Effect of upadacitinib on atopic hand eczema in patients with moderate-to-severe atopic dermatitis: Results from two randomized phase 3 trials.

BACKGROUND: Approximately 60% of patients with atopic dermatitis have involvement of the hands adding to the burden of disease. OBJECTIVE: This analysis aims to evaluate the effect of upadacitinib monotherapy on atopic hand eczema in patients with moderate-to-severe AD over 16 weeks in the Measure Up 1 and 2 studies. METHODS: Data from patients (ages 12-75) randomized 1:1:1 to receive upadacitinib 15 mg, 30 mg, or placebo once daily in the Measure Up 1 and 2 studies were analysed for impact on atopic hand eczema assessed using the Hand Eczema Severity Index (HECSI). The percent change from baseline in HECSI score was a prespecified additional endpoint at all visits. The proportion of patients with at least a 75% improvement in HECSI score (HECSI 75) was evaluated post hoc. RESULTS: Patients treated with upadacitinib 15 mg or 30 mg experienced greater improvement in HECSI score compared with placebo as early as Week 1, which was maintained through Week 16. At Week 16, the mean change from baseline in HECSI score for patients receiving upadacitinib 15 mg, 30 mg, and placebo was -68%, -74%, and -15% in Measure Up 1 and -68%, -74% and +21% (positive change indicates worsening for placebo) in Measure Up 2, respectively. A greater proportion of upadacitinib-treated patients achieved HECSI 75 compared with placebo at all timepoints beginning at Week 1 through Week 16. CONCLUSIONS: Upadacitinib 15 mg and 30 mg monotherapy provided rapid and sustained improvement in atopic hand eczema compared with placebo through Week 16 in patients with moderate-to-severe AD. At Week 16, the observed mean improvements in HECSI score in upadacitinib-treated patients were clinically meaningful based on previous interpretability studies. These results suggest that upadacitinib may be an effective treatment option for atopic hand eczema in patients with moderate-to-severe AD.

Primary mitral valve angiosarcoma: A multifaced ultra-rare tumor.

Malignant primary cardiac valve tumors are extremely rare neoplasms usually remaining silent up to late advanced stages. Getting to know the various features of this latent tumor, which needs prompt intervention, can assist in the earlier diagnosis. Herein we report a 24-year-old woman with angiosarcoma that originated from the mitral valve and manifested itself through dyspnea and pulmonary edema. The case is noteworthy with respect to appealing echocardiographic images.

The Efficacy of Rosa damascena on Liver Enzymes in Nonalcoholic Fatty Liver Disease: A Randomized Double-Blind Clinical Trial.

OBJECTIVE: This study aimed to appraise the potential effects of Rosa damascena preparation on nonalcoholic fatty liver disease (NAFLD). DESIGN: In the randomized, double-blind placebo-controlled clinical trials, seventy-four patients with NAFLD were prescribed either 1 g Rosa damascena powder or placebo three times in a day for 12 weeks. All patients were provided the lifestyle modification instructions and recommended following them precisely. ALT, AST, FBS, and lipid profiles were measured at the baseline after 12 weeks of studying. The Mann-Whitney U test was correctly used to compare the changes of variables among the groups. RESULTS: Seventy-two patients completed the study in two groups. Sixty-seven patients were men, and the mean ± standard deviation of age was 40.11 ± 9.05 years. The Rosa damascena group showed a considerable decrease in the serum ALT (23.83 ± 24.82 vs. 16.19 ± 27.41, p=0.042), waist circumference (99.73 ± 10.01 vs. 101.52 ± 8.84, p=0.003), triglyceride (TG) (186.29 ± 76.75 vs. 184.47 ± 73.05, p=0.001), cholesterol (167.47 ± 34.48 vs. 184.11 ± 33.54, p=0.001), low-density lipoprotein (LDL) (99.17 ± 28.66 vs. 107.52 ± 25.42, p=0.001), and elevation in serum high-density lipoprotein (HDL) (41.85 ± 6.56 vs. 39.20 ± 5.00, p < 0.007) compared to the control group. Improving fatty liver degree due to liver ultrasound was higher in the Rosa damascena group than the control group (p=0.001). CONCLUSION: Rosa damascena meaningfully improves liver function in NAFLD. Hence, it can be recommended along with lifestyle modification for these patients. Further studies are recommended with a larger sample size.

