|
Sr. No.
|
Name of the Project
|
Principal Investigators
|
Duration
|
Funding Agency
|
Amount Sanctioned (Rs)
|
|
1
|
To evaluate efficacy, safety and immunogenicity of Novel Corona Virus -2019-nCov vaccine
|
Dr. Sharad Agarkhedkar,
Dr. Shalaka Agarkhedkar,
|
Zycovid – March 2021 to August 2022
ongoing
|
Cadila Healthcare Limited, Ahmedabad, India
|
Rs. 10,000 per subject enrolled
|
|
2
|
Clinical trial of Molnupiravir 800 mg capsules in confirmed RT-PCR positive patients with mild COVID-19.
|
Dr. Sharad Agarkhedkar,
Dr. Shalaka Agarkhedkar,
|
May 2021 to Sep 2021 (Subjects visits completed) , study is not yet closed out
|
NATCO Pharma Limited NATCO House Road No.2, Banjara Hills Hyderabad
|
Rs. 32,00,000/-
|
|
3
|
Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)
|
Dr. S. R. Agarkhedkar,
Dr. Shalaka Agarkhedkar
|
Enrolment for the ACTIV-2 trial has been temporarily paused, effective as of 20 January 2022 globally. Trial did not start in India
|
National Institute of Allergy and Infectious Diseases.
|
Rs. 43,00,000/-
|
|
4
|
To Evaluate the Efficacy and Safety of Rilematovir in Infants and Children with Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
|
Dr. S. R. Agarkhedkar,
Dr. Shalaka Agarkhedkar
|
Strategic decision to discontinue the study by Sponsor in Jan 2022
|
Johnson & Johnson Private Limited
|
Rs. 30,00,000/-
|
|
5
|
To evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two-dose Regimen in Healthy Adolescents From 12 to 17 Years Inclusive – COVID 19 Vaccine
|
Dr. S. R.
Agarkhedkar,
Dr. Shalaka Agarkhedkar
|
Not yet started
|
Johnson & Johnson Private Limited
|
Rs. 31,65,000/-
|
|
6
|
A Prospective, Randomized, Double-blind, Placebo controlled, Phase-II by III Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of CORBEVAX Vaccine in Children and Adolescents
|
Dr. S. R. Agarkhedkar,
Dr. Shalaka Agarkhedkar
|
Dec.2021 to Aug 2022 - Ongoing
|
Biological E. Ltd, Hyderabad, Telangana
|
|
7
|
Smile TB Project for childhood Tuberculosis. (Shortened Regimen for Drug-Susceptible TB in Children)
|
Dr. Shailaja Mane
|
3 years
|
USAID through Johns Hopkins
|
374200 US
$ 3,18,07000/-INR
|
|
8
|
Metabolic Syndrome among Adolescents: A Study of Early Detection with a Comprehensive Intervention to Achieve Improvement in Clinical, Biophysical, Anthropometric, and Metabolic Markers
|
Dr. Shailaja Mane
|
Approved for three years (ongoing)
|
ICMR Investigator- Initiated Intermediate Extramural Grant
|
Rs. 4,15,69,846/-
|
|
9
|
A prospective, randomized, single blind, parallel, active controlled, multicenter, non-inferiority phase iii study to evaluate the immunogenicity and safety of live attenuated varicella vaccine of Sinovac biotech ltd, China compared to variped® vaccine (varicella vaccine live i.p by MSD pharmaceuticals pvt ltd, India) in healthy pediatric subjects in India.
|
PI- Dr. Shailaja Mane
Co-I –
Dr. Srikanth Tripathy
|
One year
|
Clinical Research Network India, (CRO)
|
Rs. 4,55,750/-
|
|
10
|
A Multicenter, Randomized, Observer-blind, Non-inferiority, Phase III Study to Evaluate the Immunogenicity and Safety of BoostagenREDTM (combined tetanus toxoid, reduced diphtheria toxoid, reduced recombinant pertussis vaccine) by BioNet-Asia compared to ADACEL® vaccine by Sanofi Pasteur Limited in Healthy Subjects Aged 4-65 years.
|
PI- Dr. Srikanth Tripathy
Co-I- Dr. Shailaja Mane
|
One year
|
Clinical Research Network India, (CRO)
|
Rs. 6,97,500/-
|
|
11
|
Antibody Response following One Dose of Cervavac® as compared to One Dose of Gardasil® Vaccine in Healthy Girls Aged 9-14 Years: A Non-inferiority, Multicenter, Double-blind, Randomized Controlled trial
|
PI- Dr. Shailaja Mane
|
One year
|
ICMR
|
Rs. 1,11,38,400/-
|
|
12
|
A Phase 3, Randomized, Double-blind, Controlled, Multi-Center Study to Compare Immunogenicity and Safety of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) with that of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Indian Children of 9 months to 17 Years of Age. In Healthy Indian Subjects.
|
PI- Dr. Shailaja Mane CO-I- Dr Tripathy
|
One year
|
Serum Institute of India Private Limited (SIPL) and
|
Rs. 59,37,250/-
|
|
13
|
A Prospective, Randomized, Double-Blind, Multi-Center, Phase III Study to Assess And Compare The Immunogenicity And Safety Of The 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine In Healthy Indian Subjects..
|
PI- Dr. Srikanth Tripathy Co-I- Dr Shailaja Mane
|
One year
|
Clinical Research Network India, (CRO)
|
Rs. 1,81,875/-
|
|
14
|
A Randomized, Open label, Multicenter, Phase II / III study to assess and compare the immunogenicity and safety of NUCOVAC® -11 {Pneumococcal Polysaccharide conjugate vaccine (Adsorbed), 11 valent}of Panacea Biotec Ltd. with PREVENAR 13® of Pfizer Inc. in healthy infants (3+1 immunization schedule).
|
PI- Dr. Shailaja Mane
CO-I- Dr. Srikanth Tripathy
|
One year
|
Panacea Biotec Limited (Sponsor) & Clinical Research Network India, (CRO)
|
Rs. 66,200/-
|
|
15
|
Comparison of Gut Microbiome among Underweight, Normal (Non obese) and obese adolescents
|
PI- Dr. Shailaja Mane
|
One year
|
PI- Dr. Shailaja Mane
|
Rs. 7,50,000/-
|
|
16
|
A stepwise approach to conduct comprehensive Nutritional Assessments, provide intervention and monitor all the patients admitted in Pediatric Intensive Care Unit over a period of one year.
|
PI-Dr. Manojkumar Patil Co-PI Dr. Shailaja Mane
RD Vaishali Madkaikar
|
One year
|
PI-Dr. Manojkumar Patil Co-PI Dr. Shailaja Mane RD Vaishali Madkaikar
|
Rs. 5,00,000/-
|
|
17
|
Studies on involvement of innate immune molecules in neonatal sepsis
|
PI-Dr. Sudhir Malwade
Co-PI Dr. Shailaja Mane
RD Vaishali Madkaikar
|
One year
|
PI-Dr. Sudhir Malwade Co-PI Dr. Shailaja Mane RD Vaishali Madkaikar
|
Rs. 5,00,000/-
|
|
18
|
A study of clinical profile and genetic etiology of idiopathic epilepsy using exome sequencing
|
PI- Dr. Pramila Menon
Co-PI Dr. Parag Tamhankar
Dr. Vishwanath Kulkarni
Dr. Shiji Chalipat
|
One year
|
PI- Dr. Pramila Menon Co-PI Dr. Parag Tamhankar Dr. Vishwanath Kulkarni Dr. Shiji Chalipat
|
Rs. 5,00,000/-
|
