A RCT of a third dose CoronaVac or BNT162b2 vaccine in adults with two doses of CoronaVac

Background. Poor immunogenicity and antibody waning were found in vaccinees of CoronaVac. There is lack of randomized controlled trial (RCT) data to compare the immunogenicity and safety of schedules using homologous and heterologous vaccine as a booster dose. Methods. We randomly assigned adults who had received 2 doses of CoronaVac with low antibody response to receive an additional booster dose of either BNT162b2 or CoronaVac. The local and systemic adverse reactions were recorded. Levels of SARS-CoV-2 neutralizing and spike binding antibody in plasma were measured. Findings. At one month after the third dose of vaccine, BNT162b2 vaccines elicited significantly higher surrogate virus neutralizing test (sVNT), spike receptor binding, spike N terminal domain binding, spike S2 domain binding levels than CoronaVac. More participants from the BNT162b2 group reported injection site pain and swelling as well as fatigue and muscle pain than those who received CoronaVac as the third dose. The mean results of the sVNT against the wild type, beta, gamma and delta variants in the BNT162b2 boosted group was 96.83%, 92.29%, 92.51% and 95.33% respectively which were significantly higher than the CoronaVac boosted group (Wild type: 57.75%; Beta: 38.79 %; Gamma: 32.22%; Delta: 48.87%) Conclusion. Our RCT study shows that BNT162b2 booster dose for those people who poorly responded to the previous vaccination of CoronaVac is significantly more immunogenic than a CoronaVac booster. BNT162b2 also elicits higher levels of SARS-CoV-2 specific neutralizing antibodies to different variants of concern. The adverse reactions were only mild and short-lived.

Download Full-text

Safety and immunogenicity of anti-SARS CoV-2 conjugate vaccine SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults: Phase IIb Clinical Trial

10.1101/2022.01.01.21268271 ◽

2022 ◽

Author(s):

Maria Eugenia-Toledo-Romani ◽

Mayra Garcia-Carmenate ◽

Leslyhana Verdecia-Sanchez ◽

Suzel Perez-Rodriguez ◽

Meybis Rodriguez-Gonzalez ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Neutralizing Antibodies ◽

Seroconversion Rate ◽

Serious Adverse Events ◽

Double Blind ◽

The Third ◽

Functional Antibodies ◽

Dose Trial ◽

To Receive

Background: We report results of immunogenicity, safety and reactogenicity of SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults in a phase IIb clinical trial. Method: This phase IIb trial was designed as parallel, multicentre, adaptive, double blind, randomized and placebo-controlled. Subjects (N=810) aged 19-80 years were randomized to receive two doses of the recombinant SARS CoV-2 receptor binding domain (RBD) conjugated to tetanus toxoid (SOBERANA 02) and a third dose of dimeric RBD (SOBERANA Plus) 28 days apart; two production batches of active ingredient of SOBERANA 02 were evaluated. Primary outcome was the percentage of seroconverted subjects with ≥4-fold the anti-RBD IgG concentration. Secondary outcomes were safety, reactogenicity and neutralizing antibodies. Results: Seroconversion rate in vaccinees was respectively 76.3 and 96.8% after two or three doses, compared with 7.3% in placebo group. Anti-RBD IgG increased significantly after first and second dose of SOBERANA 02 respect to placebo group; and the third dose with SOBERANA Plus boosts the response compared to the second dose. Neutralizing IgG antibodies were detected against D614G and VOCs α, β and δ. Specific and functional antibodies were detected until 7-8 months after the third dose. The frequency of serious adverse events (AEs) associated with vaccination was very low (0.1%); with only one serious AE consistent with vaccination. Local pain was the most frequent AE. Conclusions: Two doses of SOBERANA 02 were well tolerated, safe an immunogenic in adults aged 19-80 years old. The heterologous combination with a third dose of SOBERANA Plus increased neutralizing antibodies, detectable 7-8 months after the third dose. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000347

Download Full-text

Design and rationale of randomized, double-blind trial of the efficacy and safety of pirfenidone in patients with fibrotic hypersensitivity pneumonitis

ERJ Open Research ◽

10.1183/23120541.00054-2021 ◽

2021 ◽

pp. 00054-2021

Author(s):

Evans R. Fernández Pérez ◽

James L. Crooks ◽

Jeffrey J. Swigris ◽

Joshua J. Solomon ◽

Michael P. Mohning ◽

...

