Randomized, Controlled Trial of the Long Term Safety, Immunogenicity and Efficacy of RTS,S/AS02(D) Malaria Vaccine in Infants Living in a Malaria-Endemic Region.

The RTS,S/AS malaria candidate vaccine is being developed with the intent to be delivered, if approved, through the Expanded Programme on Immunization (EPI) of the World Health Organization. Safety, immunogenicity and efficacy of the RTS,S/AS02(D) vaccine candidate when integrated into a standard EPI schedule for infants have been reported over a nine-month surveillance period. This paper describes results following 20 months of follow up. This Phase IIb, single-centre, randomized controlled trial enrolled 340 infants in Tanzania to receive three doses of RTS,S/AS02(D) or hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received DTPw/Hib (diphtheria and tetanus toxoids, whole-cell pertussis vaccine, conjugated Haemophilus influenzae type b vaccine) at the same timepoints. The study was double-blinded to month 9 and single-blinded from months 9 to 20. From month 0 to 20, at least one SAE was reported in 57/170 infants who received RTS,S/AS02(D) (33.5%; 95% confidence interval [CI]: 26.5, 41.2) and 62/170 infants who received hepatitis B vaccine (36.5%; 95% CI: 29.2, 44.2). The SAE profile was similar in both vaccine groups; none were considered to be related to vaccination. At month 20, 18 months after completion of vaccination, 71.8% of recipients of RTS,S/AS02(D) and 3.8% of recipients of hepatitis B vaccine had seropositive titres for anti-CS antibodies; seroprotective levels of anti-HBs antibodies remained in 100% of recipients of RTS,S/AS02(D) and 97.7% recipients of hepatitis B vaccine. Anti-HBs antibody GMTs were higher in the RTS,S/AS02(D) group at all post-vaccination time points compared to control. According to protocol population, vaccine efficacy against multiple episodes of malaria disease was 50.7% (95% CI: -6.5 to 77.1, p = 0.072) and 26.7% (95% CI: -33.1 to 59.6, p = 0.307) over 12 and 18 months post vaccination, respectively. In the Intention to Treat population, over the 20-month follow up, vaccine efficacy against multiple episodes of malaria disease was 14.4% (95% CI: -41.9 to 48.4, p = 0.545). The acceptable safety profile and good tolerability of RTS,S/AS02(D) in combination with EPI vaccines previously reported from month 0 to 9 was confirmed over a 20 month surveillance period in this infant population. Antibodies against both CS and HBsAg in the RTS,S/AS02(D) group remained significantly higher compared to control for the study duration. Over 18 months follow up, RTS,S/AS02(D) prevented approximately a quarter of malaria cases in the study population. CLINICAL TRIALS: Gov identifier: NCT00289185

Immunogenicity of standard and low dose vaccination using yeast-derived recombinant hepatitis B surface antigen in elderly volunteers

There is no conclusive evidence that age influences the response to vaccination against hepatitis B virus. We therefore studied the immunogenicity of yeast-derived rHBsAg vaccine in elderly volunteers. The study was conducted in the outpatient clinics of an academic and a regional hospital, in a rural family practice and in an urban community centre. We recruited 112 healthy volunteers aged 59 years and over, to whom 10 or 20 μg yeast-derived HBsAg was given at 0, 1 and 6 months. Anti-HBs titres were measured by radioimmunoassay at 2, 6 and 7 months. Responders and non-responders were compared using univariate non-parametric tests and multivariate logistic regression analysis. Of the 116 subjects who volunteered to take part in the study, 106 vaccinees completed it. The percentage of subjects with an anti-HBs titre ⩾10 1U1−1 at 7 months was 60% (95% confidence interval: 51–70%; geometric mean titre: 253 1U1−1). Of the factors studied, i.e. setting, age, sex, alcohol consumption, current medication and vaccine dose, the use of medication at the time of the first vaccination was the only independent factor related to the response to vaccination, with a response rate of 78% (95% confidence interval: 66–89%) in those without medication. In elderly subjects, the proportion with protective concentrations of anti-HBs after vaccination with 10 or 20 μg yeast-derived recombinant HBsAg in a standard scheme is lower than in healthy adolescents. Within the older age group studied here, the use of medication, probably reflecting general health, is the only significant factor influencing the response to vaccination

