HIV prevalence among individuals having had serology performed in eight Spanish cities following heterosexual exposure, 1992-2003

BACKGROUND: The human immunodeficiency virus (HIV) epidemic in Spain was characterized throughout the first few years by the predominance of infections among injected drug users (IDU's), but everything currently points to a progressive predominance of sexual transmission. This study is aimed at describing the trend in HIV infection among several heterosexual populations groups and at characterizing the situations in which the infections occurred. METHODS: Descriptive study of the individualls who had the test conducted for the first time at nine HIV diagnosis centres within the 1992-2003 period due to high-risk heterosexual exposures, not including injected drug users. RESULTS: A total of 47,870 individuals had serology performed during the period under study. The HIV prevalence among the population under study dropped from 3.2% to 1.0% (p< 0.001). Among the individuals with an HIV infected partners, the prevalence remained at around 10%, the male users of prostitution having dropped from 1.9% to 1.0% (p=0.049); among women involved in prostitution, from 1.4% to 0.7% (p=0.008); and among all other heterosexuals, having dropped from 1.6% to 1.0% among males (p=0.014) and from 1.1% to 0.7% among women (p=0.012). CONCLUSIONS: The results indicate advances in the control of heterosexual human immunodeficiency virus transmission, mainly among women, although it is necessary to still continue stressing prevention. Fundamento:La epidemia de infecciones por el virus de lainmunodeficiencia humana (VIH) en España se caracterizó durantelos primeros años por el predominio de casos en personas usuarias dedrogas inyectadas, pero en la actualidad todo parece apuntar a unprogresivo predominio de la transmisión sexual. El objetivo de estetrabajo es describir la evolución en la prevalencia de VIH en variosgrupos de población heterosexual y caracterizar las situaciones en lasque se produjeron las infecciones.Métodos:Estudio descriptivo de las personas que se realizaronla prueba por primera vez en nueve centros de diagnóstico de VIHentre 1992 y 2003 por exposiciones heterosexuales de riesgo, exclu-yéndose a los usuarios de drogas inyectadas.Resultados:El número de personas en las que se determinó laserología fue de 47.870. La prevalencia de VIH en la población estu-diada descendió del 3,2% al 1,0% (p<0,001). En las personas conpareja con diagnóstico de infección por VIH la prevalencia se man-tuvo en torno al 10%, en hombres usuarios de prostitución descendiódel 1,9% al 1,0% (p=0,049), en las mujeres que ejercen la prostitu-ción del 1,4% al 0,7% (p=0,008), y en el resto de heterosexuales dis-minuyó del 1,6% al 1,0% en hombres (p=0,014) y del 1,1% al 0,7%en mujeres (p=0,012).Conclusiones: Los resultados indican avances en el control de latransmisión heterosexual del VIH, principalmente en mujeres, aun-que todavía se requiere insistir en la prevención

Sentinel surveillance of HIV infection in HIV test clinics, Spain 1992-2002

HIV infection in Spain was monitored in persons undergoing voluntary HIV testing in ten sentinel clinics between 1992 and 2002. Only patients on their first visit were considered for inclusion, and their numbers rose from 4426 in 1992 to 6649 in 2002. Most of them recognised their risk exposure as heterosexual. The proportion of injecting drug users decreased from 19% to 2% of the study population, and the proportion of female sex workers increased from 6% to 26%. The number of patients diagnosed with HIV infection declined from 604 in 1992 to 153 in 2002, and HIV prevalence fell from 13.6% to 2.3% in the same period. In all risk exposure categories, a decrease in HIV prevalence was observed, more pronounced during the first few years and stabilised in the later years. In 2002, the highest HIV prevalence was found in injecting drug users (IDUs) (14.2%), homo/bisexual men (7.5%) and individuals who had an HIV infected heterosexual partner (10.2%).This work was partly funded by FIPSE (Foundation formed by the Spanish Ministry of Health and Consumer Affairs, Abbott Laboratories, Boehringer Ingelheim, Bristol Myers Squibb, GlaxoSmithKline, Merck Sharp and Dohme, and Roche, exp. 3076/99 and 36303/02) and by the Spanish Red de Investigación en Sida - RIS (Network for Research on AIDS) and the Spanish Red de Centros de Investigación Cooperativa en Epidemiología y Salud Pública - RCESP (Network for cooperative research in Epidemiology and Public Health)

Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial

Background: Additional safe and efficacious vaccines are needed to control the COVID-19 pandemic. We aimed to analyse the efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate. Methods: HERALD is a randomised, observer-blinded, placebo-controlled, phase 2b/3 clinical trial conducted in 47 centres in ten countries in Europe and Latin America. By use of an interactive web response system and stratification by country and age group (18–60 years and ≥61 years), adults with no history of virologically confirmed COVID-19 were randomly assigned (1:1) to receive intramuscularly either two 0·6 mL doses of CVnCoV containing 12 μg of mRNA or two 0·6 mL doses of 0·9% NaCl (placebo) on days 1 and 29. The primary efficacy endpoint was the occurrence of a first episode of virologically confirmed symptomatic COVID-19 of any severity and caused by any strain from 15 days after the second dose. For the primary endpoint, the trial was considered successful if the lower limit of the CI was greater than 30%. Key secondary endpoints were the occurrence of a first episode of virologically confirmed moderate-to-severe COVID-19, severe COVID-19, and COVID-19 of any severity by age group. Primary safety outcomes were solicited local and systemic adverse events within 7 days after each dose and unsolicited adverse events within 28 days after each dose in phase 2b participants, and serious adverse events and adverse events of special interest up to 1 year after the second dose in phase 2b and phase 3 participants. Here, we report data up to June 18, 2021. The study is registered at ClinicalTrials.gov, NCT04652102, and EudraCT, 2020–003998–22, and is ongoing. Findings: Between Dec 11, 2020, and April 12, 2021, 39 680 participants were enrolled and randomly assigned to receive either CVnCoV (n=19 846) or placebo (n=19 834), of whom 19 783 received at least one dose of CVnCoV and 19 746 received at least one dose of placebo. After a mean observation period of 48·2 days (SE 0·2), 83 cases of COVID-19 occurred in the CVnCoV group (n=12 851) in 1735·29 person-years and 145 cases occurred in the placebo group (n=12 211) in 1569·87 person-years, resulting in an overall vaccine efficacy against symptomatic COVID-19 of 48·2% (95·826% CI 31·0–61·4; p=0·016). Vaccine efficacy against moderate-to-severe COVID-19 was 70·7% (95% CI 42·5–86·1; CVnCoV 12 cases in 1735·29 person-years, placebo 37 cases in 1569·87 person-years). In participants aged 18–60 years, vaccine efficacy against symptomatic disease was 52·5% (95% CI 36·2–64·8; CVnCoV 71 cases in 1591·47 person-years, placebo, 136 cases in 1449·23 person-years). Too few cases occurred in participants aged 61 years or older (CVnCoV 12, placebo nine) to allow meaningful assessment of vaccine efficacy. Solicited adverse events, which were mostly systemic, were more common in CVnCoV recipients (1933 [96·5%] of 2003) than in placebo recipients (1344 [67·9%] of 1978), with 542 (27·1%) CVnCoV recipients and 61 (3·1%) placebo recipients reporting grade 3 solicited adverse events. The most frequently reported local reaction after any dose in the CVnCoV group was injection-site pain (1678 [83·6%] of 2007), with 22 grade 3 reactions, and the most frequently reported systematic reactions were fatigue (1603 [80·0%] of 2003) and headache (1541 [76·9%] of 2003). 82 (0·4%) of 19 783 CVnCoV recipients reported 100 serious adverse events and 66 (0·3%) of 19 746 placebo recipients reported 76 serious adverse events. Eight serious adverse events in five CVnCoV recipients and two serious adverse events in two placebo recipients were considered vaccination-related. None of the fatal serious adverse events reported (eight in the CVnCoV group and six in the placebo group) were considered to be related to study vaccination. Adverse events of special interest were reported for 38 (0·2%) participants in the CVnCoV group and 31 (0·2%) participants in the placebo group. These events were considered to be related to the trial vaccine for 14 (<0·1%) participants in the CVnCoV group and for five (<0·1%) participants in the placebo group. Interpretation: CVnCoV was efficacious in the prevention of COVID-19 of any severity and had an acceptable safety profile. Taking into account the changing environment, including the emergence of SARS-CoV-2 variants, and timelines for further development, the decision has been made to cease activities on the CVnCoV candidate and to focus efforts on the development of next-generation vaccine candidates. Funding: German Federal Ministry of Education and Research and CureVac