We previously reported the safety and immunogenicity data from a randomized trial comparing the booster responses of vaccinees who received monovalent (MV) recombinant protein Beta-variant (MVB.1.351) and MV ancestral protein (MVD614) vaccines with AS03 adjuvant (Sanofi/GSK) to booster response of vaccinees who received mRNA MV ancestral strain BNT162b2 vaccine (Pfizer-BioNTech). First booster of the vaccines was administered in adult participants previously primed with 2 doses of MV ancestral strain BNT162b2. A subset of these participants with available blood samples collected at Day 0 (D0), at 28 days (D28), and 3 months (M3) post-booster were contacted for additional testing (195/208 participants). The persistence of cross-neutralizing antibodies, including against Omicron BA.1 and BA.4/5, up to 3 months after boosting was evaluated using a validated pseudovirus neutralization assay. Across the whole population, MVB.1.351 vaccine induces highest NAbs titers against Omicron BA.1 and BA.4/5 variants at D28 and M3 post-booster. In participants with SARS-CoV-2 infection between D28 and M3, both MVB.1.351 and BNT162b2 vaccine groups show an increase in GMTs against Omicron BA.1 and Omicron BA.4/5 following infection. Among uninfected participants, the ratio of M3 to D28 GMTs was higher for the MVB.1.351 group than the BNT162b2 group against Omicron BA.1 (0.64 [0.53;0.77] versus 0.43 [0.35;0.53]), Omicron BA.4/5 (0.61 [0.50; 0.75] versus 0.44 [0.34; 0.56]), and D614 (0.68 [0.58,0.81] versus 0.46 [0.39,0.55]). The MVB.1.351 vaccine induces higher and durable cross-neutralizing antibodies against Omicron subvariants up to 3 months after boosting compared to an MV ancestral and mRNA BNT162b2 booster vaccine. The SARS-CoV-2 virus has changed over time, resulting in new virus variants. It is important to understand how booster vaccines work against different virus variants and how long protection may last. We compared the impact of different COVID-19 vaccines on the immune response of people who had previously received an original licensed mRNA vaccine and then received a third dose (first booster) with either the same type of mRNA-based vaccine or with one of two protein-based vaccines. None of these vaccines contained the omicron variant. We saw differences in response depending on the different combinations of vaccine used. Our results suggest booster vaccination using different types of vaccines could enable people to have better protection against SARS-CoV-2 infection. This should be considered when considering which COVID-19 vaccines to use during booster vaccination programs. Launay et al compare the persistence of cross-neutralizing antibodies up to 3 months post-booster. The monovalent (MV) recombinant protein Beta-variant (MVB.1.351) vaccine induces higher and durable cross-neutralizing antibodies against Omicron subvariants compared to MV ancestral protein (MVD614) and mRNA MV ancestral strain BNT162b2 vaccines.
BACKGROUND:This study aimed to compare the humoral responses to mRNA COVID-19 vaccination in people living with HIV (PWH) and HIV-negative individuals. METHODS:We included PWH with an undetectable viral load under ART and HIV-negative participants from the French nationwide ANRS COV-POPART cohort who had received two doses of vaccine as a primary vaccination. We compared humoral response between controls and PWH, stratified by CD4 cell count (<200/mm3 and ≥200/mm3 CD4 cell counts) at 1, 6, and 12 months after primary vaccination. RESULTS:A total of 1776 participants were included in this analysis, 684 PWH (99% were on ART, median CD4 counts 673 cells/mm3) and 1092 controls. At 1 month, after adjustment on age, sex, and BMI, PWH had lower seroneutralization titers than controls, and PWH with <200 CD4 cell/mm3 had lower anti-Spike SARS-CoV-2 IgG antibodies. Same results were found at 6 months. However, in participants who received a booster dose between 6 and 12 months postprimary vaccination, we did not observe differences between PWH and controls at 12 months. CONCLUSION:PWH had high responses to primary mRNA COVID-19 vaccination. In those who received a booster dose after 6 months, the humoral response at 12 months increased to similar levels to controls, even in those with low CD4 counts at baseline.
