scholarly journals Randomized Controlled Study of the Safety and Immunogenicity of Pneumococcal Vaccine Formulations Containing PhtD and Detoxified Pneumolysin with Alum or Adjuvant System AS02Vin Elderly Adults

2014 ◽  
Vol 21 (5) ◽  
pp. 651-660 ◽  
Author(s):  
Karlis Pauksens ◽  
Anna C. Nilsson ◽  
Magalie Caubet ◽  
Thierry G. Pascal ◽  
Pascale Van Belle ◽  
...  
Keyword(s):  
Pneumococcal Vaccine ◽  
Geometric Mean ◽  
Aluminum Phosphate ◽  
Antibody Responses ◽  
Controlled Study ◽  
Control Group ◽  
Elderly Adults ◽  
Post Dose ◽  
Serious Adverse Events ◽  
Adjuvant System

ABSTRACTSix vaccine formulations containing AS02Vor alum (aluminum phosphate [AlPO4]) adjuvant with pneumococcal proteins, pneumococcal histidine triad D (PhtD), and/or detoxified pneumolysin (dPly), either as a polysaccharide carrier in an 8-valent pneumococcal conjugate vaccine (8PCV) or as free (unconjugated) proteins, were evaluated in adults -65 to 85 years of age. In this phase I observer-blind study, 167 healthy subjects were randomized to receive two doses (days 0 and 60) of 10 or 30 μg PhtD-dPly plus AS02Vor alum, 8PCV plus AS02Vor alum, or one dose (day 0) of 23-valent polysaccharide pneumococcal vaccine (23PPV) as a control (placebo on day 60). The safety, reactogenicity, and antibody-specific responses to these vaccines were evaluated. No vaccine-related serious adverse events were reported. The incidences of solicited local and specific general (fatigue and myalgia) symptoms tended to be higher in the AS02Vgroups than in other groups. Anti-PhtD and anti-Ply antibody responses were observed in all groups except the control group. One month post-dose 2, the anti-PhtD and anti-Ply antibody geometric mean concentrations tended to be higher with AS02Vthan with alum, higher with a dose of 30 μg than with 10 μg for PhtD-dPly and higher with 30-μg PhtD-dPly formulations than with conjugated PhtD and dPly (8PCV) formulations. Functional antibody responses, measured by an opsonophagocytic activity assay, tended to be higher with 8PCV than with 23PPV. In conclusion, vaccine formulations containing free or conjugated PhtD and dPly had acceptable reactogenicity and safety profiles in elderly adults. Immune responses were enhanced with an AS02V-adjuvanted formulation containing free 30-μg PhtD-dPly compared to those with alum adjuvant and conjugated proteins. (This study has been registered atClinicalTrials.govunder registration no. NCT00756067.)

scholarly journals Determination of Antibody Responses of Elderly Adults to All 23 Capsular Polysaccharides after Pneumococcal Vaccination

1999 ◽  
Vol 67 (11) ◽  
pp. 5979-5984 ◽  
Author(s):  
Jeffrey B. Rubins ◽  
Michael Alter ◽  
Joyce Loch ◽  
Edward N. Janoff
Keyword(s):  
Immune Responses ◽  
Pneumococcal Vaccine ◽  
Geometric Mean ◽  
Pneumococcal Vaccination ◽  
Antibody Responses ◽  
Elderly Subjects ◽  
Invasive Infection ◽  
Elderly Adults ◽  
Vaccine Serotypes ◽  
Low Responders

ABSTRACT The 23-valent pneumococcal polysaccharide vaccine was formulated to prevent invasive infection in the elderly and other high-risk populations from the most prevalent Streptococcus pneumoniae serotypes. However, the immunogenicity of all 23 vaccine polysaccharides has not been fully characterized in elderly adults. We previously reported that whereas the majority of elderly subjects had vigorous immune responses to selected pneumococcal vaccine polysaccharides, a subset of elderly individuals responded to fewer than two of seven vaccine serotypes after immunization. To determine whether these elderly low responders have a general inability to respond to pneumococcal vaccine and to determine whether elderly low responders might be identified by their responses to a few polysaccharides, we measured antibody responses of elderly adults to all 23 vaccine polysaccharides after pneumococcal immunization. As a group, elderly subjects showed a significant rise after immunization in geometric mean antibody levels to all 23 vaccine serotypes. However, when individual rather than group immune responses were assessed, the 23-valent vaccine did not appear to be uniformly immunogenic in these elderly subjects. Eleven elderly subjects (20%) had twofold increases in specific antibody after vaccination to only 5 or fewer of the 23 vaccine polysaccharides, and they did not respond to the most prevalent serotypes causing invasive disease. Antibody responses to serotype 9N were found to reliably distinguish low vaccine responders from other elderly subjects. However, no particular group of vaccine polysaccharides could be used as a marker for adequate immune responses if only postvaccination sera were analyzed.

