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1.
J Pediatr Hematol Oncol ; 44(5): e881-e883, 2022 07 01.
Article in English | MEDLINE | ID: mdl-35383694

ABSTRACT

Hypereosinophilic syndrome (HES) is a very rare disease during childhood. It involves the different organs like skin, gastrointestinal system, heart and lungs, besides pulmonary hypertension (PHT) is a very rare morbidity of HES that may cause life-threatening complications. PHT improves with the treatment of hypereosinophilia, without the need for pulmonary vasodilator therapy. Here, we present a case of PHT developed after recovery of pulmonary infiltration in an infant with idiopathic HES. We revealed that pulmonary pressure returned to normal range in parallel with the decrease in eosinophil count with steroid treatment.


Subject(s)
Hypereosinophilic Syndrome , Hypertension, Pulmonary , Heart , Humans , Hypereosinophilic Syndrome/complications , Hypereosinophilic Syndrome/drug therapy , Hypertension, Pulmonary/complications , Hypertension, Pulmonary/etiology , Infant , Leukocyte Count , Lung
3.
Med J Malaysia ; 76(2): 218-222, 2021 03.
Article in English | MEDLINE | ID: mdl-33742631

ABSTRACT

BACKGROUND: The relationship between the sociodemographic characteristics of the older persons and healthcare utilisation is well established. However, the process underlying this relationship is poorly understood particularly in the Malaysian context. MATERIALS AND METHODS: A cross-sectional study was conducted from February to April in 2016 to examine the mediating effect of health literacy on the relationship between age and healthcare utilisation. A total of 452 older persons were recruited from 14 public hospitals in Malaysia. RESULTS: The average age of the respondents was 66.69 years old, with an age range between 60 to 105 years. The findings reveal that the relationship between age and healthcare utilisation was mediated by health literacy. CONCLUSION: The results help to improve the understanding of healthcare utilisation among the older persons in Malaysia, which is beneficial to the healthcare provider and policymakers.


Subject(s)
Health Literacy , Aged , Aged, 80 and over , Cross-Sectional Studies , Hospitals, Public , Humans , Malaysia/epidemiology , Middle Aged , Patient Acceptance of Health Care
5.
Sci Total Environ ; 659: 1577-1584, 2019 Apr 01.
Article in English | MEDLINE | ID: mdl-31096367

ABSTRACT

The objective of this paper is to determine whether deep tubewells installed through arsenic mitigation efforts in rural Bangladesh provide better drinking water microbial quality compared to shallow tubewells. We conducted a stratified random cross-sectional survey of 484 households to assess microbial contamination of deep tubewell water at source and at point of use (POU) compared to shallow tubewell water using the Compartment Bag Test. In addition, we measured storage time, distance, travel time and ownership status among both sets of users to assess deep tubewell efficacy and under what conditions they offer poorer or better water quality. Differences in tubewell characteristics were compared using non-parametric Mann-Whitney U tests and two-proportion Z-tests. Prevalence ratios of microbial contamination stratified by water quality, storage time and distance to tubewells and ownership were estimated using unadjusted Mantel-Haenszel tests. There was no significant difference in microbial contamination between shallow and deep tubewells at source. The presence of POU water microbial contamination in storage containers in deep tubewell households was 1.11 times the prevalence in shallow tubewell storage containers (95% CI = 0.97-1.27). Deep tubewell users stored water longer and walked significantly farther to obtain water compared to shallow tubewell users. Among deep tubewell households, those residing farther away from the source were 1.24 times as likely to drink contaminated water from storage containers compared to those located nearby (95% CI = 1.04-1.48). Our findings suggest that deep tubewells have comparable water quality to shallow tubewells at source, but increasing distance from the household exacerbates risk of microbial contamination at POU.