Qualitative SARS-CoV-2 antigen assays based on immunochromatography are useful for mass diagnosis of COVID-19, even though their sensitivity is poor in comparison with RT-PCR assays. In addition, quantitative assays could improve antigenic test performance and allow testing with different specimens. Using quantitative assays, we tested 26 patients for viral RNA and N-antigen in respiratory samples, plasma and urine. This allowed us to compare the kinetics between the three compartments and to compare RNA and antigen concentrations in each. Our results showed the presence of N-antigen in respiratory (15/15, 100%), plasma (26/59, 44%) and urine (14/54, 28.9%) samples, whereas RNA was only detected in respiratory (15/15, 100%) and plasma (12/60, 20%) samples. We detected N-antigen in urine and plasma samples until the day 9 and day 13 post-inclusion, respectively. The antigen concentration was found to correlate with RNA levels in respiratory (p < 0.001) and plasma samples (p < 0.001). Finally, urinary antigen levels correlated with plasma levels (p < 0.001). Urine N-antigen detection could be part of the strategy for the late diagnosis and prognostic evaluation of COVID-19, given the ease and painlessness of sampling and the duration of antigen excretion in this biological compartment.
Les réponses immunitaires humorales 12 mois après la primovaccination Covid-19 par des vaccins à ARNm chez des personnes vivant avec le VIH (PVVIH) ont été comparées à celles obtenues chez des participants contrôles. Les réponses des PVVIH et les contrôles séronégatifs inclus dans la cohorte prospective multicentrique ANRS0001S COV-POPART ont été analysées. Le pourcentage (IC 95%) de répondeurs (anticorps IgG anti-Spike positifs) et les moyennes géométriques des titres (IC 95%) des anticorps IgG anti-Spike (BAU/mL) ont été évalués à 1 mois et 6 mois après la 2ème dose du schéma de primovaccination et à 12 mois uniquement chez ceux ayant reçu une dose de rappel. Les anticorps neutralisants spécifiques (test de neutralisation in vitro contre la souche originale, Delta et Omicron BA.1) ont été mesurés dans un échantillon de participants. Les participants ayant à l'inclusion ou au cours des visites de suivi des anticorps anti-nucléocapside (NCP) positifs ont été exclus. Les tests sérologiques (ELISA Euroimmun) et la séroneutralisation ont été évalués de manière standardisée et centralisée. Au total, 858 PVVIH et 1156 contrôles ont été inclus. Les PVVIH étaient plus âgées que les contrôles: 55,2 ans (49,6-60,6) vs 46,6 ans (36,3-56,6) et plus fréquemment des hommes (75,1% vs 48,9%). Parmi les PVVIH, 97,3% étaient sous traitement antirétroviral, 95,6% avaient une charge virale indétectable et 71,8% avaient un taux de CD4 supérieur à 500 cellules/mm3. Les participants avaient principalement reçu le BNT162b2 en primovaccination (93% des PVVIH vs 84% des témoins) et 53,1% avaient reçu une dose de rappel (57,2% des PVVIH (délai médian après la 2ème dose: 6,1 mois [5,9-6,7]) et 50,1% des contrôles (délai médian 6,0 mois [5,5-6,2])). Le pourcentage de répondeurs 1 mois après la 2ème dose était élevé mais plus faible chez les PVVIH que chez les contrôles ((98,7% [97,7; 99,3] vs 99,9% [99,5; 99,9], p=0,0001)). Les PVVIH présentaient des niveaux significativement plus faibles d'anticorps anti-Spike à 1 mois ((1188 [650; 2067] vs 1506 [950; 2507] BAU/mL, p<0,0001)) et 6 mois (149 [95; 235] vs 194 [124; 314] BAU/mL, p=<0,0001) mais des