scholarly journals Effect on Cellular and Humoral Immune Responses of the AS03 Adjuvant System in an A/H1N1/2009 Influenza Virus Vaccine Administered to Adults during Two Randomized Controlled Trials

2011 ◽  
Vol 18 (5) ◽  
pp. 835-843 ◽  
Author(s):  
François Roman ◽  
Frédéric Clément ◽  
Walthère Dewé ◽  
Karl Walravens ◽  
Cathy Maes ◽  
...  
Keyword(s):  
T Cell ◽  
Geometric Mean ◽  
Influenza Virus Vaccine ◽  
Antibody Responses ◽  
Post Dose ◽  
H1n1 Vaccine ◽  
Water Emulsion ◽  
Adjuvanted Vaccine ◽  
Humoral Immune ◽  
Adjuvant System

ABSTRACTThe influence of AS03A, a tocopherol oil-in-water emulsion-based adjuvant system, on humoral and cell-mediated responses to A/California/7/2009 H1N1 pandemic vaccine was investigated. In two observer-blind studies, a total of 261 healthy adults aged 18 to 60 years were randomized to receive either AS03A-adjuvanted H1N1 vaccine containing 3.75 μg hemagglutinin (HA) or nonadjuvanted H1N1 vaccine containing 15 or 3.75 μg HA on days 0 and 21. Hemagglutination inhibition (HI) antibody and T-cell responses were analyzed up to day 42. A first dose of AS03A-adjuvanted vaccine (3.75 μg HA) or nonadjuvanted vaccine (15 μg HA) induced HI responses of similar magnitudes that exceeded licensure criteria (e.g., 94 to 100% with titers of ≥40). A lower response following 3.75 μg HA without adjuvant was observed (73% with titers of ≥40). Following a second dose, geometric mean HI titers at day 42 were higher for AS03A-adjuvanted vaccine (636 and 637) relative to nonadjuvanted vaccine (341 for 15 μg HA and 150 for 3.75 μg HA). Over the 42-day period, the increase in frequency of A/H1N1/2009-specific CD4+T cells was significantly higher in the adjuvanted group than in the nonadjuvanted group. There was no evidence of correlation between baseline CD4+T-cell frequencies and day 21 HI antibody titers, while there was some correlation (R= 0.35) between day 21 CD4+T-cell frequencies and day 42 HI titers. AS03Aadjuvant enhanced the humoral and CD4+T-cell-mediated responses to A/H1N1/2009 vaccine. Baseline A/H1N1/2009-specific CD4+T-cell frequencies did not predict post-dose 1 antibody responses, but there was some correlation between post-dose 1 CD4+T-cell frequencies and post-dose 2 antibody responses.

scholarly journals A Reduced Dose Whole Virion Aluminum Adjuvanted Seasonal Influenza Vaccine Is Immunogenic, Safe, and Well Tolerated in Pediatric Patients

Viruses ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 500
Author(s):  
Zoltan Vajo ◽  
Gergely Balaton ◽  
Peter Vajo ◽  
Peter Torzsa
Keyword(s):  
Pediatric Patients ◽  
Geometric Mean ◽  
Age Groups ◽  
Aluminum Phosphate ◽  
Vaccine Virus ◽  
Serious Adverse Events ◽  
Reduced Dose ◽  
Viral Hemagglutinin ◽  
Virus Strains ◽  
Two Age Groups

