Immunogenicity and safety of an indigenously developed DTPw hepatitis B combination vaccine in Indian infants.

OBJECTIVE: To evaluate the safety and immunogenicity of an indigenous hepatitis B, diphtheria, tetanus and B. pertussis tetravalent vaccine (Shantetra) in comparison with Tritanrix HBTM in healthy Indian infants. DESIGN: Multicentric, randomized, single blind intention-to-treat study with 12-18 weeks of follow up period. SETTING: 5 out patient departments at tertiary care referral centers across India. PARTICIPANTS: 151 infants were randomized in a 2:1 ratio to recruit 101 in the Shantetra and 50 in the Tritanrix HBTM groups respectively. A total of 136 subjects completed the study. No patients were withdrawn from the study due to any adverse effects. INTERVENTIONS: Recruited subjects were randomized to receive three doses of either of the two DTPw-Hepatitis B combination vaccines as per the EPI schedule. MAIN OUTCOME MEASURES: Monitoring the humoral immune response (seroconversion rates) induced by each antigenic component three to six weeks after the last dose of vaccine in both the groups. RESULTS: Seroprotective immune response was observed in 98.9% subjects for diphtheria, tetanus and hepatitis B components in the Shantetra group as compared to 95.5% subjects in the Tritanrix HB group. Anti pertussis antibody response was seen in 89% and 91.1% in the Shantetra and Tritanrix HB groups, respectively. The commonly observed adverse events in both the groups were, pain at injection site, mild fever and transient crying.CONCLUSION:The safety and immunogenicity of indigenously developed DTPwHepatitis B combination vaccine was demonstrated in the present study.

A profile of bacteriologically confirmed pulmonary tuberculosis in children.

OBJECTIVE: To describe the clinical profile of children with bacteriologically confirmed tuberculosis. STUDY DESIGN: A multicentric study was conducted in three hospitals in Chennai city between July 1995 and December 1997. Children aged 6 months to 12 years with signs and symptoms suggestive of tuberculosis were investigated further. Clinical examination, chest radiograph, tuberculin skin test with 1 TU PPD and, sputum or gastric lavage for mycobacterial smear and culture were done for all and, lymph node biopsy when necessary. RESULTS: A total of 2652 children were registered and tuberculosis was bacteriologically confirmed in 201. Predominant symptoms were history of an insidious illness (49%), fever and cough (47%), loss of weight (41%) and a visible glandular swelling (49%). Respiratory signs were few and 62% were undernourished. Over half the patients with confirmed TB had normal chest X-ray. Abnormal X-ray findings included parenchymal opacities in 47% and hilar or mediastinal lymphadenopathy in 26%. The prevalence of isoniazid resistance was 12.6% and MDR TB 4%. CONCLUSIONS: Children with tuberculosis present with fever and cough of insidious onset. Lymphadenopathy is a common feature even in children with pulmonary TB. A significant proportion of children have normal chest X-rays despite positive gastric aspirate cultures. Drug resistance rates in children mirror the pattern seen in adults in this geographic area.

Safety and reactogenicity of a low dose diphtheria tetanus acellular pertussis vaccine (Boostrix) in pre-school Indian children.

OBJECTIVE: To evaluate the safety and reactogenicity of a reduced-antigen-content combined Diphtheria Tetanus Acellular Pertussis (dTpa) vaccine in Indian preschool children. METHODS: GlaxoSmithKline Biologicals combination dTpa vaccine was administered as a single booster dose to 347 children aged 46 years in seven centers across India. All children were subsequently followed up for two weeks for safety and reactogenicity assessment. RESULTS: A total of 345 subjects completed the study and two subjects were lost to follow-up. One serious adverse event (head injury) unrelated to vaccination was reported. Otherwise, all subjects were in good health throughout the study period. Three subjects (0.9%) reported transient general symptoms (such as irritability and drowsiness), which prevented normal activity. Pain at injection site, swelling and redness was reported in 31.1%, 18.2% and 8.9% subjects respectively. Five subjects (1.4%) reported severe pain preventing normal movement. This resolved within 48 hours in all cases. There were no other severe local reactions including large injection site reactions. CONCLUSION: The reduced antigen content combined dTpa vaccine is safe and well tolerated in Indian pre-school children.

