LUCIA MARIA MATTEI DE ARRUDA CAMPOS

(Fonte: Lattes)
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Instituto da Criança, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/36 - Laboratório de Pediatria Clínica, Hospital das Clínicas, Faculdade de Medicina

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  • article 7 Citação(ões) na Scopus
    Health related quality of life measure in systemic pediatric rheumatic diseases and its translation to different languages: an international collaboration
    (2014) MOORTHY, Lakshmi Nandini; ROY, Elizabeth; KURRA, Vamsi; PETERSON, Margaret G. E.; HASSETT, Afton L.; LEHMAN, Thomas J. A.; SCOT, Christiaan; EL-GHONEIMY, Dalia; SAAD, Shereen; FEKY, Reem El; AL-MAYOUF, Sulaiman; DOLEZALOVA, Pavla; MALCOVA, Hana; HERLIN, Troels; NIELSEN, Susan; WULFFRAAT, Nico; ROYEN, Annet van; MARKS, Stephen D.; BELOT, Alexandre; BRUNNER, Jurgen; HUEMER, Christian; FOELDVARI, Ivan; HORNEFF, Gerd; SAURENMAN, Traudel; SCHROEDER, Silke; PRATSIDOU-GERTSI, Polyxeni; TRACHANA, Maria; UZIEL, Yosef; AGGARWAL, Amita; CONSTANTIN, Tamas; CIMAZ, Rolando; GIANI, Theresa; CANTARINI, Luca; FALCINI, Fernanda; MANZONI, Silvia Magni; RAVELLI, Angelo; RIGANTE, Donato; ZULIAN, Fracnceso; MIYAMAE, Takako; YOKOTA, Shumpei; SATO, Juliana; MAGALHAES, Claudia S.; LEN, Claudio A.; APPENZELLER, Simone; KNUPP, Sheila Oliveira; RODRIGUES, Marta Cristine; SZTAJNBOK, Flavio; ALMEIDA, Rozana Gasparello de; JESUS, Adriana Almeida de; CAMPOS, Lucia Maria de Arruda; SILVA, Clovis; LAZAR, Calin; SUSIC, Gordana; AVCIN, Tadej; CUTTICA, Ruben; BURGOS-VARGAS, Ruben; FAUGIER, Enrique; ANTON, Jordi; MODESTO, Consuelo; VAZQUEZ, Liza; BARILLAS, Lilliana; BARINSTEIN, Laura; STERBA, Gary; MALDONADO, Irama; OZEN, Seza; KASAPCOPUR, Ozgur; DEMIRKAYA, Erkan; BENSELER, Susa
    Background: Rheumatic diseases in children are associated with significant morbidity and poor health-related quality of life (HRQOL). There is no health-related quality of life (HRQOL) scale available specifically for children with less common rheumatic diseases. These diseases share several features with systemic lupus erythematosus (SLE) such as their chronic episodic nature, multi-systemic involvement, and the need for immunosuppressive medications. HRQOL scale developed for pediatric SLE will likely be applicable to children with systemic inflammatory diseases. Findings: We adapted Simple Measure of Impact of Lupus Erythematosus in Youngsters (SMILEY (c)) to Simple Measure of Impact of Illness in Youngsters (SMILY (c)-Illness) and had it reviewed by pediatric rheumatologists for its appropriateness and cultural suitability. We tested SMILY (c)-Illness in patients with inflammatory rheumatic diseases and then translated it into 28 languages. Nineteen children (79% female, n= 15) and 17 parents participated. The mean age was 12 +/- 4 years, with median disease duration of 21 months (1-172 months). We translated SMILY (c)-Illness into the following 28 languages: Danish, Dutch, French (France), English (UK), German (Germany), German (Austria), German (Switzerland), Hebrew, Italian, Portuguese (Brazil), Slovene, Spanish (USA and Puerto Rico), Spanish (Spain), Spanish (Argentina), Spanish (Mexico), Spanish (Venezuela), Turkish, Afrikaans, Arabic (Saudi Arabia), Arabic (Egypt), Czech, Greek, Hindi, Hungarian, Japanese, Romanian, Serbian and Xhosa. Conclusion: SMILY (c)-Illness is a brief, easy to administer and score HRQOL scale for children with systemic rheumatic diseases. It is suitable for use across different age groups and literacy levels. SMILY (c)-Illness with its available translations may be used as useful adjuncts to clinical practice and research.