Background: Data suggest that pediatric patients might react differently to influenza vaccination, both in terms of immunity and side effects. We have recently shown that using a whole virion vaccine with aluminum phosphate adjuvants, reduced dose vaccines containing 6 µg of viral hemagglutinin (HA) per strain are immunogenic, and well tolerated in adult and elderly patients. Here we show the results of a multicenter clinical trial of pediatric patients, using reduced doses of a new, whole virion, aluminum phosphate adjuvanted vaccine (FluArt, Budapest, Hungary). Methods: A total of 120 healthy volunteers were included in two age groups (3–11 years, receiving 3 µg of HA per strain, and 12–18 years, receiving 6 µg of HA per strain). We used hemagglutination inhibition testing to assess immunogenicity, based on EMA and FDA licensing criteria, including post/pre-vaccination geometric mean titer ratios, seroconversion and seropositivity rates. Safety and tolerability were assessed using CHMP guidelines. Results: All subjects entered the study and were vaccinated (ITT population). All 120 subjects attended the control visit on Day 21 (PP population). All immunogenicity licensing criteria were met in both age groups for all three vaccine virus strains. No serious adverse events were detected and the vaccine was well tolerated by both age groups. Discussion: Using a whole virion vaccine and aluminum phosphate adjuvants, a reduction in the amount of the viral hemmaglutinin is possible while maintaining immunogenicity, safety and tolerability in pediatric and adolescent patients.

scholarly journals Safety, Immunogenicity, and Antibody Persistence following an Investigational Streptococcus pneumoniae and Haemophilus influenzae Triple-Protein Vaccine in a Phase 1 Randomized Controlled Study in Healthy Adults

2013 ◽  
Vol 21 (1) ◽  
pp. 56-65 ◽  
Author(s):  
Johan Berglund ◽  
Peter Vink ◽  
Fernanda Tavares Da Silva ◽  
Pascal Lestrate ◽  
Dominique Boutriau
Keyword(s):  
T Cell ◽  
Haemophilus Influenzae ◽  
Phase 1 ◽  
Geometric Mean ◽  
Controlled Study ◽  
Protein Vaccine ◽  
Serious Adverse Events ◽  
Content Type ◽  
Antibody Persistence ◽  
Systemic Symptoms

ABSTRACTWe investigated a protein-based nontypeableHaemophilus influenzae(NTHi) and pneumococcal (HiP) vaccine containing pneumococcal histidine triad D (PhtD), detoxified pneumolysin (dPly), and NTHi protein D (PD) in adults. In a phase I study, 40 healthy 18- to 40-year-old subjects were randomized (2:2:1) to receive two HiP doses administered 60 days apart, with or without AS03 adjuvant (HiP-AS and HiP groups, respectively), or Engerix B (GlaxoSmithKline, Belgium) as a control. Safety, antibodies, and antigen-specific CD4+T-cell immune responses were assessed before and until 480 days after vaccination. No serious adverse events were reported, and no subject withdrew due to an adverse event. Local and systemic symptoms were reported more frequently in the HiP-AS group than in the other two groups. The frequency and intensity of local and systemic symptoms appeared to increase after the second dose of HiP-AS or HiP but not Engerix B. Antibody geometric mean concentrations (GMCs) for PhtD, dPly, and PD increased after each dose of HiP-AS or HiP, with higher GMCs being observed in the HiP-AS group (statistically significant for anti-PD after dose 1 and anti-Ply after dose 2). GMCs remained higher at day 420 than prior to vaccination in both the HiP-AS and HiP groups. Antigen-specific CD4+T cells increased after each dose but were unmeasurable by day 480. Two doses of an investigational PhtD-dPly-PD protein vaccine induced humoral immunity and antigen-specific CD4+T-cell responses after each dose, with generally higher responses when the vaccine was administered with AS03. HiP combined with AS03 appeared to be more reactogenic than the antigens alone. (This study has been registered at ClinicalTrials.gov under registration no. NCT00814489.)

scholarly journals Persistence of Immune Response to an Adjuvanted Varicella-Zoster Virus Subunit Candidate Vaccine for up to Year 9 in Older Adults

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S415-S415 ◽  
Author(s):  
Karlis Pauksens ◽  
Stephanie Volpe ◽  
Tino F Schwarz ◽  
Jan Smetana ◽  
Nicole Toursarkissian ◽  
...  
Keyword(s):  
Immune Responses ◽  
Varicella Zoster Virus ◽  
Geometric Mean ◽  
Intracellular Cytokine Staining ◽  
Post Dose ◽  
Serious Adverse Events ◽  
Activation Markers ◽  
Varicella Zoster ◽  
Age Cohorts ◽  
Humoral Immune