Secukinumab shows high and sustained efficacy in nail psoriasis: 2.5-year results from the randomized placebo-controlled TRANSFIGURE study.

BACKGROUND: Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A, a cornerstone cytokine in psoriasis, has shown long-lasting efficacy and safety in the complete spectrum of psoriasis manifestations. OBJECTIVES: To report the long-term (2·5-year) efficacy and safety of secukinumab in nail psoriasis. METHODS: TRANSFIGURE, a double-blind, randomized, placebo-controlled, parallel-group, multicentre phase IIIb study in 198 patients, investigated secukinumab 150 mg and 300 mg in patients with moderate-to-severe nail psoriasis. RESULTS: At week 16, the primary endpoint Nail Psoriasis Severity Index (NAPSI) was met, demonstrating superiority of secukinumab to placebo. The effect was sustained over 2·5 years with a large benefit for nail clearance, with mean NAPSI improvement of -73·3% and -63·6% with secukinumab 300 mg and 150 mg, respectively. At 2·5 years, secukinumab demonstrated sustained clinically significant reductions in total mean Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) quality-of-life (QoL) scores of -52·4% and -18·1%, and 70% and 71% of patients achieved a weighted NAPPA Patient Benefit Index global score of ≥ 2 with secukinumab 300 mg and 150 mg, respectively. Patients showed considerable improvements in the EuroQol 5-Dimension health status questionnaire at 2·5 years, reporting a decrease in pain and discomfort. No new safety findings were observed. CONCLUSIONS: Secukinumab demonstrated strong and clinically meaningful efficacy for up to 2·5 years in nail psoriasis, with significant sustained QoL improvements and a favourable safety profile.

The mortality rate from self-harm in Iran.

BACKGROUND: Self-harm-related death is one of the most unfortunate, tragic, and regrettable types of death owing to injuries with a variety of socio-economic and cultural causes. The study aimed to determine the trend in the mortality of self-harm by sex and age at national and provincial levels in Iran over a period of 26 years. METHODS: The Iran Death Registration System (DRS), cemetery databanks in Tehran and Esfahan, and the national population and housing censuses of Iran were used for this study. Using a growth model, the population was estimated in the age groups. Incompleteness, misalignment, and misclassification in the DRS were all considered and addressed accordingly. We used a spatio-temporal and Gaussian process regression model to estimate mortality rates in children and adults. RESULTS: Over the study period, 67,670 deaths were estimated owing to self-harm across the country. The overall age-standardized mortality rate decreased from 4.32 per 100,000 (95% unit interface (UI): 3.25-5.75) to 2.78 (2.15-3.59) per 100,000 between 1990 and 2015, a reduction of approximately 35.65%. The M/F ratio was 2.03:1 with an annual percent change of -2.38% and -1.37% for women and men, respectively. The annual self-harm mortality rate was higher among individuals aged 15-24 years, as well as it was more in men during the study period. CONCLUSION: Mortality from self-harm has declined over the study period in Iran. Higher rates in men and in population aged 15-24 years, with considerable variation by province, were the distinguishing features of self-harm. Iran needs to improve monitoring through a comprehensive multisectoral strategy; and most importantly, provide timely, effective and low-cost preventive interventions.

Trend of fatal poisoning at national and provincial levels in Iran from 1990 to 2015.

OBJECTIVES: Comprehensive and up-to-date data on fatal injury trends are critical to identify challenges and plan priority setting. This study provides a comprehensive assessment of poisoning mortality trends across Iran. STUDY DESIGN: The data were gathered from various resources, including death registration systems, cemetery databases of Tehran and Esfahan, the Demographic and Health Survey of 2000, and three rounds of national population and housing censuses. METHODS: After addressing incompleteness for child and adult death data separately and using a spatio-temporal model and Gaussian process regression, the level and trend of child and adult mortality were estimated. For estimating cause-specific mortality, the cause fraction was calculated and applied to the level and trend of death. RESULTS: From 1990 to 2015, 40,586 deaths due to poisoning were estimated across the country. The poisoning-related age-standardized death rate per 100,000 was estimated to have changed from 3.08 (95% uncertainty interval [UI]: 2.32-4.11) in 1990 to 0.96 (95% UI: 0.73-1.25) in 2015, and the male/female ratio was 1.35 during 25 years of study with an annual percentage change of -5.4% and -4.0% for women and men, respectively. The annual mortality rate was higher among children younger than 5 years and the elderly population (≥70 years) in the study period. CONCLUSIONS: This study showed that mortality from poisoning declined in Iran over the period from 1990 to 2015 and varied by province. Understanding the reasons for the differences of poisoning mortality by province will help in developing and implementing measures to reduce this burden in Iran.

