Status of SII Bovine Rotavirus Pentavalent Vaccine (BRV-PV)
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1 Status of SII Bovine Rotavirus Pentavalent Vaccine (BRV-PV) Dr Prasad Kulkarni, MD Serum Institute of India Limited Pune Rotavirus symposium, 03 September 2014, New Delhi 03 September
2 Origins of BRV Development so far Results in nutshell Phase III studies Future plans 03 September
3 NIAID developed single gene reassortants of the bovine rotavirus UK Compton strain (G6P5[7]) as the backbone four reassortant viruses with a single gene for VP7 of either a G1, G2, G3, or G4 human serotype and 10 genes from the bovine rotavirus UK strain Three clinical studies demonstrated its safety and immunogenicity Tech transfer to SIIL in 2005 SIIL developed a hexavalent formulation (G1, G2, G3, G4, G8, G9) for toxicity studies Clinical development with a pentavalent formulation (G1, G2, G3, G4, G9) Midthun K et al. J Virol 1985; 53: ; Midthun K et al. J Clin Microbiol 1986; 24: September
4 Bovine human reassortants Kapikian AZ et al. J Infect Dis. 2005; 192: September
5 Sterile, pentavalent, lyophilized powder rotavirus reassortants G1, G2, G3, G4 and G9 alongwith stabilizer 2.5 ml antacid as diluent containing sodium bicarbonate and sodium citrate for oral administration. stable for three years at 2 to 8 C, and 25 C, for two years at 37 C. and for six months at 40 C. 03 September
6 Phase Objective No. of doses FFU/ Serotype/Dose Subjects Pre-Clinical Safety Single and repeated 10 7 Rabbits and Rats Phase I Safety adults, 18 toddlers, 18 infants Phase IIa Safety Immunogenicity infants Phase IIb Safety Immunogenicity infants 03 September
7 Single and repeated dose studies by oral route Wistar Rats and New Zealand White Rabbits. ( FFU/Serotype/Dose) No potentially serious toxicity that would preclude the use in human Trials. 03 September
8 Double-blind, randomized, placebo-controlled, single dose (10 6 FFU/Serotype/Dose) study Sequentially in healthy adults, toddlers and infants 18 subjects in each group with 2:1 random allocation BRV-PV was safe and well tolerated. No SAE. Few mild and transient adverse events. Related events - nausea, loss of appetite, diarrhoea and vomiting No significant effect on lab parameters, No shedding a small immune response (28%) in infants. 03 September
9 Randomized, double-blind, placebo controlled (1:1 ratio) 3 doses of FFU/serotype in 60 healthy infants. the vaccine was safe and well tolerated. Almost all the events were mild and transient. Two SAEs (UTI and septicemia) unrelated to study vaccines recovered uneventfully. No effect on laboratory parameters. 03 September
10 Reactogenicity of FFU/serotype BRV-PV Solicited Symptom BRV-PV Placebo Participants assessed At least one solicited symptom, 14 (51.85%) 21 (70.00%) Diarrhea 1 (3.70%) 2 (6.67%) Vomiting 11 (40.74%) 13 (43.33%) Fever 3 (11.11%) 8 (26.67%) Decreased appetite 5 (18.52%) 5 (16.67%) Decreased Activity 4 (14.81%) 1 (3.33%) Irritability 9 (33.33%) 12 (40.00%) Respiratory Symptoms 5 (18.52%) 9 (30.00%) Antipyretic Use 4 (14.81%) 7 (23.33%) 03 September
11 Seroconversion with FFU/serotype BRV-PV Study arm Phase IIa Post Dose 2 Post Dose 3 SII BRV-PV 9/25 (36.00%) 12/25 (48.00%) Placebo 2/28 (7.14%) 6/28 (21.43%) p Value* *Fisher's Exact Test. Post dose 3 GMTs in vaccine and placebo arms were U/ml; and 7.31 U/ml. 03 September
12 Randomized, double-blind, placebo controlled (1:1 ratio) assessed three doses of FFU/serotype in 60 healthy infants. the vaccine was safe and well tolerated. Almost all the events were mild and transient. No SAEs. No effect on laboratory parameters. 03 September