niveaux similaires à 12 mois (520 [269; 1198] vs 427 [259; 1087] BAU/mL, p=0,3387) chez ceux ayant reçu une dose de rappel. Les PVVIH présentaient des anticorps neutralisants significativement plus faibles contre les souches originales, Delta et Omicron BA.1 à 1, 6 et 12 mois après la primovaccination par rapport aux contrôles. La dose de rappel a augmenté de manière significative les titres d'anticorps neutralisants contre les souches originales et Delta et, dans une moindre mesure, contre Omicron. Les taux de répondeurs à 1 et 6 mois d'un schéma de primo-vaccination Covid-19 à ARNm étaient élevés chez les PVVIH mais leurs titres d'anticorps totaux et neutralisants étaient inférieurs à ceux des contrôles. Une dose de rappel d'ARNm a augmenté les titres d'anticorps IgG anti-Spike à des niveaux similaires à ceux des contrôles, mais l'activité neutralisante, notamment contre Omicron, est restée plus faible. P.L. Interventions ponctuelles: Astrazeneca, GSK, Moderna, MSD, Pfizer, Sanofi
BACKGROUND:Men who have sex with men (MSM) have an increased risk of infection by pathogens transmitted by the oro-fecal route. Here, we investigated the seroprevalence and incidence of hepatitis E virus (HEV) infection in 416 MSM included in the ANRS IPERGAY PrEP trial.RESULTS:Among the 62 (14.9% (95% CI: [11.6%-18.7%]) seropositive for HEV at inclusion, the only factor associated with testing seropositive for HEV was older age. Geographical origin, use of recreational drugs, number of sexual partners, status for HAV and bacterial sexually transmitted infection (STI) at inclusion were not associated. Among the 342 HEV-seronegative patients with available samples, 9 seroconverted after a median of follow-up of 2.1 years (IQR (interquartile range): [1.6; 3.0]).CONCLUSION:Overall, the HEV incidence was 1.19% per 100 person-years [95% CI: 0.54%; 2.26%]. Sexual transmission does not seem to be a major route of HEV infection in MSM, unlike HAV.
Background In order to understand the pandemic COVID-19 crisis in a forward-looking way, the French High Council for public health (HCSP) has designed a conceptual scheme for public health planning based on L. Green's model in order to better understand the issues at stake, by identifying dangers and levers for action. The final aim was to establish priorities and guidelines in order to anticipate the collateral consequences of the management of the crisis and be better prepared for the next one. Method A public health conceptual framework PRECEDE-PROCEED adapted to the Covid-19 health crisis was developed using both a graphic (concept map) and analytic (to make the conceptual scheme functional) approaches. Then, a "meta-method" was applied using three distinct cognitive stages: understanding, anticipation and proposals of action. Results The conceptual framework was broken down into 10 technical sheets covering essential diagnoses and integrating different public health determinants. Each of these was broken down into three cognitive stages, allowing for a diagnosis of understanding, a scenario of anticipation and a strategic analysis of action according to the chronology: understand-anticipate-propose. From these 10 technical sheets, 32 guidelines have been proposed. Conclusion This work is intended to allow reflections on public health approaches to strengthen and anticipate health crisis management and health planning by politic managers working at national or sub-national level.
