scholarly journals Immunogenicity and safety of subunit influenza vaccines in pregnant women

2018 ◽  
Vol 4 (2) ◽  
pp. 00060-2017 ◽  
Author(s):  
Mikhail P. Kostinov ◽  
Alexander P. Cherdantsev ◽  
Nelli K. Akhmatova ◽  
Daria A. Praulova ◽  
Aristitsa M. Kostinova ◽  
...  

Pregnancy is a condition of modulated immune suppression, so this group of patients has increased risk of infectious diseases.Trivalent subunit vaccines, unadjusted Agrippal S1 (group I) and immunoadjuvant Grippol Plus (group II), containing 5 μg of actual influenza virus strains, were administered respectively to 37 and 42 women in the second and third trimester of physiological pregnancy.The administration of subunit influenza vaccines was accompanied by the development of local reactions in no more than 10% of patients, compared with 4.9% of the 41 pregnant women in the placebo group (group III). Systemic reactions were of a general somatic nature, did not differ between vaccinated and placebo groups, and were not associated with vaccination. Physiological births in groups I, II and III were 94.6%, 92.9% and 85.4%, respectively, and the birth rates of children without pathologies were 91.9%, 90.5% and 80.5%, respectively, and were comparable between groups. Vaccination stimulated the production of protective antibodies against influenza virus strains in 64.8–94.5% of patients after immunisation with an unadjusted vaccine and in 72.5–90.0% of patients after the administration of an immunoadjuvant vaccine. After 9 months, antibody levels were recorded in 51.3–72.9% in group I and 54.2–74.2% in group II. Immunisation against influenza in pregnant women provided a high level of seroprotection and seroconversion. Nevertheless, the level of seroprotection against the influenza strain A(H3N2, Victoria) was slightly lower in the group immunised with an unadjusted vaccine compared to those vaccinated with the immunoadjuvant vaccine.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 715-715
Author(s):  
Rupert M. Bauersachs ◽  
Joachim Dudenhausen ◽  
Andree Faridi ◽  
Thorsten Fischer ◽  
Samson Fung ◽  
...  

Abstract Women with a history of VTE, thrombophilia or both are at increased risk for VTE during pregnancy, but the optimal management strategy, and the need for thromboprophylaxis is not well defined in clinical guidelines because of limited trial data. The EThIG (Efficacy of Thromboprophylaxis as an Intervention during Gravidity) is a multicenter trial that prospectively enrolled 810 pregnant women at risk of VTE. Women were assigned to one of 3 management strategies: Low risk group I (including women with prior secondary VTE, or asymptomatic thrombophilia) with “watchful waiting” management, and dalteparin prophylaxis postpartum (50–100 IU/kg), or earlier if additional risk factors occurred; high risk group II (e.g. idiopathic VTE or symptomatic thrombophilia) receiving 50–100 IU/kg dalteparin; and very high-risk group III (e.g. acute VTE, prior long-term OAC, symptomatic AT-deficiency or antiphospholipid syndrome), receiving 100–200 IU/kg dalteparin. Primary efficacy outcome measure was symptomatic VTE, main safety outcome measures were haemorrhages, osteoporosis, thromboctopenia and pregnancy outcome. Results (mean ± SD / 95% CI): 810 women (age 30.8±5.4 years, weight 73.6±16.1kg) were enrolled, 28 % in group I, 58 % in II and 14% in III, including 66 women with acute VTE. 60.1% had prior VTE, 75.4% had thrombophilia (42.1 % FV-Leiden, 2.1 % homozygous, 9.5 % FII G20210A, 4.1% PC-, 1 % AT-deficiency; 17.4 % APS). 35.8 % had previous miscarriage, still birth or physical malformation. Comorbid conditions included lupus erythematosus, liver transplantation, ventricular septum defect, paraplegia, hepatitis C, nephrotic syndrome, asthma, chronic haemolytic anaemia, thalassaemia, osteoporosis and thrombocytopaenia. Median treatment initiation was at 17.0 weeks, at 24.0 weeks in group I, 14.5 weeks in group II and 16.0 weeks for group III. Mean daily dose was 66.2 ± 22.5 IU per kg (group I), 76.8 ± 24.1 IU per kg (group II) and 120.0 ± 49.1 IU per kg (group III). Objectively confirmed, symptomatic VTE occurred in 5 of 810 women (0.6%;0.2–1.5%). The rate of serious bleeding was 3.0% (1.9–4.4%), 0.9% (0.3–1.8%) occurred in the antepartum period, 2.1% (1.3–3.4%) peri-partum;1.1% (0.5–2.2%) was possibly heparin-related. There was no evidence of heparin-induced thrombocytopenia, and one case of osteoporosis (fracture of the saccygous bone during delivery). There were 94.4% successful pregnancies, 40 foetuses (4.9%; 3.6–6.7%) were lost due to miscarriage, 7 due to elective termination. Risk-stratified heparin prophylaxis was associated with a low incidence of symptomatic venous thromboembolism and few clinically important adverse events. Antepartum heparin prophylaxis is warranted in pregnant women with prior idiopathic thrombosis or symptomatic thrombophilia.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eissa Khalifa ◽  
Alaa El-Sateh ◽  
Mohamed Zeeneldin ◽  
Ahmed M. Abdelghany ◽  
Mahmoud Hosni ◽  
...  

