Immunogenicity and safety evaluation of a newly manufactured recombinant Baculovirus-Expressed quadrivalent influenza vaccine in adults 18 years old and Above: An Open-Label, phase III extension study.

In the face of global health threats, there is a growing demand for vaccines that can be manufactured on a large scale within compressed timeline. This study responds to this imperative by delving into the evaluation of FluGuard, a novel recombinant influenza vaccine developed by Nivad Pharmed Salamat Company in Iran. Positioned as a phase 3 extension, the research aimed to evaluate the safety and immunogenicity of FluGuard in volunteers aged 18 and above. The study was conducted as a single-center, open-label clinical trial. All eligible volunteers received FluGuard (2021-2022 Formula) on day 0. Safety assessments occurred at days 1, 4, 7, 14, 28 and 42 post-vaccination. Immunogenicity was measured through seroconversion, seroprotection, and geometric mean titer fold increase in subgroups of 250 volunteers. Among the 4,260 volunteers were screened and assessed for eligibility, 1000 were enrolled. At day 28 post-vaccination, seroconversion rates for A/H1N1, A/H3N2, B/Yamagata, B/Victoria were 53.4 % [95 %CI: 46.7-60], 57.7 % [95 %CI: 51.1-64.3], 54.3 % [95 %CI: 47.7-60.9], and 36.2 % [95 %CI: 29.8-42.6], respectively in volunteers 18 years and above. The most common solicited adverse events were pain at the injection site, malaise, and headache. No suspected unexpected adverse events and adverse events of special interest occurred during the study period. Our findings suggested that FluGuard® exhibits a desirable safety profile and provides sufficient immunogenicity against influenza virus types A and B. However, extended studies are warranted to assess the long-term protective efficacy. Trial Registration: The study protocol was accepted by Iranian registry of clinical trial; https://www.irct.ir; IRCT20201104049265N2.

Safety and immunogenicity of COReNAPCIN, a SARS-CoV-2 mRNA vaccine, as a fourth heterologous booster in healthy Iranian adults: A double-blind, randomized, placebo-controlled, phase 1 clinical trial with a six-month follow-up.

The recurrent COVID-19 infection, despite global vaccination, highlights the need for booster doses. A heterologous booster has been suggested to enhance immunity and protection against emerging variants of concern of the SARS-CoV-2 virus. In this report, we aimed to assess the safety, and immunogenicity of COReNAPCIN, as a fourth booster dose after three doses of inactivated vaccines. METHODS: The study was conducted as a double-blind, randomized, placebo-controlled phase 1 clinical trial of the mRNA-based vaccine candidate, COReNAPCIN. The vaccine was injected as a heterologous booster in healthy Iranian adults aged 18-50 who had previously received three doses of inactivated SARS-CoV-2 vaccines. In the study, 30 participants were randomly assigned to receive either COReNAPCIN in two different doses (25 µg and 50 µg) or placebo. The vaccine candidate contained mRNA encoding the complete sequence of the pre-fusion stabilized Spike protein of SARS-CoV-2, formulated within lipid nanoparticles. The primary endpoint was safety and the secondary objective was humoral immunogenicity until 6 months post-vaccination. The cellular immunogenicity was pursued as an exploratory outcome. RESULTS: COReNAPCIN was well tolerated in vaccinated individuals in both doses with no life-threatening or other serious adverse events. The most noticeable solicited adverse events were pain at the site of injection, fatigue and myalgia. Regarding the immunogenicity, despite the seroprevalence of SARS-CoV-2 antibodies due to the vaccination history for all and previous SARS-CoV-2 infection for some participants, the recipients of 25 and 50 µg COReNAPCIN, two weeks post-vaccination, showed 6·6 and 8·1 fold increase in the level of anti-RBD, and 11·5 and 21·7 fold increase in the level of anti-spike antibody, respectively. The geometric mean virus neutralizing titers reached 10.2 fold in the 25 µg group and 8.4 fold in 50 µg group of pre-boost levels. After 6 months, the measured anti-spike antibody concentration still maintains a geometric mean fold rise of 2.8 and 6.3, comparing the baseline levels in 25 and 50 µg groups, respectively. Additionally, the significant increase in the spike-specific IFN-ϒ T-cell response upon vaccination underscores the activation of cellular immunity. CONCLUSION: COReNAPCIN booster showed favorable safety, tolerability, and immunogenicity profile, supporting its further clinical development (Trial registration: IRCT20230131057293N1).