OBJECTIVE:High rates of sexually transmitted infections (STIs) have been reported among pre-exposure prophylaxis (PrEP) users. We wished to assess the incidence and risk factors for recurrent STIs. DESIGN:The ANRS IPERGAY trial was a prospective study investigating PrEP among MSM and transgender women in outpatient clinics in France and Canada. In all, 429 participants were enrolled, offered up to 4 years of PrEP and screened for bacterial STIs (syphilis, chlamydia and gonorrhea) at baseline and every 6 months. METHODS:STIs incidence was calculated yearly. Cox proportional hazards model regression was used to explore associations between participants characteristics at baseline and recurrent STI during follow-up. RESULTS:Over a median follow-up of 23 months, bacterial STI incidence was 75, 33, 13, 32 and 30 per 100 person-years for all STIs, rectal STIs, syphilis, gonorrhea and chlamydia, respectively. STI incidence significantly increased from the first year to the fourth year of the study (55 vs. 90 per 100 person-years, P < 0.001). During the study period, 167 participants (39%) presented with more than one bacterial STIs which accounted for 86% of all STIs. Baseline risk factors associated with recurrent STIs in a multivariate analysis were an STI at baseline [hazards ratio: 1.48 (95% confidence interval (CI): 1.06-2.07), P = 0.02], more than eight sexual partners in prior 2 months [hazards ratio: 1.72 (95% CI: 1.21-2.43), P = 0.002] and the use of gamma-hydroxybutyrate [hazards ratio: 1.66 (95% CI: 1.16-2.38), P = 0.005]. CONCLUSION:STI incidence was high and increased over time. Most STIs were concentrated in a high-risk group that should be targeted for future interventions.
Given the number of people leaving the war zone in Ukraine and arriving in France, the French high council for public health (HCSP) has drawn up a number of recommendations. The experts have taken into account the vulnerability of migrant populations, which is exacerbated by (a) promiscuity that increases the risk of exposure to infectious agents; (b) the psychological consequences of conflict, family separation and exile; (c) prevalence in Ukraine of communicable diseases such as (possibly) multi-resistant) tuberculosis, HIV and HCV; (d) low vaccination coverage (risk of circulation of poliovirus) and (e) the risk of spreading infectious diseases (Covid-19, measles…).Consequently, experts recommend that priority be given to: i) Initial (immediate) reception, which will help to provide emergency care and to assess immediate needs (psychological disorders, risk of medication breakdown and risk of infection); (ii) Other priority measures (vaccination catch-up, including vaccination against SARS-CoV-2 and mandatory vaccination for children's entry into school, screening for post-traumatic stress disorder and tuberculosis) must be implemented as soon as feasible. At this stage, it is imperative: To ensure coordination and access to information throughout the country, by providing medico-social support (opening of social rights and access to care); To digitize medical data for the purposes of traceability; To use professional interpreting and/or health facilitators, or else, if necessary, digital translation tools. (iii) Finally, experts stress the need for vigilance in terms of management, conservation of social rights and continuity of care after the initial period, and organization of a "health rendezvous" within four months of a migrant’s entering the country.
ABSTRACTBackgroundVariant-adaptated vaccines against coronavirus disease 2019 (COVID-19) as boosters are needed to increase a broader protection against SARS CoV-2 variants. New adjuvanted recombinant protein vaccines as heterologous boosters could maximize the response.MethodsIn this randomized, single-blinded, multicenter trial, adults who had received two doses of Pfizer-BioNTech mRNA vaccine (BNT162b2) 3 to7 months before were randomly assigned to receive a boost of BNT162b2, Sanofi/GSK SARS-CoV-2 adjuvanted recombinant protein MV D614 (monovalent parental formulation) or SARS-CoV-2 adjuvanted recombinant protein MV B.1.351 vaccine (monovalent Beta formulation). The primary endpoint was the percentage of subjects with a ≥10-fold increase in neutralizing antibody titers for the Wuhan (D614) and B.1.351 (Beta) SARS-CoV-2 viral strains between day 0 and day 15.FindingsThe percentages of participants whose neutralizing antibody titers against the Wuhan (D614) SARS-CoV-2 strain increased by a factor ≥10 between day 0 and day 15 was 55.3% (95% CI 43.4-66.7) in MV D614 group (n=76), 76.1% (64.5-85.4) in MV B.1.351 (Beta) group (n=71) and 63.2% (51.3-73.9) in BNT162b2 group (n=76). These percentages were 44.7% (33.3-56.6), 84.5% (74.0-92.0) and 51.3% (39.6-63.0) for the B.1.351 (Beta) viral strain, respectively. Higher neutralizing antibodies rates against Delta and Omicron BA.1 variants were also elicited after Sanofi/GSK MV Beta vaccine compared to the other vaccines. Comparable reactogenicity profile was observed with the three vaccines.InterpretationHeterologous boosting with the Sanofi/GSK Beta formulation vaccine resulted in a higher neutralizing antibody response against Beta variant but also the original strain and Delta and Omicron BA.1 variants, compared with mRNA BNT162b2 vaccine or the Sanofi/GSK MVD614 formulation. New vaccines containing Beta spike protein may represent an interesting strategy for broader protection against SARS CoV-2 variants.FundingFrench Ministries of Solidarity and Health and Research and SanofiTrial registration numberClinicalTrials.gov identifier NCT05124171; EudraCT identifier 2021-004550-33.
