Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India.

BACKGROUND: This study assessed safety and immunogenicity of Serum Institute of India Pvt Ltd (SIIPL)'s tetanus toxoid (TT), diphtheria toxoid (DT), and acellular pertussis booster vaccine (Tdap). RESEARCH DESIGN AND METHODS: In this Phase II/III, multicenter, randomized, active-controlled, open-label study, 1500 healthy individuals, aged 4-65 years, were randomized to receive a single dose of SIIPL Tdap or comparator Tdap vaccine (Boostrix®; GlaxoSmithKlines, India). Adverse events (AEs) during initial 30 minutes, 7-day, 30-day post-vaccination were assessed. Blood samples were taken before and 30 days post-vaccination for immunogenicity assessment. RESULTS: No significant differences in incidence of local and systemic solicited AEs were observed between the two groups; no vaccine-related serious AEs were reported. SIIPL Tdap was non-inferior to comparator Tdap in achieving booster responses to TT and DT in 75.2% and 70.8% of the participants, respectively, and to pertussis toxoid (PT), pertactin (PRN), and filamentous hemagglutinin (FHA) in 94.3%, 92.6%, and 95.0% of the participants, respectively. Anti-PT, anti-PRN, and anti-FHA antibody geometric mean titers in both the groups, were significantly higher post-vaccination compared to pre-vaccination. CONCLUSIONS: Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to immunogenicity against tetanus, diphtheria, and pertussis and was well tolerated.

Cognitive Function in Children With b-Thalassemia Major.

OBJECTIVES: To assess intelligence Quotient (IQ) in transfusion dependent b-thalassemia major patients using Malin Intelligence Scale for Indian Children (MISIC) and to correlate verbal IQ (VIQ), performance IQ (PIQ) and full scale IQ (FSIQ) with serum ferritin levels and annual blood transfusion requirements. METHODS: Cross-sectional study design, enrolling 100 patients of transfusion-dependent b-thalassemia aged 6 years to 15 years 11 months. IQ was assessed using MISIC. RESULTS: Mean (SD) full scale IQ was 95.96 (7.23). IQ was 'average' in most of the patients. There was a significant negative correlation of serum ferritin levels with object assembly (r=-0.215, P=0.034) component of PIQ; annual blood requirement with general comprehension component of VIQ (r=-0.275, P=0.006) and age at diagnosis with PIQ (r=-0.273, P=0.006). There was a significant linear correlation of PIQ (r=0.280, P=0.005) and FSIQ (r=0.274, P=0.006) with pre-transfusion hemoglobin. CONCLUSION: IQ correlates with age at diagnosis and average annual pre-transfusion hemoglobin. This highlights the importance of early diagnosis and maintenance of satisfactory hemoglobin levels.

Evaluation of AIIMS Modified INCLEN Tool for Diagnosis of Epilepsy.

OBJECTIVES: To evaluate the AIIMS Modified INCLEN tool for the diagnosis of epilepsy. METHODS: This cross-sectional study enrolled 250 children aged 1 month to 18 years presenting with complaints of abnormal body movements to either the pediatric or neurology outpatient departments in our institution between October 1, 2018 and June 30, 2020. The All India Institute of Medical Sciences (AIIMS) modified International Clinical Epidemiology Network (INCLEN) diagnostic tool for epilepsy (AIIMS modified INDT-EPI) was administered and a diagnosis was made, which was further verified by a pediatrician or a neurologist. Specificity, sensitivity, positive predictive value (PPV) and negative predictive value (NPV) were calculated. RESULTS: The study tool had a sensitivity of 87.6% and specificity of 84.0%. The PPV and NPV of the study tool were 86.8% and 84.9%, respectively. CONCLUSION: The study tool has good psychometric properties for physician assessment with regard to diagnosis of epilepsy.

A phase III randomized, open-label, non-inferiority clinical trial comparing liquid and lyophilized formulations of oral live attenuated human rotavirus vaccine (HRV) in Indian infants.