Pulmonary rehabilitation in Iranian outpatients with mustard gas lung disease: a randomised controlled trial.

OBJECTIVE: People with mustard gas lung disease experience cough, sputum, breathlessness and exercise limitation. We hypothesised that pulmonary rehabilitation (PR) would be beneficial in this condition. DESIGN: An assessor-blind, two-armed, parallel-design randomised controlled clinical trial. SETTING: Secondary care clinics in Iran. PARTICIPANTS: 60 men with breathlessness due to respiratory disease caused by documented mustard gas exposure, mean (SD) age 52.7 (4.36) years, MRC dyspnoea score 3.5 (0.7), St. George's Respiratory Questionnaire (SGRQ) 72.3 (15.2). INTERVENTIONS: Participants were allocated either to a 6-week course of thrice-weekly PR (n=31) or to usual care (n=29), with 6-week data for 28 and 26, respectively. OUTCOME MEASURES: Primary endpoint was change in cycle endurance time at 70% baseline exercise capacity at 6 weeks. Secondary endpoints included 6 min walk distance, quadriceps strength and bulk, body composition and health status. For logistical reasons, blood tests that had been originally planned were not performed and 12-month follow-up was available for only a small proportion. RESULTS: At 6 weeks, cycle endurance time increased from 377 (140) s to 787 (343) s with PR vs 495 (171) s to 479 (159) s for usual care, effect size +383 (231) s (p<0.001). PR also improved 6 min walk distance+103.2 m (63.6-142.9) (p<0.001), MRC dyspnoea score -0.36 (-0.65 to -0.07) (p=0.016) and quality of life; SGRQ -8.43 (-13.38 to -3.48) p<0.001, as well as quadriceps strength+9.28 Nm (1.89 to 16.66) p=0.015. CONCLUSION: These data suggest that PR can improve exercise capacity and quality of life in people with breathlessness due to mustard gas lung disease and support the wider provision of this form of care. TRIAL REGISTRATION NUMBER: IRCT2016051127848N1.

The influence of different gums compared with surfactants as encapsulating stabilizers on the thermal, storage, and low-pH stability of chlorophyllin.

Sodium copper chlorophyllin (SCC), with a higher stability and water solubility than chlorophyll, has limited applications in acidic products due to precipitation. We investigated the effect of pectin (PE), carboxymethyl cellulose (CMC), xanthan gum (XG), carrageenan gum (CG), gellan gum (GG), tragacanth gum (TG), gum Arabic (GA), and polysorbate 80 (PS80) on SCC stability in acidic model solutions (pH = 3.5). These stabilizers led to a significant reduction in particle size and zeta-potential compared to control sample. GA (33.3:1), PE (8:1), CMC (4:1), XG (1.33:1), and PS80 (0.67:1) stabilized SCC in acidic systems for 28 days. The FTIR analysis showed that mainly electrostatic and hydrogen bonds between SCC and stabilizers led to a substantial decline in particle size, improving SCC distribution and stability within acidic environment. Thus, XG and CMC could be effectively used for SCC stabilization under acidic solutions where applying PS80 surfactant is a health concern.

Efficacy and safety of an inactivated virus-particle vaccine for SARS-CoV-2, BIV1-CovIran: randomised, placebo controlled, double blind, multicentre, phase 3 clinical trial.