Immunogenicity and safety of hepatitis B vaccine (Shanvac-B) using a novel pre-filled single use injection device Uniject in Indian subjects.

BACKGROUND: Hepatitis B is a major public health problem, which has now been controlled to some extent by vaccination especially with the recombinant hepatitis B vaccine, which has been proven to be safe and efficacious since its introduction in the 1990s. But problems of unsafe injection practices still persist. Now newer delivery devices like uniject are available for making vaccination very safe. OBJECTIVE: To evaluate the immunogenicity and safety of the Hepatitis-B (Shanvac-B) vaccine in Uniject pre-filled device administered to healthy adults and infants at 0, 1, 2 months schedule. METHODS: A total of 122 healthy subjects (62 adults and 60 infants) were administered three doses of the recombinant Hepatitis-B vaccine using Uniject pre-filled device. Blood samples for antibody titer estimation were taken before vaccination and 4-6 weeks after third dose. Subjects, parents or guardians were given diary cards to record any adverse reactions. RESULTS: Protective immune responses to the vaccine were seen in 96.4% of adults and 100% of infants who completed the study. The Geometric Mean Titers (GMT) in adults and infants were 518.5 and 385.41 mIU/ml respectively. Mild fever, itching, and swelling at injection site were the most common side effects observed. CONCLUSION: The safety and immunogenicity of the Hepatitis B Vaccine in the novel pre-filled device Uniject was effectively demonstrated in the present study.

Drug therapy of acute diarrhoea in children--actual practice and recommendations.

Forty eight private medical practitioners and fifty six pharmacists were interviewed, using a prepared questionnaire in each group, in an attempt to evaluate the awareness and practice in the treatment of acute diarrhoea in children among private medical practitioners and the role of pharmacists in the dispensing of drugs for diarrhoea in children. 83% of the doctors prescribed an antibacterial agent, 56% prescribed loperamide, 19% of them prescribed diphenoxylate plus atropine while 31% prescribed an absorbent in children for the treatment of acute diarrhoea. Of fifty six pharmacists interviewed, 30 of them sold diphenoxylate on their own and 26 of them honoured a doctor's prescription of the same. 80% of pharmacists interviewed dispensed loperamide, more than 50% of them dispensed an antibacterial agent while 14% dispensed a binding agent such as pectin or kaolin for the treatment of acute diarrhoea without a valid prescription from a doctor. We recommend that the pharmaceuticals prominently display the harmful effects in children of drugs such as the antimotility drugs and immediately withdraw from the market, all pediatric preparations of the same.

Awareness of and attitude towards oral rehydration therapy.

Forty eight Medical practitioners, 56 pharmacists and 55 mothers of children with diarrhoea were interviewed, using a prepared questionnaire, in an attempt to evaluate in each group, the awareness of and attitude towards oral rehydration therapy. 69% of mothers interviewed were aware of oral rehydration therapy, but only 66% among them practised it. 48% of mothers interviewed, received advice regarding oral rehydration therapy from medical personnel and health care providers. It was found that the ORS preparations not conforming to WHO formulation were the most widely stocked and used and the most widely sold. 9% of pharmacists advocated only glucose as a treatment for diarrhoea on their own. 60% of doctors advised and prescribed ORS preparation not conforming to WHO formulation, 44% of medical practitioners were not sure of the exact method of dilution and preparation of the commercially available preparations. The study has shown that there is more to be done towards realising the total success of ORT. We recommend that ORS preparations not conforming to WHO formulation be withdrawn from the market and further that the responsibility of their manufacture be undertaken by governmental agencies.