Abstract Background This study aims to detect the effects of increased BMI on labor outcomes in primigravida pregnant women. Methods A cross-sectional study involved 600 full-term singleton primigravida pregnant women who presented in the active phase of labor to the labor ward. They were divided according to BMI into three equals groups; women with normal BMI (group I), overweight women (group II), and women with class I obesity (group III). Results We found that high BMI was associated with a significantly increased risk of Caesarean section (C.S.) (13% in group I, 18% in group II and 40% in group III). Women with higher BMI and delivered vaginally had a significantly prolonged first and second stage of labor, consequently increased the need for oxytocin augmentation as well as the oxytocin dose. Regarding the maternal and fetal outcomes, there are significantly increased risks of postpartum sepsis, perineal tears, wound infection, as well as significantly increased birth weight and longer neonatal stay in the neonatal unit (NNU). Conclusion Obese primigravida pregnant women were at higher risk of suboptimal outcomes. Besides, prolonged first and second stages of labor and the incidence of C.S. have also been increased.


1998 ◽  
Vol 83 (8) ◽  
pp. 2886-2891 ◽  
Author(s):  
Vallabh O. Shah ◽  
Marina Scavini ◽  
Jovanka Nikolic ◽  
Yijuan Sun ◽  
Silvia Vai ◽  
...  

abstract Epidemiological studies support the hypothesis that genetic factors modulate the risk for diabetic nephropathy (DN). Aldose reductase (ALDR1), the rate-limiting enzyme in the polyol pathway, is a potential candidate gene. The present study explores the hypothesis that polymorphisms of the (A-C)n dinucleotide repeat sequence, located 2.1 kb upstream of the transcription start site, modulate ALDR1 gene expression and the risk for DN. We conducted studies at two different institutions, the University of New Mexico Health Sciences Center (UNMHSC), and the Istituto Scientifico H San Raffaele (HSR). There were four groups of volunteers at UNMHSC: group I, normal subjects; group II, patients with insulin-dependent diabetes mellitus (IDDM) without DN; group III, IDDM with DN; and group IV, nondiabetics with kidney disease. At HSR we studied volunteers in groups I, II, and III. ALDR1 genotype was assessed by PCR and fluorescent sequencing of the (A-C)n repeat locus, and ALDR1 messenger ribonucleic acid (mRNA) was measured by ribonuclease protection assay in peripheral blood mononuclear cells. At UNMHSC we identified 10 alleles ranging from Z−10 to Z+8. The prevalence of the Z−2 allele among IDDM patients was increased in those with DN. Sixty percent of group III and 22% of group II were homozygous for Z−2. Moreover, 90% and 67% of groups III and II, respectively, had 1 or more copy of Z−2. In contrast, among nondiabetics, 19% of group IV and 3% of group I were homozygous for Z−2, and 69% and 32%, respectively, had 1 copy or more of Z−2. Among diabetics, homozygosity for the Z−2 allele was associated with renal disease [odds ratio (OR), 5.25; 95% confidence interval, 1.71–17.98; P = 0.005]. ALDR1 mRNA levels were higher in patients with DN (group III; 0.113 ± 0.050) than in group I (0.068 ± 0.025), group II (0.042 ± 0.020), or group IV (0.015 ± 0.011; P < 0.01). Among diabetics, ALDR1 mRNA levels were higher in Z−2 homozygotes (0.098 ± 0.06) and Z−2 heterozygotes (0.080 ± 0.04) than in patients with no Z−2 allele (0.043 ± 0.02; P < 0.05). In contrast, among nondiabetics, ALDR1 mRNA levels in Z−2 homozygotes (0.034 ± 0.04) and Z−2 heterozygotes (0.038 ± 0.03) were similar to levels in patients without a Z−2 allele (0.047 ± 0.03; P = NS). At HSR we identified eight alleles ranging from Z−12 to Z+2. The prevalence of the Z−2 allele was higher in group III than in group II. In group III, 43% of the patients were homozygous for Z−2, and 81% had one copy or more of the Z−2 allele. In contrast, in group II, 4% were homozygous for Z−2, and 36% had one copy or more of the Z−2 allele. IDDM patients homozygous for Z−2 had an increased risk for DN compared with those lacking the Z−2 allele (OR, 18; 95% confidence interval, 2–159). IDDM patients who had one copy or more of Z−2 had increased risk (OR, 7.5; 95% confidence interval, 1.9–29.4) for DN compared with those without the Z−2 allele. These results support our hypothesis that environmental-genetic interactions modulate the risk for DN. Specifically, the Z−2 allele, in the presence of diabetes and/or hyperglycemia, is associated with increased ALDR1 expression. This interaction may explain the observed association between the Z−2 allele and DN.


