The effects of increased dose of hepatitis B vaccine on mother-to-child transmission and immune response for infants born to mothers with chronic hepatitis B infection: a prospective, multicenter, large-sample cohort study

Background Appropriate passive-active immunoprophylaxis effectively reduces mother-to-child transmission (MTCT) of hepatitis B virus (HBV), but the immunoprophylaxis failure was still more than 5% under the current strategy. The study objective was to investigate the effects of high dose of HB vaccine on MTCT and immune response for infants born to hepatitis B surface antigen (HBsAg)-positive mothers. Methods This was a prospective, multicenter, large-sample cohort study in four sites of China, and 955 pairs of HBsAg-positive mothers and their infants were enrolled in our investigation. The infants were given 10 μg or 20 μg HB vaccine (at age 0, 1, and 6 months) plus HB immunoglobulin (at age 0 and 1 month). Serum HBsAg, antibody to HBsAg (anti-HBs), and/or HBV DNA levels in the infants were determined at age 12 months. The safety of 20 μg HB vaccine was evaluated by adverse events and observing the growth indexes of infants. Results Thirteen of 955 infants were HBsAg-positive at 12 months. Stratification analysis showed that immunoprophylaxis failure rates in the 20 μg group were not significantly different from the 10 μg group, whatever maternal HBV load was high or not. But the high dose of HB vaccine significantly reduced low-response rate (anti-HBs 10–100 IU/L) (P = 0.002) and middle-response rate (anti-HBs 100–1000 IU/L) (P = 0.022) and improved high-response rate (anti-HBs ≥ 1000 IU/L) (P < 0.0001) in infants born to mothers with HBV DNA < 5 log10 IU/mL. For infants born to mothers with HBV DNA ≥ 5 log10 IU/mL, 20 μg HB vaccine did not present these above response advantages. The 20 μg HB vaccine showed good safety for infants. Conclusions The 20 μg HB vaccine did not further reduce immunoprophylaxis failure of infants from HBsAg-positive mothers, but increased the high-response and decreased low-response rates for infants born to mothers with HBV DNA < 5 log10 IU/mL. Trial registration Chinese Clinical Trial Registry, ChiCTR-PRC-09000459

Effects of Baby Massage in Reducing Body Temperature after Combined Diptheri Pertussis Tetanus/Hepatitis B Immunization

Background: Side effects that may often occur after immunization include fever in infants after to combined Diptheri Pertusis Tetanus/Hepatitis B (DPT/HB) vaccine. Fever in infants or toddlers is a case that cannot be ignored because it can interfere with the comfort and development of infants and toddlers. Objectives: This research aims to analyze the effects of baby massage in lowering body temperature among babies given combined DPT/HB immunization. Material and Methods: It is a quasi-experiment using one intervention group. The population and sample are babies aged 2-5 months visiting the Work Area of Puskesmas Lombok Barat in Indonesia that meet inclusion criteria. Baby massage was administered in the morning and in the afternoon for 5 days, with the first 2 days prior to combined DPT/HB immunization 1, the second 1 day at the time of immunization, and the last 2 days after immunization. The same treatment was also carried out for combined DPT/HB immunization 2. Prior and after massage, baby temperatures were measured at the axila using a digital thermometer, with the results put in an observation sheet (graph). Body temperature measurement was observed for 2 months. Data gathered were then tested using non-parametric test (Wilcoxon). Results: there is reduction in body temperature among babies given combined DPT/HB immunization 1 and combined DPT/HB immunization 2. Babies given combined DPT/HB immunization 1 had average body temperature of 0,2±0.18 °C in the morning and 0,21±0.25 °C in the afternoon. Meanwhile, babies given combined DPT/HB immunization 2 had average body temperature of 0,26±0.19 °C in the morning and 0,2±0.23 °C in the afternoon. Effect of massage in reducing body temperature among babies given combined DPT/HB immunization 1 is at (p<0.005) and at (p<0.005) for combined DPT/HB immunization 2. Conclusion: massage can be performed before or after babies are immunized with combined DPT/HB to lower their body temperature.