Subject(s)
Arsenic/analysis , Environmental Monitoring , Water Microbiology , Water Pollutants, Chemical/analysis , Water Pollution, Chemical/statistics & numerical data , Water Wells , Bangladesh/epidemiology , Cross-Sectional Studies , Groundwater , Humans , Rural Population , Water Pollution, Chemical/prevention & control , Water Quality , Water Supply/statistics & numerical data
6.
Trop Biomed ; 36(4): 1014-1026, 2019 Dec 01.
Article in English | MEDLINE | ID: mdl-33597471

ABSTRACT

The influx of low skilled migrant workers to Malaysia from low socio-economic countries where gastrointestinal parasitic infections are prevalent has raised concerns about transmission to the local population. Three methods for detection (serology, microscopy and molecular techniques) were utilized to identify Entamoeba infections amongst the targeted cohort and determine risk factors associated with infection. Serological screening of 484 migrant workers from five working sectors in Peninsular Malaysia using IgG4 ELISA based on the rPPDK antigen showed an overall seroprevalence of 7.4% (n = 36; CL95 = 5.3-10.1%) with only one factor statistically associated with seropositivity of anti-amoebic antibodies, i.e. years of residence in Malaysia (χ2 1 = 4.007, p = 0.045). Microscopic examination of 388 faecal samples for protozoan cysts and trophozoites showed a slightly higher prevalence (11.6%; n=45; CL95: 8.4-14.8%). Meanwhile, amplification of the 16S rDNA gene detected two species i.e. Entamoeba dispar (23/388; 5.9%; CL95: 3.6-8.3%) and E. histolytica (11/388; 2.8%; CL95: 1.2-4.5%) and mixed infections with both parasites in only three samples (3/388; 0.8%; CL95: 0.2-2.2%). Entamoeba dispar infection was significantly associated with those employed in food and domestic services (χ2 4 = 12.879, p = 0.012). However, none of the factors affected the prevalence of E. histolytica infection. Despite the low prevalence of E. histolytica in faecal samples of the study cohort, the presence of this pathogenic parasite still poses potential public health risks and calls for tighter control strategies based on better availability of chemotherapeutic treatment and accessibility to appropriate health education.


Subject(s)
Entamoebiasis/epidemiology , Transients and Migrants , Adult , Entamoeba/classification , Entamoeba/isolation & purification , Feces/parasitology , Female , Humans , Malaysia/epidemiology , Male , Middle Aged , Prevalence , Risk Factors , Seroepidemiologic Studies
7.
Tropical Biomedicine ; : 1014-1026, 2019.
Article in English | WPRIM (Western Pacific) | ID: wpr-787785

ABSTRACT

@#The influx of low skilled migrant workers to Malaysia from low socio-economic countries where gastrointestinal parasitic infections are prevalent has raised concerns about transmission to the local population. Three methods for detection (serology, microscopy and molecular techniques) were utilized to identify Entamoeba infections amongst the targeted cohort and determine risk factors associated with infection. Serological screening of 484 migrant workers from five working sectors in Peninsular Malaysia using IgG4 ELISA based on the rPPDK antigen showed an overall seroprevalence of 7.4% (n = 36; CL95 = 5.3–10.1%) with only one factor statistically associated with seropositivity of anti-amoebic antibodies, i.e. years of residence in Malaysia (χ2 1 = 4.007, p = 0.045). Microscopic examination of 388 faecal samples for protozoan cysts and trophozoites showed a slightly higher prevalence (11.6%; n=45; CL95: 8.4–14.8%). Meanwhile, amplification of the 16S rDNA gene detected two species i.e. Entamoeba dispar (23/388; 5.9%; CL95: 3.6–8.3%) and E. histolytica (11/388; 2.8%; CL95: 1.2–4.5%) and mixed infections with both parasites in only three samples (3/388; 0.8%; CL95: 0.2–2.2%). Entamoeba dispar infection was significantly associated with those employed in food and domestic services (χ2 4 = 12.879, p = 0.012). However, none of the factors affected the prevalence of E. histolytica infection. Despite the low prevalence of E. histolytica in faecal samples of the study cohort, the presence of this pathogenic parasite still poses potential public health risks and calls for tighter control strategies based on better availability of chemotherapeutic treatment and accessibility to appropriate health education.

