scholarly journals Randomized, triple-blind, placebo-controlled study to evaluate the safety of 6′-Sialyllactose in healthy adults

2021 ◽  
pp. 105110
Author(s):  
Ji Hyun Kim ◽  
Sung Hoon Kim ◽  
Ahreum Baek ◽  
Tae-Hwa Go ◽  
Dae-Ryong Kang ◽  
...  
Keyword(s):  
Healthy Adults ◽  
Controlled Study

scholarly journals 902. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of a Single Immunization of Ad26.RSV.preF against RSV Infection in a Viral Challenge Model in Healthy Adults

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S27-S28 ◽  
Author(s):  
John DeVincenzo ◽  
Efi Gymnopoulou ◽  
Els De Paepe ◽  
Bryan Murray ◽  
Arangassery Rosemary Bastian ◽  
...  
Keyword(s):  
Disease Severity ◽  
Healthy Adults ◽  
Controlled Study ◽  
Clinical Strain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Qrt Pcr ◽  
Rsv Infection ◽  
First Time ◽  
Over Time

Abstract Background Despite the high disease burden of RSV in older adults and children, there is currently no approved vaccine. Ad26.RSV.preF, an experimental RSV vaccine, has demonstrated immunogenicity and tolerability in first-in-human clinical studies. The aim of this study was to assess the potential of the Ad26.RSV.preF vaccine to protect against RSV infection and disease in an established RSV human challenge model, used for the first time to evaluate a vaccine. Methods We conducted a randomized, double-blind, placebo-controlled, human challenge study (NCT03334695). Healthy adults received 1 × 1011 vp Ad26.RSV.preF vaccine (active) or placebo (pbo) intramuscularly. After 28 days, volunteers were challenged intranasally with a low-passage clinical strain of RSV-A (0.8 mL of Memphis 37b) and then quarantined for 12 days. Nasal washes were collected twice daily throughout quarantine, starting 2 days post-challenge (viral load [VL] by qRT-PCR and quantitative cultures). Disease severity was recorded thrice daily using symptom diary cards. Results Fifty-three volunteers (active, n = 27; pbo, n = 26) were challenged with RSV-A. Quantitative viral assessments were consistently lower in active than pbo. The primary endpoint of the study was met: the area under the curve (AUC) for RSV VL over time (via qRT-PCR) was significantly lower in active pbo (P = 0.012). Median peak VL was lower for active (0 log10 copies/mL) than pbo (5.4 log10 copies/mL). Median AUC for RSV VL over time (quantitative culture) was lower for active than pbo (0 vs. 109, P = 0.002). Disease severity was lower for active than pbo, with a median AUC total symptom score of 35 (active) vs. 167 (pbo) (P = 0.002). Overall, RSV infection (defined by qRT-PCR alone or combined with symptoms) and disease severity over time were lower in active vs. pbo. Conclusion RSV infections, VL, and RSV disease severity were consistently lower in healthy adults receiving Ad26.RSV.preF vs. placebo, demonstrating promising protection from RSV infection and disease. This was the first time that antiviral prevention was observed against RSV after active immunization. Ad26.RSV.preF warrants further evaluation in field trials for efficacy against natural RSV infections in populations considered at risk of severe RSV disease. Disclosures All Authors: No reported Disclosures.

scholarly journals A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults

Vaccines ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 296
Author(s):  
Irina Kiseleva ◽  
Irina Isakova-Sivak ◽  
Marina Stukova ◽  
Marianna Erofeeva ◽  
Svetlana Donina ◽  
...  
Keyword(s):  
Adverse Events ◽  
Influenza Vaccine ◽  
Phase 1 ◽  
Healthy Adults ◽  
Controlled Study ◽  
Temperature Sensitive ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Human Influenza Virus ◽  
Live Attenuated Influenza Vaccine

This study describes a double-blind randomized placebo-controlled phase I clinical trial in healthy adults of a new potential pandemic H7N9 live attenuated influenza vaccine (LAIV) based on the human influenza virus of Yangtze River Delta hemagglutinin lineage (ClinicalTrials.gov Identifier: NCT03739229). Two doses of H7N9 LAIV or placebo were administered intranasally to 30 and 10 subjects, respectively. The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events. Vaccine virus was detected in nasal swabs during the 6 days after vaccination or revaccination. A lower frequency of shedding was observed after the second vaccination. Twenty-five clinical viral isolates obtained after the first and second doses of vaccine retained the temperature-sensitive and cold-adapted phenotypic characteristics of LAIV. There was no confirmed transmission of the vaccine strain from vaccinees to placebo recipients. After the two H7N9 LAIV doses, an immune response was observed in 96.6% of subjects in at least one of the assays conducted.

