-
Hitt J Sharma,
Vishwanath D Patil,
Sanjay K Lalwani,
Mamta V Manglani,
Latha Ravichandran,
Subhash V Kapre,
Suresh S Jadhav, Sameer S Parekh,
Girija Ashtagi,
Nandini Malshe,
Sonali Palkar,
Minal Wade,
T K Arunprasath,
Dinesh Kumar,
Sunil D Shewale
[show abstract]
[hide abstract]
ABSTRACT: Hib vaccine can be easily incorporated in EPI vaccination schedule as the immunization schedule of Hib is similar to that of DTP vaccine. To meet the global demand of Hib vaccine, SIIL scaled up the Hib conjugate manufacturing process. This study was conducted in Indian infants to assess and compare the immunogenicity and safety of DTwP-HB+Hib (Pentavac(®)) vaccine of SIIL manufactured at large scale with the 'same vaccine' manufactured at a smaller scale.
720 infants aged 6-8 weeks were randomized (2:1 ratio) to receive 0.5 ml of Pentavac(®) vaccine from two different lots one produced at scaled up process and the other at a small scale process. Serum samples obtained before and at one month after the 3rd dose of vaccine from both the groups were tested for IgG antibody response by ELISA and compared to assess non-inferiority.
Neither immunological interference nor increased reactogenicity was observed in either of the vaccine groups. All infants developed protective antibody titres to diphtheria, tetanus and Hib disease. For hepatitis B antigen, one child from each group remained sero-negative. The response to pertussis was 88% in large scale group vis-à-vis 87% in small scale group. Non-inferiority was concluded for all five components of the vaccine. No serious adverse event was reported in the study.
The scale up vaccine achieved comparable response in terms of the safety and immunogenicity to small scale vaccine and therefore can be easily incorporated in the routine childhood vaccination programme.
Vaccine 11/2011; 30(3):510-6. · 3.77 Impact Factor
-
Hitt J. Sharma,
Vishwanath D. Patil,
Sanjay K. Lalwani,
Mamta V. Manglani,
Latha Ravichandran,
Subhash V. Kapre,
Suresh S. Jadhav, Sameer S. Parekh,
Girija Ashtagi,
Nandini Malshe,
Sonali Palkar,
Minal Wade,
T.K. Arunprasath,
Dinesh Kumar,
Sunil D. Shewale
Vaccine. 11/2011;
-
Hitt J Sharma,
Sangita Yadav,
Sanjay K Lalwani,
Subhash V Kapre,
Suresh S Jadhav,
Anita Chakravarty, Sameer S Parekh,
Sonali Palkar,
Subodh H Bhardwaj,
Gajanan S Namjoshi,
Vikas Verma
[show abstract]
[hide abstract]
ABSTRACT: An open label, controlled clinical study was conducted in Indian infants aged 6-14 weeks to compare the immunogenicity and safety of a reconstituted pentavalent vaccine (DTwP-HBV+Hib) of Serum Institute of India Ltd (SIIL) with TritanrixHB+Hiberix vaccine of Glaxo Smithkline (GSK).
Eligible infants were randomized to receive three doses of the study / comparator vaccine. The vaccines were reconstituted prior to administration, by mixing DTwP-HBV (liquid) with the Hib (lyophilized) vaccine. IgG antibody titres were assessed by ELISA at baseline and after one month following the 3-dose primary immunization schedule. Safety was evaluated after each dose. Further, safety and immunogenicity was also evaluated following a booster dose in the same cohort of children (aged between 15-24 months).
Tertiary-care hospitals in India Important outcome measures: Immunogenicity and safety following a 3-dose primary vaccination series and a booster vaccination.
Post-primary immunization, 100% seroprotection was noted for Diphtheria, Tetanus, Hepatitis B and PRP-Hib components in both the vaccine groups. For pertussis, response was 96.1% in SIIL and 95.4% in GSK group. The overall safety profile as well as persistence of antibodies against all vaccine components up to the time of booster immunization was comparable between the SIIL and GSK groups. A marked rise of all antibody concentrations indicated effective priming. The booster dose was safe, well tolerated with a significant increase in antibody concentrations of all the vaccine antigens in both the groups.
DTwP-HBV+Hib vaccine of SIIL was found to be safe and immunogenic. This Indian vaccine compared well with the licensed vaccine and is a cost-effective alternative for incorporating into the immunization schedule of various countries so as to control worldwide Hepatitis B and Hib infections.
Human vaccines 04/2011; 7(4):451-7. · 3.58 Impact Factor
-
Hitt J. sharma,
sangita Yadav,
sanjay K. Lalwani,
subhash V. Kapre,
suresh s. Jadhav,
Anita chakravarty, sameer s. parekh,
sonali palkar,
subodh H. Bhardwaj,
Gajanan s. Namjoshi,
Vikas Verma
Human Vaccines. 04/2011;
-
The Journal of Infection in Developing Countries 02/2011; · 1.19 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Serologic surveys conducted in different countries indicate that rubella is a worldwide infection. Several such sero surveys conducted in India have also confirmed that 6-47% of women are susceptible to rubella infection. The current study was conducted on 1,329 female adolescents in 12 districts of Maharashtra, India, to assess their serological status in terms of rubella exposure.
After enrollment, a pre-vaccination blood sample was collected from the participants followed by rubella vaccination (R-vac). Adverse events were monitored for the next 6-8 weeks, at which time a post-vaccination sample was collected.
Pre-vaccination rubella immunity was higher in the urban (80.2%) population compared to the rural (73.1%) population. Following R-vac vaccination, out of 1,159 participants who completed the study, all (100%) in the urban and 99.5% of participants in the rural area developed antibodies against rubella.
Substantial numbers of women reach childbearing age without immunity against rubella and thus are at a risk of passing the infection to their fetuses, who can then develop subsequent congenital defects leading to congenital rubella syndrome (CRS). An immunization policy recommending vaccination with rubella or rubella containing vaccine is highly desirable to prevent rubella and CRS.
The Journal of Infection in Developing Countries 01/2011; 5(12):874-81. · 1.19 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: In Hyderabad, India, diphtheria is common among children aged 5-19 years. On account of low coverage of diphtheria vaccine boosters recommended under the universal immunization programme, a large proportion of children were susceptible/partially immune against diphtheria and/or tetanus. We evaluated immunogenicity and safety of single dose of indigenously developed tetanus-diphtheria (Td) vaccine (diphtheria-toxoid < or =5 Lf) among 483 school children from Hyderabad aged 7-17 years and susceptible/partially immune against diphtheria and/or tetanus. Serological testing 6 weeks after vaccination indicated that vaccine was highly immunogenic with >96% sero-protected against both antigens. The immune response observed indicated a booster response to previously acquired immunity. Administration of additional dose of Td vaccine to the older school children and replacing the tetanus toxoid vaccine with Td in the school health programme would considerably reduce diphtheria burden in Hyderabad.
Vaccine 08/2010; 28(37):5934-8. · 3.77 Impact Factor
-
Vaccine. 07/2010;
-
Human vaccines 05/2009; · 3.58 Impact Factor