OBJECTIVE: To report the efficacy, safety, and exploratory immunogenicity findings of two 5 µg doses of the BIV1-CovIran vaccine. DESIGN: Randomised, placebo controlled, double blind, multicentre, phase 3 clinical trial. SETTING: In six cities of Iran, including Bushehr, Isfahan, Karaj, Mashhad, Shiraz, and Tehran. The first vaccine or placebo injection of the first participant was on 16 May 2021 in Tehran. The last vaccine or placebo injection of the last participant occurred on 15 July 2021 in Isfahan. PARTICIPANTS: 20 000 participants aged 18-75 years were randomly assigned to the intervention or placebo groups with a ratio of 2:1. INTERVENTION: 5 µg vaccine or placebo with the interval of 28 days. MAIN OUTCOME MEASURES: Vaccine efficacy for a 90 day follow-up period, safety and explanatory immunogenicity assessment, and variant detection during the trial. RESULTS: 20 000 participants were recruited and randomly assigned to receive BIV1-CovIran (n=13 335 (66.7%)) or placebo (n=6665 (33.3%)). Participants' mean age was 38.3 (standard deviation 11.2) years, and 6913 (34.6%) were female. Among vaccinated participants that had covid-19 reported during the follow-up (median 83 days), 758 (5.9%) had symptoms, 144 (1.1%) had severe infection, and seven (0.1%) were critical. Among participants who received placebo during the follow-up, 688 (10.7%) had symptoms, 221 (3.4%) had severe infection, and 19 (0.3%) were critical. Overall efficacy was 50.2% (95% confidence interval 44.7% to 55.0%) against symptomatic covid-19, 70.5% (63.7% to 76.1%) against severe disease, and 83.1% (61.2% to 93.5%) against critical cases. Two deaths were reported in the efficacy population in the placebo group, no deaths were from the intervention group. During follow-up, 41 922 adverse events were reported: 28 782 (68.7%) were adverse reactions, of which 19 363 (67.3%) were in the intervention group. Most adverse reactions were mild or moderate in severity (grade 1 or 2) and self-limiting. No serious adverse events were related to the injections. For variant investigation, of 119 participants positive for the SARS-CoV-2 variant, 106 (89.1%) were positive for the delta variant. CONCLUSIONS: A two dose regimen of the BIV1-CovIran vaccine conferred efficacy of 50.2% against symptomatic covid-19, 70.5% against severe disease, and 83.1% against critical disease. Vaccination was well tolerated, with no safety concerns raised. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20201202049567N3. FUNDING: Shifa-Pharmed Industrial Group.

Efficacy and safety of "Jollab Monzej" as a traditional persian compound medicine for the treatment of multiple sclerosis-related fatigue: A randomized placebo-controlled trial.

Background: The purpose of this study was to investigate the efficacy and safety of Jollab monzej (JMZ), a Traditional Persian compound medicine, on multiple sclerosis-related fatigue (MSRF). Methods: We did a double-blind randomized controlled phase3 clinical trial on the JMZ syrup in fifty-six relapsing-remitting MS (RRMS) patients aged 18-55 years with moderate to severe fatigue using the Expanded Disability Status Scale (EDSS) score ≤ 6. We randomly assigned (1;1) participants to the JMZ syrup or placebo syrup groups treated for one month. Participants, investigators, and assessors were unaware of the assignments. The primary outcome was changes in the fatigue score on the Fatigue Severity Scale (FSS), at baseline and one month after treatment using the intention-to-treat (ITT) analysis. The secondary outcomes were changes in the score of Visual Analogue Scale (VAS), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI). Outcomes were measured at baseline, one month after treatment, and 2-week follow-up. Safety was detected in all participants. Results: We randomly assigned 56 participants to the JMZ group (n=28) and placebo group (n=28). Fatigue scores significantly changed in both groups; however, the JMZ group had a greater reduction in FSS score in the ITT analysis. The adjusted mean difference was 8.80 (Confidence interval (CI) 95%, 2.90-14.70, P = 0.00). The mean difference of VAS, BDI, and global PSQI scores were statistically significant (P=0.01, P₌0.00, P₌0.01; respectively). Regarding safety, mild adverse events (AEs) were reported. Conclusion: The results of our study revealed that the administration of JMZ syrup alleviated MSRF and also could improve depression and sleep disorders.