The effect of inhaling mother’s breast milk odor on the behavioral responses to pain caused by hepatitis B vaccine in preterm infants: a randomized clinical trial

Background Nowadays, it is generally assumed that non-pharmacologic pain relief in preterm infants is an important measure to consider. Research findings suggest that familiar odors have soothing effects for neonates. The aim of this study was to compare the effect of maternal breast milk odor (MBMO) with that of another mother’s breast milk odor (BMO) on the behavioral responses to pain caused by hepatitis B (HB) vaccine injection in preterm infants. Methods This single-blind randomized clinical trial was performed over the period between February 2019 and March 2020 in the neonatal intensive care unit of Babol Rouhani Hospital, Iran. Ninety preterm infants, who were supposed to receive their HB vaccine, were randomly assigned into three groups: MBMO (A), another mother’s BMO (B), and control with distilled water(C). Oxygen saturation (SaO2), blood pressure (BP) and heart rate (HR) were recorded for all participants through electronic monitoring. In addition, premature infant pain profiles (PIPP) were determined through video recording for all three groups during intervention. The chi-square, ANOVA and ANCOVA were used for analyzing the data, and P < 0.05 was considered significant in this study. Results No significant differences were found between the three groups in mean ± SD of HR, BP, and Sao2 before the intervention (P > 0.05). After the intervention, however, the means for heart rate in groups A, B, and C were 146 ± 14.3, 153 ± 17.5 and 155 ± 17.7, respectively (P = 0.012). Moreover, the means for PIPP scores in groups A, B and C were 6.6 ± 1.3, 10 ± 2, and 11.4 ± 1.9, respectively (P < 0.001). There was no significant difference found between groups in their means of SaO2, systolic and diastolic blood pressure after the intervention (P > 0.05). Conclusions The results indicate that stimulation with MBMO is effective in reducing pain in preterm infants; therefore, it can be postulated that this technique can be considered in less invasive procedures such as needling. Trial registration IRCT, IRCT20190220042771N1. Registered 18 May 2019- Retrospectively registered,

The effect of inhaling mother’s breast milk odor on the behavioral responses to pain caused by hepatitis B vaccine in preterm infants: a randomized clinical trial

Background: Nowadays, it is generally assumed that non-pharmacologic pain relief in preterm infants is an important measure to consider. Research findings suggest that familiar odors have soothing effects for neonates. The aim of this study was to compare the effect of maternal breast milk odor (MBMO) with that of another mother’s breast milk odor (BMO) on the behavioral responses to pain caused by hepatitis B (HB) vaccine injection in preterm infants.Methods: This single-blind randomized clinical trial was performed over the period between February 2019 and March 2020 in the neonatal intensive care unit of Babol Rouhani Hospital, Iran. Ninety preterm infants, who were supposed to receive their HB vaccine, were randomly assigned into three groups: MBMO (A), another mother’s BMO (B), and control with distilled water(C). Oxygen saturation (SaO2), blood pressure (BP) and heart rate (HR) were recorded for all participants through electronic monitoring. In addition, premature infant pain profiles (PIPP) were determined through video recording for all three groups during intervention. The chi-square, ANOVA and ANCOVA were used for analyzing the data, and P<0.05 was considered significant in this study.Results: No significant differences were found between the three groups in mean± SD of HR, BP, and Sao2 before the intervention (P>0.05). After the intervention, however, the means for heart rate in groups A, B, and C were 146±14.3, 153±17.5 and 155±17.7, respectively (P=0.012). Moreover, the means for PIPP scores in groups A, B and C were 6.6±1.3, 10 ±2, and 11.4±1.9, respectively (P<0.001). There was no significant difference found between groups in their means of SaO2, systolic and diastolic blood pressure after the intervention (P>0.05). Conclusions: The results indicate that stimulation with MBMO is effective in reducing pain in preterm infants; therefore, it can be postulated that this technique can be considered in less invasive procedures such as needling.Trial registration: IRCT, IRCT20190220042771N1. Registered 18 May 2019- Retrospectively registered, https://en.irct.ir/trial/37646

