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Background: Dengue is hyperendemic in Colombia. It imposes a substantial economic burden on patients, caregivers, society, and the national health system. We intend to identify and synthesize the evidence regarding the economic burden of dengue in Colombia., Methods: A systematic review (PROSPERO CRD42021257985) of economic studies was performed. A comprehensive search was completed in PubMed, EMBASE, the Cochrane Library, the LILACS, and SciELO databases. Study selection and data extraction was made by two researchers., Results: 160 records were identified. Of these, 14 studies were selected for data extraction. Direct medical cost of dengue is mainly represented by hospitalization (USD 823 to 1,754). The annual aggregated cost is near to USD 159.6 million, with ambulatory care (USD 90.1 million) and fatal cases (USD 30.7 million) representing 75% of the total cost. The aggregate indirect cost (due to loss in income while sick or as a caretaker) was USD 92.8 million. Vaccination seems to reduce the economic cost of dengue., Conclusions: Dengue financial burden could be challenging for low-income communities as those affected in Colombia. An integrated approach including vector control and the introduction of a vaccine for dengue has the potential to reduce the economic burden of the disease., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Ivan Arboleda is an employee of Baxalta (Takeda) Colombia SAS, Riona Hanley, Randee Kastner, are employees of Takeda Pharmaceuticals. Elaine Gallagher and Marcela Fuquen were employees of Takeda Pharmaceuticals and Baxalta (Takeda) Colombia respectively at the time this systematic literature review was conducted., (Copyright: © 2024 Rodríguez-Morales et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Dengue cases rose to record levels during 2023-2024. We investigated dengue in Valle del Cauca, Colombia, to determine if specific virus serotypes or lineages caused its large outbreak. We detected all 4 serotypes and multiple lineages, suggesting that factors such as climatic conditions were likely responsible for increased dengue in Colombia.

Dengue is the most important viral vector-borne disease in the tropics, with Colombia being one of the most affected countries. In this context, it is essential to identify and synthesize the existing evidence on the epidemiology of dengue in Colombia. A systematic review (PROSPERO CRD42021257985) was conducted by searching for epidemiological data in populations with suspected or confirmed dengue in Colombia from 2012 to 2020. We searched PubMed, EMBASE, the Cochrane Library, the LILACS, and SciELO databases, and 104 publications out of 1,234 records were selected. The dengue annual incidence rate varied through the years without a clear trend. The lowest annual incidence rate was observed in 2017 (90.7 per 100,000 population) and the highest in 2013 (476.2 per 100,000 population). The proportion of severe cases in the same period ranged between 0.89% in 2016 and 2.7% in 2012. The four dengue virus (DENV) serotypes co-circulated in the country, and DENV-2 was the predominant serotype. Fifty percent of dengue cases occurred in people under 20 years, and those between 5 and 14 years had the highest incidence rate. The mortality rate for all dengue cases ranged from 0.07% in 2020 to 0.16% in 2012 and 2015. In conclusion, dengue is a hyperendemic disease in Colombia with the circulation of four serotypes. New strategies must be implemented to prevent the contagion and impact of the disease on the population at risk.

