Vadu Vaccine Research Unit

 

Vadu Rural Health Program (VRHP) a division of KEM Hospital Research Centre Pune was started with the mission “To Provide evidence-based, sustainable and rational health care solutions for the rural population using globally relevant community-based ethical research”. Today VRHP has a rich tradition in health care and development being in the forefront of needs-based, issue-driven research over almost 35 years. Many community based clinical trials has been conducted at Vadu in collaboration with WHO, PATH, ICMR and many national and international research organizations. Vadu Vaccine Research Unit is one of the great achievements of VRHP. Vadu is now getting recognized as well established and well furnished Core Vaccine Research Unit (CVRU) at National and International level.

CVRU has a separate well equipped infrastructure. Enough refrigerators for the storage of vaccines in air conditioned room, separate documentation rooms, Generator back up, Internet and a separate server facility, Separate archival area with fire alarm, fire extinguishers, and fire proof cabinet; these are the main features of CVRU. This unit has a well equipped laboratory for the collection storage and testing of samples collected during trial.

The CVRU is attached with KEM hospital’s Shirdi Sai Baba Rural Hospital (SSH) which is also a part of Vadu Rural Health Program. This helps us in providing a better health care to subjects in case of any AEs and SAEs. A separate clinic is also developed under the CVRU at Vadu. The main purpose of this clinic is “consent process, TA/Placebo administration, observation of subject for IAEs, administration of other childhood vaccines as per National Immunization schedule and regular check up of trial subjects”. Well qualified and trained staff, doctors, nurses are working on the trials who are always keen to follow the GCP and SOPs. A separate well equipped ambulance is available for CVRU.

Apart from SSH, we have tie up with eight well equipped Paediatric Hospitals in study area. These hospitals help us to provide emergency care for the subjects. The paediatricians are trained with protocol, SOPs, Sample collection, as well as for maintenance of records as per protocol need. A separate study clinics also has been developed in every paediatric hospital for study related follow up and TA/Placebo, vaccines administration activities.

We have the strength of near about forty Field Workers; Field Supervisors who are responsible for regular follow up of study subjects and to assess them in any emergency. Twenty four hour On call Medical Officer with well equipped ambulance is one of the main central arrangements of CVRU. All subjects, FWs, FSs, Paediatricians can call On Call Medical Officer at any time to seek care.

Vadu Vaccine Trial unit has been successfully completed

  1. 1)PsA-TT-003. A phase II/III, observer-blind, randomized, active controlled study to compare the safety and immunogenicity of a Meningococcal A Conjugate Vaccine with Meningococcal ACWY polysaccharide vaccine administered in healthy children 2-10 years of age.

Sample size- 340. Period – 2008-09. Sponsored by- PATH and SIIL

  1. 2)A Phase IV, Open label, Comparative, Parallel group, Clinical Study to evaluate the safety and immunogenicity of HaemophilusInfluenzae Type B vaccine (SIIHibPro) in Indian Infants.

Sample size- 204. Period- 2008-09. Sponsored by- SIIL.

  1. 3)PsA-TT-A Phase III double blind randomized, active controlled study to evaluate the safety & consistency of immunogenicity of three consecutive lots of meningococcal A conjugate vaccine administered as a single dose to healthy children at 5-10 years of age.

Sample size- 830. Period – 2009-10. Sponsored by- PATH and SIIL.

  1. 4)WHO/MAP/IND/02 Pivotal study to evaluate the immunogenicity and safety of the measles vaccine given by aerosolized inhalation: Phase II/III randomized controlled trial.

Sample size- 2000 infants of 9 to 12 months. Period – 2009-11. Sponsored by- WHO and SIIL.

  1. 5)A Phase IIa, Randomized, Controlled, Observer Blind, Age De-Escalation Study of the Safety, Reactogenicity& Immunogenicity of Vi-CRM197vaccine against S. Typhi in Adults, Children, Older Infants, and Infants.

Sample size- 40. Period – 2011-12. Sponsored by- NVGH.

One ongoing Trial-

  1. 1)A Phase III Randomized Double Blind Placebo Controlled Trial to evaluate the protective Efficacy of three doses of oral Rotavirus vaccine (ORV) 116E, against severe rotavirus gastroenteritis in infants.

Sample size- 1500 Infants of 6-7 weeks of age, period- 2010-13, sponsored by- DBT, PATH, BBIL.

 

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