 28.3- (p = 0.001) fold higher compared to the PRF and LLLT groups, and osteopontin was 22.9- and 1.23-fold higher, respectively (p < 0.05), after 7 days of interaction. The transcriptomic profile revealed that the combination of PRF + LLLT induces MSX1, TGFB1, and SMAD1 expression, after 21 days of osteogenic differentiation conditions exposition. More studies are required to understand the complete cellular and molecular mechanisms of PRF plus LLLT on stem cells. Overall, we demonstrated for the first time that the combination of PRF and LLLT would be an excellent therapeutic tool that can be employed for dental, oral, and craniofacial repair and other tissue engineering applications.

Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial.

BACKGROUND: A range of safe and effective vaccines against SARS CoV 2 are needed to address the COVID 19 pandemic. We aimed to assess the safety and efficacy of the COVID-19 vaccine SCB-2019. METHODS: This ongoing phase 2 and 3 double-blind, placebo-controlled trial was done in adults aged 18 years and older who were in good health or with a stable chronic health condition, at 31 sites in five countries (Belgium, Brazil, Colombia, Philippines, and South Africa). The participants were randomly assigned 1:1 using a centralised internet randomisation system to receive two 0·5 mL intramuscular doses of SCB-2019 (30 µg, adjuvanted with 1·50 mg CpG-1018 and 0·75 mg alum) or placebo (0·9% sodium chloride for injection supplied in 10 mL ampoules) 21 days apart. All study staff and participants were masked, but vaccine administrators were not. Primary endpoints were vaccine efficacy, measured by RT-PCR-confirmed COVID-19 of any severity with onset from 14 days after the second dose in baseline SARS-CoV-2 seronegative participants (the per-protocol population), and the safety and solicited local and systemic adverse events in the phase 2 subset. This study is registered on EudraCT (2020-004272-17) and ClinicalTrials.gov (NCT04672395). FINDINGS: 30 174 participants were enrolled from March 24, 2021, until the cutoff date of Aug 10, 2021, of whom 30 128 received their first assigned vaccine (n=15 064) or a placebo injection (n=15 064). The per-protocol population consisted of 12 355 baseline SARS-CoV-2-naive participants (6251 vaccinees and 6104 placebo recipients). Most exclusions (13 389 [44·4%]) were because of seropositivity at baseline. There were 207 confirmed per-protocol cases of COVID-19 at 14 days after the second dose, 52 vaccinees versus 155 placebo recipients, and an overall vaccine efficacy against any severity COVID-19 of 67·2% (95·72% CI 54·3-76·8), 83·7% (97·86% CI 55·9-95·4) against moderate-to-severe COVID-19, and 100% (97·86% CI 25·3-100·0) against severe COVID-19. All COVID-19 cases were due to virus variants; vaccine efficacy against any severity COVID-19 due to the three predominant variants was 78·7% (95% CI 57·3-90·4) for delta, 91·8% (44·9-99·8) for gamma, and 58·6% (13·3-81·5) for mu. No safety issues emerged in the follow-up period for the efficacy analysis (median of 82 days [IQR 63-103]). The vaccine elicited higher rates of mainly mild-to-moderate injection site pain than the placebo after the first (35·7% [287 of 803] vs 10·3% [81 of 786]) and second (26·9% [189 of 702] vs 7·4% [52 of 699]) doses, but the rates of other solicited local and systemic adverse events were similar between the groups. INTERPRETATION: Two doses of SCB-2019 vaccine plus CpG and alum provides notable protection against the entire severity spectrum of COVID-19 caused by circulating SAR-CoV-2 viruses, including the predominating delta variant. FUNDING: Clover Biopharmaceuticals and the Coalition for Epidemic Preparedness Innovations.

Androgen responsiveness to simulated territorial intrusions in Allobates femoralis males: Evidence supporting the challenge hypothesis in a territorial frog.

Territoriality has been widely described across many animal taxa, where the acquisition and defence of a territory are critical for the fitness of an individual. Extensive evidence suggests that androgens are involved in the modulation of territorial behaviours in male vertebrates. Short-term increase of androgen following a territorial encounter appears to favour the outcome of a challenge. The "Challenge Hypothesis" proposed by Wingfield and colleagues outlines the existence of a positive feedback relationship between androgen and social challenges (e.g., territorial intrusions) in male vertebrates. Here we tested the challenge hypothesis in the highly territorial poison frog, Allobates femoralis, in its natural habitat by exposing males to simulated territorial intrusions in the form of acoustic playbacks. We quantified repeatedly androgen concentrations of individual males via a non-invasive water-borne sampling approach. Our results show that A. femoralis males exhibited a positive behavioural and androgenic response after being confronted to simulated territorial intrusions, providing support for the Challenge Hypothesis in a territorial frog.