Background: Venereal syphilis, caused by the spirochete Treponema pallidum subsp. pallidum (TPA), is surging worldwide, underscoring the need for a vaccine with global efficacy. Vaccine development requires an understanding of syphilis epidemiology and clinical presentation as well as genomic characterization of TPA strains circulating within at-risk populations. The aim of this study was to describe the clinical, demographic, and molecular features of early syphilis cases in Cali, Colombia., Methods and Findings: We conducted a cross-sectional study to identify individuals with early syphilis (ES) in Cali, Colombia through a city-wide network of public health centers, private sector HIV clinics and laboratory databases from public health institutions. Whole blood (WB), skin biopsies (SB), and genital and oral lesion swabs were obtained for measurement of treponemal burdens by polA quantitative polymerase chain reaction (qPCR) and for whole-genome sequencing (WGS). Among 1,966 individuals screened, 128 participants met enrollment criteria: 112 (87%) with secondary (SS), 15 (12%) with primary (PS) and one with early latent syphilis; 66/128 (52%) self-reported as heterosexual, while 48 (38%) were men who have sex with men (MSM). Genital ulcer swabs had the highest polA copy numbers (67 copies/μl) by qPCR with a positivity rate (PR) of 73%, while SS lesions had 42 polA copies/μl with PR of 62%. WB polA positivity was more frequent in SS than PS (42% vs 7%, respectively; p = 0.009). Isolation of TPA from WB by rabbit infectivity testing (RIT) was achieved in 5 (56%) of 9 ES WB samples tested. WGS from 33 Cali patient samples, along with 10 other genomic sequences from South America (9 from Peru, 1 from Argentina) used as comparators, confirmed that SS14 was the predominant clade, and that half of all samples had mutations associated with macrolide (i.e., azithromycin) resistance. Variability in the outer membrane protein (OMP) and vaccine candidate BamA (TP0326) was mapped onto the protein's predicted structure from AlphaFold. Despite the presence of mutations in several extracellular loops (ECLs), ECL4, an immunodominant loop and proven opsonic target, was highly conserved in this group of Colombian and South American TPA isolates., Conclusions: This study offers new insights into the sociodemographic and clinical features of venereal syphilis in a highly endemic area of Colombia and illustrates how genomic sequencing of regionally prevalent TPA strains can inform vaccine development., Competing Interests: Outside the submitted work, ACS reports royalties from UptoDate Inc, ELM reports research grants from Sanofi Pasteur, Janssen, Moderna and GSK, grants and consulting fees from Takeda and MSD, and honoraria from Pfizer, JAGL reports support for attending meetings/travel from Janssen, MAM reports membership in an advisory board for GSK, JDR receives royalties from Biokit SA, Chembio, and Span Diagnostics for syphilis serodiagnostic reagents outside the scope of the current work, JBP reports research support from Gilead Sciences, non-financial support from Abbott Diagnostics, and consulting for Zymeron Corporation. All other authors report no competing interests. The commercial funders indicated above provided support in the form of royalties for stated authors but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript., (Copyright: © 2024 Salazar et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

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., Competing Interests: Declaration of interests IS, HHH, PLi, RH, CB, BH, and JL are full-time employees of Clover Biopharmaceuticals. FR is a statistical adviser for Clover Biopharmaceuticals. RC, DA, PR, and GS are scientific advisers for Clover Biopharmaceuticals. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Colombia's climatological variety, added to pathogen diversity, creates local niches for infectious diseases. In Bogotá, respiratory syncytial virus causes 30%-52% of the cases of respiratory infections. In coastal or inter-Andean cities with higher temperature and longer dry seasons, frequency of this virus is 7%-13%. By 2017, increased hospitalizations due to airway infections occurred in regions whose weather is differently influenced by "El Niño Southern Oscillation" than in Bogotá, although microbial diversity might have also been involved., Methods: For Cali, an inter-Andean city with warm tropical weather, records of respiratory syncytial virus from 2014 to 2018, in children two years old or younger, were analyzed, and genotypes transmitted during 2016-2017 were identified based on partial sequences of glycoprotein G., Results: Most cases of respiratory syncytial virus in Cali occur in the first semesters, with peaks expressed around March-April, without a clear association with pluviosity. Unlike the biannual rotating pattern of Bogotá, co-circulation of types A and B was detected. As years pass, transmission seasons are becoming longer and frequencies of the virus augment. The viral genotypes identified follow international trends with dominance of Ontario and Buenos Aires clades. Similar to other isolates in these clades, viruses from Cali exhibit glycosylation variability that may account for their fitness., Conclusions: The pattern of respiratory syncytial virus transmission in Cali differs from that in Bogotá. Its epidemiology is shifting and will remain so with the advent of novel respiratory diseases. This may impact the introduction of vaccination schemes for these or other respiratory viruses., (© 2021 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.)