Reflective teaching and academic optimism as correlates of work engagement among university instructors.

As teaching is a complex and demanding activity especially in university and higher education contexts, exploring the correlates of work engagement in university contexts seems to be a promising research area. As an attempt to further clarify this research area, this study sought to examine the significance of reflective teaching and academic optimism as correlates of work engagement among university instructors in Iran. Having been selected via convenience sampling, a sample of 289 Iranian English as a foreign language (EFL) university instructors participated in this survey. The electronic versions of the scales of teacher academic optimism, reflective teaching, and work engagement were administered to the participants. Initially, the construct validity of the scales was verified for the university contexts via performing confirmatory factor analysis. Then the hypothesized structural relationships among the constructs were tested using structural equation modelling (SEM). The results demonstrated that both reflective teaching and academic optimism significantly predicted work engagement among English university instructors. Some notable implications are finally discussed based on these findings.

The protection quest is a primary key to sharing the neutralizing antibody response to cover against all emerging VOCs based on BIV1-CovIran studies.

Over time, the antigenic evolution of emerging variants of SARS-CoV-2 has demanded the development of potential protective vaccines. Administration of additional doses of current vaccines based on the WT spike protein may boost immunity, but their effectiveness has dwindled for patients with more recent variants. Here, we studied the neutralization activity of post-WT strain-based vaccination and a structural simulation in-silico based on the interactions of the RBD-hACE2 as the key to initiating infection among the VOCs of SARS-CoV-2. Our data display shows that WT sera showed a markedly greater reduction in Delta and Omicron, suggesting that the Wuhan-based vaccines may be more susceptible to breakthrough and new VOCs. According to the MD simulation, mutations of Omicron result in a significant change in the variant charge distribution throughout the binding interface that consequently alters the critical interface electrostatic potential in comparison to other variants. This observation provides new insights into immunization policy and next-generation vaccine development.

Patient and Physician Perspectives in the Management of Immune Thrombocytopenia in Iran: Responses from the ITP World Impact Survey (I-WISh).

Data describing physicians' and patients' perspectives towards immune thrombocytopenia (ITP) management and impact of disease in Iran are limited. This ITP World Impact Survey was conducted between October 2019 and October 2020. Of the 114 patients included in the survey, 17 were aged ≤18 years. Forty-seven physicians, including 22 pediatric hematologists, participated in the survey. Fatigue and anxiety around stable platelet counts were frequent patient-reported symptoms at diagnosis and at survey completion. According to physicians, "watch-and-wait" was the preferred treatment option for mean (standard deviation) proportion of 50.1 (24.1) and 48.6 (21.8) of their adult and pediatric patients, respectively, following first diagnosis. Per adult and pediatric hematologists, the most prescribed treatments for newly diagnosed patients based on available answers were steroids (100%, n = 20/20; 89%, n = 16/18), respectively. Forty percent of adult (n = 10/25) and 38% of pediatric hematologists (n = 8/21) reported that ITP reduced patients' quality of life. Energy levels (46%, n = 52/112) and ability to concentrate on everyday activities (42%, n = 47/113) were the most affected aspects of patients' lives. This I-WISh study in Iran underlined the negative impact of ITP on patients.

The impact of essential oils on the qualitative properties, release profile, and stimuli-responsiveness of active food packaging nanocomposites.