Fv antibodies to aflatoxin B1 derived from a pre-immunized antibody phage display library system

The production and characterization of recombinant antibodies to aflatoxin B[SUB1] (AFB[SUB1]), a potent mycotoxin and carcinogen is described. The antibody fragments produced were then applied for use in a surface plasmon resonance-based biosensor (BIAcore), which measures biomolecular interactions in 'real-time'. Single chain Fv (scFv) antibodies were generated to aflatoxin B1 from an established phage display system, which incorporated a range of different plasmids for efficient scFv expression. The scFv's were used in the development of a competitive ELISA, and also for the development of surface plasmon resonance (SPR)-based inhibition immunoassays. They were found to be suitable for the detection of AFB[SUB1], in this format, with the assays being sensitive and reproducible

Uji Serologi Setelah Imunisasi Hepatitis B 3 Dosis di Puskesmas Daerah Bogor dan Padang

Immunization is the best way to prevent hepatitis. In Indonesia, immunization has been held since 1997. Three doses of hepatitis B vaccine to be given to infants with, the following schedules; the first dose is given to infants at 2, 3 and 4 months of age together with DTP vaccine, or at the day of birth for the first dose, and at 2, 3 months of age for the later doses. The objective of this study was to determine the immunity of hepatitis B immunized children under 5 years old and to define the factors influencing the immunity. One hundred thirty four samples from Community Health Center (Puskesmas) Kedung Badak, Bogor district and 136 samples from Puskesmas Andalas, Padang district were carried out in this study. Bogor district was presenting low prevalence of hepatitis B region and Padang district was presenting highly prevalence hepatitis B region. HBsAg and and HBs titre was determined by ELISA. The protective level of hepatitis B antibody was defined by titre > 10 mIU/ml. The result shows that there was no difference on the sample characteristic e.g age groups, sex, body weight and height between Puskesmas Kedung Badak and Puskesmas Andalas.. The hepatitis B immunization schedule was variative in there. The proportion of infant immunized at the day of bi,rth was 4.1%. Immunization status was taken from immunization card (KMS) or immunization record kept in Puskesmas, and all of the samples had completely immunization status of DPT, BCG, Polio, Hepatitis B and measles. Prevalence of HBsAg in Padang was higher than in Bogor, that was 1.47% and 0% respectively. All (100%) of the samples had protective antibody titre of hepatitis B with geometric mean titer (GMT) of 130.67 mIU/ml in Bogor district and 151.68 mlU/ml in Padang district. There was no significant difference of GMT between Bogor and Padang district. The GMT was not influenced by sex factor, birth weight and interval of immunizations. The GMT of infant with immunization at day of birth is lower than later, due to immature immune system and maternal antibody still remained. Although immunity produced was not optimal, it was above the protective level. The seroprotection hepatitis B antibody of the children who had 3 doses of hepatitis B vaccine was 100%, with GMT 130.67 mIU/ml at Puskesmas Kedung Badak and 151.68 mlU/ml at Puskesmas Andalas. A further test was still required reconsidering that children with positive HBsAg were still exist even though 3 doses immunizations has been given. Screening of hepatitis B virus at pregnant women have not been done, so immunization hepatitis B soonafter birth is very important