8.
Int J Oral Maxillofac Surg ; 47(12): 1511-1518, 2018 Dec.
Article in English | MEDLINE | ID: mdl-30837061

ABSTRACT

The mandibulotomy is a procedure that was developed to improve access in tumour resection. This study aimed to investigate the complications associated with mandibulotomy and analyze factors that could affect the risks of developing these complications. The hospital records of all patients who underwent a mandibulotomy as part of their tumour ablative surgery at two major centres in Malaysia were reviewed retrospectively. Demographic, clinical, and complications data were recorded and analyzed. Early postoperative complications occurred in 46.5% of the patients and post-radiation therapy complications in 16.1%. Wound dehiscence (27.9%) and inferior alveolar nerve injury (25.6%) were the common early postoperative complications. Dental injuries (9.7%) and plate exposure/infection (9.7%) were the common post-radiation therapy complications. Furthermore, inferior alveolar nerve injury and early abscess formation were significantly associated with the site of the mandibulotomy. The T-stage of a tumour but not the site of mandibulotomy was significantly associated with tumour margin clearance. Mandibulotomy does pose an added risk of complications for a patient undergoing tumour surgery. The benefits of mandibulotomy in terms of gaining margin clearance could not be proven in this study. The site of mandibulotomy appears to increase the risk of developing an inferior alveolar nerve injury.


Subject(s)
Mandibular Neoplasms/surgery , Mandibular Osteotomy/methods , Adult , Aged , Female , Humans , Male , Mandibular Neoplasms/pathology , Middle Aged , Neoplasm Staging , Postoperative Complications/pathology , Retrospective Studies
10.
Oral Health Prev Dent ; 14(2): 149-55, 2016.
Article in English | MEDLINE | ID: mdl-25789362

ABSTRACT

PURPOSE: The oral cavity is a rich ecosystem with a plethora of microorganisms, and different components of fixed orthodontic appliances may contribute to a shift in the balance of oral ecology. The purpose of this study was to investigate the antimicrobial potential of hexane and ethanol extracts of Salvadora persica on a monospecies biofilm model established on orthodontic brackets in vitro. MATERIALS AND METHODS: Streptococcus mutans biofilm was formed on mini diamond orthodontic brackets following three days of anaerobic incubation at 37˚C. The bacterial cell viability of this biofilm was measured after their exposure to saline, hexane extract of S. persica, ethanol extract of S. persica and 0.2% chlorhexidine using 3-(4, 5-dimethylthiazol- 2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulphophenyl)-2H-tetrazolium (MTS) assay. On half of the brackets, the colony forming units (CFU) were counted. Both experiments were performed in triplicate. RESULTS: The absorbance values obtained from the MTS reduction assay after exposure to the different test agents showed a decline in the bacterial cell viability of the S. mutans biofilm as follows: chlorhexidine (+)0.05). The CFU counts of S. mutans obtained from chlorhexidine exposure were lower than from hexane and ethanol extracts. CONCLUSION: S. persica extracts were found to have antimicrobial effects on S. mutans biofilm established in vitro on orthodontic brackets suggestive of its potential use as an oral antimicrobial agent for orthodontic patients.


Subject(s)
Anti-Bacterial Agents/pharmacology , Biofilms/drug effects , Orthodontic Brackets/microbiology , Plant Extracts/pharmacology , Salvadoraceae , Streptococcus mutans/drug effects , Anti-Infective Agents, Local/pharmacology , Bacterial Load/drug effects , Bacteriological Techniques , Chlorhexidine/pharmacology , Coloring Agents , Ethanol/chemistry , Hexanes/chemistry , Humans , Materials Testing , Methylphenazonium Methosulfate , Microbial Viability/drug effects , Solvents/chemistry , Tetrazolium Salts , Thiazoles
11.
J Pharm Bioallied Sci ; 7(4): 300-3, 2015.
Article in English | MEDLINE | ID: mdl-26681888

ABSTRACT

OBJECTIVE: The antimicrobial effect of aerial part of Rumex nervosus obtained from the Southern region of Saudi Arabia was evaluated on bacterial strains Staphylococcus aureus, methicillin resistant S. aureus, Enterococcus faecalis, Escherichia coli, Pseudomonas Aeruginosa, and fungal strain Candida albicans. MATERIALS AND METHODS: The solvents used for the extraction were aqueous, hexane, and methanol. The in vitro antimicrobial activity was performed by agar diffusion and disk diffusion methods and the confirmation of this activity was done by the enumeration of colony forming units (CFU). RESULTS: The aqueous extract showed the growth inhibitory effect on Gram-positive bacteria while the Gram-negative P. aeruginosa was the most sensitive microorganism as determined by the agar diffusion technique. Surprisingly, the extract showed little antibacterial activity on other Gram-negative bacteria (E. coli) by this technique. Ethanolic extract was also found to be inhibitory to the growth of microorganisms. Hexane extract was relatively low in antimicrobial activity on Gram-negative E. coli and P. aeruginosa, while both the organic extracts were inhibitory to the growth of the fungus, C. albicans. Hexane gave no conclusive results with agar or disk diffusion methods, but showed the microbial growth inhibition in CFU enumeration. The antibacterial activity of active extracts was compared with vancomycin while antifungal activity of was compared with amphotericin B. CONCLUSION: The results obtained in the present study suggest that R. nervosus showed a marked antimicrobial activity with the test organisms.