  • article 11 Citação(ões) na Scopus
    Subclinical pulmonary abnormalities in childhood-onset systemic lupus erythematosus patients
    (2016) VEIGA, C. S.; COUTINHO, D. S.; NAKAIE, C. M. A.; CAMPOS, L. M. A.; SUZUKI, L.; CUNHA, M. T.; LEONE, C.; SILVA, C. A.; RODRIGUES, J. C.
    Objective The aims of this study were to analyze the pulmonary function of childhood-onset systemic lupus erythematosus (cSLE) patients and to identify possible correlations between the high-resolution computed chest tomography (HRCT) score, disease activity, disease cumulative damage, and the participants' quality of life. Methods Forty cSLE patients, median age: 14.1 years (range: 7.4-17.9), underwent spirometry and plethysmography. Carbon monoxide diffusing capacity (DLCO), HRCT, disease activity, disease cumulative damage, and quality of life were assessed. Results Pulmonary abnormalities were evident in 19/40 (47.5%) cSLE patients according to spirometry/DLCO. Forced expired volume in one second (FEV1%) was the parameter most affected (30%). The HRCT showed some abnormality in 22/30 patients (73%), which were minimal in 43%. Signs of airway affects were found in 50%. Twelve patients were hospitalized due to cSLE-related pulmonary complications before the study began (median discharge: 2.1 years earlier). Total lung capacity (TLC%), vital capacity (VC%), forced vital capacity (FVC%), and FEV1% were significantly lower in the group with hospitalization compared to the group without hospitalization (p=0.0025, p=0.0022, p=0.0032, and p=0.0004, respectively). Of note, DLCO was positively correlated with disease duration (r=+0.4; p=0.01). The HRCT-score was negatively correlated with FEV1/VC (r=-0.63; p=0.0002), FEV1 (r=-0.54; p=0.018), FEF25%-75% (r=-0.67; p<0.0001), and HRCT-score was positively correlated with resistance (r=+0.49; p=0.0056). Conclusions Almost half of patients with cSLE had subclinical pulmonary abnormalities, especially airway abnormalities. The cSLE-related pulmonary complications seem to determine long-term functional damage.
  • article 0 Citação(ões) na Scopus
    Safety and immunogenicity of influenza A(H3N2) component vaccine in juvenile systemic lupus erythematosus
    (2023) AIKAWA, Nadia Emi; BORBA, Eduardo Ferreira; BALBI, Verena Andrade; SALLUM, Adriana Maluf Elias; BUSCATTI, Izabel Mantovani; CAMPOS, Lucia Maria Arruda; KOZU, Katia Tomie; GARCIA, Cristiana Couto; CAPAO, Artur Silva Vidal; PROENCA, Adriana Coracini Tonacio de; LEON, Elaine Pires; DUARTE, Alberto Jose da Silva; LOPES, Marta Heloisa; SILVA, Clovis Artur; BONFA, Eloisa