Food industries attempt to introduce a new food packaging by blending essential oils (EOs) into the polymeric matrix as an active packaging, which has great ability to preserve the quality of food and increase its shelf life by releasing active compounds within storage. The main point in designing the active packaging is controlled-release of active substances for their enhanced activity. Biopolymers are functional substances, which suggest structural integrity to sense external stimuli like temperature, pH, or ionic strength. The controlled release of EOs from active packaging and their stimuli-responsive properties can be very important for practical applications of these novel biocomposites. EOs can affect the uniformity of the polymeric matrix and physical and structural characteristics of the composites, such as moisture content, solubility in water, water vapor transmission rate, elongation at break, and tensile strength. To measure the ingredients of EOs and their migration from food packaging, chromatographic methods can be used. A head-space-solid phase micro-extraction coupled to gas chromatography (HS-SPME-GC-MS) technique is as a good process for evaluating the release of Eos. Therefore, the aims of this review were to evaluate the qualitative characteristics, release profile, and stimuli-responsiveness of active and smart food packaging nanocomposites loaded with essential oils and developing such multi-faceted packaging for advanced applications.

A model of classroom social climate, foreign language enjoyment, and student engagement among English as a foreign language learners.

With the advent of positive psychology in second language (L2) learning, some researchers have undertaken empirical studies to explore emotional variables affecting L2 learning and how positive emotions can enhance the engagement of L2 learners. As an attempt to contribute to this research domain, this project sought to test a model of student engagement based on classroom social climate (CSC) and foreign language enjoyment (FLE) among English language learners in Iran. A sample of 386 intermediate English as a foreign language (EFL) learners took part in this survey by completing the online battery of questionnaires. Structural equation modeling (SEM) was employed for the analysis of the gathered data. The results showed that both CSC and FLE were significant predictors of student engagement, with FLE acting as a stronger predictor. Furthermore, CSC exerted a slight influence on FLE. The findings of the present study verify the contributions of positive psychology to L2 pedagogy, implying that pleasant perceptions of learning context and positive emotions can lead to further student engagement.

Nitronium salts as mild and inexpensive oxidizing reagents toward designing efficient strategies in organic syntheses; A mechanistic investigation based on the DFT insights.

Today, introducing and evaluating the performance of novel reagents are an undeniable part of designing a successful synthetic strategy. Herein, we study the efficiency and mechanism of recently synthesized nitronium salts (e.g., NO2FSO3, NO2CF3SO3, NO2HS2O7, NO2BF4, NO2PF6, and NO2HSO4) in the oxidation reaction of ethanol to acetic acid, as a model of the primary alcohol transformations to linear carboxylic acid. An aldehyde molecule is the first produced species in this reaction which is converted to the acetic acid molecule in the presence of in situ-produced nitric acid. Concerning the proposed mechanism, among the studied nitronium salts, two different behaviors can be observed in the transition state of the step in which the aldehyde molecule is formed. The calculated barrier energies of this step have been scrutinized by powerful descriptors such as Quantum Theory of Atoms in Molecules (QTAIM), Natural Bond Orbital (NBO), Electrostatic Potential (ESP) surfaces, and Activation Strain Model (ASM). The outcomes of the studied descriptors illustrate that nitronium salts have different performances in progressing the formation of the aldehyde molecule. Indeed, the likeness of the transition state of this step to the products for NO2FSO3, NO2CF3SO3, and NO2HS2O7 species is more significant than the others. Accordingly, these reagents have more potential to apply as oxidizing agents in the primary alcohol transformations to linear carboxylic acid.

Effect of "Mehrpishegan" web-based support group on depression, anxiety, and stress among elderly informal caregivers: a protocol for a randomized-controlled trial.

BACKGROUND: Elderly population in low- and middle-income countries is rapidly growing, which indicates an increase in the number of dependent people needing long-term care. Caring for the elderly is difficult and stressful and threatens physical and mental health of informal caregivers. We aim to design a web-based support group and assess its effectiveness on depression, anxiety, and stress among elderly informal caregivers. METHODS: This is a protocol for a two-arm randomized controlled trial. A total of 160 informal elderly caregivers will be recruited from the southern area of Tehran. Eligible participants will be randomly allocated to two intervention and control groups. The inclusion criteria include not receiving salary for caring, having primary responsibility for care, having smartphone/tablet/computer, being able to use the contents and web applications, having at least one month of experience in caring for the elderly, and having access to the Internet at least once weekly. The intervention will be implemented by giving an account access to the designed website. Depression, anxiety, and stress will be assessed using the DASS21 questionnaire at baseline, and at the end of third and sixth months. DISCUSSION: Our findings can pave the way for improving the mental health of informal caregivers of the elderly through provision of web-based supportive services. This study stands as an opportunity to address the needs of caregivers and help them support each other in a novel way. TRIAL REGISTRATION: Iran Randomized Clinical Trial Center IRCT20201012048999N1 . Registered on 25 December 2020 (current status: ongoing). The World Health Organization Trial Registration Data Set is in Additional file 1 PROTOCOL VERSION: Second version 2021-05-27.

