scholarly journals An in-depth investigation of the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine

2020 ◽  
Author(s):  
Jing Pu ◽  
Qin Yu ◽  
Zhifang Yin ◽  
Ying Zhang ◽  
Xueqi Li ◽  
...  
Keyword(s):  
Yunnan Province ◽  
Adverse Reactions ◽  
Cytotoxic T Lymphocyte ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Serum Samples ◽  
N Protein ◽  
Human Natural Killer Cells ◽  
Double Blinded ◽  
Different Doses

AbstractBACKGROUNDIn-depth investigations of the safety and immunogenicity of inactivated SARS-CoV-2 vaccines are needed.METHODIn a phase I randomized, double-blinded, and placebo-controlled trial involving 192 healthy adults 18-59 years of age, two injections of three different doses (50 EU, 100 EU and 150 EU) of an inactivated SARS-CoV-2 vaccine or the placebo were administered intramuscularly with a 2- or 4-week interval between the injections. The safety and immunogenicity of the vaccine were evaluated within 28 days.FINDINGIn this study, 191 subjects assigned to three doses groups or the placebo group completed the 28-day trial. There were 44 adverse reactions within the 28 days, most commonly mild pain and redness at the injection site or slight fatigue, and no abnormal variations were observed in 48 cytokines in the serum samples of immunized subjects. The serum samples diluted from 1:32 to 1:4096 and incubated with the virus did not show antibody-dependent enhancement effects (ADEs) with regard to human natural killer cells, macrophages or dendritic cells. At day 14, the seroconversion rates had reached 92%, 100% and 96% with geometric mean titers (GMTs) of 18.0, 54.5 and 37.1, and at day 28, the seroconversion rates had reached 80%, 96% and 92% with GMTs of 10.6, 15.4 and 19.6in 0, 14 and 0, 28 procedures, respectively. Seroconversion was associated with the synchronous upregulation of ELISA antibodies against the S protein, N protein and virion and a cytotoxic T lymphocyte (CTL) response. Transcriptome analysis shaped the genetic diversity of immune response induced by the vaccine.INTERPRETATIONIn a population aged 18-59 years, this inactivated SARS-CoV-2 vaccine was safe and immunogenic.Trial registrationNCT04412538FUNDINGThe National Key R&D Program of China (2020YFC0849700), the Program of Chinese Academy of Medicine Science and the Major Science and Technology Special Projects of Yunnan Province.

scholarly journals Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in Healthy Adults

2020 ◽  
Author(s):  
Yanchun Che ◽  
Xiaoqiang Liu ◽  
Yi Pu ◽  
Meijian Zhou ◽  
Zhimei Zhao ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Adverse Reactions ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Neutralizing Antibody ◽  
Healthy Adults ◽  
High Dose ◽  
Serious Adverse Events ◽  
Phase 2 Trial ◽  
Double Blinded

Abstract Background We evaluated an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine for immunogenicity and safety in adults aged 18–59 years. Methods In this randomized, double-blinded, controlled trial, healthy adults received a medium dose (MD) or a high dose (HD) of the vaccine at an interval of either 14 days or 28 days. Neutralizing antibody (NAb) and anti-S and anti-N antibodies were detected at different times, and adverse reactions were monitored for 28 days after full immunization. Results A total of 742 adults were enrolled in the immunogenicity and safety analysis. Among subjects in the 0, 14 procedure, the seroconversion rates of NAb in MD and HD groups were 89% and 96% with geometric mean titers (GMTs) of 23 and 30, respectively, at day 14 and 92% and 96% with GMTs of 19 and 21, respectively, at day 28 after immunization. Anti-S antibodies had GMTs of 1883 and 2370 in the MD group and 2295 and 2432 in the HD group. Anti-N antibodies had GMTs of 387 and 434 in the MD group and 342 and 380 in the HD group. Among subjects in the 0, 28 procedure, seroconversion rates for NAb at both doses were both 95% with GMTs of 19 at day 28 after immunization. Anti-S antibodies had GMTs of 937 and 929 for the MD and HD groups, and anti-N antibodies had GMTs of 570 and 494 for the MD and HD groups, respectively. No serious adverse events were observed during the study period. Conclusions Adults vaccinated with inactivated SARS-CoV-2 vaccine had NAb as well as anti-S/N antibody and had a low rate of adverse reactions. Clinical Trials Registration NCT04412538.

scholarly journals Safety and Immunogenicity of a Shigella Bivalent Conjugate Vaccine (ZF0901) in 3-Month- to 5-Year-Old Children in China

Vaccines ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 33
Author(s):  
Yi Mo ◽  
Wenjian Fang ◽  
Hong Li ◽  
Junji Chen ◽  
Xiaohua Hu ◽  
...  
Keyword(s):  
Immune Responses ◽  
Conjugate Vaccine ◽  
Adverse Reactions ◽  
Geometric Mean ◽  
Age Groups ◽  
Specific Serum ◽  
Covalently Bonded ◽  
Double Blinded ◽  
Infants And Young Children ◽  
Number Of Injections