Prognostic value of the nodal yield in elective neck dissections in patients with head and neck carcinomas.

PURPOSE: The objective of this study is to assess the prognostic capacity of the nodal yield in elective neck dissections performed in patients with head and neck squamous cell carcinomas (HNSCC) without clinical or radiological evidence of regional involvement (cN0) at the time of diagnosis. METHODS: Retrospective study including 647 patients with HNSCC treated with an elective neck dissection. RESULTS: Patients with < 15 dissected nodes (n = 172, 26.6%) had a 5-year disease-specific survival of 64.9% (95% CI: 57.3-72.5%), while for patients with ≥ 15 dissected nodes (n = 475, 73.4%), it was of 81.9% (95% CI: 78.4-85.4%) (P = 0.0001). The nodal yield category had prognostic capacity on the disease-specific survival in patients with tumors located in the oral cavity (P = 0.001), the oropharynx (P = 0.023) and the hypopharynx (P = 0.034), while for patients with tumors located in the larynx, no significant differences appeared (P = 0.779). Differences in regional recurrence-free survival were also observed based on the nodal yield category in patients with extra-laryngeal tumors (5-year regional recurrence-free survival of 81.0% in patients with < 15 dissected nodes vs 89.0% in patients with ≥ 15 dissected nodes; P = 0.046). CONCLUSION: The nodal yield in elective neck dissections in patients without evidence of lymph node disease (cN0) had prognostic capacity depending on the location of the primary tumor. For tumors located in the larynx, the number of dissected nodes did not significantly influence the prognosis. For tumors located in the oral cavity, oropharynx or hypopharynx, patients with < 15 dissected nodes had a disease-specific mortality 2.9 times higher than patients with ≥ 15 dissected nodes.

Underlying dimensions of the EORTC QLQ-C30 in a Cuban population of patients with advanced non-small cell lung cancer.

BACKGROUND: Quality of Life Core Questionnaire of the European Organization for the Research and Treatment of Cancer (EORTC QLQ-C30) is one of the most used quality of life questionnaires in cancer studies. It provides scores for five functional scales, nine symptom scales, and two single items which assess overall health status and quality of life. However, high correlations among QLQ-C30 items suggest a reduced dimensionality for the scale. OBJECTIVE: To assess the dimensionality of the EORTC QLQ-C30 using item response theory (IRT) in a training sample and confirmatory factor analysis (CFA) in a test sample. METHODS: We analyzed responses to QLQ-C30 from 1,107 patients with advanced lung cancer who were included in five clinical trials of immunotherapy. We used non-parametric and parametric IRT models (Mokken, and Samejima's graded response) in a random training set (n = 332) for initial assessment of dimensions and item characteristics of the QLQ-C30. Finally, we used CFA in the test set (n = 775) to confirm the measurement domains. RESULTS: Mokken model showed that QLQ-C30 fits a unidimensional scale, whereas Samejima model showed that most QLQ-C30 items present adequate difficulty and discrimination. All items showed adequate scalability indexes with an overall scalability of 0.47 (medium scale). The QLQ-C30-reduced dimensionality was confirmed by CFA (comparative fit index = 0.98, root mean square error of approximation = 0.055) with all items presenting factorial loadings > 0.40. CONCLUSIONS: The EORTC QLQ-C30 fits a unidimensional latent construct identified with perceived quality of life in advanced lung cancer patients. TRIAL REGISTRATION: RPCEC00000161, RPCEC00000181 and RPCEC00000205.

Palliative sedation in advanced cancer patients hospitalized in a specialized palliative care unit.