Effect of secukinumab on the clinical activity and disease burden of nail psoriasis: 32-week results from the randomized placebo-controlled TRANSFIGURE trial.

BACKGROUND: Nail psoriasis is associated with functional impairment, pain and reduced quality of life. OBJECTIVES: To demonstrate the superiority of secukinumab over placebo in clearing nail psoriasis as assessed by the Nail Psoriasis Severity Index (NAPSI) at week 16 and over time up to week 132. Presented here is the week 32 interim analysis. Impact on quality of life was assessed by Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) patient questionnaires. METHODS: TRANSFIGURE is a double-blind, randomized, placebo-controlled study in patients with moderate-to-severe plaque and nail psoriasis. RESULTS: The primary objective of this study was met: both doses of secukinumab were superior to placebo at week 16 (NAPSI improvements of -45·3%, -37·9% and -10·8% for secukinumab 300 mg and 150 mg and placebo, respectively, P < 0·001). Significant improvements were seen in patients' quality of life: the NAPPA-Quality of Life total score median decreases at week 16 were 60·9%, 49·9% and 15·8% for secukinumab 300 mg and 150 mg and placebo, respectively (P < 0·001). Improvement in nail psoriasis continued to week 32: NAPSI percentage change reached -63·2% and -52·6% for secukinumab 300 mg and 150 mg, respectively. Skin clearance measured by ≥ 90% improvement in Psoriasis Area and Severity Index was significant (rates of 72·5%, 54·0% and 1·7% for secukinumab 300 mg and 150 mg and placebo at week 16, respectively, P < 0·001) and was sustained to week 32. The most common adverse events were nasopharyngitis, headache and upper respiratory tract infections. CONCLUSIONS: Secukinumab demonstrated significant and clinically meaningful efficacy and quality-of-life improvements for patients with nail psoriasis up to week 32. What's already known about this topic? Nail psoriasis is understudied and there is a lack of effective treatment options. Nail psoriasis is correlated with more severe psoriatic disease and the development of psoriatic arthritis. What does this study add? TRANSFIGURE is one of the few prospective placebo-controlled trials specifically in nail psoriasis and includes nail-specific quality-of-life measures such as Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA)-Quality of Life and NAPPA-Patient Benefit Index. In this trial, secukinumab demonstrates significant efficacy and quality-of-life improvements in this difficult-to-treat population.

Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial.

BACKGROUND: User satisfaction is an important factor associated with treatment adherence in chronic diseases including moderate-to-severe psoriasis. OBJECTIVE: To evaluate the efficacy, safety and patient acceptability of 300 and 150 mg secukinumab - a fully human anti-interleukin-17A monoclonal antibody that has demonstrated efficacy in the treatment of patients with moderate-to-severe plaque psoriasis - self-administered by autoinjection. METHODS: Patients with moderate-to-severe plaque psoriasis were randomized to secukinumab 300 mg, secukinumab 150 mg or placebo self-administered by autoinjection at baseline, Weeks 1, 2 and 3 and then every 4 weeks from Week 4 to Week 48. Efficacy responses [≥75/90/100% improvement in Psoriasis Area and Severity Index (PASI 75/90/100) and clear/almost clear skin by Investigator's Global Assessment 2011 modified version (IGA mod 2011 0/1)] were measured at Week 52. Patient-reported usability of the autoinjector was evaluated by the self-injection assessment questionnaire to Week 48. RESULTS: At Week 52 with secukinumab 300 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 81.4/64.1/38.8% and 69.6% of patients, respectively, by multiple imputation. At Week 52 with secukinumab 150 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 75.2/57.4/33.1% and 60.2% of patients, respectively, by multiple imputation. Patient-assessed acceptability of the autoinjector remained high to Week 48. The proportion of patients experiencing adverse events was greater with secukinumab 300 mg (88.6%) than with secukinumab 150 mg (78.7%). CONCLUSION: Self-administration of secukinumab using an autoinjector was associated with robust and sustained efficacy, a good safety profile and high acceptability.