The human rotavirus vaccine (HRV; Rotarix, GSK) is available as liquid (Liq) and lyophilized (Lyo) formulations, but only Lyo HRV is licensed in India. In this phase III, randomized, open-label trial (NCT02141204), healthy Indian infants aged 6-10 weeks received 2 doses (1 month apart) of either Liq HRV or Lyo HRV. Non-inferiority of Liq HRV compared to Lyo HRV was assessed in terms of geometric mean concentrations (GMCs) of anti-RV immunoglobulin A (IgA), 1-month post-second dose (primary objective). Reactogenicity/safety were also evaluated. Seroconversion was defined as anti-RV IgA antibody concentration ≥20 units [U]/mL in initially seronegative infants (anti-RV IgA antibody concentration <20 U/mL) or ≥2-fold increase compared with pre-vaccination concentration in initially seropositive infants. Of the 451 enrolled infants, 381 (189 in Liq HRV and 192 in Lyo HRV group) were included in the per-protocol set. The GMC ratio (Liq HRV/Lyo HRV) was 0.93 (95% confidence interval [CI]: 0.65-1.34), with the lower limit of the 95% CI reaching ≥0.5, the pre-specified statistical margin for non-inferiority. In the Liq HRV and Lyo HRV groups, 42.9% and 44.3% (baseline) and 71.4% and 73.4% (1-month post-second dose) of infants had anti-RV IgA antibody concentration ≥20 U/mL, and overall seroconversion rates were 54.5% and 50.0%. Incidences of solicited and unsolicited adverse events were similar between groups and no vaccine-related serious adverse events were reported. Liq HRV was non-inferior to Lyo HRV in terms of antibody GMCs and showed similar reactogenicity/safety profiles, supporting the use of Liq HRV in Indian infants.

PLAIN LANGUAGE SUMMARYWhat is the context?Rotavirus is the most common cause of acute gastronenteritis and contributes to the high number of hospitalizations and deaths in young children worldwide.Vaccination against rotavirus has led to a significant decrease in rotavirus-related infections.The human rotavirus vaccine Rotarix (GSK) is currently used as a liquid or lyophilized formulation.In clinical trials conducted in European and North American infants, the liquid vaccine showed ability to induce immune response and safety comparable to the lyophilized formulation.Only the lyophilized vaccine is currently marketed in india.What is new?We compared the 2-dose liquid and lyophilized human rotavirus vaccines in indian infants in a phase III clinical trial:The ability to induce immune response for thw liquid formulation was not inferior to that observed for the lyophilized vaccine.The safety profiles of the 2 formulations were comparable.Why is this important?This study shows that the liquid human rotavirus vaccine can be administrated to infants from india.

Synthesis, spectroscopic characterization, electrochemical behaviour, reactivity and antibacterial activity of some transition metal complexes with 2-(N-salicylideneamino)-3-carboxyethyl-4,5-dimethylthiophene.

Mn(II), Fe(II), Co(II), Ni(II), Cu(II) and Zn(II) complexes with a potentially tridentate Schiff base, formed by condensation of 2-amino-3-carboxyethyl-4,5-dimethylthiophene with salicylaldehyde were synthesized and characterized on the basis of elemental analyses, molar conductance values, magnetic susceptibility measurements, UV-vis, IR, EPR and NMR spectral data, wherever possible and applicable. Spectral studies reveal that the free ligand exists in a bifunctionally hydrogen bonded manner and coordinates to the metal ion in a tridentate fashion through the deprotonated phenolate oxygen, azomethine nitrogen and ester carbonyl group. On the basis of electronic spectral data and magnetic susceptibility measurements, suitable geometry has been proposed for each complex. The EPR spectral data of the Cu(II) complex showed that the metal-ligand bonds have considerable covalent character. The Ni(II) complex has undergone facile transesterification reaction when refluxed in methanol for a lengthy period. X-ray diffraction studies of Cu(II) complex showed that the complex has an orthorhombic crystal lattice. In view of the biological activity of thiophene derivatives, the ligand and the complexes were subjected to antibacterial screening. It has been observed that the antibacterial activity of the ligand increased on chelation with metal ion.

Measles in adults in Canada and the United States: implications for measles elimination and eradication.

BACKGROUND: Despite the implementation of mass school catch-up campaigns for measles in Canada, an outbreak of measles occurred in early 1997 mostly affecting the adult population. The higher incidence in Canada in adults led us to compare immunization policies and the evolution of measles among adults in Canada and the US. METHODS: Based on information gathered from both national immunization programmes and surveillance systems. RESULTS: Although the proportion of cases occurring in adults has increased tremendously in both countries in the past decade, there was no increase in measles incidence in these populations. The most likely factors to explain the higher rate of measles occurring in adults in Canada are the younger age at administration of first dose in Canada, the delay in implementation of a second dose policy in Canada compared with the US combined with the lack of prematriculation immunization requirements in Canadian colleges and universities, and the higher rate of overseas travel to and from Canada. The situation in Canada may also have been exacerbated by incomplete efforts to control measles for many years without attempting to eliminate the disease. CONCLUSIONS: In order to prevent measles in adults, high-risk groups must be identified and catch-up for selected groups considered. Vaccination of international travellers to endemic areas should be recommended until global elimination has been achieved. Appropriate measles control strategies in younger populations seem to be effective in preventing measles in adults. The experience in Canada and the US suggests that measles transmission in adults is unlikely to be a major impediment to regional elimination or global eradication.