Late gestational exposure to Zika increases the odds of delay in the Bayley-II mental developmental index (MDI) in children with normal baseline neurologic assessments; 9-fold when comparing third and first trimester exposure. Risk of MDI developmental delay increases by 8% for each week of gestational age at time of exposure., (© The Author(s) 2020. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: There is a relative lack of information about infections occurring in children following allogeneic hematopoietic stem cell transplants (allo-HSCT) in developing countries. Herein, we describe the incidence rates of different infections according to the transplant period and baseline condition in Colombia., Methods: In a retrospective cohort study of all children who underwent allo-HSCTs from 2012 to 2017 in a hospital in Cali, Colombia, we reviewed medical records from the first post-transplant day until day + 365 to describe microbiologically confirmed incidence rates of infections and deaths during three post-transplant periods and according to baseline condition., Results: Most allo-HSCT (n = 144, 96%) were followed by infections over the following year, mostly due to bacteria and cytomegalovirus (4.3 and 3.3 per 1000 patient-days, respectively). Children were at the highest risk for infection in the first 30 days post-HSTC, but mortality was highest after 100 days. Overall, high mortality (n = 44, 31.7%) was associated with infections, especially from extensively drug-resistant bacteria, adenovirus, and aspergillosis. Infection rates were similar independent of the baseline condition., Conclusion: Almost all children in this cohort developed infections post allo-HSCT. Describing the distribution of infections throughout the first post allo-HSCT year allows clinicians to narrow the differential diagnosis of infections according to the post-transplant period. This is especially useful when prioritizing interventions in children receiving HSCT in stringent healthcare systems in developing countries., (© 2020 Wiley Periodicals LLC.)

Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has rapidly spread throughout Latin America, a region swept by multiple previous and ongoing epidemics. There are significant concerns that the arrival of COVID-19 is currently overlapping with other viruses, particularly dengue, in various endo-epidemic regions across South America. In this report, we analyzed trends for both viral infections in Colombia during the first 20 epidemiological weeks (EWs) of 2020. From 1st January to 16th May 2020 (EWs, 1-20), a total of 52 679 cases of dengue and 14 943 cases of COVID-19 have been confirmed in Colombia. As both conditions may potentially lead to fatal outcomes, especially in patients with chronic co-morbidities, overlapping infections, and co-occurrence may increase the number of patients requiring intensive care and mechanical ventilation. In regions, such as Valle del Cauca, intensified preparation for such scenarios should be pondered, and further studies should be performed to address this critical issue in a timely matter., (© 2020 Wiley Periodicals LLC.)