The effect of inhaling mother’s breast milk odor on the behavioral responses to pain caused by hepatitis B vaccine in preterm infants: a randomized clinical trial

Background: Non-pharmacologic pain relief in preterm infant is an important measure. Familiar odors for neonates have soothing effects in some researches. The aim of this study was to compare the effect of maternal breast milk odor (MBMO) with that of another mother’s breast milk odor (BMO) on the behavioral responses to pain caused by hepatitis B (HB) vaccine injection in preterm infants.Methods: This single-blind randomized clinical trial was performed in the neonatal intensive care unit of Babol Rouhani Hospital, Iran from February 2019 to March 2020. Ninety preterm infants who must to be receive the HB vaccine, were randomly assigned into three groups of MBMO (A), another mother’s BMO (B) and control with distilled water(C). Oxygen saturation(SaO2), blood pressure(BP) and heart rate(HR) were recorded by electronic monitoring and premature infant pain profile (PIPP) were determined through video recording in tree groups during intervention. The chi-square, ANOVA and ANCOVA were used for analyzing data, and P<0.05 was considered significant.Results: No significant differences were seen between tree groups in mean± SD of HR, BP, Sao2 before intervention, (P>0.05). After intervention, the mean heart rate in group A, B and C was 146. 6±14.3, 153.70±17.5 and 155.70±17.7 respectively, (P=0.01). There was no significant difference between groups in the mean of SaO2, systolic and diastolic blood pressure after intervention (P>0.05). The mean PIPP score in groups A, B and C was 6.6±1.3, 10 ±2 and 11.4±1.9 respectively, (P<0.001).Conclusions: Stimulation with MBMO is effective in reducing the pain of preterm infants, so it can be used in less invasive procedures such as needling.Trial registration: IRCT, IRCT20190220042771N1. Registered 18 May 2019- Retrospectively registered, https://en.irct.ir/trial/37646

Cross-Protection of Hepatitis B Vaccination among Different Genotypes

Hepatitis B (HB) vaccination is the most effective method for preventing HB virus (HBV) infection. Universal HB vaccination containing recombinant HB surface antigens (HBsAg) is recommended. Our data revealed that human monoclonal HB surface antibody (anti-HBs) from individuals inoculated with genotype C-based HB vaccine induced cross-protection against HBV genotype A infection. An in vitro infection model demonstrated anti-HBs-positive sera from individuals inoculated with genotype A- or C-based HB vaccine harbored polyclonal anti-HBs that could bind to non-vaccinated genotype HBV. However, because there were low titers of anti-HBs specific for HBsAg of non-vaccinated genotype, high anti-HBs titers would be required to prevent non-vaccinated genotype HBV infection. Clinically, the 2015 Centers for Disease Control and Prevention guidelines state that periodic monitoring of anti-HBs levels after routine HB vaccination is not needed and that booster doses of HB vaccine are not recommended. However, the American Red Cross suggests that HB-vaccine-induced immune memory might be limited; although HB vaccination can prevent clinical liver injury (hepatitis), subclinical HBV infections of non-vaccinated genotypes resulting in detectable HB core antibody could not be completely prevented. Therefore, monitoring anti-HBs levels after routine vaccination might be necessary for certain subjects in high-risk groups.

High Level of Vaccination and Protection Against Hepatitis B with Low Rate of Hepatitis C HCV infection Markers among Hospital Health Care Personnel in North of Iran: A cross-Sectional study.