    Introduction Seasonal influenza A (H3N2) virus is an important cause of morbidity and mortality in the last 50 years in population that is greater than the impact of H1N1. Data assessing immunogenicity and safety of this virus component in juvenile systemic lupus erythematosus (JSLE) is lacking in the literature.Objective To evaluate short-term immunogenicity and safety of influenza A/Singapore (H3N2) vaccine in JSLE.Methods 24 consecutive JSLE patients and 29 healthy controls (HC) were vaccinated with influenza A/Singapore/INFIMH-16-0019/2016(H3N2)-like virus. Influenza A (H3N2) seroprotection (SP), seroconversion (SC), geometric mean titers (GMT), factor increase in GMT (FI-GMT) titers were assessed before and 4 weeks post-vaccination. Disease activity, therapies and adverse events (AE) were also evaluated.Results JSLE patients and controls were comparable in current age [14.5 (10.1-18.3) vs. 14 (9-18.4) years, p = 0.448] and female sex [21 (87.5%) vs. 19 (65.5%), p = 0.108]. Before vaccination, JSLE and HC had comparable SP rates [22 (91.7%) vs. 25 (86.2%), p = 0.678] and GMT titers [102.3 (95% CI 75.0-139.4) vs. 109.6 (95% CI 68.2-176.2), p = 0.231]. At D30, JSLE and HC had similar immune response, since no differences were observed in SP [24 (100%) vs. 28 (96.6%), p = 1.000)], SC [4 (16.7%) vs. 9 (31.0%), p = 0.338), GMT [162.3 (132.9-198.3) vs. 208.1 (150.5-287.8), p = 0.143] and factor increase in GMT [1.6 (1.2-2.1) vs. 1.9 (1.4-2.5), p = 0.574]. SLEDAI-2K scores [2 (0-17) vs. 2 (0-17), p = 0.765] and therapies remained stable throughout the study. Further analysis of possible factors influencing vaccine immune response among JSLE patients demonstrated similar GMT between patients with SLEDAI < 4 compared to SLEDAI >= 4 (p = 0.713), as well as between patients with and without current use of prednisone (p = 0.420), azathioprine (p = 1.0), mycophenolate mofetil (p = 0.185), and methotrexate (p = 0.095). No serious AE were reported in both groups and most of them were asymptomatic (58.3% vs. 44.8%, p = 0.958). Local and systemic AE were alike in both groups (p > 0.05).Conclusion This is the first study that identified adequate immune protection against H3N2-influenza strain with additional vaccine-induced increment of immune response and an adequate safety profile in JSLE. (www.clinicaltrials.gov, NCT03540823).
  • article 0 Citação(ões) na Scopus
    Risk factors for mortality in 1528 Brazilian childhood-onset systemic lupus erythematosus patients
    (2023) SAKAMOTO, Ana P.; SILVA, Clovis A.; PITA, Ana C.; TRINDADE, Vitor C.; ISLABAO, Aline G.; FIOROT, Fernanda J.; LOPES, Sandra R. M.; PEREIRA, Rosa M. R.; SAAD-MAGALHAES, Claudia; RUSSO, Gleice C. S.; LEN, Claudio A.; PRADO, Rogerio do; CAMPOS, Lucia M. A.; AIKAWA, Nadia E.; APPENZELLER, Simone; FERRIANI, Virginia P. L.; SILVA, Marco F.; FELIX, Marta; FONSECA, Adriana R.; ASSAD, Ana P. L.; SZTAJNBOK, Flavio R.; SANTOS, Maria C.; BICA, Blanca E.; SENA, Evaldo G.; MORAES, Ana J.; FRAGA, Melissa M.; ROBAZZI, Teresa C.; SPELLING, Paulo F.; SCHEIBEL, Iloite M.; CAVALCANTI, Andre S.; MATOS, Erica N.; GUIMARAES, Luciano J.; SANTOS, Flavia P.; MOTA, Licia M. H.; BONFA, Eloisa; TERRERI, Maria T.