No licensed Shigella vaccine is presently available globally. A double-blinded, randomized, placebo-controlled, age descending phase II clinical trial of a bivalent conjugate vaccine was studied in China. The vaccine ZF0901 consisted of O-specific polysaccharides purified and detoxified from lipopolysaccharide (LPS) of S. flexneri 2a and S. sonnei and covalently bonded to tetanus toxoid. A total of 224, 310, and 434 children, consented by parents or guardians, aged 3 to 6 and 6 to 12 months and 1 to 5 years old, respectively, were injected with half or full doses, with or without adjuvant or control Hib vaccine. There were no serious adverse reactions in all recipients of ZF0901 vaccine independent of age, dosage, number of injections, or the adjuvant status. Thirty days after the last injection, ZF0901 induced robust immune responses with significantly higher levels of type-specific serum antibodies (geometric mean concentrations (GMCs) of IgG anti-LPS) against both serotypes in all age groups compared with the pre-immune or the Hib control (p < 0.0001). Here, we demonstrated that ZF0901 bivalent Shigella conjugate vaccine is safe and immunogenic in infants and young children and is likely suitable for routine immunization.

scholarly journals Does selenium supplementation affect thyroid function? Results from a randomized, controlled, double-blinded trial in a Danish population

2015 ◽  
Vol 172 (6) ◽  
pp. 657-667 ◽  
Author(s):  
Kristian Hillert Winther ◽  
Steen Joop Bonnema ◽  
Frederik Cold ◽  
Birgit Debrabant ◽  
Mads Nybo ◽  
...  
Keyword(s):  
Thyroid Function ◽  
Controlled Trial ◽  
Selenium Supplementation ◽  
Serum Samples ◽  
Free Triiodothyronine ◽  
Autoimmune Thyroid Diseases ◽  
Autoimmune Thyroid ◽  
Treatment Groups ◽  
Double Blinded ◽  
Serum Tsh

ObjectiveSelenium is present in the active site of proteins important for thyroid hormone synthesis and metabolism. The objective of this study is to investigate the effect of selenium supplementation in different doses on thyroid function, under conditions of suboptimal dietary selenium intake.DesignThe Danish PREvention of Cancer by Intervention with SElenium pilot study (DK-PRECISE) is a randomized, double-blinded, placebo-controlled trial. A total of 491 males and females aged 60–74 years were randomized to 100 μg (n=124), 200 μg (n=122), or 300 μg (n=119) selenium-enriched yeast or matching yeast-based placebo tablets (n=126). A total of 361 participants, equally distributed across treatment groups, completed the 5-year intervention period.MethodsPlasma samples were analyzed for selenium and serum samples for TSH, free triiodothyronine (FT3), and free thyroxine (FT4) at baseline, and after 6 months, and 5 years of supplementation.ResultsPlasma selenium concentrations increased significantly and dose-dependently in treatment groups receiving selenium (P<0.001). Serum TSH and FT4concentrations decreased significantly and dose-dependently by 0.066 mIU/l (P=0.010) and 0.11 pmol/l (P=0.015), respectively, per 100 μg/day increase, with insignificant differences between 6 months and 5 years. No significant effects were found for FT3and FT3:FT4ratio.ConclusionsIn euthyroid subjects, selenium supplementation minutely and dose-dependently affects thyroid function, when compared with placebo, by decreasing serum TSH and FT4concentrations. Based on these findings, selenium supplementation is not warranted under conditions of marginal selenium deficiency. However, a role for selenium supplementation in the treatment of autoimmune thyroid diseases is still unresolved.

scholarly journals Analgesic effects of intra-articular ropivacaine following arthroscopic knee surgery: Results of a double-blind, randomized controlled trial between two different doses

2014 ◽  
Vol 6 (1) ◽  
pp. 81-86
Author(s):  
Rajdip Hazra ◽  
Md. Babrak Manuar ◽  
SM Manjunatha ◽  
Sisir Chakraborty ◽  
Kaushik Ghosh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Knee Surgery ◽  
Rescue Analgesia ◽  
Arthroscopic Knee Surgery ◽  
Analgesic Effects ◽  
Randomized Controlled ◽  
Arthroscopic Knee ◽  
Double Blinded ◽  
Different Doses