12.
Article in English | WPRIM (Western Pacific) | ID: wpr-629112

ABSTRACT

The Community Health Posting teaching module is incorporated in the fourth year medical curriculum at Universiti Sains Islam Malaysia (USIM). The integration of Islamic principles and values in the medical curriculum is emphasized during the Community Health Posting. The Community Health curriculum allow students to appreciate and understand the medical and fiqh aspects of health and disease, the social issues in medical practice and research and to inculcate the practice of Islamic professional etiquettes. The teaching module illustrates the relevance of humanities in understanding illness and medical care within the community. Teaching and learning activities include components that enable the students to explore a wide range of influencing factors and how these affect the patients and their families. Issues pertaining to psychosocial and ecological perspectives of the community are also discussed. This posting utilizes various teaching and learning techniques such as lectures, tutorials, seminars, group discussions, educational visits, practical sessions and patient bedside teaching. In addition, the students are equipped with Islamic knowledge through the integration of Naqli and Aqli components in the Community Health Posting curriculum.

13.
Epidemiol Infect ; 142(9): 1859-68, 2014 Sep.
Article in English | MEDLINE | ID: mdl-24168897

ABSTRACT

This study examined the effects of meteorological factors, particularly, extreme weather events, on the prevalence of childhood diarrhoeal disease in Matlab, Bangladesh. Logistic regression models were used to examine impacts of temperature, rainfall and the extreme weather factors (the number of hot days and days with heavy rainfall) on childhood diarrhoea from 2000 to 2006 at the bari (cluster of dwellings) level. The results showed that the increases in the number of hot days and days with heavy rainfall were associated with an increase in daily diarrhoea cases by 0·8-3·8% and 1-6·2%, respectively. The results from multivariable stepwise models showed that the extreme weather factors were still positively associated with childhood diarrhoea, while the associations for average temperature and rainfall could be negative after other variables were controlled. The findings showed that not only the intensity, but also the frequency of extreme weather events had significant effects on childhood diarrhoea.


Subject(s)
Diarrhea/epidemiology , Rural Population , Weather , Bangladesh/epidemiology , Child, Preschool , Humans , Infant , Logistic Models , Odds Ratio , Risk Factors
14.
Theor Appl Genet ; 126(11): 2671-82, 2013 Nov.
Article in English | MEDLINE | ID: mdl-23921956

ABSTRACT

Maize was first domesticated in a restricted valley in south-central Mexico. It was diffused throughout the Americas over thousands of years, and following the discovery of the New World by Columbus, was introduced into Europe. Trade and colonization introduced it further into all parts of the world to which it could adapt. Repeated introductions, local selection and adaptation, a highly diverse gene pool and outcrossing nature, and global trade in maize led to difficulty understanding exactly where the diversity of many of the local maize landraces originated. This is particularly true in Africa and Asia, where historical accounts are scarce or contradictory. Knowledge of post-domestication movements of maize around the world would assist in germplasm conservation and plant breeding efforts. To this end, we used SSR markers to genotype multiple individuals from hundreds of representative landraces from around the world. Applying a multidisciplinary approach combining genetic, linguistic, and historical data, we reconstructed possible patterns of maize diffusion throughout the world from American "contribution" centers, which we propose reflect the origins of maize worldwide. These results shed new light on introductions of maize into Africa and Asia. By providing a first globally comprehensive genetic characterization of landraces using markers appropriate to this evolutionary time frame, we explore the post-domestication evolutionary history of maize and highlight original diversity sources that may be tapped for plant improvement in different regions of the world.