    Objectives: To identify associations between mortality in cSLE patients and their characteristics: clinical and laboratory features, disease activity and damage scores, and treatment; to evaluate risk factors associated with mortality in cSLE; and to determine the most frequent causes of death in this group of patients.Methods: We performed a multicenter retrospective cohort using data from 1,528 cSLE patients followed in 27 pediatric rheumatology tertiary centers in Brazil. Patients' medical records were reviewed according to a standardized protocol, in which information regarding demographic and clinical features, disease activity and damage scores, and treatment were collected and compared between deceased cSLE patients and survivors. Univariate and multivariate analyses by Cox regression model were used to calculate risk factors for mortality, whereas survival rates were analyzed by Kaplan-Meier plots.Results: A total of 63/1,528 (4.1%) patients deceased, 53/63 were female (84.1%), median age at death was 11.9 (9.4-13.1) years and median time interval between cSLE diagnosis and death was 3.2 (0.5-5.3) years. Sepsis was the main cause of death in 27/63 (42.8%) patients, followed by opportunistic infections in 7/63 (11.1%), and alveolar hemorrhage in 6/63 (9.5%) patients. The regression models resulted in neuropsychiatric lupus (NP-SLE) (HR = 2.56, 95% CI = 1.48-4.42) and chronic kidney disease (CKD) (HR = 4.33, 95% CI = 2.33-4.72), as risk factors significantly associated with mortality. Overall patient survival after cSLE diagnosis at 5, 10, and 15 years were 97%, 95.4%, and 93.8%, respectively.Conclusions: This study confirmed that the recent mortality rate in cSLE in Brazil is low, but still of concern. NP-SLE and CKD were the main risk factors for mortality, indicating that the magnitude of these manifestations was significantly high.
  • article 22 Citação(ões) na Scopus
    Dyslipidaemia in juvenile dermatomyositis: the role of disease activity
    (2013) KOZU, K. T.; SILVA, C. A.; BONFA, E.; SALLUM, A. M.; PEREIRA, R. M. R.; VIANA, V. S.; BORBA, E.; CAMPOS, L. M.
    Objective To evaluate the presence of dyslipidaemia in JDM and its possible risk factors. Methods Twenty-five JDM patients were compared to 25 healthy controls according to demographic data, body composition, fasting lipoproteins, glycaemia, insulin, antibodies and muscle enzymes. JDM scores were assessed: CMAS, MMT, DAS, MYOACT and MYTAX. Results Abnormal lipid profile was found in nine patients and four controls (36% vs. 16%, p=0.196). TDM patients demonstrated significant higher levels of triglycerides (TG) [80(31-340) vs. 61(19-182) mgldL, p=0.011 j and higher frequency of abnormal levels of high density lipoproteins (HDL) (28% vs. 4%, p=0.04) when compared to controls. JDM patients with dyslipidaemia demonstrated significant lower median of HDL levels 129(0-49) vs. 50(39-72) mgldL, p=0.0005, higher frequency of low HDL levels (77% vs. 0%, p=0.0001),.higher TG levels [128(31-340) vs. 69(46-138) mgldL, p=0.011), and also a higher frequency of increased levels of TG (44% vs. 0%, p=0.01), and TC (33% vs. 0%, p=0.03) when compared to those without this condition. Positive anti-LPL antibody was detected in just one JDM patient with abnormal lipid profile. JDM with dyslipidaemia had higher ESR (26 vs. I 4.5mmllsthour, p=0.006), CRP (2.1 vs. 0.4mgldL, p=0.01), DAS (6 vs. 2, p=0.008), MYOACT(0.13 vs. 0.01, p=0.012), MYTAX(0.06vs.0,p=0.018), and lower scores of CMAS (47 vs. 52, p=0.024) and MMT (78 vs. 80, p=0.001) compared to JDM without dyslipidaemia. Positive correlations were detected between TG levels and CRP (7-.19.697, p=0.001), DAS (r-0.610, p=0.001), MYOACT (r=0.661, p=0.001),114YTAX (r-0.511, p=0.008), and negative correlations with CMAS (r=-0.506, p=0.009) and MMT (r=-0.535, p=0.005). No differences were found between these groups regarding body composition, lipodystrophy, anti-LPL antibodies, and treatment except by higher frequency of cyclosporine current use in patients with dys.lipidaemia (33% vs. 0%, p=0.03). Conclusions Dyslipidaemia in JDM patients was characterised by increased levels of TG and low levels of HDL. Disease activity and cyclosporine use were the mainly factors associated to these abnormalities.