Abstract Background In the ZOE-50 and ZOE-70 clinical trials, the candidate herpes-zoster subunit vaccine (HZ/su; 50µg varicella-zoster virus glycoprotein E [gE] and AS01B Adjuvant System) demonstrated high efficacy against HZ, with limited waning over 4 years and consistent efficacy across age cohorts. In adults ≥60 years of age, the immune responses elicited by 2 HZ/su doses administered 2 months apart persisted for at least 6 years.1 Here we report immunogenicity and safety 9 years post-initial vaccination. Methods This Phase IIIB, open, long-term extension study (NCT02735915) followed 70 participants who received 2 HZ/su doses in the initial trial (NCT00434577). Blood samples to evaluate the persistence of cellular (intracellular cytokine staining) and humoral (ELISA) immune responses were taken at 9 years post-initial vaccination. Limited safety follow-up was performed (1 visit). Results All 70 participants (mean age at dose 1: 72.3 years; 61.4% female) were included in the according-to-protocol analysis. The fold increases over pre-vaccination in the frequency of gE-specific CD4+ T-cells expressing ≥2 activation markers plateaued after 4 years post-dose 1 (year 4: 3.4, year 5: 3.0, year 6: 3.4, year 9: 3.4). Anti-gE antibody geometric mean concentrations were also stable from year 4 onwards (Table 1) and remained above the pre-vaccination value of 1213.1mIU/mL. Cellular and humoral responses at year 9 were similar across age strata (60–69, ≥70 years). No vaccine-related serious adverse events nor suspected HZ episodes were reported. Conclusion In adults ≥60 years of age, HZ/su-induced cellular and humoral immune responses remained above pre-vaccination levels for at least 9 years post-initial vaccination, confirming immune persistence predictions2 based on 6-year data. Disclosures S. Volpe, GSK: Employee, Salary; T. F. Schwarz, GSK: Investigator and Scientific Advisor, Consulting fee; J. Smetana, GSK: Investigator, personal fees; 
S. Ravault, GSK: Employee, GSK shares and Salary; M. P. David, GSK: Employee, Salary and stock; A. Bastidas, GSK: Employee, Salary; L. Oostvogels, GSK: Employee and Shareholder, Salary and shares

scholarly journals 636. Immunogenicity, Safety and Tolerability of a Booster Dose of Clostridium difficile Vaccine and 4 Year Antibody Persistence

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S378-S378
Author(s):  
Shon A Remich ◽  
Nicholas Kitchin ◽  
Michael W Pride ◽  
Annaliesa S Anderson ◽  
Ping Li ◽  
...  
Keyword(s):  
Safety Profile ◽  
Booster Dose ◽  
Geometric Mean ◽  
Primary Vaccination ◽  
The United States ◽  
Post Dose ◽  
Serious Adverse Events ◽  
Antibody Persistence ◽  
Dose Levels ◽  
To Receive

Abstract Background Clostroidides difficile (C difficile) is a common cause of antibiotic-associated diarrhea. To date, there is no vaccine to prevent C. difficile infection (CDI). This extension of a phase 2 study explores the immunogenicity, safety, and tolerability of a 4th dose, and antibody persistence of a three-dose regimen of a toxoid-based C difficile vaccine in 300 healthy adults 65 to 85 years of age in the United States. Methods The first stage of this study was conducted from 16 July 2015 to 7 March 2017, in which subjects were enrolled and randomized to receive one of two antigen dose levels (100µg or 200µg total toxoid A and B) or placebo, administered in one of two three-dose regimens: Days 1, 8 & 30 or Months 0, 1 & 6. Immunogenicity testing was conducted on samples obtained at each of nine study visits through 12 months post dose 3. In this extension stage, subjects who had received vaccine in the first stage were re-randomized at 12 months post dose 3 to receive either a booster dose or placebo in a 1:1 ratio. Subjects were followed for immunogenicity three (3) years post booster (four years post dose #3) Results Peak antibody response to vaccination was observed between day 8 and 30 following booster administration. Both regimens demonstrated robust anamnestic responses with peak levels above the three-dose peak (stage 1). Toxin A geometric mean concentrations (GMCs) remained above pre-booster GMCs, 3 years post booster for both dose levels and regimens. Antibody persistence for both groups demonstrated stable antibody levels four years after the primary vaccination series among subjects who did not receive a booster dose. No Grade 4 reactogenicity was reported during the study. Pain was the most common local reaction. Adverse event rates per subject were similar between both regimens and placebo. There were no Serious Adverse Events (SAEs) considered related to the investigational product at any dose or regimen. The safety profile was consistent with what was seen in the first stage of the study. Conclusion A booster dose of Clostroidides difficile vaccine candidate is highly immunogenic, well tolerated and demonstrates an acceptable safety profile in both dose groups for the Day and the Month regimens. Antibody persistence remains stable from 12 months to 4-year post dose 3. Disclosures Nicholas Kitchin, MD, Pfizer, Inc (Employee) Michael W. Pride, PhD, Pfizer (Employee, Shareholder) Annaliesa S. Anderson, PhD, Pfizer (Employee, Shareholder) Chris Webber, MD, Pfizer Inc (Employee, Shareholder)