The direct and indirect effects of bioactive compounds against coronavirus.

Emerging viruses are known to pose a threat to humans in the world. COVID-19, a newly emerging viral respiratory disease, can spread quickly from people to people via respiratory droplets, cough, sneeze, or exhale. Up to now, there are no specific therapies found for the treatment of COVID-19. In this sense, the rising demand for effective antiviral drugs is stressed. The main goal of the present study is to cover the current literature about bioactive compounds (e.g., polyphenols, glucosinolates, carotenoids, minerals, vitamins, oligosaccharides, bioactive peptides, essential oils, and probiotics) with potential efficiency against COVID-19, showing antiviral activities via the inhibition of coronavirus entry into the host cell, coronavirus enzymes, as well as the virus replication in human cells. In turn, these compounds can boost the immune system, helping fight against COVID-19. Overall, it can be concluded that bioactives and the functional foods containing these compounds can be natural alternatives for boosting the immune system and defeating coronavirus.

Safety and immunogenicity of an inactivated virus particle vaccine for SARS-CoV-2, BIV1-CovIran: findings from double-blind, randomised, placebo-controlled, phase I and II clinical trials among healthy adults.

OBJECTIVE: Assessing safety and immunogenicity of an inactivated whole virus particle vaccine. DESIGN: Single-centre, double-blind, randomised, placebo-controlled, phase I (stage I: 18-50, stage II: 51-75 years), phase II (18-75 years) clinical trials. SETTING: 29 December 2020 to 22 April 2021. PARTICIPANTS: Stage I-phase I: 56 participants; stage II-phase I: 32; phase II: 280. INTERVENTION: During stage I, participants randomly (3:3:1) received 3 µg, 5 µg vaccine or placebo in a 14-day interval. Participants in stage II received two shots of 5 µg vaccine or placebo (3:1). In phase II, participants received 5 µg vaccine or placebo (4:1) in a 28-day interval. PRIMARY AND SECONDARY OUTCOME MEASURES: Safety assessment and immunogenicity assessment via antibody response and conventional virus neutralisation test (cVNT). RESULTS: All adverse events (AEs) were mild or moderate and transient in both phase I and phase II, and no AEs of special interest were reported. The seroconversion-rate of neutralising, antireceptor binding-domain (RBD) and anti-spike-glycoprotein (anti-S) antibodies 14-days after second dose of 5 µg vaccine in stage I was 70.8% (95% CI 48.9% to 87.4%), 87.5% (95% CI 67.6% to 97.3%), 91.7% (95% CI 73.0% to 99.0%). The antibody titres increased more among 5 µg than 3 µg. The corresponding rates for 3 µg vaccine were 45.8% (95% CI 25.6% to 67.2%), 54.2% (95% CI 32.8% to 74.5%) and 70.8% (95% CI 48.9% to 87.4%), respectively. In stage II, 100% (95% CI 84.6% to 100%), 86.4% (95% CI 65.1% to 97.1%) and 86.4% (95% CI 65.1% to 97.1%) of participants seroconverted for neutralising, anti-RBD and anti-S antibodies. In phase II, the seroconversion rate of neutralising-antibody was 82.8% (95% CI 77.0% to 87.6%), anti-RBD 77.0% (95% CI 70.7% to 82.6%) and anti-S 79.9% (95% CI 73.8% to 85.1%) on day 42. In the cVNT, the sera at 1/64 times dilution would neutralise SARS-CoV-2 among 91.7%, 77.3% and 82.5% of vaccinated participants in phase I-stage I, phase I-stage II and phase II clinical trials, respectively. CONCLUSIONS: These results support further evaluation of this inactivated whole virus particle vaccine. TRIAL REGISTRATION NUMBERS: IRCT20201202049567N1 and IRCT20201202049567N2 for phase I and IRCT20201202049567N3 for phase II.