  • article 0 Citação(ões) na Scopus
    Heart function in juvenile idiopathic arthritis patients: A biventricular two-dimensional speckle-tracking echocardiography study
    (2022) LIANZA, Alessandro C.; LEAL, Gabriela N.; AIKAWA, Nadia E.; KOZU, Katia T.; DINIZ, Maria De Fatima R.; SAWAMURA, Karen S. S.; MENEZES, Carolina R. B.; MARTINS, Camila Lino; CAMPOS, Lucia M.; ELIAS, Adriana M.; SILVA, Clovis A.
    Objectives We evaluated cardiac function in juvenile idiopathic arthritis (JIA) patients by 2D speckle-tracking echocardiography (2DSTE) and to assess possible associations with clinical, laboratorial, and treatment data. Methods A group of 42 JIA patients and 42 healthy controls were evaluated using both conventional echocardiography and 2DSTE. JIA patients underwent clinical and laboratory assessment. Results Conventional echocardiography data demonstrated normal left ventricular (LV) ejection fraction in both groups (71 vs. 71%; p = .69). 2DSTE analysis demonstrated that JIA patients presented significantly lower LV global systolic longitudinal strain (LVGLS) (-18.76 vs. -22%; p < .0001), LV systolic strain rate (LVSSR) (1.06 vs. 1.32 s(-1); p < .0001), LV diastolic strain rate (LVDSR) (1.58 vs. 1.8 s(-1); p < .0137), right ventricular global systolic strain (RVGLS) (-24.1% vs. -27.7%; p = .0002), and right ventricular systolic strain rate (RVSSR) (1.4 vs. 1.8 s(-1); p = .0035). JIA patients under biological agents presented higher LVGLS (p = .02) and RVLS (p = .01). We also detected an association between LVGLS and C-reactive protein [CRP; -20% in normal CRP (10/42) vs. -18% in elevated CRP patients (32/42), p = .03]. Conclusions JIA patients present different echocardiographic status from healthy patients. Moreover, our data suggest that JIA patients under biological agents present association with better cardiac function as shown by strain analysis.
  • article 2 Citação(ões) na Scopus
    Munchausen by proxy syndrome mimicking childhood-onset systemic lupus erythematosus
    (2019) KUHNE, A. C. A.; PITTA, A. C.; GALASSI, S. C.; GONCALVES, A. M. F.; CARDOSO, A. C. A.; PAZ, J. A.; CAMPOS, L. M. A.; SILVA, C. A.
    Childhood-onset systemic lupus erythematosus (cSLE) is a chronic inflammatory multisystem autoimmune disease that requires multiple differential diagnoses. Munchausen by proxy syndrome (MBPS) is a form of child abuse, where a caregiver intentionally creates a medical history and induces or fabricates signs or disease in a patient. To our knowledge, there is no case report of MBPS mimicking cSLE diagnosis. We reported herein a 9-year-old male patient, with a history of multiple hospitalizations due to seizures with altered levels of consciousness. The mother reported malar rash, photosensitivity, alopecia, arthralgia, arterial hypertension, macroscopic hematuria, seizure and positive antinuclear antibodies. In the other service, he was treated with intravenous methylprednisolone, prednisone and mycophenolate mofetil. At 8 years and 8 months, he was admitted to our tertiary center with history of fever and macroscopic hematuria. Laboratory examinations were normal, including negative for antinuclear antibodies, anti-double stranded DNA, anticardiolipin, anti-Ro/SSA, anti-La/SSB, anti-RNP and anti-Sm antibodies. Multiple urine cultures revealed the presence of Enterococcus faecium, Acinetobacter sp., Stenotrophomonas maltophilia and Serratia marcescens, without any association with pyuria. At 8 years and 9 months, he was readmitted at emergency room with history of severe fever, headache, vomiting, photophobia, phonophobia and dizziness. The physical examination showed agitation, confusion, ataxic gait, slurred speech, horizontal nystagmus, painful facial expressions, tachycardia and weight loss. Brain magnetic resonance angiography and cerebrospinal fluid analysis were normal. During hospitalization, he had an acute episode of epistaxis and otalgia with excoriation in the auditory canal. At that moment, the suspicion of MBPS mimicking cSLE was raised and phenytoin intoxication was confirmed (peak phenytoin concentration was 45.4 mcg/mL, therapeutic range 10-20 mcg/mL). The mother and the patient were immediately separated, and she was replaced by another legal guardian. One week later, the neurological and other signs and symptoms were completely resolved. The child was placed under paternal custody with a court order and moved to another state. After that, the mother reported phenytoin use for her child and was referred to psychiatric follow-up. In conclusion, the first case of MBPS mimicking cSLE, resulting in multiple unnecessary examinations and treatments with delayed diagnosis was reported.