PURPOSE: To describe the practice of palliative sedation (PS) in patients with advanced cancer in a specialized palliative care (PC) unit in Colombia. METHODS: Descriptive prospective study including all adults with cancer hospitalized under PS in a cancer institute between January and July 2015 in Colombia. Variables examined were diagnosis, physical functioning, symptoms at the start of sedation, medications and dosages used, and type, level, and time of sedation. Descriptive and correlational statistics were obtained. RESULTS: Sixty-six patients were included, 70% of which were women. The patients had an average age of 61 years (range 24-87), and 74% had a Karnofsky Index (KI) of 50% or less. The most frequent diagnosis was breast cancer (22%), and 82% had metastatic cancer. The prevalence of palliative sedation was 2% and the most common symptoms indicating it were dyspnea (59%), delirium (45%), and pain (32%). All patients received midazolam as a sedative. The average time between the interval start and culmination of sedation was 44 h. There was a significant and inverse relationship between functionality and time under sedation. CONCLUSIONS: Palliative sedation is a valid therapeutic option for refractory symptoms causing suffering. The results correspond to international reports and guidelines, which suggests that PS is tailored to the needs of the individual patient while maintaining a high scientific standard, even in a context where PC is under development. However, further development of strategies and clear indications towards the use of PS in Colombia are needed, given its still scarce use.

Relationship between response to induction chemotherapy and disease control in patients with advanced laryngeal carcinoma included in an organ preservation protocol.

The aim of the study is to analyze the relationship between the degree of response to induction chemotherapy and the disease control in patients with locally advanced laryngeal carcinomas candidates to total laryngectomy. This retrospective study includes 389 patients with T3-T4 laryngeal tumors candidates to total laryngectomy, diagnosed between 1985 and 2013, treated with induction chemotherapy in an organ preservation protocol. Five-year local recurrence-free survival for patients receiving conservative treatment with radiotherapy after a complete response to induction chemotherapy was 75.4%; for patients with partial response greater than 50%, it was 62.0%; and for patients with the absence of response, it was 32.7%. There were significant differences in local recurrence-free survival and laryngeal dysfunction-free survival according to the response to induction chemotherapy (P = 0.0001) at the expense of patients with absence of response to induction chemotherapy. Patients with partial response greater than 50% treated with radiotherapy had a tendency to have worse local recurrence-free survival and laryngeal dysfunction-free survival than patients with complete response, but the differences did not reach statistical significance. Patients with the absence of response after induction chemotherapy had significant differences in disease-specific survival according to the second treatment: for patients treated with surgery it was 70.2%, whereas for patients treated with radiotherapy, it was 28.2% (P = 0.0001). In patients with the absence of response to induction chemotherapy, conservative treatment with radiotherapy implies a significant decrease in survival.

Novel potential scaffold for periodontal tissue engineering.

OBJECTIVE: The objective of the study is characterization of novel calcium and zinc-loaded electrospun matrices to be used for periodontal regeneration. MATERIALS AND METHODS: A polymethylmetacrylate-based membrane was calcium or zinc loaded. Matrices were characterized morphologically by atomic force and scanning electron microscopy and mechanically probed by a nanoindenter. Biomimetic calcium phosphate precipitation on polymeric tissues was assessed. Cell viability tests were performed using oral mucosa fibroblasts. Data were analyzed by Kruskal-Wallis and Mann-Whitney tests or by ANOVA and Student-Newman-Keuls multiple comparisons. RESULTS: Zinc and calcium loading on matrices did not modify their morphology but increased nanomechanical properties and decreased nanoroughness. Precipitation of calcium and phosphate on the matrix surfaces was observed in zinc-loaded specimens. Matrices were found to be non-toxic to cells in all the assays. Calcium- and zinc-loaded scaffolds presented a very low cytotoxic effect. CONCLUSIONS: Zinc-loaded membranes permit cell viability and promoted mineral precipitation in physiological conditions. Based on the tested nanomechanical properties and scaffold architecture, the proposed membranes may be suitable for cell proliferation. CLINICAL RELEVANCE: The ability of zinc-loaded matrices to promote precipitation of calcium phosphate deposits, together with their observed non-toxicity and its surface chemistry allowing covalent binding of proteins, may offer new strategies for periodontal regeneration.

Envelope-based technique for liquid level sensors using an in-line fiber Mach-Zehnder interferometer.

This paper proposes a sensor interrogation technique based on the analysis of the overall spectrum envelope of an in-line Mach-Zehnder interferometer structure with three different fibers. The interference pattern created by a level sensor of 120 mm was evaluated with both the traditional and the proposed interrogation techniques. The result shows that the technique here proposed improves the sensitivity of the sensor by more than an order of magnitude. Moreover, our new interrogation technique allows the length of an in-line Mach-Zehnder interferometer to be extended up to 470 mm while maintaining high linearity and sensitivity.

Cell viability and proliferation capability of long-term human dental pulp stem cell cultures.