Assessment of BIV1-CovIran inactivated vaccine-elicited neutralizing antibody against the emerging SARS-CoV-2 variants of concern.

OBJECTIVES: The BIV1-CovIran vaccine is highly effective against COVID-19. The neutralizing potency of all SARS-CoV-2 vaccines seems to be decreased against variants of concern. We assessed the sensitivity of the Alpha (B.1.1.7), Beta (B.1.351), and Delta (B.1.617.2) variants to neutralizing antibodies (NAbs) present in sera from individuals who had received the BIV1-CovIran candidate vaccine compared with an original Wuhan-related strain. METHODS: The ability of vaccine serum to neutralize the variants was measured using the conventional virus neutralization test. The correlation of spike (S) protein antibody and anti-receptor binding domain with neutralizing activity was investigated. RESULTS: The current study demonstrated that 29 of 32 (90.6%; 95% CI: 75.0-98.0) of the vaccinees developed NAbs against a Wuhan-related strain. It is noteworthy that 28 (87.50%) and 24 of 32 (75%) of the recipients were able to produce NAbs against Alpha, Beta, and Delta variants, respectively. Serum virus-neutralizing titres for different SARS-CoV-2 strains were weakly correlated with anti-receptor binding domain antibodies (Spearman r = 36-42, p < 0.05), but not S-binding antibodies (p > 0.05). DISCUSSION: Although there was a reduction in neutralization titres against the Alpha, Beta, and Delta variants compared with the Wuhan strain, BIV1-CovIran still exhibited potent neutralizing activity against the SARS-CoV-2 variants of concern.

Immunogenicity and safety of a bivalent, adjuvant system 04-adjuvanted human papillomavirus vaccine in healthy female volunteers aged 15-25: a randomized, double-blind, phase III, noninferiority clinical trial.

OBJECTIVE: Vaccination is proven to significantly reduce the risk of human papillomavirus (HPV)-related complications, especially cervical cancer. This study aimed to assess the immunogenicity and safety of the investigational bivalent HPV vaccine (16/18), named Papilloguard (Noyan Pajouhan Biopharma, Tehran, Iran), in comparison with the reference product (Cervarix, bivalent HPV vaccine (16/18) manufactured by GlaxoSmithKline, Rixensart, Belgium) in a three-dose regimen. METHODS: This trial was a randomized, controlled, double-blind, phase III study of two HPV vaccines in healthy female volunteers aged 15-25. The primary endpoint was to test the noninferiority of Papilloguard (Noyan Pajouhan Biopharma) to Cervarix (GlaxoSmithKline) as measured by the geometric mean titer (GMT) ratios of HPV-16 and HPV-18 7 months after the first vaccination. Secondary endpoints were the proportion of local and systemic solicited and unsolicited events, and the number of females with seroconversion against HPV-16 and HPV-18 7 months after the first vaccination. RESULTS: Out of 504 screened women, 218 were enrolled. Seven months after the first vaccination, GMT ratios of HPV-16 and HPV-18 were 0.59 and 0.93, respectively. The seroconversion rates of both Papilloguard (Noyan Pajouhan Biopharma) and Cervarix (GlaxoSmithKline) were more than 96%. Both vaccinated groups had a generally good profile of solicited and unsolicited adverse events (AEs). The most common AE was discomfort at the injection site, which was well tolerated. CONCLUSION: The result analysis of this study supports the noninferiority of Papilloguard (Noyan Pajouhan Biopharma) to Cervarix (GlaxoSmithKline) in terms of safety and immunogenicity based on the GMT ratio. However, long-term comparative studies to evaluate the sustainability of GMT response and risk of cervical intraepithelial neoplasia grades 2-3 are needed.