  • article 30 Citação(ões) na Scopus
    Childhood-onset bullous systemic lupus erythematosus
    (2014) LOURENCO, D. M. R.; GOMES, R. Cunha; AIKAWA, N. E.; CAMPOS, L. M. A.; ROMITI, R.; SILVA, C. A.
    Bullous systemic lupus erythematosus has rarely been described in pediatric lupus population and the real prevalence of childhood-onset bullous systemic lupus erythematosus has not been reported. From January 1983 to November 2013, 303 childhood-onset SLE (c-SLE) patients were followed at the Pediatric Rheumatology Unit of the Childres Institute of Hospital das Clinicas da Faculdade de Medicina Universidade da Universidade de SAo Paulo, three of them (1%) diagnosed as childhood-onset bullous systemic lupus erythematosus. All three cases presented tense vesiculobullous lesions unassociated with lupus erythematosus lesions, with the median duration of 60 days (30-60). All patients fulfilled bullous systemic lupus erythematosus criteria. Two had nephritis and serositis and presented specific autoantibodies. The histological pattern demonstrated subepidermal blisters with neutrophils-predominant infiltrates within the upper dermis. Direct immunofluorescence (DIF) showed deposits of IgG and complement along the epidermal basement membrane, in the presence or absence of IgA and/or IgM. A positive indirect immunofluorescence on salt-split skin demonstrating dermal binding was observed in two cases. All of them had moderate/severe disease activity at diagnosis with median Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) of 18 (14-24). Two patients received dapsone and one with severe nephritis received immunosuppressive drugs. In conclusion, in the last 30 years the prevalence of bullous lupus in childhood-onset lupus population was low (1%) in our tertiary University Hospital. A diagnosis of SLE should always be considered in children with recurrent tense vesiculobullous lesions with or without systemic manifestations.
  • article 48 Citação(ões) na Scopus
    Exposure to Air Pollutants and Disease Activity in Juvenile-Onset Systemic Lupus Erythematosus Patients
    (2015) FERNANDES, Elisabeth C.; SILVA, Clovis A.; BRAGA, Alfesio L. F.; SALLUM, Adriana M. E.; CAMPOS, Lucia M. A.; FARHAT, Sylvia C. L.
    ObjectiveTo investigate the association between exposure to air pollutants in the Sao Paulo metropolitan area and disease activity in juvenile-onset systemic lupus erythematosus (SLE) patients. MethodsA longitudinal panel study based on 409 consecutive visits of juvenile-onset SLE patients living in the Sao Paulo metropolitan area was carried out. Disease activity was evaluated in accordance with the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), and the patients were divided into 2 groups: those with SLEDAI scores 8 and those with SLEDAI scores >8. Daily concentrations of inhaled particulate matter (PM10), sulfur dioxide, nitrogen dioxide (NO2), ozone, and carbon monoxide (CO) were evaluated on the 21 days preceding the medical visits. A generalized estimation equation model was used to assess the impact of these measurements on SLEDAI-2K scores, considering the fixed effects for repetitive measurements. The models were adjusted for erythrocyte sedimentation rate, corticosteroid use (daily and cumulative doses), antimalarial use, the use of immunosuppressive agents, the presence of infection 20 days preceding the medical appointment, and the minimum temperature and relative humidity outdoors. ResultsPM(10), NO2, and CO were risk factors for juvenile-onset SLE disease activity (SLEDAI-2K score >8) approximately 2 weeks after exposure. A 13.4 g/m(3) increase in the PM10 moving average (from lag 12 to lag 15) was associated with a 34% increase (95% confidence interval 7.0-68.0) in the risk of a SLEDAI-2K score >8. ConclusionThis is the first study to show that exposure to inhaled pollutants may increase the risk of disease activity in children with juvenile-onset SLE in a large urban center.