BACKGROUND AIMS: Evaluation of cell viability is one of the most important steps of the quality control process for therapeutic use of cells. The aim of this study was to evaluate the long-term cell viability profile of human dental pulp stem cell (hDPSC) subcultures (beyond 10 passages) to determine which of these passages are suitable for clinical use and to identify the cell death processes that may occur in the last passages. METHODS: Four different cell viability assays were combined to determine the average cell viability levels at each cell passage: trypan blue exclusion test, water-soluble tetrazolium 1 (WST-1), LIVE/DEAD Viability/Cytotoxicity Kit and electron probe x-ray microanalysis (EPXMA). Apoptosis was assessed by terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay and caspase 4 and BCL7C Western blotting, and cell proliferation was analyzed by WST-1 and proliferating cell nuclear antigen protein detection. RESULTS: hDPSCs showed high average cell viability levels from passages 11-14, with adequate cytoplasmic and mitochondrial functionality at these subcultures. A non-significant trend to decreased cell proliferation was found from passages 16-20. EPXMA and TUNEL analyses suggested that a pre-apoptotic process could be activated from passages 15-20 (P < 0.001), with a correlation with caspase 4 and BCL7C expression. CONCLUSIONS: hDPSCs corresponding to passages 11-14 show adequate cell function, proliferation and viability. These cells could be considered as potentially useful for clinical applications.

Autoimmune Liver Disease Associated Uveitis: An Extrahepatic Manifestation or a Polyautoimmunity Phenomenon? Case Reports.

PURPOSE: To report two cases of non-granulomatous unilateral anterior uveitis in two female patients associated with autoimmune liver diseases (ALD), emphasizing the possibility of this rare coexistence as a polyautoimmunity phenomenon. CASE DESCRIPTIONS: Case 1: An 18-year-old female with a history of congenital renal hypoplasia and metabolic syndrome presented with anterior uveitis in OS and a history of jaundice, blood elevated hepatic enzymes, and cholangioresonance compatible with primary sclerosing cholangitis (PSC). Laboratory work-up for additional autoimmune and infective causes were within normal limits. Case 2: An 58-year-old female presented an episode of anterior uveitis in OD and a history of Sjögren syndrome diagnosed at the age of 53, primary biliary cholangitis (PBC), systemic sclerosis, Raynaud's phenomenon, bilateral sacroiliitis, and vitiligo, consistent with polyautoimmunity and multiple autoimmune syndrome. CONCLUSIONS: Uveitis rarely coexists with ALD. However, it is essential to recognize the possibility of polyautoimmunity in patients presenting with ophthalmic manifestations and a previous diagnosis of ALD, such as PSC or PBC.

Exploration of photoprotective and antibiotic activity of wild Polypodiaceae ferns from Costa Rica.

Skin disorders affect millions of people all over the world. There are limited options to treat dermal illnesses such as vitiligo, psoriasis, and atopic dermatitis (eczema). Central American ferns are a potential source of bioactive metabolites against those diseases. Currently, Polypodium leucotomos Poir. is the only one being commercially utilized for this purpose. In this work, we evaluated the concentration of the skin bioactive compounds: quinic and chlorogenic acid, in the extract of 20 wild ferns from Costa Rica. We also evaluated the antimicrobial capabilities of the crude extracts of wild ferns and the sun protection factor (SPF) of the extracts. We found 19 out of 20 have either an important concentration of the compounds mentioned above or antimicrobial properties. Also, most samples result in higher SPF than P. aureum's rhizome. We also have studied the fern acclimatization, at different shading conditions, finding a significant influence of the culturing conditions on metabolite production. After acclimatization. So far, we demonstrate that various ferns included in this study are a potential source of treatments for skin conditions.

Colombian Ocular Diseases Epidemiology Study (CODES): Prevalence Incidence, and Sociodemographic Characterization of Vision Impairment (2015-2019), A Nationwide Study.