A controlled study analyzing the temporal activity patterns of individuals with stroke compared to healthy adults

2019 ◽  
Vol 82 (5) ◽  
pp. 288-295
Author(s):  
İbrahim Yavuz Tatlı ◽  
Burcu Semin Akel
Keyword(s):  
Activity Pattern ◽  
Activity Patterns ◽  
Healthy Adults ◽  
Controlled Study ◽  
Healthy Controls ◽  
Daily Routines ◽  
Type 1 Error ◽  
Meaningful Activity ◽  
Temporal Aspect

Introduction The understanding of the temporal pattern of individuals can add a wider perspective to interventions. Therefore, the present study is aimed toward analysis of the temporal activity pattern of individuals with stroke compared to healthy adults. Method This study is a prospective, case–control, analytic research study. The study sample comprised 50 individuals with stroke and 50 individuals without disease, for 80% power with a 5% type 1 error. The Modified Occupational Questionnaire was administered to assess the temporal activity pattern. Individuals identified the activities performed at each hour of the day and data was analyzed. Results The temporal activity pattern of individuals with stroke differed from healthy controls; education and play activities were not part of stroke participants’ daily routines. Also, participation in work, leisure and social participation activities was significantly different for people with stroke compared to healthy controls ( p < 0.01 ). The study group assigned very low values to the activities; the value perceived by individuals differed significantly between groups ( p < 0.01 ). Conclusion Clinicians are in a position to enable individuals’ time use and help to engage them in meaningful activity. Individuals with stroke may benefit from a program focusing on the temporal aspect of activities.

Electrocardiographic and Hemodynamic Effects of Panax Ginseng

2002 ◽  
Vol 36 (5) ◽  
pp. 758-763 ◽  
Author(s):  
Michael F Caron ◽  
Audrea L Hotsko ◽  
Stacy Robertson ◽  
Lilia Mandybur ◽  
Jeffrey Kluger ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Panax Ginseng ◽  
Study Drug ◽  
Healthy Adults ◽  
Controlled Study ◽  
Qtc Interval ◽  
Double Blind ◽  
Ginseng Extract ◽  
Days Of Therapy

OBJECTIVE: To determine whether Panax ginseng ingestion can acutely or chronically alter electrocardiographic parameters: PR, QRS, QT, QTc, and RR intervals, and QT and QTc interval dispersion. Effects of P. ginseng on blood pressure and heart rate also were evaluated. METHODS: This is a prospective, randomized, double-blind, placebo-controlled study of healthy adults at the University of Connecticut. Thirty subjects were randomly allocated to receive 28 days of therapy with either P. ginseng extract 200 mg or placebo. Baseline 12-lead electrocardiograms (ECGs) were obtained. Subsequent ECGs were performed following study drug ingestion at 50 minutes, 2 hours, and 5 hours on days 1 and 28. Blood pressure readings were taken with each ECG. RESULTS: P. ginseng ingestion increased the QTc interval by 0.015 seconds on day 1 at 2 hours compared with the placebo group (p = 0.03). It also reduced diastolic blood pressure from 75 ± 5 mm Hg at baseline to 70 ± 6 mm Hg at the same time point (p = 0.02). The observed effects are not believed to be clinically significant. No other statistically significant changes were found in electrocardiographic or hemodynamic variables on days 1 or 28. CONCLUSIONS: P. ginseng, at doses of 200 mg of the extract daily, increases the QTc interval and decreases diastolic blood pressure 2 hours after ingestion in healthy adults on the first day of therapy.

scholarly journals Effect of Acute Acai (Euterpe oleracea Mart.) Supplementation on Postprandial Glycaemia in Healthy Adults: A Pilot Randomised Controlled Study

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 853-853
Author(s):  
Kyriaki Myrissa ◽  
Paul Chappell ◽  
Eirini Kelaiditi
Keyword(s):  
Dietary Intervention ◽  
Disease Risk ◽  
Blood Glucose Concentration ◽  
Healthy Adults ◽  
Controlled Study ◽  
Euterpe Oleracea ◽  
Double Blind ◽  
Postprandial Glycaemia ◽  
Significant Difference ◽  
Acai Berry

Abstract Objectives Anthocyanin rich foods may ameliorate postprandial glycaemia. Postprandial glycaemia is associated with Type 2 Diabetes and a risk factor for cardiovascular disease. Acai berry is high in anthocyanins and has received attention for its health benefits. However, human trials are limited. The objective of the present study was to investigate the effect of acai berry extract on postprandial glycaemia responses in healthy adults. Methods Ten healthy participants, aged 18–65 years (mean 33 ± 16), with a body mass index (BMI) of 18.5–24.9 kg/m2 (mean 22.2 ± 1.5) completed a randomized, controlled, double-blind, crossover, acute dietary intervention trial. Participants consumed either an acai-based smoothie (AS) containing 150g acai pulp or a macronutrient-matched control placebo smoothie (PS). The primary endpoint was blood glucose concentration (BGC) which was determined by a capillary sampling method at baseline and at regular intervals up to 2 hours postprandially. Results Consumption of acai resulted in lower mean BGC compared to placebo (5.38 ± 0.46mmol/l vs. 5.40 ± 0.63mmol/l), but this was not significant (p = 0.888), even after controlling for age and BMI. There was no significant difference in BGC incremental area under the curve (iAUC) for acai relative to placebo. Conclusions In this acute study on heathy adults of a wide age range, acai consumption was not associated with improvements in postprandial glycaemia. Future long-term, adequately powered intervention studies, assessing additional biomarkers of disease risk are needed to fully elucidate the benefits of acai to health. Funding Sources None.

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