Keyword(s):

Hypersensitivity Pneumonitis ◽

Controlled Trial ◽

Lung Parenchyma ◽

Double Blind ◽

Safety And Efficacy ◽

Secondary Endpoints ◽

The Mean ◽

Predicted Values ◽

Study Participants ◽

To Receive

Hypersensitivity pneumonitis (HP) is an immunologically mediated form of lung disease resulting from inhalational exposure to any of a large variety of antigens. A subgroup of patients with HP develops pulmonary fibrosis (fibrotic HP, FHP), a significant cause of morbidity and mortality. This study will evaluate the safety and efficacy of the antifibrotic pirfenidone in treating FHP.This single-center, randomized, double-blind, placebo-controlled trial is enrolling adults with FHP (ClinicalTrials.gov: NCT02958917). Study participants must have fibrotic abnormalities involving ≥5% of the lung parenchyma on high-resolution CT scan, forced vital capacity ≥40% and diffusing capacity of the lung for carbon monoxide ≥30% of predicted values. Study participants will be randomized in a 2:1 ratio to receive pirfenidone 2403 mg·d−1 or placebo. The primary efficacy endpoint is the mean change in %FVC from baseline to week 52. A number of secondary endpoints have been chosen to evaluate the safety and efficacy in different domains.

Download Full-text

Changes of Humoral Immunity Response in SARS-CoV-2 Convalescent Patients over 8 months

10.1101/2020.11.06.20227439 ◽

2020 ◽

Author(s):

Pai Peng ◽

Jie Hu ◽

Hai-jun Deng ◽

Bei-zhong Liu ◽

Kai Wang ◽

...

Keyword(s):

Neutralizing Antibodies ◽

Neutralizing Antibody ◽

Receptor Binding Domain ◽

Wild Type ◽

Sharp Rise ◽

Specific Igg ◽

The Mean ◽

Second Wave ◽

Igg Level ◽

A Current

AbstractMany countries around the world have all seen a sharp rise in COVID-19 cases as the second wave since the beginning of October 2020. Decline of antibodies response to severe acute respiratory syndrome coronavirus (SARS-CoV-2) that was reported exclusively in the early month increases the risk of reinfection for convalescent individuals. There is a current need to follow the maintenance of special antibodies against SARS-CoV-2. Here, we reported changes of antibodies against SARS-CoV-2 in convalescent patients over 8 months. Antibodies of all 20 participants targeting SARS-CoV-2 spike receptor binding-domain (RBD) had decreased from a mean OD450 value 1.78 to 0.38 over 8 months. The neutralizing antibody (NAb) titers decreased from the mean ID50 value 836 to 170. The NAb titers were significantly correlated with IgG level during 8 months (P<0.001). Furthermore, while RBD-specific IgG existence of 25% (5/20) convalescent plasma was undetectable, the NAb titers of 15% (3/20) convalescent plasma decreased below the threshold. In addition, compared to wild-type SARS-CoV-2 (S-D614), lower titers of neutralizing antibodies against its G614 variant were shown at 8 months after symptom onset. This study has important implications when considering antibody protection against SARS-CoV-2 reinfection.

Download Full-text

The effect of nadolol on heart rate in hyperthyroidism. A controlled trial

Acta Endocrinologica ◽

10.1530/acta.0.1140102 ◽

1987 ◽

Vol 114 (1) ◽

pp. 102-106

Author(s):

J. H. Lazarus ◽

J. C. Kingswood ◽

R. John

Keyword(s):

Heart Rate ◽

Placebo Group ◽

Controlled Trial ◽

Circadian Variation ◽

Maximum Heart Rate ◽

Double Blind ◽

Early Management ◽

The Mean ◽

To Receive ◽

Hyperthyroid Patients

Abstract. Twenty hyperthyroid patients were randomly assigned in a double-blind fashion to receive either nadolol 80 mg/day or placebo for 2 weeks; all patients then took carbimazole as well from 2–6 weeks. Twenty-four hour Holter ECG recordings at 0, 2 and 6 weeks showed that nadolol reduced the mean maximum heart rate by 19.9% (P < 0.0005) at 2 weeks and by 30.3% (P < 0.0005) at 6 weeks compared to 5.2% (ns) and 18.3% (P < 0.0005) in patients taking placebo. There was no alteration of the normal circadian variation of heart rate by nadolol. The minimum heart rate before therapy was significantly correlated with FT4 (r = 0.52) and with FT3 (r = 0.44). The percentage of time per hour during which the heart rate was greater than 100 was reduced by 79% at week 2 by nadolol compared to 22% in the placebo group. At the 6 week point the placebo group still had a tachycardia (mean maximum heart rate 101.6 beats/min ± 15.2 sd) compared to the nadolol group (80.4 ± 7.7). Nadolol did not cause excessive bradycardia. It is effective in the early management of hyperthyroidism and should be given for at least the first 4–6 weeks.