Antenatal period: an educational opportunity.

In this study the impact of an educational programme during antenatal period was evaluated. Pregnant women attending the antenatal clinic formed the study material. The first 100 mothers who were not given health education served as controls. The subsequent 201 cases constituted the study group and were given health education on certain aspects of maternal and child care. The control and study groups were well matched for age, parity, education, income and number of antenatal visits. The results indicated that the mothers in study group gained statistically significant knowledge regarding the purpose of antenatal care, hematinics and tetanus toxoid vaccination. The awareness regarding breast feeding and its advantages also increased significantly in the study group. The knowledge about individual vaccine especially measles and DPT was poor which increased significantly after the educational intervention in the study group. It is recommended that the antenatal period should be optimally utilized to impart health education on the various aspects of maternal and child health.

Neonatal conjunctivitis: a profile.

Neonatal conjunctivitis is one of the commonest infections encountered in the newborn. A prospective study was conducted on all babies born over a period of one year. No prophylactic ocular medication was instilled routinely in newborns. Babies developing purulent eye discharge were diagnosed to have conjunctivitis. Eye Swab from the neonates and maternal vaginal/cervical swabs were sent for culture. Chloromycetin eye drops were used for treatment and in case of no response, changed as per sensitivity report or to gentamicin eye drops. Oral erthromycin was given for dacryocystitis or when there was no response to topical therapy. The incidence of conjunctivitis was 7.2%. Two seasonal peaks, namely, February and then May and June, were noted. In 91.6% of the babies, conjunctivitis developed within the first week. A prolonged rupture of membranes was associated with a significantly higher incidence of conjunctivitis (p < 0.01). The most common organism grown from conjunctival swab was Staph aureus (35.2%) followed by Enterococcus (4.3%), Klebsiella (3.5%) and E. coli (2.8%). From vaginal/cervical swabs, E. coli was the most common organism isolated. No concurrence of organisms was noted between eye swabs and vaginal/cervical swabs. A uniformly good response to chloromycetin eye drops was noted with only 3.5% requiring a change of therapy. It is concluded that neonatal conjunctivitis is commonly acquired postnatally and responds well to topical chloromycetin therapy. Oral erythromycin may be used in resistant cases which will cover the chlamydial infection also.

Outcome of hospitalised out-born preterm babies.

PIP: 187 babies born elsewhere and referred to the Pediatric Department of the Christian Medical College and Hospital, Ludhiana, for management of prematurity over a period of 6 years were studied. Babies with hypothermia and those below 1200 g were given iv fluids. Preterm babies delivered in the institution and managed in the neonatal special care nursery over 1 year were also studied for comparison. The preterm babies were evenly distributed in the different gestation age groups between 28 and 36 weeks. About half the babies were appropriate for gestational age, while 47% were small for gestational age. The weight ranged from 760 to 2260 g. Males (166) outnumbered females (21) by a ratio of 8:1. There was a high incidence of hypothermia (54%) at the time of admission, more so in babies with gross prematurity. In babies less than 30 weeks old, 80% had become hypothermic during transit to the hospital. A fatal outcome was seen in 69% of babies with hypothermia as compared to 38% of babies admitted without hypothermia. 85% of babies were born in circumstances of potential infection in the form of prolonged rupture of membranes, multiple unsterile vaginal examinations, foul smelling liquor, fever of the mother, or a combination of these. Septicemia, purulent meningitis, bronchopneumonia, and diarrhea were the common infections. Other common morbidities were hyaline membrane disease, necrotizing enterocolitis, and metabolic disturbances. The overall mortality was 54% and it was inversely proportional to the gestational age, increasing from 36% at 35-36 weeks to 82% at 28-30 weeks. On the other hand, there was only a 21% mortality rate among preterm babies delivered at the hospital and managed in the neonatal nursery. Mortality was 9% in babies at 35-36 weeks. Intracranial hemorrhage was the most common cause of death in the study group, accounting for 42% of total deaths (59% of deaths at 28-30 weeks gestation, decreasing to only 4% at 35-36 weeks), followed by septicemia in 31%. On the other hand, septicemia caused about one-third of deaths at 35-36 weeks.^ieng