Author(s):  
Sairam Vankadara ◽  
Padmaja K ◽  
Praveen Kumar Balmuri ◽  
Naresh G ◽  
Vikas Reddy G

Objectives: The aim was to evaluate and compare pretreatment serum C-reactive protein (CRP) levels in patients with oral premalignancies and malignancies with that in healthy controls. Materials and Methods: The study sample consisted of 90 patients of both genders. The subjects were divided into three groups. Group I comprised 30 healthy controls, while group II included 30 patients with potential oral malignancies including leukoplakia, oral submucous fibrosis (OSMF), and oral lichen planus (OLP), and group III included 30 squamous cell carcinoma (SCC) patients confirmed by histopathological examination. All samples were subjected to CRP analysis. Serum CRP levels were quantitatively determined using the automated immunoturbidimetric method. Results: In group I, CRP levels were ranging from 0.1 to 18.3 mg/l with the mean ± standard deviation (SD) CRP level of 3.88±4.50 mg/l. In group II, CRP levels were ranging from 0.8 to 53.9 mg/l with the mean ± SD CRP level of 5.59±9.86 mg/l. In group III, CRP levels were ranging from 3.3 to 96 mg/l with the mean ± SD CRP level of 31.72±31.01 mg/l. Conclusions: According to the results, prediagnostic concentrations of CRP are associated with subsequent development of oral cancer and suggest that plasma CRP level is a potential marker of increased risk of cancer


2000 ◽  
Vol 38 (11) ◽  
pp. 3967-3970 ◽  
Author(s):  
Yasuhiro Suzuki ◽  
Raymund Ramirez ◽  
Cindy Press ◽  
Shuli Li ◽  
Stephen Parmley ◽  
...  

We examined the efficiency of detection of immunoglobulin M (IgM) antibodies to a 35-kDa antigen (P35) of Toxoplasma gondiifor serodiagnosis of acute infection in pregnant women. A double-sandwich enzyme-linked immunosorbent assay (ELISA) with recombinant P35 antigen (P35-IgM-ELISA) was used for this purpose. On the basis of the clinical history and the combination of results from the toxoplasma serological profile (Sabin-Feldman dye test, conventional IgM and IgA ELISAs, and the differential agglutination test), the patients were classified into three groups: group I, status suggestive of recently acquired infection; group II, status suggestive of infection acquired in the distant past; group III, status suggestive of persisting IgM antibodies. Eighteen (90.0%) of 20 serum samples from group I patients were positive by the P35-IgM-ELISA, whereas none of the 33 serum samples from group II patients were positive. Only 4 (25.0%) of 16 serum samples from group III patients were positive by the P35-IgM-ELISA, whereas all these serum samples were positive by the conventional IgM ELISA. These results indicate that demonstration of IgM antibodies against P35 by the P35-IgM-ELISA is more specific for the acute stage of the infection than demonstration of IgM antibodies by the ELISA that uses a whole-lysate antigen preparation. Studies with sera obtained from four pregnant women who seroconverted (IgG and IgM antibodies) during pregnancy revealed that two of them became negative by the P35-IgM-ELISA between 4 and 6 months after seroconversion, whereas the conventional IgM ELISA titers remained highly positive. The P35-IgM-ELISA appears to be useful for differentiating recently acquired infection from those acquired in the distant past in pregnant women.