scholarly journals Immunogenicity and Safety of Porcine Circovirus-Free Human Rotavirus Vaccine in Healthy Infants: A Phase 3 Randomized Trial

2020 ◽  
Author(s):  
Ignacio Salamanca de la Cueva ◽  
Barbara Pahud ◽  
Li-Min Huang ◽  
Michael Leonardi ◽  
José Garcia-Sicilia ◽  
...  
Keyword(s):  
Adverse Events ◽  
Limit Of Detection ◽  
Geometric Mean ◽  
Porcine Circovirus Type ◽  
Porcine Circovirus ◽  
Rotavirus Vaccine ◽  
Post Dose ◽  
Serious Adverse Events ◽  
Healthy Infants ◽  
Human Rotavirus

Abstract Background Porcine circovirus type 1 (PCV-1) material was detected in the human rotavirus vaccine (HRV) in 2010. In this study we compared immunogenicity and safety of the PCV-free HRV vaccine (PCV-free HRV) with HRV. PCV-free HRV is an HRV with no detectable PCV-1 and PCV-2 according to the limit of detection of the tests used. Methods Healthy infants 6–12 weeks of age were randomized (1:1:1:1) to receive 2 doses of 1 of the 3 lots of PCV-free HRV or HRV. The study objectives were to demonstrate lot-to-lot consistency of the PCV-free HRV and noninferiority of PCV-free HRV as compared to HRV in terms of immunogenicity, 1–2 months post dose 2. Reactogenicity and safety were also assessed. Results Overall, 1612 infants were enrolled and 1545 completed the study. Study objectives were demonstrated because the predefined criteria were met. Among participants receiving PCV-free HRV and HRV, 79.27% and 81.76% seroconverted and geometric mean concentrations were 159.5 and 152.8 U/mL, respectively. The incidences of adverse events and serious adverse events were similar between the pooled PCV-free HRV and HRV groups. Conclusions The 3 PCV-free HRV lots demonstrated consistency and PCV-free HRV was noninferior compared to HRV in terms of immunogenicity. Clinical trials registration NCT02914184.

Morphometric analysis of peroxisomes in hepatocytes of alcohol-fed rats

1989 ◽  
Vol 47 ◽  
pp. 1100-1101
Author(s):  
D.C. Dominguez ◽  
J.T. Ellzey
Keyword(s):  
Caloric Intake ◽  
Volume Density ◽  
Controlled Study ◽  
Control Group ◽  
Numerical Density ◽  
Cacodylate Buffer ◽  
Paired Control ◽  
Experimental Group ◽  
Liver Peroxisomes ◽  
Single Lesion

Peroxisomes which participate in 1ipid metabolism have been shown to be altered in several metabolic disorders and toxic conditions. In alcoholic liver disease, the single lesion most frequently found is lipid accumu1ation in hepatocytes. However, the mechanisms for this 1ipid accumu1ation are not clear. The occurrence of modifications of liver peroxisomes due to excess alcohol consumption has not been subjected to a controlled study. We utilized a combination of cytochemica1 and morphometrictechniques to study the size and number of liver peroxisomes in rats fed an alcohol-supplemented diet compared to those of matched-paired control animals.Male Sprague-Daw1ey rats (400-500 g) received a liquid diet. The experimental group (N = 5/group) was fed a diet containing 30% ethanol-derived calories (EDC) and the control group was fed an isocaloric diet to 30% EDC. A pair feeding procedure was employed to control for caloric intake. Small pieces of liver randomly selected, were fixed in 2.3% -glutaraldehyde in 0.1 M sodium cacodylate buffer, pH 7.2, incubated in a DAB medium and postfixed with. 2% aqueous osmium tetroxide. EM photographs were taken from sections of 3 tissue blocks from each sample (7,200X) with a Zeiss EM10-A (60 kV). With the use of a point counting method and a digital planimeter the volume density (Vv) and numerical density (Nv) were determined.