Subject(s)
Internationality , Zea mays/genetics , Americas , Cluster Analysis , Genetic Loci , Genetic Variation , Geography , Microsatellite Repeats/genetics , Phylogeny , Principal Component Analysis
15.
J Postgrad Med ; 59(2): 121-6, 2013.
Article in English | MEDLINE | ID: mdl-23793313

ABSTRACT

Hypotension during cesarean section under spinal anesthesia remains a frequent scenario in obstetric practice. A number of factors play a role in altering the incidence and severity of hypotension. Counteracting aortocaval compression does not significantly prevent hypotension in most singleton pregnancies. Intravenous crystalloid pre-hydration is not very efficient. Thus, the focus has changed toward co-hydration and use of colloids. Among vasopressors, phenylephrine is now established as a first line drug, although there is limited data in high-risk patients. Though ephedrine crosses the placenta more than phenylephrine and can possibly cause alterations in the fetal physiology, it has not been shown to affect the fetal Apgar or neurobehavioral scores.


Subject(s)
Anesthesia, Obstetrical/methods , Anesthesia, Spinal/adverse effects , Cesarean Section , Hypotension/etiology , Pregnancy Complications, Cardiovascular/etiology , Anesthesia, Obstetrical/adverse effects , Crystalloid Solutions , Disease Management , Ephedrine/therapeutic use , Female , Fluid Therapy , Humans , Hypotension/therapy , Isotonic Solutions , Pregnancy , Pregnancy Complications, Cardiovascular/prevention & control , Pregnancy Outcome , Vasoconstrictor Agents/therapeutic use
16.
Biomed Sci Instrum ; 48: 296-302, 2012.
Article in English | MEDLINE | ID: mdl-22846297

ABSTRACT

The pathology of multiple sclerosis (MS) is characterized by an inflammatory mononuclear infiltration in the white matter. The oxidative stress plays a role in the onset and progression of MS. We hypothesized that the decreasing oxidative stress might improve MS inflammatory lesions. The experimental allergic encephalomyelitis (EAE) induced in the Lewis rats were used to test this hypothesis. 24 animals were placed into two groups: 1) those on normal rat chow, 2) those on rat chow containing 7.5 g/kg of tetra-butyl-hydroxy-anisole (BHA), a food preservative. All the animals were induced to have EAE and examined daily in a double-blinded fashion. On 28th day of the induction, all animals were sacrificed, blood collected for glutathione (GSH) measurements and tissues collected for histology. All the animals, regardless of their diet status developed symptoms of EAE on a different days ranging from tail weakness to hind limb paralysis and all reached remission of acute EAE before the 28th day of induction. 8 animals of the non-BHA fed animals developed hind limb weakness in and 4 animlas developed hind limb paralysis, while 2 animals of BHA fed group developed tail paralysis, 2 hind limb weaknesses and 8 hind limb paralysis. The histology of the non-BHA group correlated well with the clinical symptoms of perivascular mononuclear infiltration, however, the BHA fed group revealed complete pathological recovery. Animals fed with BHA diet had significantly raised their GSH blood level, indicating up regulation of anti-oxidants activity. We conclude that dietary phase 2 enzyme inducers show potential therapeutic benefits in EAE, this result might assist in treating patients with MS.

17.
Saudi Med J ; 33(7): 750-5, 2012 Jul.
Article in English | MEDLINE | ID: mdl-22821309

ABSTRACT

OBJECTIVE: To examine susceptibility of Pseudomonas aeruginosa (P. aeruginosa) and Acinetobacter baumannii (A. baumannii ) against carbapenems along with colistin and tigecycline as alternative therapeutic options. METHODS: A total of 117 strains of multidrug-resistant (MDR) non-fermenting Gram negative bacteria isolated from non-duplicate samples were collected consecutively. We included one sample from each patient (84 isolates of A. baumannii and 33 isolates of P. aeruginosa isolated from patients seen at King Khalid University Hospital, Riyadh, Saudi Arabia, from June to December 2010). Isolates were identified by the MicroScan WalkAway 96 Plus system. The minimum inhibitory concentrations (MICs) were determined by E-test following the Clinical and Laboratory Standards Institute breakpoint recommendations. RESULTS: Most A. baumannii strains were resistant to imipenem (90.5%), meropenem (90.5%), and doripenem (77.4%). Whereas, a higher percentage of P. aeruginosa was resistant to imipenem (90.9%), and meropenem (81.8%), only 39.4% were resistant to doripenem. Colistin had excellent activity against both A. baumannii (100%) and P. aeruginosa (93.9%), while 89.3% of A. baumannii strains were susceptible to tigecycline. CONCLUSION: Among the carbapenems, doripenem was found to be the most potent antimicrobial agent against P. aeruginosa, whereas colistin proved to be an effective alternative antimicrobial agent for treatment of A. baumannii or P. aeruginosa. Tigecycline remains the best therapeutic option for MDR A. baumannii.