Background: A substantial unmet need remains for safe and effective vaccines against dengue virus disease, particularly for individuals who are dengue-naive and those younger than 9 years. We aimed to assess the efficacy, safety, and immunogenicity of a live attenuated tetravalent dengue vaccine (TAK-003) in healthy children aged 4-16 years., Methods: We present data up to 18 months post-vaccination from an ongoing phase 3, randomised, double-blind trial of TAK-003 in endemic regions of Asia and Latin America (26 medical and research centres across Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, and Thailand). Healthy children aged 4-16 years were randomly assigned 2:1 (stratified by age and region) to receive two doses of TAK-003 or two doses of placebo, 3 months apart. Investigators, participants and their parents or guardians, and sponsor representatives advising on trial conduct were masked to trial group assignments. Participants presenting with febrile illness were tested for virologically confirmed dengue (VCD) by serotype-specific RT-PCR. In timeframes beginning 30 days post-second dose, the primary endpoint (overall vaccine efficacy) was assessed in the first 11 months, and the secondary endpoints (efficacy by baseline serostatus, serotype, hospitalised dengue, and severe dengue) in the first 17 months. This study is registered with ClinicalTrials.gov, NCT02747927., Findings: 20 099 participants were randomly assigned and vaccinated between Sept 7, 2016, and Aug 18, 2017; 19 021 (94·6%) were included in the per protocol analysis, and 20 071 (99·9%) in the safety set. The primary endpoint was achieved with an overall vaccine efficacy of 80·2% (95% CI 73·3 to 85·3; 61 cases of VCD in the TAK-003 group vs 149 cases of VCD in the placebo group). In the secondary endpoint assessment timeframe, an overall vaccine efficacy of 73·3% (95% CI 66·5 to 78·8) was observed. Analysis of secondary endpoints showed efficacies of 76·1% (95% CI 68·5 to 81·9) in individuals who were seropositive at baseline, 66·2% (49·1 to 77·5) in individuals who were seronegative at baseline, 90·4% (82·6 to 94·7) against hospitalised dengue, and 85·9% (31·9 to 97·1) against dengue haemorrhagic fever. Efficacy varied by individual serotypes (DENV 1, 69·8% [95% CI 54·8 to 79·9]; DENV 2, 95·1% [89·9 to 97·6]; DENV 3, 48·9% [27·2 to 64·1]; DENV 4, 51·0% [-69·4 to 85·8]). Cumulative rates of serious adverse events were similar in TAK-003 (4·0%) and placebo (4·8%) recipients, and were consistent with expected medical disorders in the study population. Infection was the most frequent reason leading to serious adverse events. 20 participants (<0·1% of the safety set) were withdrawn from the trial due to 21 adverse events by the end of part two; 14 of these participants received TAK-003 and six received placebo., Interpretation: TAK-003 was well tolerated and efficacious against symptomatic dengue in children regardless of serostatus before immunisation. Vaccine efficacy varied by serotype, warranting continued follow-up to assess longer-term vaccine performance., Funding: Takeda Vaccines., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: Despite increasing information in the literature regarding congenital Zika infection, gaps remain in our knowledge of its clinical manifestations., Methods: We did a prospective observational study of exposed fetuses and infants whose mothers developed symptomatic and confirmed Zika infection during pregnancy in Valle del Cauca, Colombia. We performed neurological, ophthalmologic and audiologic evaluations, and classified outcomes as possibly or uncertainly related to Zika. Frequencies of outcomes were compared according to the trimester of pregnancy when infection occurred., Results: We evaluated 171 products of gestation including 17 pregnancy losses and 154 patients evaluated postnatally. Ninety (52.6%) pregnancies presented an adverse outcome, 36% possibly related with Zika and the remaining 64% of uncertain relation. Infection in the first trimester had the highest frequencies of adverse outcomes possibly related with Zika compared with the second and third trimesters (39% vs. 12.5% vs. 12%) with risk ratios of adverse outcomes possibly related to Zika in pregnancies infected in the first versus second or third trimester of 3.1 (95% CI: 2.4-4.1) and 3.3 (95% CI: 2.5-4.2), respectively. The frequencies of pregnancy loss and microcephaly were 9.4% and 4.5%, respectively. Auditory and ophthalmic abnormalities possibly related with Zika were present in 3% and 6% of the patients evaluated, respectively., Conclusions: We observed a high frequency of gestational and neonatal complications in pregnant women who acquired Zika infection, especially in early pregnancy, resulting in a broad spectrum of clinical manifestations. Preventive measures are urgently needed to reduce the clinical burden during future Zika outbreaks.

As infants suffer significant morbidity and mortality due to norovirus-related acute gastroenteritis (AGE), we assessed four formulations of the bivalent virus-like particle (VLP) vaccine candidate (HIL-214) in Panamanian and Colombian infants. 360 infants aged 6 weeks to 5 months were randomly allocated to 8 groups to receive three doses of HIL-214 or two doses of HIL-214 and one dose of placebo (Days 1, 56 and 112), where HIL-214 doses contained 15/15, 15/50, 50/50 or 50/150 μg of GI.1/GII.4c genotype VLPs and 0.5 mg Al(OH) 3 . Solicited injection-site and systemic adverse events (AE) were collected within 7 days after each dose, unsolicited AEs were collected within 28 days after each, and serious AEs throughout the study. Pan-Ig and histoblood group antigen-blocking antibodies (HBGA) were measured on Days 1, 56, 84, and 140. All formulations were well-tolerated causing mainly mild-to-moderate transient solicited AEs, most frequently local pain and irritability/fussiness, but no vaccine-related serious AEs. Two doses of each formulation induced high titers of high avidity Pan-Ig and also HBGA antibodies; a third dose increased titers against both antigens and the avidity of Pan-Ig antibodies against GII.4c but not against GI.1. Two and three doses of HIL-214 were well-tolerated and induced potent immune responses at 4-6 months of age supporting further clinical assessment to protect against norovirus-related AGE.