SCOPE:Since April 2022, a large number of monkeypox (MPX) cases have emerged across the globe in regions that are known to be totally free of zoonotic reservoir. The High Council for Public Health is a national institute commissioned to provide guidelines to the French Ministry of Health. The objective of these guidelines and recommendations is to inform the public, people at risk of severe MPX infection, infected patients and their families and contacts and healthcare workers in charge of infected patients. METHODS:A review of the literature from the MEDLINE database was carried out using the single keyword 'monkeypox', including recent and older articles from January 2000 to June 2022. There was no filter for the type of study, except English language. The titles and summaries of all the articles were read by the experts to select articles of interest. The High Council for Public Health brought together specialists with expertise in the field to analyse the scientific literature and international recommendations. Recommendations were classified with clinical practice methodology using four levels (strong recommendation, recommendation, optional recommendation and no recommendation) without grading the level of evidence. To develop and methodologically validate the recommendations, the Appraisal of Guidelines for Research and Evaluation Instrument (AGREE-II)chart was partially used. QUESTIONS ADDRESSED BY THE GUIDELINES AND RECOMMENDATIONS: (a) What are the therapeutic management measures for hospitalized patients with severe forms of MPX infection, and what are the preventive measures to protect healthcare professionals? (b) What are the isolation and prevention measures in the community for patients with mild or moderate severity MPX infection? (c) what are the preventive measures for contacts of an MPX-infected person? (d) Who should be vaccinated? (e) What are the specific prevention measures for children and schools?
Introduction:The objectives were to elaborate new recommendations for the French Government taking into account the new epidemiological situation due to Omicron variant of SARS-CoV-2 virus and to maintain essential functions of the State through socioeconomic and health life. Method:Two self-decision matrix were built for isolation (cases) and quarantine (contacts) and for citizen testing, respectively. The recommendations included in the two matrix were validated internally by experts and scientists from the scientist literature. Results:A strategic breakdown into five phases corresponding to the possible phases of Omicron variants spread was built. Exceptional and transitory derogation for essential activities was proposed in fully vaccinated professionals. Suspension of quarantine period for fully vaccinated contacts and professionals was proposed with routine self-testing program. Conclusion:These new HCSP guidelines aims to preserve public health as a whole and to minimize the socioeconomic and health consequences linked to the emergence of the Omicron variant by making trade-offs/adaptations in dependent scientist contexts. Patient or Public Contribution:HCSP scientists and experts were in charge of drafting the recommendations and promoting them to the Government for their application by regulatory decree voted by law.