PURPOSE: To describe the prevalence, incidence, and sociodemographic characterization of moderate to severe vision impairment (MSVI) and blindness in Colombia based on the National Health Registry Integrated Social Protection Information System (SISPRO) Database. METHODS: We performed a nationwide population-based study using SISPRO and the International Classification of Diseases. Total and new cases were identified to calculate the prevalence and incidence per 100,000 inhabitants of MSVI and blindness between 2015 and 2019. Blindness was defined as a best-corrected visual acuity (BCVA) of less than 20/400 in the better-seeing eye. Meanwhile, MSVI is a BCVA from 20/70 to equal or better than 20/400 in the better-seeing eye. An ANOVA test was performed to identify age differences. A conditional autoregressive model was also employed to depict standardized morbidity rate maps. RESULTS: From the 50 million inhabitants, the average prevalence and incidence of MSVI were 13.94 and 13.34 between 2015 and 2019, respectively, while for blindness, they were 4.03 and 3.53. Females accounted for most reported cases, and there was a notable shift towards individuals over 50 years (p < 0.001). Valle del Cauca was the region with the most cases reported and the greatest disease burden. CONCLUSION: This is the first nationwide population-based study describing the prevalence, incidence, and sociodemographic characterization of blindness and MSVI in Colombia. In recent years, there has been an increased number of cases, prevalence, and incidence, with females over 50 particularly affected. This research provides insight into the country's vision impairment epidemiology landscape and contributes to formulating public health policies to improve eye health care.

Average cell viability levels of human dental pulp stem cells: an accurate combinatorial index for quality control in tissue engineering.

BACKGROUND AIMS: One of the most important issues in tissue engineering (TE) is the search for a suitable stem cell reservoir with optimal cell viability levels for the development of new tissues relevant for therapeutic needs. The aim of this study was to evaluate the cell viability levels of 10 sequential cell passages of human dental pulp stem cells (hDPSC) to determine their potential for TE techniques. METHODS: To assess the average cell viability levels of hDPSC, four cell viability assays were used in a combinatorial approach: trypan blue exclusion test, water-soluble tetrazolium 1 assay, live/dead assay and electron probe x-ray microanalysis. RESULTS: The results showed that cell viability as determined by trypan blue staining and live/dead assays was greater than 85%, with a significant decrease at the second passage (P < 0.05) and a significant increase at the ninth passage (P < 0.05). Electron probe x-ray microanalysis showed that the highest cell viability corresponded to the ninth passage, with the lowest K/Na values found at the third passage. No statistical differences were found among the different passages for the water-soluble tetrazolium 1 assay (P = 0.219). CONCLUSIONS: Assessment of average cell viability levels showed that the highest viability of hDPSC was reached after nine passages, suggesting that this passage would be the most adequate for use in TE protocols.

Urgent Revascularization of the Left Proximal Circumflex Following Cessation of Cangrelor Within Six Hours of Procedure.

Patients undergoing procedures are often transitioned off anticoagulants using anti-platelet agents with short half-lives as a "bridge." We present the case of a patient with a history of in-stent thromboses who experienced a thrombotic event following a literature-guided bridging protocol. This case is one of the first to show that stopping cangrelor within six hours led to a need for urgent revascularization and suggests that the timing for discontinuing bridging agents should be customized based on the patient's history of increased blood clotting.

Is long-term screening for lung cancer justified in patients with head and neck carcinoma?

OBJECTIVE: Patients with head and neck squamous cell carcinoma (HNSCC) have a higher risk of second lung neoplasms than the general population. The aim of the present study is to evaluate the long-term incidence of second lung malignancies after the diagnosis of a HNSCC and to consider the convenience of the screening for lung cancer in these patients. MATERIAL AND METHODS: We conducted a retrospective study performed on 4954 patients with an index tumor located in the oral cavity, oropharynx, hypopharynx, or larynx during the period 1985-2017. RESULTS: During the follow-up period 469 patients (9.5%) presented a second pulmonary neoplasm. The incidence of second lung neoplasm was 1.26% per year and remained practically constant throughout the 25-year follow-up period analyzed. According to the results of a multivariate study, male patients, aged between 50 and 80 years, with a history of tobacco use, and with tumors located in the oropharynx or the supraglottis were those with the highest risk of second lung neoplasms. CONCLUSION: Patients with a HNSCC index tumor have a high risk of second neoplasms located in the lung. In order to achieve an early diagnosis of these second neoplasms, it would be advisable to establish screening protocols based on the use of low-dose lung CT, which should be maintained indefinitely during the follow-up period.

Resilience mediates the effect of the COVID-19 pandemic on mental health in a sample of adults in Panama.