Skin metastasis, an uncommon course of prostate carcinoma: a report of two cases.

Prostate cancer is one of the most common cancers among men worldwide and in the USA. Most prostate cancer progression either locally invades to seminal vesicles or metastasizes distally to bone. Skin is not a common site of metastasis for the majority of malignancies including prostate cancer. This paper reports two extremely rare cases of prostate carcinoma metastatic to the skin: a 74-year-old man previously treated with radiation for prostate cancer with cutaneous metastases to the shoulder and a 68-year-old man with prostate adenocarcinoma and cutaneous metastases to the groin. Both patients were diagnosed with skin punch biopsy and later confirmed with immunohistochemical staining for PSA and prostate specific acid phosphatase, specific for prostatic carcinoma. Although unusual, development of multiple skin lesions in patients with prostate adenocarcinoma should raise the flags of cutaneous metastases.

Clearance of HBV DNA in immunized children born to HBsAg-positive mothers, years after being diagnosed with occult HBV infection.

In a previous study, we observed immunoprophylaxis failure due to occult hepatitis B virus (HBV) infection (OBI) despite the presence of adequate levels of anti-HBs in 21 (28%) of 75 children born to HBsAg-positive mothers. The aim of the study was to explore the maintenance of this cryptic condition in this population. Of 21 OBI-positive children, 17 were enrolled. HBV serological profiles were determined by enzyme-linked immunosorbent assay. Highly sensitive real-time and standard PCR followed by direct sequencing were applied in positive cases. The mean age (±SD) of studied patients was 6.57 ± 2.75 years. All children still were negative for HBsAg. All but one (94%) were negative for HBV DNA. Only two children were positive for anti-HBc. The results of the most recent anti-HBs titration showed that 4 (23.5%) and 13 (76.5%) had low (<10 IU/mL) and adequate (>10 IU/mL) levels of anti-HBs, respectively. The only still OBI-positive patient had an HBV DNA level of 50 copy/mL, carried the G145R mutation when tested in 2009 and again in 2013 in the 'a' determinant region of the surface protein. Further follow-up showed that after 18 months, he was negative for HBV DNA. In high-risk children, the initial HBV DNA positivity early in the life (vertical infection) does not necessarily indicate a prolonged persistence of HBV DNA (occult infection). Adequate levels of anti-HBs after vaccine and hepatitis B immune globulin immunoprophylaxis following birth could eventually clear the virus as time goes by. Periodic monitoring of these children at certain time intervals is highly recommended.

The effect of alpha-lipoic acid (ALA) supplementation on cardiovascular risk factors in men with chronic spinal cord injury: a clinical trial.

STUDY DESIGN: A randomized, double-blind, placebo-controlled clinical trial. OBJECTIVE: To assess the effect of alpha-lipoic acid (ALA) supplementation on IL-6, hs-CRP, FBS, anthropometric indices, food intake and blood pressure in male patients with chronic spinal cord injury (SCI). SETTING: Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran. METHODS: Fifty-eight men with chronic SCI participated in the study. Participants were divided in two groups: one group received 600 mg of supplemental ALA (n=28) and the other group received placebo (n=30) for 12 weeks. At the beginning and end of the study, biochemical parameters, anthropometric indices, blood pressure and dietary intakes were measured. Dietary intake was measured using N4 software, and statistical analyses were carried out using SPSS16. RESULTS: No significant reduction was found in IL-6 (P=0.97) and hs-CRP levels (P=0.23). There was significant reduction in fasting blood sugar (P=0.001), body weight (P=0.001), BMI (P=0.001), waist circumference (P=0.001) and blood pressure (P=0.001). Dietary intake was significantly reduced, including fat (P=0.001), carbohydrate (P=0.001), protein (P=0.002) and energy intakes (P=0.001). CONCLUSION: Lipoic acid supplementation had no significant effect on the measured inflammatory markers but it reduces fasting blood sugar, anthropometric parameters, food intake and blood pressure in men with chronic SCI.

Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE).