Background:Although effective mRNA vaccines for SARS-CoV-2 infection have been deployed worldwide, their interchangeability could facilitate the scale-up of vaccination programs. The objective of the trial was to assess whether the immune response induced by a heterologous SARS-CoV-2 mRNA primo vaccination is non-inferior to that of a homologous mRNA vaccination. Methods:We conducted a multicenter, randomized, open-label trial in adults 18 years of age and older who received a first dose of SARS-CoV-2 mRNA vaccine. Participants were randomly assigned in a 1:1 ratio to receive a second dose of BNT162b2 or mRNA-1273, 28 to 49 days after the first dose. Randomization was stratified on the vaccine received at the first vaccination. The primary endpoint was the anti-spike IgG antibodies titer measured 28 days after the second vaccine dose. This study is registered with ClinicalTrials.gov, Trial, NCT04900467. Findings:Of the 414 randomized participants recruited from May 28 to July 2, 2021, 390 were included in the per protocol analysis: 94 participants in group 1 (BNT162b2/BNT162b2), 96 in group 2 (BNT162b2/mRNA-1273), 97 in group 3 (mRNA-1273/mRNA-1273), and 103 in group 4 (mRNA-1273/BNT162b2). The geometric mean titers ratios of anti-spike IgG antibodies for each heterologous regimen relative to the corresponding homologous regimen were 1·37 (two-sided 95% CI, 1·10 to 1·72) in the groups 1 and 2 and 0·67 (two-sided 95% CI, 0·55 to 0·82) in the groups 3 and 4. Levels of neutralizing antibodies to the main circulating SARS-Cov-2 viral strains were higher with the vaccine regimen containing mRNA-1273. Participants who received mRNA-1273 as a second dose experienced a higher rate of local adverse reactions and general symptoms than those who received BNT162b2 (p < 0·0001). Interpretation:The two SARS-CoV-2 mRNA vaccines could be used with flexibility for the second dose of COVID-19 primo vaccination. Tolerance remains good regardless of vaccine sequence although mRNA-1273 was more reactogenic. Funding:French Ministries of Solidarity and Health and Research. BNT162b2 was provided by Pfizer/BioNTech. mRNA-1273 was provided by Moderna.
Malaria diagnosis based on microscopy is impaired by the gradual disappearance of experienced microscopists in non-endemic areas. Aside from the conventional diagnostic methods, fluorescence flow cytometry technology using Sysmex XN-31, an automated haematology analyser, has been registered to support malaria diagnosis. The aim of this prospective, monocentric, non-interventional study was to evaluate the diagnostic accuracy of the XN-31 for the initial diagnosis or follow-up of imported malaria cases compared to the reference malaria tests including microscopy, loop mediated isothermal amplification, and rapid diagnostic tests. Over a one-year period, 357 blood samples were analysed, including 248 negative and 109 positive malaria samples. Compared to microscopy, XN-31 showed sensitivity of 100% (95% CI: 97.13–100) and specificity of 98.39% (95% CI: 95.56–100) for the initial diagnosis of imported malaria cases. Moreover, it provided accurate species identification asfalciparumor non-falciparumand parasitaemia determination in a very short time compared to other methods. We also demonstrated that XN-31 was a reliable method for patient follow-up on days 3, 7, and 28. Malaria diagnosis can be improved in non-endemic areas by the use of dedicated haematology analysers coupled with standard microscopy or other methods in development, such as artificial intelligence for blood slide reading. Given that XN-31 provided an accurate diagnosis in 1 min, it may reduce the time interval before treatment and thus improve the outcome of patient who have malaria.