Background: hepatitis B virus (HBV) and C virus (HCV) are among the leading causes of mortality worldwide. Health care personnel (HCP) are subjected to increased risk of these infections. Therefore, HBV vaccination and post-vaccination serologic testing (PVST) are recommended for them. Our Objectives in this study were investigate how well the vaccination guidelines for hospital HCPs were implemented. Moreover, the prevalence rates of HBV and HCV infections were calculated. To determine the presence of immunological memory, vaccinated personnel negative to antibody against HB surface antigen with one dose of HB vaccine were boosted. Methods: From 1 July to 30 November 2017, a cross-Sectional study among HCPs working in public hospitals were conducted. All HCPs from various professional categories potentially at risk of exposure to contaminated sources were included. The information was gathered via interview and self-administered questionnaire. The questions were focused on the demographic characteristics, HB vaccination and immunity status and time elapsed since initial vaccination series, and frequency of needelstick injuries during the past 12 months of their work. Moreover, the prevalence rate of HBV and HCV infections were calculated. To determine the presence of immunological memory, subjects negative to HBV seromarkers received a booster dose of the vaccine.Results: A total of 186 out of 766 participants were male and nurses comprised 71% of personnel. Although all HCP were vaccinated, 84% of them completed the course and less than 5% of them received PVST. According to the results, 0.78%, 4.6%, and 83% were serologically positive to HBV surface antigen, antibodies against HBV core, and S antigens, respectively. Approximately, 91% of seronegative participants responded to a booster dose and only 0.91% of the personnel was Anti-HCV positive.Conclusion: Most HCP received full HBV vaccination course. Although a minority did PVST, the HBV vaccine-induced long-term protection and HB vaccine booster were not required. Therefore, policies should be made to increase the rate PVST after immunization. According to the results, the HCV infection rate was low and thus pre-recruitment screening was not necessary.

Intention to Hepatitis B Vaccinate: Evidence from Migrant Workers in Tianjin, China

Background: Migrant workers are a susceptible population to the hepatitis B virus and a vulnerablespot in China’s immunization procedures. There is no free HB immunization program for migrant workers in China, so understanding migrant workers’ motivation to receive the hepatitis B vaccine is the first step in designing effect immunization policies.Method: A cross-sectional study was carried out in three migrant-dense industries in Tianjin, China. Our sample consisted of 406 migrant workers, 133 from the retail industry, 119 from the manufacturing industry, and 154 from the service industry. Protection motivation theory (PMT) factors were produced by principal component factor analysis. Socio-demographic variables, migration-industry variablesand PMT factors were estimated in a step-by-step binary logistic regression model to explore migrant workers intention to vaccinate.Results: The nested binary logistic regression model results suggested that the severity factor, self-efficacy factor and response cost factor from the PMT constructs were the three statistically significant factors (p<0.05) that affect the migrant workers vaccination intention. The severity factor and self-efficacy factor to HB vaccination were positively related to HB vaccination intention (OR=1.500, OR=1.631) while the response cost was negatively related to motivation to take HB vaccine (OR=0.626). The socio-demographic variables showed that younger, married and good self-rated health status participants were statistically associated with the intention of taking the HB vaccine. Sex, education level and income group were not significantly associated with vaccination intentions. The migration-industry variables show that migrant location had astrong effect on migrant workers’ vaccination intention.Conclusions: Applying integrated PMT constructs to the vaccination intention of Tianjin’s migrant population provide new insights into migrant workers’ intention to the HB vaccinate. Our findings suggest specific recommendations on health education and immunization management policies for migrant workers.

Impaired trophoblast Toll-Like Receptor 3 signaling pathway involves in hepatitis B vaccine non- or hypo-response of infants born to HBsAg-positive mothers