Background: Though local anesthetic agents are widely used to provide postoperative analgesia in intra-articular route, their efficacy is not accepted universally. Objective: The present study has been conducted to compare the analgesic effects of intra-articular ropivacaine between two different doses following arthroscopic knee surgery. Study design: Double-blinded randomized controlled trial. Total 60 patients of ASA (American Society of Anesthesiologists) physical status I and II, 34 male and 26 female, aged between 18 to 60 years, were randomized into 3 groups receiving 10 ml normal saline, 10 ml 0.5% ropivacaine and 10 ml 0.75% ropivacaine respectively, administered in intra-articular space at the end of operation. Results: Ropivacaine groups had significantly delayed first post-operative rescue analgesic request with significantly lesser requirement of rescue analgesia in first 24 hours (p<0.001 in both cases). Except 6th post-operative hours, ropivacaine groups also showed significantly less VAS scores (Visual Analogue Scale) up to 12 hours post-operatively (p<0.05). Conclusion: In our double-blinded randomized controlled trial, administration of intra-articular 0.75% ropivacaine showed superior analgesic efficacy following arthroscopic knee surgery. Further, larger trials are needed to confirm our findings. DOI: http://dx.doi.org/10.3126/ajms.v6i1.9703 Asian Journal of Medical Sciences Vol.6(1) 2015 81-86

scholarly journals Safety and efficacy of the ChAdOx1 nCoV-19 (AZD1222) Covid-19 vaccine against the B.1.351 variant in South Africa

2021 ◽  
Author(s):  
Shabir A. Madhi ◽  
Vicky Baillie ◽  
Clare L. Cutland ◽  
Merryn Voysey ◽  
Anthonet L. Koen ◽  
...  
Keyword(s):  
South Africa ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Serum Samples ◽  
Serious Adverse Events ◽  
Live Virus ◽  
Safety And Efficacy ◽  
Primary Endpoints ◽  
Gates Foundation ◽  
Double Blinded

AbstractBackgroundAssessing safety and efficacy of Covid-19 vaccines in different populations is essential, as is investigation of efficacy against emerging SARS-CoV-2 variants of concern including the B.1.351 (501Y.V2) variant first identified in South Africa.MethodsWe conducted a randomized multicentre, double blinded controlled trial on safety and efficacy of ChAdOx1-nCoV19 in HIV-uninfected people in South Africa. Participants age 18 to <65 years randomized (1:1) to two doses of vaccine containing 5×1010 viral particles or placebo (0.9%NaCl) 21-35 days apart. Post 2nd-dose serum samples (n=25) were tested by pseudotyped (PSVNA) and live virus (LVNA) neutralization assays against the D614G and B.1.351 variants. Primary endpoints were safety and vaccine efficacy (VE) >14 days following second dose against laboratory confirmed symptomatic Covid-19.Results2026 HIV-uninfected adults were enrolled between June 24th and Nov 9th, 2020; 1010 and 1011 received at least one dose of placebo or vaccine, respectively. Median age was 31 years. The B.1.351 variant showed increased resistance to vaccinee sera using the PSVNA and LVNA. In the primary endpoint analysis, 23/717 (3.2%) placebo and 19/750 (2.5%) vaccine recipients developed mild-moderate Covid-19; VE 21.9% (95%Confidence Interval: −49.9; 59.8). Of the primary endpoint cases, 39/42 (92.9%) were the B.1.351 variant; against which VE was 10.4% (95%CI: −76.8; 54.8) analyzed as a secondary objective. The incidence of serious adverse events was balanced between the vaccine and placebo groups.ConclusionsA two-dose regimen of ChAdOx1-nCoV19 did not show protection against mild-moderate Covid-19 due to B.1.351 variant, however, VE against severe Covid-19 is undetermined.(Funded by The Bill & Melinda Gates Foundation and South African Medical Research Council; ClinicalTrails.gov number, NCT04444674).

Therapeutic Effects of Hab Shabyar on Open-Angle Glaucoma: A Double-Blinded, Randomized, Placebo-Controlled Trial

2019 ◽  
Vol 8 ◽  
pp. 1218
Author(s):  
Ebrahim Khalil BaniHabib ◽  
Ali Mostafai ◽  
Seyyed Mohammad Bagher Fazljou ◽  
Ghadir Mohammdi
Keyword(s):  
Placebo Group ◽  
Intraocular Pressure ◽  
Open Angle Glaucoma ◽  
Controlled Trial ◽  
Intervention Group ◽  
Therapeutic Effects ◽  
Open Angle ◽  
The Mean ◽  
The Right ◽  
Double Blinded

Background: Open-angle glaucoma (OAG) is one of the leading causes of blindness worldwide. This study evaluates the therapeutic effects of hab shabyar in patients with open-angle glaucoma. Materials and Methods: In this clinical randomized controlled trial, 50 patients with OAG were randomized into two groups. The intervention group was received a drop of timolol plus 500 mg of hab shabyar every 12 hours. The placebo group was received a drop of timolol every 12 hours plus 500 mg of wheat germ as a placebo. The intraocular pressure in patients with OAG was measured in each group and compared at before the intervention (t1), one month (t2), and two months (t3) after the intervention. Results: The mean decrease in intraocular pressure for the right eye at three times in the intervention group was statistically significant, but the mean decrease in the placebo group was not significant. Similar results were obtained for the left eye at t1 when compared to t3. The patients in the intervention group expressed more satisfaction than the patients in the placebo group (P≤0.001). Conclusion: Our study demonstrated that consumption of timolol plus hab shabyar instead of consuming of timolol alone was probably more effective for reducing intraocular pressure in patients with OAG.[GMJ.2019;In press:e1218]

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