Hepatitis B immunisation : a survey of surgeons and theatre nurses

Acute viral hepatitis remains a serious condition. Its long-term sequelae include cirrhosis and hepatocellular carcinoma. Health workers constitute a high-risk group for contracting hepatitis B. A group of clinicians associated with invasive procedures and nurses working in operating theatres were invited to answer a confidential questionnaire concerning hepatitis B immunisation and the use of protective measures. A self-administered confidential questionnaire was sent to 152 clinicians and 97 theatre nurses, of whom 82 and 74 respectively responded, giving an overall response rate of 63 %. Whilst 91% of respondents considered their speciality as being of high risk for hepatitis B only 63% of them were fully immunised and of these only 51% had had their immunity tested. Out of those who checked their antibody status 19% did so following a needle stick injury. 60% of our respondents had had a needle stick injury over the past year. Even so barrier precaution techniques were used infrequently with only 17% always or at least frequently using double gloving and 10% wearing a visor during operations. Some respondents also commented on the poor availability of resources such as impermeable gowns or blunt needles which are established precautions against contamination from hepatitis B.peer-reviewe

Monoclonal antibodies to the cells of a regenerating limb

Monoclonal antibodies were raised against differentiated cells, and blastemal cells from regenerating limbs of adult newts (Notophthalmus viridescens) and screened for specific staining by immunocytochemistry. In addition to antibodies that identify muscle, Schwann cells and cartilage, two reagents were specific for subpopulations of blastemal cells. One of these latter antibodies, termed 22/18, has provided new evidence about the origin of blastemal cells from Schwann cells and rnyofibres, and also identifies blastemal cells whose division is persistently dependent on the nerve supply

Immunization against Hepatitis B Surface Antigen (HBsAg) in a Cohort of Nursing Students Two Decades after Vaccination: Surprising Feedback

Health-care students can be exposed to biological risks during university training. The persistence of long-term immunogenicity against hepatitis B virus (HBV) was analyzed in a cohort of nursing students two decades after primary vaccination. A total of 520 students were enrolled at the University of Palermo and were evaluated for levels of anti-HBsAg antibodies. ThestudentswereexaminedduringthefirstyearoftheirDegreeCourseandwerecheckedtwoyears later. All students with anti-HBsAg <10 mIU/mL during their first or third year were boosted within onemonth. Theproportionofstudentsthatwerevaccinatedduringadolescenceshowinganti-HBsAg ≥10 mIU/mL was higher than that observed in students who were vaccinated during infancy (69% versus31.7%;p-value<0.001). ReceivingHBVvaccinationatadolescencewassignificantlyassociated with a fourfold increased possibility of having anti-HBsAg titers≥10 mIU/mL (adj-OR = 4.21, 95% CI: 2.43–7.30). Among the students who were checked at the third year and boosted after the first year (n = 279), those who were vaccinated during infancy showed a higher percentage of antibody titers <10 mIU/mL (20.3% versus 8.7% among vaccinated during adolescence; p < 0.01). This study confirms that HBV vaccination at adolescence might determine a higher long-term persistence of anti-HBsAg titers≥10 mIU/mL and that anti-HBV booster could increase levels of anti-HBsAg over a relatively short period, especially in subjects who were vaccinated during infancy

Respon Kekebalan Pasca Imunisasi Hepatitis B Pada Anak Umur 4-6 Tahun

ABSTRACT The objective of HB immunization is to protect people from Hepatitis B disease . The effect of those protection is showed that there is variation of amount of titre anti HBs when conducted the research . To increase the access of HB immunization and effective vaccination therefore the observation of the effectiveness of anti HBs after immunized to protect people after 3-5 years immunization could be analyzed. The present study was conducted to discover the amount of titre anti HBs for 4-6 years old children which had been immunized Hepatitis B when they were a baby (< lyear) The study was conducted with the designed of cross-section The subject is a 4-6 year old child at kindergarten school. The total sample is 94 children that divided into 2 groups. One groups is for children at completed immunization, another group is for children uncompleted immunization. Overall sample is conducted weight and height measure, mother and chid blood specimen test which obtain respond data of resistance after immunization Hepatitis B at 4-6 years old and mother Hepatitis status. The results are children 4-6 years which had been uncompleted immunized Hepatitis B when they were baby will have mean titre anti HBs 25,99 mlU/ml or 87% lower than children in the same age which have been completed Hepatitis B immunization have mean titre anti HBs 199,21 mlU/ml. Keywords: anti HBs â uncompleted immunization - time interval at immunization HB doses