Deep Vein Thrombosis and Fibrinolysis

1991 ◽  
Vol 66 (04) ◽  
pp. 426-429 ◽  
Author(s):  
Marcel Levi ◽  
Anthonie W A Lensing ◽  
Harry R Büller ◽  
Paolo Prandoni ◽  
Gerard Dooijewaard ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Plasminogen Activator ◽  
Plasminogen Activator Inhibitor ◽  
Tissue Type ◽  
Controlled Study ◽  
First Episode ◽  
Control Group ◽  
Vein Thrombosis ◽  
Type Plasminogen Activator ◽  
Deep Vein

SummaryIn the present study 57 consecutive patients with a first episode of venographically proven deep vein thrombosis were investigated to evaluate the release of tissue-type plasminogen activator (t-PA) and of urokinase-type plasminogen activator (u-PA) in response to DDAVP stimulation as well as the resting plasminogen activator inhibitor (PAI) concentration, comparing this to the results obtained in 66 similar patients with a clinical suspicion of thrombosis but with a normal venogram. All assays were performed without knowledge of the patient's status.Four patients in the deep vein thrombosis-group (7%) had an absent u-PA antigen response upon DDAVP infusion, while a normal response was observed in all control subjects. Patients and controls showed similar increases in t-PA antigen level upon DDAVP. High resting PAI antigen levels were encountered in 5 patients in the deep vein thrombosis-group (9%) and in 6 subjects in the control group (9%).The results from this controlled study indicate that a defective release of u-PA may occur in patients with deep vein thrombosis and may have pathogenetic significance. Furthermore it is concluded that elevation of PAI levels cannot be considered as a specific risk factor for venous thrombosis.

A Randomized Controlled Study of the Effectiveness of Electrophysiological Monitoring of Dexmedetomidine in Patients with Brain Damage of Various Origins

2020 ◽  
Vol 75 (5) ◽  
pp. 490-499
Author(s):  
Yuri Y. Kiryachkov ◽  
Marina V. Petrova ◽  
Bagautdin G. Muslimov ◽  
Sergey A. Bosenko ◽  
Mikhail M. Gorlachev
Keyword(s):  
Intervention Group ◽  
Clinical Effectiveness ◽  
Protective Role ◽  
Digital Data ◽  
Controlled Study ◽  
Control Group ◽  
Average Dose ◽  
Autonomic Nervous System Dysfunction ◽  
Sympathetic Hyperactivity ◽  
Starting Dose

Background.At the same time, the main effect of the use of this drug is the elimination of the autonomic nervous system dysfunction and sympatholysis. It seems important to search for a method of indications and selection of a dose of dexmedetomidine in intensive care.Aims to improve the clinical effectiveness of the electrophysiological navigation of the prolonged use of dexmedetomidine in patients with brain pathology of various origins.Methods.The study included 83 patients 2050 days after the traumatic brain injury, anoxic damage; consequences of acute disorders of cerebral. 37 patients comprised the 1st intervention group with a clinical course of dexmedetomidine (male 28; female 9; average age 49.62.3 years) and 46 patients comprised the 2nd control group without pharmacological correction with dexmedetomidine (male 23; female 23, average age 512.5 years). Criteria for the inclusion of prolonged infusion of the drug dexmedetomidine (Orion Pharma, Finland) are based on heart rate variability (HRV) indicators characteristic of sympathetic hyperactivity, the target task of titration of doses of dexmedetomidine served as the parameters for achieving normal HRV indicators, the appearance of parasympathetic hyperactivity served as the basis for reducing the dosage of the drug or stopping it of application. HRV parameters were recorded before dexmetomedine infusion-initially, on 13; 45; 910; 1520 days of drug administration.Results.The starting dose of dexmedetomidine with sympathetic hyperactivity in patients was 0.12 to 0.24 g.kg1.hr1(average dose 0.160.01; total 200 mg/day). According to digital data from HRV, the effective dose of dexmedetomidine ED50 was 0.260.03 g.kg1.hr1(total daily 353.835.1 g) and was achieved on day 910 using dexmedetomidine.Conclusions.The protective role of dexmedetomidine with correction of sympathetic hyperactivity based on electrophysiological navigation according to the HRV is reliable in the following indicators: The improvement of consciousness; a significant decrease in the incidence of distress lung syndrome; septic shock; mortality.

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