Download Full-text

Recombinant human erythropoietin treatment in cisplatin-associated anemia: a randomized, double-blind trial with placebo.

Journal of Clinical Oncology ◽

10.1200/jco.1994.12.5.1058 ◽

1994 ◽

Vol 12 (5) ◽

pp. 1058-1062 ◽

Cited By ~ 140

Author(s):

S Cascinu ◽

A Fedeli ◽

E Del Ferro ◽

S Luzi Fedeli ◽

G Catalano

Keyword(s):

Recombinant Human Erythropoietin ◽

Saline Solution ◽

Hemoglobin Level ◽

Double Blind ◽

The Third ◽

Human Erythropoietin ◽

Transfusion Requirements ◽

Erythropoietin Treatment ◽

The Mean ◽

To Receive

PURPOSE To evaluate the effect of exogenous recombinant human erythropoietin (rHuEPO) on the increase of hemoglobin levels and on the transfusion requirements in patients with cisplatin (CDDP)-induced anemia, we performed a double-blind randomized trial with placebo. PATIENTS AND METHODS One hundred patients with CDDP-associated anemia (hemoglobin level < 90 g/L) were randomized to receive either placebo (saline solution) or rHuEPO (100 U/kg body weight subcutaneously) three times per week. The end points of this study were the increase in hemoglobin levels to greater than 100 g/L after 3, 6, and 9 weeks and the effect on transfusion requirements. RESULTS Ninety-nine of 100 patients were assessable for response and toxicity. In the rHuEPO arm, mean hemoglobin levels were statistically significantly increased after the third, sixth, and ninth weeks of therapy (101.1 +/- 9.0, 102.4 +/- 6.6, and 105.1 +/- 9.4 g/L, respectively) compared with the mean baseline value (86.3 +/- 6.2 g/L). In the placebo arm, there were no increases in mean hemoglobin levels at the third, sixth, and ninth weeks (81.0 +/- 5.2, 81.3 +/- 9.2, and 81.2 +/- 11 g/L, respectively) compared with the mean baseline value (87.3 +/- 5.2 g/L). Furthermore only 20% of patients required blood transfusions in the rHuEPO arm versus 56% of patients in the placebo arm (P = .01), with a mean units of blood transfused per patient of 0.30 in the rHuEPO arm and 1.8 in the placebo arm (P = .01). Treatment was well tolerated, with no significant side effects. CONCLUSION CDDP-induced anemia is corrected by rHuEPO, which results in reduced blood transfusion requirements.

Download Full-text

Norepinephrine infusion increases urine output in children under sedative and analgesic infusion

Revista da Associação Médica Brasileira ◽

10.1590/1806-9282.60.03.008 ◽

2014 ◽

Vol 60 (3) ◽

pp. 208-215 ◽

Cited By ~ 3

Author(s):

Jefferson Piva ◽

Tamila Alquati ◽

Pedro Celiny Garcia ◽

Humberto Fiori ◽

Paulo Einloft ◽

...

Keyword(s):