Background: Babies born to hepatitis B surface antigen (HBsAg) positive mothers bear a high risk of being non- or hypo-responsive to hepatitis B (HB) vaccine with unilluminated mechanisms. Placental immunity is closely related to the development of baby immune system, however, the roles of the placental immunity in the insufficient response of these babies are unclear. This study was aimed to investigate the role of placental trophoblast Toll-Like Receptor 3（TLR3）signaling pathway in HB vaccine non- or hypo-response of these special babies. Methods: A total of 399 pairs of HBsAg-positive mothers and their neonates were recruited to perform a nested case-control study. The maternal and children’s HBV DNA and the HBV serological markers were detected by Fluorescence Quantitative Polymerase Chain Reaction (FQ-PCR) and Electrochemiluminescence Immunoassay (ECLIA). The trophoblast TLR3 signaling pathway proteins and infant cytokines IL-6, IL-12, TNF-α, IFN-α and IFN-γ were tested by immunohistochemistry (IHC) and Enzyme–Linked Immunosorbent Assay (ELISA). Results: The expression of TLR3 and NF-κB, a TLR3 downstream protein, were significantly decreased in the non- or hypo-responders ( Z= -3.00 and -2.46, P <0.01 and =0.01). Furthermore, the trophoblast TLR3 expression negatively correlated with maternal HBV DNA ( r = -0.29, P = 0.003), HBeAg ( r = -0.28, P = 0.01) and HBV DNA+HBeAg ( r = -0.24, P = 0.02). Besides, NF-κB positively correlated with infant IL-6 ( r = 0.24, P = 0.026). By comprehensive analysis of maternal, placental and infant information, a Bayesian network model showed that the trophoblast TLR3 signaling pathway contacted with the non- or hypo-responsiveness. onclusions: Maternal HBV infection affected the trophoblast TLR3 signaling pathway protein expression, and consequently the impaired TLR3 signaling pathway involved in the HB vaccine non- or hypo-responsiveness mainly by influencing infant IL-6.

UJI EFEK ANTIPIRETIK EKSTRAK ETANOL DAUN MIANA(COLEUS SCUTELLARIOIDES [L]) BENTH PADA TIKUS PUTIH JANTAN GALUR WISTAR (RATTUS NORVEGICUS)

ABSTRACTThis study aims to determine the antipyretic effect of miana leaves extract (Coleus scutellariodes L Bent) in white male rats strain wistar. The subjects of this study were 15 white male rats, which were divided into 5 groups, namely the negative control group (1% CMC), the positive control group (Paracetamol), and the treatment group (miana leaf extracts). This type of research is a laboratory experiment, which carried out on the test animals based on a Completely Randomized Design (CRD) by testing the antipyretic effect carried out by administering the DPT-Hb vaccine. The observed response was in the form of data retrieval related to rat temperature after 2 hours of DPT-hb vaccine administration. Body temperature measurements were carried out before administering the vaccine, then successively at the 30th, 60th, 90th, and 120th minutes, respectively. The results showed miana leaf extracts at a dose of 25 mg, 50 mg and 75 mg had an antiperetic effect in white male rats but the dose 75mg provides the most effective antipyretic effect. Thus it can be concluded that the ethanol extracts of miana leaves has an antipyretic effect in white male rats, which were induced orally. Keywords: Antipyretics, Miana Leaves, Male White Rat. ABSTRAK Penelitian ini bertujuan untuk mengetahui Efek Antipiretik Ekstrak daun Miana (Coleus scutellariodes [L] Bent) pada Tikus Putih Jantan Galur Wistar. Subjek penelitian ini ialah 15 ekor tikus putih jantan yang dibagi menjadi 5 kelompok yaitu kelompok kontrol negatif (CMC 1%), kelompok kontrol positif (Parasetamol), dan kelompok perlakuan (ektrak daun miana).Jenis penelitian ini ialah eksperimental laboratorium yang akan dilakukan pada hewan uji berdasarkan Rancangan Acak Lengkap (RAL) dengan pengujian efek antipiretik dilakukan dengan cara memberikan vaksin DPT-Hb. Respon yang diamati yaitu berupa pengambilan data terkait suhu tikus setelah 2 jam pemberian vaksin DPT-hb. Pengukuran suhu tubuh dilakukan sebelum pemberian Vaksin, kemudian berturut-turut pada menit ke-30, 60, 90, dan 120. Hasil penelitian menunjukan ekstrak daun Miana dengan dosis 25 mg, 50 mg dan 75 mg memiliki efek antiperetik pada tikus putih jantan namun dosis 75 mg memberikan efek antipiretik yang paling efektif. Dengan demikian dapat disimpulkan bahwa ekstrak daun miana memiliki efek antipiretik pada tikus putih jantan yang di induksi secara oral. Kata kunci : Antipiretik, Daun Miana, Tikus Putih Jantan