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INTRODUCTION: The objective of the study was to evaluate the estrogenic activity of four Indian medicinal plants Saraca indica (Si), Symplocos racemosa (Sr), Cyperus rotundus (Cr), Terminalia arjuna (Ta), a marketed preparation of Si (Asokarista) and a combination of Si + Sr using an experimental model of estrogenicity. MATERIALS AND METHODS: After approval of the institutional animal ethics committee, 22 day old female rats (n = 54) were randomly allocated to 9 groups - Group 1 and Group 2: Vehicle controls, Group 3: Ethinyl estradiol, Group 4: Si (270 mg/kg), Group 5: Sr (270 mg/kg), Group 6: Cr (540 mg/kg), Group 7: Ta (270 mg/kg), Group 8: Ashokarishta (4 ml/kg), Group 9: Si + Sr (135 mg/kg). Variables studied were: Body weight, uterine weight, relative uterine weight, presence of vaginal opening, histomorphology of the uterus and total uterine glycogen content. Parametric data were analyzed using one-way ANOVA and the categorical data were analyzed using Chi-square test. RESULTS: All animals in the ethinyl estradiol group showed a significant change in all the variables. None of the individual test drugs, neither the marketed preparation produced change in any of the variables. The plant drug combination also did not produce a change in any of the variables studied except in histomorphology wherein it caused a slight increase in the height of the luminal epithelium of the uterus (P < 0.05 vs. Group 1). CONCLUSION: The plant drugs Si, Sr, Cr, Ta and Asokarista did not demonstrate estrogenic activity in the immature rat model. The plant drug combination Si + Sr showed questionable estrogenic activity which needs to be evaluated in further studies.

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Statistics plays a vital role in biomedical research. It helps present data precisely and draws the meaningful conclusions. While presenting data, one should be aware of using adequate statistical measures. In biomedical journals, Standard Error of Mean (SEM) and Standard Deviation (SD) are used interchangeably to express the variability; though they measure different parameters. SEM quantifies uncertainty in estimate of the mean whereas SD indicates dispersion of the data from mean. As readers are generally interested in knowing the variability within sample, descriptive data should be precisely summarized with SD. Use of SEM should be limited to compute CI which measures the precision of population estimate. Journals can avoid such errors by requiring authors to adhere to their guidelines.

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AIM: Because of the high mother-to-infant transmissibility of hepatitis B (HB) infection, neonatal vaccination is necessary, but the further doses of HB vaccines can be combined with conventional diphtheria-tetanus-whole cell pertussis (DTPw) vaccines. We compared immunogenicity and reactogenicity of two tetravalent vaccines in Indian children, who after neonatal HB immunization, were vaccinated thrice with one of these vaccines. METHODS: In this open-label randomized study, 287 infants received a dose of an Indian- (Q-Vac (TM )) or European-made (Tritanrix-HB (TM )) tetravalent vaccine at age 6, 10, and 14 weeks. The ELISA antibodies were measured prior to the first and one month after the third dose. Immunogenicity was determined by measuring the seroprotection/seropositivity rates and geometric mean titres (GMT), whereas vaccine reactogenicity was elucidated with diary cards for 7 days following each dose. The potential unsolicited events were queried throughout the whole 3-month study period. RESULTS: Out of the 250 subjects who completed the study, 123 received the Indian and 127 the European vaccine. After 3 doses, the seroprotection/seropositivity rates were 99 % and 100% for diphtheria, 98% and 95% for tetanus, 89% and 94% for pertussis, and 100% and 100% for hepatitis B, respectively. GMT of tetanus antibodies was significantly higher with the Indian vaccine. Low-grade reactogenicity was rather similar in the two vaccine groups, the most common events being local pain, redness, swelling, fever, irritability, unusual crying, drowsiness, and non-specific gastrointestinal symptoms. CONCLUSIONS: Since both immunogenicity and reactogenicity of the two vaccines were almost identical, the Indian vaccine poses a good alternative to the costlier competitor vaccines.