Mean Arterial Pressure ◽

Arterial Pressure ◽

Urine Output ◽

Controlled Trial ◽

Hemodynamic Variables ◽

Norepinephrine Infusion ◽

The Mean ◽

Double Blinded ◽

To Receive ◽

Furosemide Administration

Objective: to evaluate the effects of early norepinephrine (NE) infusion in children submitted to mechanical ventilation (MV) requiring continuous sedative and analgesic infusion. Methods: double-blinded, randomized, placebo-controlled trial enrolling children (1 month to 12 years of age) admitted to a Brazilian PICU and expected to require MV and continuous sedative and analgesic drug infusions for at least five days. Children were randomized to receive either norepinephrine (NE) (0.15 mcg/kg/min) or normal saline infusion, started in the first 24 hours of MV, and maintained for 72 hours. We compared hemodynamic variables, fluid intake, renal function and urine output between groups. Results: forty children were equally allocated to the NE or placebo groups, with no differences in baseline characteristics, laboratorial findings, PRISM II score, length of MV, or mortality between groups. The average norepinephrine infusion was 0.143 mcg/kg/min. The NE group showed higher urine output (p = 0.016) and continuous increment in the mean arterial pressure compared to the baseline (p = 0.043). There were no differences in the remaining hemodynamic variables, fluid requirements, or furosemide administration. Conclusion: early norepinephrine infusion in children submitted to MV improves mean arterial pressure and increases urine output. These effects were attributed to reversion of vasoplegia induced by the sedative and analgesic drugs.

Download Full-text

Memantine Augmentation Improves Symptoms in Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder: A Randomized Controlled Trial

Pharmacopsychiatry ◽

10.1055/s-0043-120268 ◽

2017 ◽

Vol 51 (06) ◽

pp. 263-269 ◽

Cited By ~ 7

Author(s):

Atieh Modarresi ◽

Mehdi Sayyah ◽

Setareh Razooghi ◽

Kaveh Eslami ◽

Mohammadreza Javadi ◽

...

Keyword(s):

Treatment Response ◽

Controlled Trial ◽

Large Body ◽

Obsessive Compulsive ◽

Double Blind ◽

Compulsive Disorder ◽

Randomized Controlled ◽

Clinical Benefits ◽

The Mean ◽

To Receive

Abstract Introduction There is a large body of evidence on the clinical benefits of augmentation therapy with glutamate-modulating agents, such as memantine in reducing OCD symptoms. Methods A double-blind, placebo-controlled trial was conducted on SRIrefractory OCD patients. Thirty-two patients were randomized to receive either 20 mg/day memantine or placebo augmentation and were visited at baseline and every 4 weeks for 12 weeks. Results were measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Results The Y-BOCS total score was significantly reduced in the memantine group at the end of weeks 8 and 12, while no improvement was observed in the placebo group throughout the trial. A reduction of 40.9% in the mean Y-BOCS total score by week 12 in the memantine group resulted in 73.3% of patients achieving treatment response. The findings showed that a time to effect of 8 weeks was necessary to observe significant improvement in OCD symptoms, while treatment response was only seen after 12 weeks of memantine augmentation. Discussion Memantine is an effective and well-tolerated augmentation in severe OCD patients refractory to SRI monotherapy.

Download Full-text

12-month SARS-CoV-2 antibody persistency in a Tyrolean COVID-19 cohort

Wiener klinische Wochenschrift ◽

10.1007/s00508-021-01985-x ◽

2021 ◽

Author(s):

Florian Deisenhammer ◽

Angelika Bauer ◽

Chiara Kavelar ◽

Dagmar Rudzki ◽

Annika Rössler ◽

...

Keyword(s):

Antibody Response ◽

Neutralizing Antibodies ◽

Disease Onset ◽

Strong Increase ◽

Wild Type ◽

Viral Binding ◽

Antibody Assays ◽

Binding Antibody ◽

Further Development

Summary Background Short-term antibody response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been shown previously. The further development remains to be determined. Methods We prospectively followed 29 coronavirus disease 2019 cases, mean age 44 ± 13.2 years. Except for one participant in whom rheumatoid arthritis existed, all other cases were previously healthy. We determined anti-viral binding antibodies at 2–10 weeks, 3 months, 6 months, and 12 months after disease onset as well as neutralizing antibodies (NAb) against wild type at 6 and 12 months and the B.1.1.7 and B.1.351 variants at month 12. Three binding antibody assays were used, targeting the nucleocapsid protein (NCP), the S1 subunit of the spike protein, and the receptor binding domain (RBD). Results Antibodies to the RBD persisted for 12 months in all cases with increasing concentrations, whereas antibodies to S1 dropped below cut-off point in 7 participants and NCP antibodies were above cut-off point in only 5 subjects at month 12. The NAb against wild type were detected in all but 2 samples at 12 months of follow-up but clearly less frequently when targeting the variants. In 5 participants who were vaccinated against COVID-19 there was a strong increase of antibodies against S1 and RBD as well as an increase of NAb titres against wild type and the variants. Conclusion There was a persisting antibody response against SARS-CoV‑2 up to 12 months after COVID-19 with declining concentrations except for RBD and a strong increase of all antibody concentrations after vaccination.