BACKGROUND: Secukinumab is a fully human anti-interleukin-17A monoclonal antibody. OBJECTIVE: Determine the efficacy, safety and usability of secukinumab administered via autoinjector/pen. METHODS: This phase III trial randomized subjects with moderate to severe plaque psoriasis to secukinumab 300 mg, 150 mg or placebo self-injection once weekly to Week 4, then every 4 weeks. Co-primary end points at Week 12 were ≥75% improvement in Psoriasis Area and Severity Index (PASI 75) and clear/almost clear skin by investigator's global assessment 2011 modified version (IGA mod 2011 0/1). Secondary end points included autoinjector usability, assessed by successful, hazard-free self-injection and subject-reported acceptability on Self-Injection Assessment Questionnaire. RESULTS: Week 12 PASI 75 and IGA mod 2011 0/1 responses were superior with secukinumab 300 mg (86.7% and 73.3%, respectively) and 150 mg (71.7% and 53.3%, respectively) vs. placebo (3.3% and 0%, respectively) (P < 0.0001 for all). All subjects successfully self-administered treatment at Week 1, without critical use-related hazards. Subject acceptability of autoinjector was high throughout 12 weeks. Adverse events were higher with secukinumab (300 mg, 70.0%; 150 mg, 63.9%) vs. placebo (54.1%), with differences largely driven by mild/moderate nasopharyngitis. CONCLUSION: Secukinumab delivered by autoinjector/pen is efficacious, well-tolerated and associated with high usability in moderate to severe plaque psoriasis.

Hepatitis B virus surface protein mutations clustered mainly in CTL immune epitopes in chronic carriers: results of an Iranian nationwide study.

Mutations within the coding region of hepatitis B surface antigen (HBsAg) have been found naturally in chronic carriers. To characterize the mutations of HBsAg from Iranian chronic carriers who were vaccine and/or medication naive. The surface genes from 360 patients were amplified and directly sequenced. The distribution of amino acid substitutions was classified according to different immune epitopes of the surface protein. All isolates belonged to genotype D. 222 (61.6%) of 360 patients contained at least one amino acid substitution. 404 (74.5%) of 542 amino acid changes occurred in different immune epitopes of HBsAg, of which 112 (27.7%) in 32 residues of B-cell epitopes (62 in the 'a' determinant); 111 (27.4%) in 32 residues of T helper; and 197 (48.7%) in 32 residues inside cytotoxic T lymphocyte (CTL) epitopes. One Th (186-197) and two CTL (28-51 and 206-215) epitopes were found to be hotspot motifs for the occurrence of 213 (52.7%) substitutions. 20 stop codons were identified in different epitopes. There was a significant association between amino acid substitutions and anti-HBe seropositivity; however, the correlation between such changes with viral load and ALT levels was not significant. In chronic hepatitis B virus(HBV) carriers, positive selection in particular outside the 'a' determinant appeared to exert influence on the surface proteins. These changes could be immune escape mutations naturally occurring due to the host immune surveillance especially at the T-cell level.

Epigenetic modification: possible approach to reduce Salmonella enterica serovar enteritidis susceptibility under stress conditions.

Stressors may influence chicken susceptibility to pathogens such as Salmonella enterica. Feed withdrawal stress can cause changes in normal intestinal epithelial structure and may lead to increased attachment and colonization of Salmonella. This study aimed to investigate modulatory effects of epigenetic modification by feed restriction on S. enterica serovar Enteritidis colonization in broiler chickens subjected to feed withdrawal stress. Chicks were divided into four groups: ad libitum feeding; ad libitum feeding with 24-h feed withdrawal on day 42; 60% feed restriction on days 4, 5, and 6; and 60% feed restriction on days 4, 5, and 6 with 24-h feed withdrawal on day 42. Attachment of S. Enteritidis to ileal tissue was determined using an ex vivo ileal loop assay, and heat shock protein 70 (Hsp70) expression was evaluated using sodium dodecyl sulphate-polyacrylamide gel electrophoresis and western blotting. Feed withdrawal stress increased S. Enteritidis attachment to ileal tissue. However, following feed withdrawal the epigenetically modified chickens had significantly lower attachment of S. Enteritidis than their control counterparts. A similar trend with a very positive correlation was observed for Hsp70 expression. It appears that epigenetic modification can enhance resistance to S. Enteritidis colonization later in life in chickens under stress conditions. The underlying mechanism could be associated with the lower Hsp70 expression in the epigenetically modified chickens.