Abstract Background New adjuvanted recombinant protein vaccines against coronavirus disease 2019 (COVID-19) as heterologous boosters could maximize the benefits of vaccination against SARS CoV-2. Methods In this randomized, single-blinded, multicenter trial, adults who had received two doses of Pfizer-BioNTech mRNA vaccine (BNT162b2) 3–7 months before were randomly assigned to receive a boost of BNT162b2, Sanofi/GSK SARS-CoV-2 adjuvanted recombinant protein MV D614 (monovalent parental formulation) or SARS-CoV-2 adjuvanted recombinant protein MV B.1.351 vaccine (monovalent Beta formulation). The primary endpoint was the percentage of subjects with a ≥ 10-fold increase in neutralizing antibody titers for the Wuhan (D614) and B.1.351 (Beta) SARS-CoV-2 viral strains between D0 and D15. Results The percentages of participants whose neutralizing antibody titers against the Wuhan (D614) SARS-CoV-2 strain increased by a factor ≥ 10 between Day 0 and Day 15 was 55.3% (95% CI 43.4-66.7) in MV(D614) group (n=76), 76.1% (64.5-85.4) in MV(Beta) group (n=71) and 63.2% (51.3-73.9) in BNT162b2 group (n=76). These percentages were 44.7% (33.3-56.6), 84.5% (74.0-92.0) and 51.3% (39.6-63.0) for the B.1.351 (Beta) viral strain, respectively. Higher neutralizing antibodies rates against Delta and Omicron BA.1 variants were also elicited after Sanofi/GSK MV(Beta) vaccine compared to the other vaccines. Comparable reactogenicity profile was observed the three vaccines. Table 1.Characteristics of patients at inclusion (per-protocol population).Figure 2.Neutralizing antibodies against D614 (wild-type; Wuhan) SARS-CoV-2 and variants Beta, Delta and Omicron BA.1 at D0, D15 and D28 after the boost dose (“post D3”)with Sanofi/GSK-D614, Sanofi/GSK-B.1.351 or BNT162b2 (per-protocol population); dotted line represents the positivity threshold.Figure 4.Rates and grades of severity of solicited adverse events reported from D0 to D7 by participants from the three randomized groups of the safety population (G1, Sanofi/GSK-D614; G2, Sanofi/GSK-B.1.351; G3, BNT162b2) according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Modified FDA scale/September 2007) Conclusion All three vaccines boosted antibodies and neutralizing response after BNT162b2 initial course. Heterologous boosting with the Sanofi/GSK SARS-CoV-2 adjuvanted recombinant protein vaccine B.1.351 (Beta formulation) provided higher neutralizing antibodies response rates against variants, including Omicron BA.1, compared with the mRNA BNT162b2 vaccine. Disclosures Odile Launay, MD, PhD, AstraZeneca: Financial|GlaxoSmithKline: Advisor/Consultant|GlaxoSmithKline: Grant/Research Support|Johnson & Johnson: Advisor/Consultant|Johnson & Johnson: Grant/Research Support|MD: Advisor/Consultant|Moderna: Advisor/Consultant|MSD: Data safety monitoring board|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Sanofi Pasteur: Advisor/Consultant|Sanofi Pasteur: Grant/Research Support|Sanofi Pasteur: Data safety monitoring board Liem Binh Luong, MD, Pfizer: Advisor/Consultant|Pfizer: Honoraria Karine Lacombe, MD, PhD, Gilead: Advisor/Consultant|Janssen: Grant/Research Support|MSD: Grant/Research Support|ViiV Healthcare: Grant/Research Support Elisabeth Botelho-Nevers, MD, PHD, Janssen: Board Member|Pfizer: Board Member|Sanofi Pasteur: Board Member.
BACKGROUND:Mycoplasma genitalium (MG) is an emerging pathogen among men who have sex with men (MSM) with raising rates of antibiotic resistance. This study assessed the prevalence and incidence of MG infection in MSM enrolled in the open-label phase of the ANRS IPERGAY trial with on-demand tenofovir disoproxil fumarate/emtricitabine for human immunodeficiency virus prevention and the impact of doxycycline post-exposure prophylaxis (PEP).METHODS:210 subjects were tested at baseline and at 6 months by real-time PCR assays for MG detection in urine samples and oropharyngeal and anal swabs. Resistance to azithromycin (AZM), to fluoroquinolones (FQs), and to doxycycline was investigated in the French National Reference Center of Bacterial Sexually Transmitted Infections (STIs).RESULTS:The all-site prevalence of MG at baseline was 10.5% (6.3% in urine samples, 4.3% in anal swabs, 0.5% in throat swabs) and remained unchanged at 6 months whether or not PEP was used: 9.9% overall, 10.2% with PEP, 9.6% without. The overall rate of MG resistance (prevalent and incident cases) to AZM and FQs was 67.6% and 9.1%, respectively, with no difference between arms. An in vivo mutation of the MG 16S rRNA, which could be associated with tetracycline resistance, was observed in 12.5% of specimens tested.CONCLUSIONS:The prevalence of MG infection among MSM on pre-exposure prophylaxis was high and its incidence was not decreased by doxycycline prophylaxis with a similar high rate of AZM and FQ resistance, raising challenging issues for the treatment of this STI and supporting current recommendations to avoid testing or treatment of asymptomatic MG infection.