Subject(s)
Acinetobacter baumannii/drug effects , Anti-Bacterial Agents/pharmacology , Drug Resistance, Multiple, Bacterial , Pseudomonas aeruginosa/drug effects , Carbapenems/pharmacology , Colistin/pharmacology , Microbial Sensitivity Tests , Minocycline/analogs & derivatives , Minocycline/pharmacology , Tigecycline
18.
Vaccine ; 30 Suppl 1: A106-13, 2012 Apr 27.
Article in English | MEDLINE | ID: mdl-22520119

ABSTRACT

BACKGROUND: We evaluated the immunogenicity of the pentavalent rotavirus vaccine (PRV) in two GAVI-eligible Asian countries, Bangladesh and Vietnam, nested in a larger randomized, double-blind, placebo-controlled efficacy trial conducted over a two-year period from 2007 through 2009. METHODS: 2036 infants were randomly assigned, in a 1:1 ratio, to receive three oral doses of PRV or placebo approximately at 6, 10, and 14 weeks of age. Concomitant use of EPI vaccines, including oral poliovirus vaccine (OPV) and diphtheria-tetanus-whole cell pertussis (DTwP) vaccine, was encouraged in accordance to the local EPI schedule. A total of 303 infants were evaluated for immunogenicity and blood samples were collected before the first dose (pD1) and approximately 14 days following the third dose (PD3). The seroresponse rates (≥3-fold rise from pD1 to PD3) and geometric mean titers (GMTs) were measured for anti-rotavirus immunoglobulin A (IgA) and serum neutralizing antibody (SNA) to human rotavirus serotypes G1, G2, G3, G4, and P1A[8], respectively. RESULTS: Nearly 88% of the subjects showed a ≥3-fold increase in serum anti-rotavirus IgA response in the analysis of the two countries combined. When analyzed separately, the IgA response was lower in Bangladeshi children (78.1% [95% CI: 66.0, 87.5]) than in Vietnamese children (97.0% [95% CI: 89.6, 99.6]), with a PD3 GMT of 29.1 (units/mL) and 158.5 (units/mL), respectively. In the combined population, the SNA responses to the individual serotypes tested ranged from 10 (G3) to 50 (G1) percentage points lower than the responses shown in the developed countries. However, the SNA response to G3 in Vietnamese subjects was 37.3% (95% CI: 25.8, 50.0), which was similar to the G3 response rate in developed countries. CONCLUSIONS: Three oral doses of PRV were immunogenic in two GAVI-eligible Asian countries: Bangladesh and Vietnam. The GMTs of both the serum anti-rotavirus IgA and SNA responses were generally higher in Vietnamese than in Bangladeshi children. The SNA responses varied by individual serotypes and were lower than the results from developed countries. The clinical significance of these observations is not understood because an immune correlate of protection has not been established.


Subject(s)
Rotavirus Infections/prevention & control , Rotavirus Vaccines/immunology , Vaccination/methods , Administration, Oral , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , Bangladesh , Developing Countries , Double-Blind Method , Humans , Immunoglobulin A/blood , Infant , Placebos/administration & dosage , Rotavirus/classification , Rotavirus/isolation & purification , Rotavirus Vaccines/administration & dosage , Serotyping , Vaccines, Attenuated/administration & dosage , Vaccines, Attenuated/immunology , Vietnam
19.
Vaccine ; 30 Suppl 1: A101-5, 2012 Apr 27.
Article in English | MEDLINE | ID: mdl-22520118