Evaluation of the safety and efficacy of a biosimilar abobotulinum toxin type A in treating moderate-to-severe glabellar lines: A non-inferiority double blinded randomized controlled trial.

BACKGROUND: Injection of botulinum toxin for cosmetic purposes is a well-established practice. OBJECTIVES: This study was conducted to compare the safety and efficacy of Dyston® (investigational biosimilar abobotulinumtoxinA) with Dysport® (abobotulinumtoxinA, Ipsen) in the treatment of moderate-to-severe glabellar lines. METHODS: Out of 193 screened subjects, 126 volunteers with moderate-to-severe glabellar lines fulfilling eligibility criteria were randomized in a 1:1 ratio to receive either an intramuscular injection of 40-60 units of Dyston® or Dysport® . The primary objective was to test the non-inferiority of Dyston® compared with Dysport® as measured by the percentage of volunteers who achieved no or mild glabellar lines at maximum frown assessed by the physicians based on the Glabellar Line Severity Score (GLSS) at Day 30. Secondary endpoints included the improvement in the glabellar lines at maximum frown and rest states at Days 14, 60, 90, and 120 as well as the side effects of the treatment. RESULTS: Response rates at maximum frown were 75.44% (43/57) in the Dyston® group and 76.67% (46/60) in the Dysport® group on Day 30 (p value: 0.88, 95% CI: -14.24 to 16.70, diff: 1.23) as per-protocol set, and were 75.81% (47/62) and 76.19 (48/63) (p value: 0.96, 95% CI: -14.59 to 15.35, diff: 0.3) in the Dyston® and the Dysport® groups, respectively, based on modified intention to treat population. Adverse events were similar in both groups and mostly mild and well-tolerated. CONCLUSION: Treatment of moderate-to-severe glabellar lines with Dyston® was effective, tolerable, and non-inferior compared with Dysport® .

Effect of oral administration of Triphala, a polyphenol-rich prebiotic, on scalp sebum in patients with scalp seborrhea a randomized clinical trial.

BACKGROUND: Although there are various therapeutic options to control oily skin, they have potential side effects and limitations especially in long-term use. Pre/probiotics may have beneficial effects in atopic dermatitis' acne, dandruff, and seborrhea, demonstrated by some clinical trials. This trial conducted to determine whether the herbal prebiotic Triphala is effective in reducing scalp sebum secretion in patients with scalp seborrhea. METHODS: In this 8 week patient and outcome assessor-blinded, placebo-controlled trial participants with scalp seborrhea aged 14-50 years were randomized to Triphala or placebo groups. 1 g of Triphala (standardized as 91.82 ± 0.5 mg gallic acid) or placebo (wheat flour) were administered BID. Scalp sebum levels were detected objectively using Sebumeter® sm 815, and treatment satisfaction was measured using a score between 0 and 100. [Registration no. IRCT2014070218332N1]. RESULTS: Eighty patients completed the study (40 in Triphala group and 40 in placebo group). Participants in the Triphala group experienced 25.34 scores (95% CI, 0.39-50.29: p = .047) more improvement in scalp sebum levels compared with the placebo group. The mean percentage of patients' satisfaction was 37.91 (24.88) in the Triphala group and 17.89 (25.80) in the placebo group (p = .001). CONCLUSION: Herbal prebiotic Triphala significantly reduced scalp sebum scores compared to placebo.

COVID-19 vaccines: What dermatologists should know?

As COVID-19 vaccination has started worldwide to control this pandemic, dermatologists may face various challenges with these new vaccines. In this manuscript, we review different types of available COVID-19 vaccines and their various production platforms. Vaccination considerations in patients with skin diseases, especially those using immunomodulatory drugs will be presented. Finally, adverse cutaneous reactions of COVID-19 vaccines will be reviewed.