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OBJECTIVE: To compare the immunogenicity and safety of two different lots of SII Haemophilus influenzae type-B-tetanus toxoid conjugate (SII HibP(RO)) vaccine manufactured at different scales when given in 3-dose schedule. DESIGN: Phase IV, open label, comparative, randomized parallel group study. SETTING: Shirdi Sai Baba Hospital, Vadu Budruk, Pune and Pediatrics Department of King Edward Memorial Hospital Research Centre, Pune. SUBJECTS: 204 normal healthy infants of age 6-8 weeks at the time of first vaccination. METHODS: The eligible subjects received 3 doses of 0.5 ml of SII HibP(RO) vaccine of either lot depending upon randomization number, intramuscularly in right thigh in the EPI schedule of 6, 10 and 14 weeks. They also received concomitantly DTP-HB vaccine intramuscularly on left thigh and Oral Polio vaccine (OPV). Solicited reactions were captured for 7 days following each vaccination; the events beyond 7 days till day 28 were captured as unsolicited adverse events. Serious Adverse Events (SAEs) were looked for throughout the subject participation. Blood samples were collected at baseline (before the first dose) and one month after the third dose for anti-PRP (polyribosylribitol phosphate) antibodies. RESULTS: In both groups, more than 98% subjects achieved short-term seroprotection (anti-PRP ≥ 0.15 µg/ml) after 3 doses. The long-term seroprotection (anti-PRP ≥ 1 µg/ml) was 87% and 80% in infants receiving lot manufactured at industrial scale and small scale respectively. Short and long term seroprotection and GMTs increased significantly as compared to baseline in both the groups. Overall local pain (52% and 58%), redness (30% and 41%), swelling (34% and 44%), fever (6% and 6%) and irritability (52% and 50%) were reported in infants receiving lot manufactured at industrial scale and small scale respectively. Majority of the reactions were mild and resolved without any sequelae. Four SAEs, none of them causally related to the study vaccine, occurred during study. CONCLUSION: SII HibP(RO) vaccines manufactured in small and industrial scale are equally immunogenic, safe and confer adequate seroprotection to infants of 6-14 weeks of age. Scaling up production process has not affected the safety and immune response in the target population.

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In the event of a highly pathogenic influenza pandemic, the Indian subcontinent would need 1.2 billion doses of vaccine to immunize its entire population, double if two doses were required to assure immunity. Serum Institute of India Limited (SII) thus became one of six initial grantees of the World Health Organization (WHO) technology transfer initiative to create capacity in developing countries to manufacture H5N1 pandemic influenza vaccine. At the outbreak of the A(H1N1) 2009 influenza pandemic, experience gained from the H5N1 project was used to develop a live attenuated influenza vaccine (LAIV), since this was the only option for the level of surge capacity required for a large-scale immunization campaign in India. SII took <12 months to develop and market its LAIV intranasal vaccine from receipt of the seed strain from WHO. As of November 2010, over 2.5 million persons have been vaccinated with Nasovac(®) with no serious adverse reactions or vaccine failure after 3 months' post-marketing surveillance. The product has been submitted for prequalification by WHO for purchase by United Nations agencies. In parallel, SII also developed an inactivated influenza vaccine, and is currently looking to ensure the sustainability of its influenza vaccine manufacturing capacity.

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Rise of diphtheria cases in adults is a cause of concern worldwide. Pertussis is also now affecting adults. We assessed serum levels of tetanus, diphtheria and pertussis antibodies in 62 adults in Pune, India, who had missed their primary immunization. All adults were then given three doses of tetanus-diphtheria (Td) vaccine at 0, 1, and 6 months. All adults were immune to tetanus but 78% had long-term protection. For diphtheria, 88% were protected but only 9% had long term immunity. Only 60% were immune to pertussis. After three doses of the vaccine, long term immunity to both tetanus and diphtheria increased to 87% and 97%, respectively (P < 0.05). Geometric mean titres (GMT) of both antibodies also increased significantly. The vaccine caused minor local reactions and mild fever in a few subjects. There is need of three doses of Td vaccination in those Indian adults, who missed their primary immunization. Susceptibility to pertussis also needs to be further explored.