Hepatitis B vaccine: prophylactic, therapeutic, and diagnostic dilemma.

Hepatitis B virus (HBV) remains a serious public health problem worldwide, accounting for high morbidity and mortality rates as well as significant personal, societal, and economic costs. Hepatitis B is a preventable disease; a safe and effective vaccine has been available for 30 years. The World Health Organization aims to control HBV worldwide by integrating HB vaccination into infant, possibly adolescent, and at-risk adult routine immunization programs. In recent years, a drastic reduction in the mortality and morbidity of chronic HBV, including hepatocellular carcinoma, has occurred, particularly in hyperendemic areas. In addition, a therapeutic vaccine that enhances patient immune response has been considered as a possible alternative to antiviral agents. However, mutant HBV may infect individuals who are anti-HBs positive after immunization (vaccine-escape) and/or fail for detection of HBsAg (diagnostic-escape), which may lead to transmission through donated blood or organs. This review attempts to summarize the prophylactic, therapeutic, and diagnostic concerns on HBV vaccines.

Correlation of Hepatitis B surface antigen mutations with clinical status of the chronically infected patients from Kermanshah, West of Iran.

AIM: Hepatitis B virus (HBV) genetic and protein variations have been found in chronic HBV infected patients who did not receive any treatment and active or passive immunizations. The aims of this study were to determine the genotypes as well as the patterns of variations distribution in chronically infected patients from the west part of Iran. METHODS: Forty-six people with chronic HBV infection were enrolled in the study. The surface genes were amplified, sequenced and subsequently aligned using international and national Iranian database. RESULTS: All strains belonged to genotype D, subgenotype D1 and subtype ayw2. Of all 116 "mutations" that occurred at 59 nucleotide positions, 49 (42.2 %) were missense (amino acid altering) and 67 (57.7%) were silent (no amino acid changing), respectively. At the amino acid level, 38 (79.1%) out of 48 amino acid mutations occurred in different immune epitopes within the surface proteins, of which 2 (5.2%) occurred in B cell; 12 (31.5%) in T helper and 24 (63.1%) inside CTL epitopes. There were significant associations between amino acid mutations (especially within immune epitopes) and anti-HBe positivity and increased ALT levels (P values: 0.014 and 0.04, respectively). CONCLUSION: The distribution of amino acid mutations as well as the ratio between silent and missense nucleotide mutations showed that a narrowly focused immune pressure had already been on the surface protein T cell epitopes (94.9% of mutations), particularly CTL epitopes which led to the emergence of escape mutants in these patients.

Validation of an in-vitro method for Hepatitis B vaccine potency assay: specification setting.

AIM: Production batches of the Hepatitis B vaccine should be tested by the National Control Laboratory (NCL) before being released to the market, in terms of their potency. This can be done either by means of the mouse immunogenicity (in-vivo) method, which is a time-consuming and labor intensive process, or by an in-vitro method with acceptable analytical performance and with specifications determined based on the results obtained from testing some production batches of the vaccine with proven efficacy. Here we report the feasibility of using and validation of a commercial enzyme-linked immunosorbent assay (ELISA) kit replacing the manufacturer's method and setting of different specification for potency of the particular vaccine. METHODS: For the in-vitro potency assay of the Hepavax-Gene®, produced by Berna Biotech Korea Corp, a commercial ELISA kit for hepatitis B surface antigen (HBsAg) quantitation (Hepanostika® HBsAg Ultra from Biomerieux) was used to determine the relative potency. Validation parameters were evaluated following the International Conference on Harmonization (ICH) guidelines. Specification of the vaccine potency was determined based on the results generated by the commercial ELISA kit. Some batches were tested by in-vivo method as well. RESULTS: It was confirmed that the ELISA kit, when used for vaccine potency testing, meets the criteria for accuracy (80% to 110% recovery), precision (repeatability, with a CV% less than 5%; and intermediate precision, with a CV% less than 10%) and Linearity (r2> 98%), as well as being able to detect HBsAg specifically. Specification of the in-vitro method was also determined as having a relative potency of >50%. CONCLUSION: The Hepanostika® HBsAg Ultra kit from Biomerieux can be used to determine the relative potency of the Hepavax-Gene® Hep B vaccine as an alternative to the manufacturer's method and with different specifications.