  • article 2 Citação(ões) na Scopus
    Dose-sparing effect of two adjuvant formulations with a pandemic influenza A/H7N9 vaccine: A randomized, double-blind, placebo-controlled, phase 1 clinical trial
    (2022) VANNI, Tazio; THOME, Beatriz C.; SPARROW, Erin; FRIEDE, Martin; FOX, Christopher B.; BECKMANN, Anna Marie; HUYNH, Chuong; MONDINI, Gabriella; SILVEIRA, Daniela H.; VISCONDI, Juliana Y. K.; BRAGA, Patricia Emilia; SILVA, Anderson da; SALOMAO, Maria da Graca; PIORELLI, Roberta O.; SANTOS, Joane P.; GATTAS, Vera Lucia; LUCCHESI, Maria Beatriz B.; OLIVEIRA, Mayra M. M. de; KOIKE, Marcelo E.; KALLAS, Esper G.; CAMPOS, Lucia M. A.; COELHO, Eduardo B.; SIQUEIRA, Marilda A. M.; GARCIA, Cristiana C.; MIRANDA, Milene Dias; PAIVA, Terezinha M.; TIMENETSKY, Maria do Carmo S. T.; ADAMI, Eduardo A.; AKAMATSU, Milena A.; HO, Paulo Lee; PRECIOSO, Alexander R.
    The emergence of potentially pandemic viruses has resulted in preparedness efforts to develop candidate vaccines and adjuvant formulations. We evaluated the dose-sparing effect and safety of two distinct squalene-based oil-in-water adjuvant emulsion formulations (IB160 and SE) with influenza A/H7N9 antigen. This phase I, randomized, double-blind, placebo-controlled, dose-finding trial (NCT03330899), enrolled 432 healthy volunteers aged 18 to 59. Participants were randomly allocated to 8 groups: 1A) IB160 + 15 mu g H7N9, 1B) IB160 + 7.5 mu g H7N9, 1C) IB160 + 3.75 mu g H7N9, 2A) SE + 15 mu g H7N9, 2B) SE + 7.5 mu g H7N9, 2C) SE + 3.75 mu g H7N9, 3) unadjuvanted vaccine 15 mu g H7N9 and 4) placebo. Immunogenicity was evaluated through haemagglutination inhibition (HI) and microneutralization (MN) tests. Safety was evaluated by monitoring local and systemic, solicited and unsolicited adverse events (AE) and reactions (AR) 7 and 28 days after each study injection, respectively, whereas serious adverse events (SAE) were monitored up to 194 days post-second dose. A greater increase in antibody geometric mean titers (GMT) was observed in groups receiving adjuvanted vaccines. Vaccinees receiving IB160-adjuvanted formulations showed the greatest response in group 1B, which induced an HI GMT increase of 4.7 times, HI titers >= 40 in 45.2% of participants (MN titers >= 40 in 80.8%). Vaccinees receiving SE-adjuvanted vaccines showed the greatest response in group 2A, with an HI GMT increase of 2.5 times, HI titers >= 40 in 22.9% of participants (MN titers >= 40 in 65.7%). Frequencies of AE and AR were similar among groups. Pain at the administration site and headache were the most frequent local and systemic solicited ARs. The vaccine candidates were safe and the adjuvanted formulations have a potential dose-sparing effect on immunogenicity against influenza A/H7N9. The magnitude of this effect could be further explored.