Author(s):  
Esengul Turkyilmaz ◽  
Selma Tural Hesapcioglu

<p><strong>Objective:</strong> Child/adolescent 'marriages' and following pregnancies have adverse effects both on the child and adolescent mother.<br />The aim of this study is to detect whether the adult pregnant women who have previous adolescent pregnancy more susceptible to the depression and anxiety than current adolescent pregnants and the adult pregnant women who have no adolescent pregnancy history. </p><p><strong>Study Design:</strong> This cross sectional study evaluated a total of 163 pregnant women who attended to our antenatal clinic. Subjects aged between 16 and 43 years including both adolescent and adult pregnant women were divided into three groups. These groups are current adolescent pregnant women (Group I), adult pregnant women who have adolescent pregnancy history (Group II), adult pregnant women who have no adolescent pregnancy history (Group III). Three groups were compared in terms of the pregnancy status, socio-demographic variables and depression-anxiety scores.</p><p><strong>Result:</strong> In the current study the highest depression and anxiety scores were observed in Group II [depression scores’ median (IQR) values respectively 5 (8.5) points for Group I, 12.5 (8.5) for Group II, 9 (12) for Group III (p&lt;0.001 between Group I and Group II for BDI comparison). Anxiety scores’ median (IQR) values respectively 19.5 (15.5) for group II, 9 (15.5) for group I, 14 (15.25) for Group III (p=0.005 between Group I and Group II for BAI comparison). </p><p><strong>Conclusion:</strong> Marriage and pregnancy at an early age are considered as risk factors for psychiatric morbidity in the next pregnancy. Therefore, women with a history of teenage pregnancy should be carefully monitored for depression and anxiety symptoms.</p>


2018 ◽  
Vol 25 (1) ◽  
Author(s):  
Zinovii Ozhohan ◽  
Andrii Biben

The objective of the research was to study and assess the quality of prosthetic treatment using aesthetic fixed restorations.Materials and methods. The study included 79 patients without a comorbidity who underwent prosthetic rehabilitation. All the patients were divided into 3 groups: Group I included 25 patients with metal-plastic restorations; Group II comprised 34 patients with porcelain-fused-to-metal restorations; Group III consisted of 20 patients with a combined occlusal surface of prosthetic restorations. The patients were observed 6 months after prosthetic repair. Only patients with single molar and premolar crowns were examined. Bridge prostheses were not taken into account in order to eliminate the effect of masticatory force redistribution on the abutment crowns.Results. In Group I, 11 (44%) patients were satisfied with the results of prosthetic treatment. In Group II, 25 (78.12%) patients reported that they were satisfied with their treatment. In Group III, there were 17 (85%) patients satisfied with their outcome. However, the patients’ complaints are often subjective and do not fully reflect the objective state of the dentoalveolar system. An objective examination revealed that in indirect restorations, marginal periodontium pathology is typical. Conclusions. Aesthetic fixed restorations with a combined occlusal surface have demonstrated good clinical results, even at long-term follow-up. Combining positive properties of two different construction materials, namely zirconium dioxide and ceramics, they reduce the risk of complications such as marginal periodontium pathology and chipping along the occlusal surface as well as contribute to minimal abrasion of the occlusal surfaces of the antagonistic teeth. We cannot recommend metal-plastic restorations due to their low clinical effectiveness, poor aesthetic qualities as well as a high level of marginal periodontium pathology.


2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Hulya Ozdemir ◽  
Ipek Akman ◽  
Senay Coskun ◽  
Utku Demirel ◽  
Serap Turan ◽  
...  

Aim.To investigate obstetric features of pregnant women with thyroid disorders and thyroid function tests of their newborn infants.Methods.Women with hypothyroidism and having anti-thyroglobulin (ATG) and anti-thyroid peroxidase (anti-TPO) antibodies were assigned as group I, women with hypothyroidism who did not have autoantibodies were assigned as group II, and women without thyroid problems were assigned as group III.Results.Pregnant women with autoimmune hypothyroidism (group I) had more preterm delivery and their babies needed more frequent neonatal intensive care unit (NICU) admission. In group I, one infant was diagnosed with compensated hypothyroidism and one infant had transient hyperthyrotropinemia. Five infants (23.8%) in group II had thyroid-stimulating hormone (TSH) levels >20 mIU/mL. Only two of them had TSH level >7 mIU/L at the 3rd postnatal week, and all had normal free T4 (FT4). Median maternal TSH level of these five infants with TSH >20 mIU/mL was 6.6 mIU/mL. In group III, six infants (6.5%) had TSH levels above >20 mIU/mL at the 1st postnatal week.Conclusion.Infants of mothers with thyroid problems are more likely to have elevated TSH and higher recall rate on neonatal thyroid screening. Women with thyroid disorders and their newborn infants should be followed closely for both obstetrical problems and for thyroid dysfunction.