Background: The COVID-19 pandemic was characterized by global increases in depression, anxiety, and stress symptoms. Previous studies have shown that resilience mitigates these symptoms, however there is limited research exploring the link between resilience and mental illness during the COVID-19 pandemic in Central America. Objective: To examine the role of resilience as it relates to the perceived effect of the pandemic on mental health symptoms. Methods: A sample of 480 adults in Panama were recruited from March to May 2021 to complete an online survey. The online survey consisted of sociodemographic questions and scale measures assessing depression, anxiety and stress symptoms, resilience, and social support. Results: Results indicated that resilience mediated the relationship between the perceived effect of the COVID-19 pandemic and mental health symptoms; participants who felt more personally affected by the pandemic reported more depression, anxiety, and stress symptoms via decreased resilience. Further analyses revealed that resilience was moderated by sex and social support, showing that the indirect effect of resilience was greater for women and individuals who perceived low social support. Discussion: These findings contribute to a growing body of research documenting the adverse effects of the COVID-19 pandemic on mental health and reveal potential mechanisms through which pandemic-related distress decreases resilience, thereby increasing symptoms of mental illness.

Dermoscopy of very small basal cell carcinoma (≤3mm).

BACKGROUND: Basal cell carcinoma (BCC) dermoscopy is key to lower the biopsy threshold of suspicious lesions. There is a scarcity of published data on the dermoscopy of very small BCC (≤3mm) and its differences from larger BCCs. OBJECTIVE: To describe and compare dermoscopic features of BCCs measuring ≤3mm, with those from 3 to 10mm. METHODS: An analytical cross-sectional study, included biopsy-proven BCCs that had dermoscopic photographic images, between January 2017 and December 2022 in a Skin Cancer Center in Medellín, Colombia. Demographic, clinic-pathological and dermoscopic features were compared between very small BCCs (vsBCCs) and a reference group. RESULTS: A total of 326 BCCs in 196 patients were included, of whom 60% were male. The most common Fitzpatrick phototype was III. vsBCCs accounted for 25% of the lesions (81/326). Face and neck were the most frequent locations (53%), especially in very small tumors. The nodular type was more common in very small tumors than in larger lesions, the superficial type was less frequent, and aggressive types were equally prevalent in both groups. On dermoscopy, very small tumors were statistically more likely to present pigmented structures than reference lesions, especially blue-gray dots (67% vs. 54%), vessels were less frequent, particularly short-fine telangiectasias (SFT) (52% vs. 66%), as were other structures such as shiny white structures (SWS), ulceration, micro-erosions, and scales. STUDY LIMITATIONS: Latin-American sample, lacks information on dark phototypes CONCLUSIONS: Pigmented structures, especially blue-gray dots, were most common in vsBCCs when compared to larger lesions; SFT, SWS and other findings were less prevalent.

Safety and immunogenicity of SCB-2019, an adjuvanted, recombinant SARS-CoV-2 trimeric S-protein subunit COVID-19 vaccine in healthy 12-17 year-old adolescents.

We previously demonstrated the efficacy of the COVID-19 vaccine candidate, SCB-2019, in adults in the SPECTRA phase 2/3 efficacy study. We extended the study to include 1278 healthy 12-17-year-old adolescents in Belgium, Colombia, and the Philippines who received either two doses of SCB-2019 or placebo 21 days apart, to assess immunogenicity as neutralizing antibodies against prototype SARS-CoV-2 and variants of concern, and safety and reactogenicity as solicited and unsolicited adverse events with a comparator group of young adults (18-25 years). In participants with no evidence of prior SARS-CoV-2 infection SCB-2019 immunogenicity in adolescents was non-inferior to that in young adults; respective geometric mean neutralizing titers (GMT) against prototype SARS-CoV-2 14 days after the second vaccination were 271 IU/mL (95% CI: 211-348) and 144 IU/mL (116-178). Most adolescents (1077, 84.3%) had serologic evidence of prior SAR-CoV-2 exposure at baseline; in these seropositive adolescents neutralizing GMTs increased from 173 IU/mL (135-122) to 982 IU/mL (881-1094) after the second dose. Neutralizing titers against Delta and Omicron BA SARS-CoV-2 variants were also increased, most notably in those with prior exposure. SCB-2019 vaccine was well tolerated with generally mild or moderate, transient solicited and unsolicited adverse events that were comparable in adolescent vaccine and placebo groups except for injection site pain - reported after 20% of SCB-2019 and 7.3% of placebo injections. SCB-2019 vaccine was highly immunogenic against SARS-CoV-2 prototype and variants in adolescents, especially in those with evidence of prior exposure, with comparable immunogenicity to young adults. Clinical trial registration: EudraCT 2020-004272-17; ClinicalTrials.gov NCT04672395.