Download Full-text

Analgesic effect of lidocaine in paracervical block in women undergoing colposcopy and cervical biopsy: a randomized clinical trial

10.21203/rs.3.rs-423703/v1 ◽

2021 ◽

Author(s):

Fahimeh Nokhostin ◽

Shekoufeh Behdad ◽

Reyhaneh Sadat Mousavi-Roknabadi ◽

Razieh Sadat Mousavi-Roknabadi

Keyword(s):

Treatment Group ◽

Pain Score ◽

Controlled Trial ◽

Patients Satisfaction ◽

Cervical Biopsy ◽

The Mean ◽

American Society ◽

American Society Of Anesthesiologists ◽

To Receive ◽

Paracervical Block

Abstract Objective: To investigate the effect of lidocaine in paracervical block in women undergoing colposcopy and cervical biopsy.Methods: This a triple-blind randomized controlled trial (July-September 2020) was conducted on women who were candidate for the colposcopy and cervical biopsy with American Society of Anesthesiologists classification Class I or II. They were randomly allocated to receive a single dose of lidocaine hydrochloride 2% or injectable sodium chloride 0.9% paracervical block, and then, cervical biopsy was done. The pain score was asked and intra-procedural and 5-minutes post-procedural in both groups, using the VAS tool. Also, patients' satisfaction after the procedure and complications were recorded.Results: Totally, 74 patients (37 in each groups) were enrolled, with the mean±SD age of 35.91±8.10 years. The mean±SD of pain score intra-procedural was statistically higher in patients in the treatment group (0.92±1.53 vs. 2.73±2.34, P<0.001), as well the pain score 5-minutes post-procedural (0.27±0.65 vs. 0.95±1.15, P=0.003). Also, the mean±SD of patients' satisfaction score was higher in the treatment group (4.65±0.82 vs. 4.05±1.41, P=0.03). Dizziness were observed only in the treatment group, statistically (P<0.001).Conclusion: Paracervical block using lidocaine could reduce the intra-procedural and 5-minutes post-procedural pain. Also, it can increase the patients' satisfaction with the procedure.

Download Full-text

Effect of Prayer on Intensity of Migraine Headache

Journal of Evidence-Based Complementary & Alternative Medicine ◽

10.1177/2156587215627551 ◽

2016 ◽

Vol 22 (1) ◽

pp. 37-40 ◽

Cited By ~ 3

Author(s):

Haleh Tajadini ◽

Nasser Zangiabadi ◽

Kouros Divsalar ◽

Hossein Safizadeh ◽

Zahra Esmaili ◽

...

Keyword(s):

Pain Intensity ◽

Migraine Headache ◽

Controlled Trial ◽

Prospective Randomized Controlled Trial ◽

Group A ◽

The Mean ◽

Group B ◽

To Receive ◽

Pain Coping Strategy

Background and Aim. Migraine is a common form of headache that affects patients quality of life negatively. In addition to pharmacologic treatment, there are a variety of nonpharmacologic treatments for migraine headache. In present study, we examined the effect of prayer on intensity of migraine pain. Methods. In a prospective, randomized, controlled trial from October 2013 to June 2014, this study has been conducted in Kerman, Iran. We randomly assigned 92 patients in 2 groups to receive either 40 mg of propranolol twice a day for 2 month (group “A”) or 40 mg of propranolol twice a day for 2 months with prayer (group “B”). At the beginning of study and 3 months after intervention, patients’ pain was measured using the visual analogue scale. Results. At the beginning of study and before intervention, the mean score of pain in patients in groups A and B were 5.7 ± 1.6 and 6.5 ± 1.9, respectively. According to results of independent t test, mean score of pain intensity at the beginning of study were similar between patients in 2 groups ( P > .05). Three month after intervention, mean score of pain intensity decreased in patients in both groups. At this time, the mean scores of pain intensity were 5.4 ± 1.1 and 4.2 ± 2.3 in patients in groups A and B, respectively. This difference between groups was statistically significant ( P < .001). Conclusions. The present study revealed that prayer can be used as a nonpharmacologic pain coping strategy in addition to pharmacologic intervention for this group of patients.

Download Full-text