Author(s):  
L.E. Tumanova ◽  
◽  
E.V. Kolomiets ◽  

Purpose — to study the indicators of quality of life in pregnant women with a history of different types of infertility. Materials and methods. The study of quality of life indicators was carried out in 127 women aged 20 to 49 years, 97 of whom had a history of infertility of various origins and 30 pregnant women who had it. The distribution of pregnant women into groups was based on the factor of infertility: Group I — 35 pregnant women with a history of endocrine infertility, Group II — 37 pregnant women with a history of inflammatory infertility, Group III — 25 pregnant women with a history of combined infertility of inflammatory genesis with endocrine, Group IV (control) — 30 healthy pregnant women who did not have a history of infertility. The method of assessing quality of life was the WHOQOL-BREF Short Questionnaire. Results. The indicators of quality of life and general health, according to the subjective assessment of the patients, were the lowest in group III — 2.5±0.10 points and 2.1±0.05 points. In group I patients, the score was 3.1±0.15 points and 3.2±0.20 points and in group II — 3.2±0.10 points and 3.3±0.07 points, respectively. It should be noted that the most positive assessment of these indicators took place in the control group of pregnant women — 5.0±0.3 points. Thus, the physical functioning was assessed by the patients of group III at 16.7±1.1 points, and self+perception — at 20.5±1.6 points. A patient of groups I and II with a history of infertility assessed these indicators — 18.2±1.3 points; 23.4±1.5 points and 19.5±1.4 points; 22.6±1.6 points, respectively. The women in the control group had higher scores — 24.7±1.8 points; 25.7±1.7 points. Microsocial support in groups I, II, III was assessed 8.2±0.3 points; 9.3±0.5 points; 7.7±0.2 points, but in the control group — 13.7±0.1 points. The indicators of social well+being were 22.4±1.8 points; 23.5±1.9 points; 20.6±1.5 in groups I, II, III, and in the control group — 36.4±2.1 points. Conclusions. In women who became pregnant after long-term treatment of infertility in anamnesis, there was a significant deterioration in quality of life indicators compared with healthy women, which is explained by the high incidence of obstetric complications in them. Determination of quality of life indicators in women with a history of infertility is an integral part of monitoring during pregnancy, which allows adequate assessment and timely correction of physical, social and psycho-emotional functions in the interests of the mother and the fetus. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of these Institutes. The informed consent of the patient was obtained for conducting the studies. No conflict of interest was declared by the authors. Key words: short WHO questionnaire, quality of life assessment, pregnancy after infertility.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yunsuk Choi ◽  
Ki-Bum Won ◽  
Hyeon Hui Kang ◽  
Hyuk-Jae Change

Abstract Background The serum hemoglobin (Hb) level is closely related to adverse clinical outcomes. However, data on the association of Hb levels with subclinical atherosclerosis beyond metabolic abnormalities are limited. Methods This study evaluated the association among serum Hb level, metabolic syndrome (MetS), and the risk of carotid plaque formation in asymptomatic adults without a history of major adverse clinical events. Results A total of 2560 participants (mean age: 60 ± 8 years, 32.9% men) were stratified into four groups based on Hb quartiles, as follows: ≤ 12.8 g/dL (group I), 12.9–13.6 g/dL (group II), 13.7–14.5 g/dL (group III), and ≥ 14.6 g/dL (group IV). The overall prevalence of MetS and carotid plaque was 37.2% and 33.4%, respectively. The prevalence of MetS increased with increasing Hb level (group I: 27.4% vs. group II: 35.9% vs. group III: 42.6% vs. group IV: 44.1%, p < 0.001). The prevalence of carotid plaque was 34.3%, 28.1%, 32.8%, and 39.5% in groups I, II, III, and IV, respectively. Univariate logistic regression analysis showed that MetS was associated with an increased risk of carotid plaque (odds ratio [OR] 1.568, 95% confidence interval [CI] 1.326–1.856, p < 0.001). Only group II showed a lower risk of carotid plaque than group I (OR 0.750, 95% CI 0.596–0.943, p = 0.014). Multiple logistic regression models showed consistent results after adjusting for clinical factors, including MetS and its individual components. Conclusion Serum Hb level is associated with the risk of carotid plaque beyond MetS and its components in a relatively healthy adult population.


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