Avis Relatif au risque de transmission du virus SARS-CoV-2 par la dispersion d’aerosols lors d’activites liees aux differents types de tabagisme et aux caracteristiques des lieux (HCSP, Avis et Rapports) Zeina MANSOUR, Daniel CAMUS, Christian CHIDIAC, Jean-Francois GEHANNO, Bruno POZZETTO, Serge AHO-GLELE, Didier LEPELLETIER, Jean-Marc BRIGNON, Evelyne GEHIN, Philippe HARTEMANN, Yves LEVI, Francelyne MARANO, Jean-Louis ROUBATY, Fabien SQUINAZI, Francois ALLA, Agathe BILLETTE de VILLEMEUR, Anne BERGER-CARBONNE, Eric GAFFET, Brigitte MOLTRECHT, Marie France d’ACREMONT, Camille BRUAT, Soizic URBAN-BOUDJELAB Date du document : 17/12/2020 Date de mise en ligne : 15/01/2021 https://www.hcsp.fr/Explore.cgi/AvisRapportsDomaine?clefr=967 Risque de transmission du virus SARS-CoV-2 par les activites liees au tabagisme et au vapotage Le HCSP a analyse le risque de transmission du SARS-CoV-2 par les activites liees au tabagisme et au vapotage. Aucune donnee scientifique n’est disponible pour determiner si la diffusion du SARS-CoV-2 peut etre facilitee par la fumee exhalee par le fumeur et inhalee par des personnes a proximite. En revanche, par la pratique du tabagisme et la diminution de l’observance des mesures de prevention (regroupement physique, retrait du masque, partage d’objets et de cigarettes) le risque de contamination entre fumeurs peut etre plus eleve qu’entre non-fumeurs. Le HCSP recommande de respecter une distance d’au moins 2 metres entre les fumeurs/vapoteurs et les personnes qui les entourent (fumeurs/vapoteurs ou non). Il est recommande de ne pas fumer/vapoter dans des espaces exterieurs semi-clos lorsqu’ils sont peu ventiles et sans possibilite d’aeration. Les espaces exterieurs non cloisonnes facilitant le renouvellement d’air naturel sont recommandes pour reduire l’exposition aux aerosols des activites de tabagisme et de vapotage. Le tabagisme en milieu clos de la sphere privee est deconseille. Par ailleurs, le HCSP emet des recommandations concernant les espaces fumeurs des entreprises et les pratiques a observer lors de la consommation de tabac et le vapotage (partage d’objets et de cigarettes, expiration de la fumee …). Ces recommandations s’integrent aux mesures individuelles et collectives habituellement preconisees par le HCSP. Lire aussi dans les avis et rapports : Avis relatif au lien entre le tabagisme et la Covid-19 du 9 mai 2020 SARS-CoV-2 : actualisation des connaissances sur la transmission du virus par aerosols du 23 juillet 2020 Coronavirus SARS-CoV-2 : actualisation de la prise en charge du 23 juillet 2020 Coronavirus SARS-CoV-2 : chauffage, aeration, ventilation, preparation hivernale des bâtiments du 14 octobre 2020 Lire aussi : Ministere des solidarites et de la sante : information aux professionnels de sante