ABSTRACT

A double-masked, individually randomized Phase 3 clinical trial to assess the efficacy, safety and immunogenicity of the pentavalent rotavirus vaccine (PRV), RotaTeq™, was conducted in rural Matlab, Bangladesh (NCT00362648). A total of 1136 infants were enrolled and randomized to receive either vaccine or placebo in a 1:1 ratio administered with the standard EPI vaccines at a mean age of approximately 8, 12, and 16 weeks. Weight was collected at four time points (study vaccine doses 1, 2, and 3, and a close-out visit in March 2009 at 15-26 months of age), and birth weight was retrospectively collected from information contained on the mother's health card when available. Approximately one year following trial completion a separate study was conducted to collect anthropometry measurements, including weight and height. These measurements were linked with Phase 3 trial data and a post hoc analysis was conducted to assess the effects of rotavirus vaccination on malnutrition among enrolled children who could be located when they were between 27 and 38 months old. Among the 1033 (91%) children located, and measured, for this analysis height-for-age and weight-for-height Z scores were calculated and compared between vaccine and placebo recipients at the anthropometry follow-up 1-year post-trial, and weight-for-age Z scores were calculated at four trial time points in addition to the anthropometry follow-up. The data indicated that there was no effect of rotavirus vaccination on malnutrition in this population at any of the measured time points. PRV, estimated to have about 43% efficacy against severe rotavirus gastroenteritis in this population, may not reduce the overall burden of diarrheal illness sufficiently among all vaccinees to appreciably measure impact on growth compared with non-vaccinees. Regardless of the impact on malnutrition indicators, rotavirus vaccines are an important intervention for reducing morbidity and mortality in children in developing countries.


Subject(s)
Gastroenteritis/prevention & control , Malnutrition/chemically induced , Rotavirus Infections/prevention & control , Rotavirus Vaccines/adverse effects , Rotavirus Vaccines/immunology , Vaccination/adverse effects , Vaccination/methods , Administration, Oral , Anthropometry , Antibodies, Viral/blood , Bangladesh/epidemiology , Body Weight , Child, Preschool , Double-Blind Method , Female , Gastroenteritis/epidemiology , Humans , Infant , Infant, Newborn , Male , Malnutrition/epidemiology , Placebos/administration & dosage , Rotavirus Infections/epidemiology , Rotavirus Vaccines/administration & dosage , Vaccines, Attenuated/administration & dosage , Vaccines, Attenuated/adverse effects , Vaccines, Attenuated/immunology
20.
Vaccine ; 30 Suppl 1: A94-100, 2012 Apr 27.
Article in English | MEDLINE | ID: mdl-22520143

ABSTRACT

An efficacy clinical trial with pentavalent rotavirus vaccine (PRV), RotaTeq(®), was conducted at Matlab field site of ICDDR,B, Bangladesh from March 2007 to March 2009. The methodology, including operation logistics, and lessons-learned are described in this report. Vaccination was organized at 41 fixed-site clinics twice/month. A total of 1136 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age with routine vaccines of the Expanded Programme on Immunization (EPI) schedule. Twelve field-workers routinely visited study participants for safety and efficacy follow-up. The study was conducted following good clinical practices and maintaining cold-chain requirements. There were no temperature deviations of clinical vaccine supplies. Data entry was done using the source documents to a central database developed by the sponsor which was linked to web. Among enrolled infants, 1128 (99.3%) received 3 doses of PRV/placebo and efficacy follow-up was conducted for a median of 554 days. For the evaluation of immunogenicity, blood samples were collected from 150 participants predose 1 and from 147 (98%) of the same participants post dose 3. Stool samples were collected from 778 (99.9%) acute gastroenteritis episodes among children who reported to diarrhoea treatment centres. Thirty-nine serious adverse events, including 6 deaths, occurred among study participants. The efficacy of PRV against severe rotavirus gastroenteritis was 42.7% through the entire follow-up period; serum anti-rotavirus IgA response was 78.1%. Inclement weather, difficult transportation, and movement of study participants were some of the challenges identified. This is the first vaccine trial in rural Bangladesh with online data entry. The study was well accepted in the community and was completed successfully.


Subject(s)
Gastroenteritis/prevention & control , Rotavirus Infections/prevention & control , Rotavirus Vaccines/immunology , Rotavirus Vaccines/supply & distribution , Vaccination/methods , Administration, Oral , Antibodies, Viral/blood , Bangladesh/epidemiology , Double-Blind Method , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Gastroenteritis/epidemiology , Humans , Immunoglobulin A/blood , Infant , Male , Placebos/administration & dosage , Refrigeration/methods , Rotavirus Infections/epidemiology , Rotavirus Vaccines/administration & dosage , Rotavirus Vaccines/adverse effects , Vaccination/adverse effects , Vaccines, Attenuated/administration & dosage , Vaccines, Attenuated/adverse effects , Vaccines, Attenuated/immunology , Vaccines, Attenuated/supply & distribution
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