13 Reactogenicity of FFU/serotype BRV-PV Solicited Symptom BRV-PV Placebo Participants Assessed At least one Solicited Symptoms 18 (60.00%) 20 (66.67%) Diarrhea 3 (10.00%) 2 (6.67%) Vomiting 8 (26.67%) 7 (23.33%) Fever 3 (10.00%) 5 (16.67%) Decreased appetite 6 (20.00%) 4 (13.33%) Decreased activity 3 (10.00%) 2 (6.67%) Irritability 9 (30.00%) 6 (20.00%) Respiratory symptoms 11 (36.67%) 9 (30.00%) Antipyretic use 9 (30.00%) 5 (16.67%) 03 September
14 Seroconversion with FFU/serotype BRV-PV Study arm Post Dose 2 Post Dose 3 SII BRV-PV 17/30 (56.67%) 18/30 (60.00%) Placebo 3/26 (11.54%) 2/26 (7.69%) p Value* *Fisher's Exact Test. Post dose 3 GMTs in vaccine and placebo arms were U/ml; and 0.85 U/ml. Results in line with published studies. 03 September
15 A double blind, placebo controlled, multi-centric Phase 3 study Sample size 7500 infants; event driven trial 1:1 randomization to vaccine : placebo Multicentre in India Vaccination at 6, 10 and 14 weeks of age concurrently with UIP vaccines Follow up till 2 years of age 03 September
16 to demonstrate that the vaccine is efficacious against severe rotavirus gastroenteritis in Indian infants Weekly home visits Approved by DCGI, HMSC and ethics committees Initiated on 9 May 2014 > 1000 infants recruited so far Data on first 500 shows no safety concern DSMB oversight on safety issues 03 September
17 Study initiation 9 May 2014 Complete enrolment March 2015 Study completion March 2017 Interim analysis 122 cases of severe rotavirus GE 03 September
18 A double blind, placebo controlled, Phase 3 study In Niger by Epicentre Sample size 7770 infants; event driven trial 1:1 randomization to vaccine : placebo Vaccination at 6, 10 and 14 weeks of age concurrently with EPI vaccines Follow up till 2 years of age 03 September
19 to demonstrate that the vaccine is efficacious against severe rotavirus gastroenteritis in African infants Weekly home visits Approved by Niger NRA, WIRB and WHO ERC Initiated on 9 July 2014 > 600 infants recruited so far DSMB oversight on safety issues 03 September
20 A double blind, placebo controlled, multi-centric Phase 3 study Sample size 1500 infants; 1:1 randomization to vaccine : placebo Multicentre in India Vaccination at 6, 10 and 14 weeks of age concurrently with UIP vaccines 03 September
21 to demonstrate Non-interfere with immune response of UIP vaccines Lot-to-lot consistency Submitted to DCGI, HMSC and ethics committees DSMB oversight on safety issues Hope to start early next year 03 September
22 Apart from the lyophilized presentation, SIIL is working on a fully liquid; ready-to-use vaccine contains the reassortants of the same serotypes. Animal toxicity studies started in June Phase I trial Q September
23 Investigators Late Albert Kapikian; NIAID, Carl Kirkwood, Australia; Gagandeep Kang and Sudhir Babji, CMC, Vellore, Ashish Bavdekar; KEM, Pune, Sanjay Lalwani; BVMC, Pune SIIL Rajeev Dhere, Sajjad Desai, Jagdish Zade, Rajendra Sable, Sameer Naik, SIIL, Pune PATH John Bosselego Jorge Flores Alan Fix Maureen Power A Balaji Tushar Tiwari Niraj Rathi Vidya Upreti Soumya Hazara Gompanna Gracy 03 September
24 Thanks 03 September
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Study No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
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Rotarix TM. Rotavirus vaccine. 1 dose (1.5 ml) contains: Live attenuated human rotavirus RIX4414 strain
Rotarix TM Rotavirus vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.5 ml) contains: Live attenuated human rotavirus RIX4414 strain not less than 10 6.0 CCID50 PHARMACEUTICAL FORM Oral suspension.
Study No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
PDF of Trial CTRI Website URL -
Clinical Trial Details (PDF Generation Date :- Thu, 18 Oct 2018 14:39:26 GMT) CTRI Number Last Modified On 06/04/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study
To demonstrate that DTPa-HBV-IPV/Hib-MenC-TT co-administered with 10Pn, is non-inferior to DTPa-HBV-IPV/Hib coadministered
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
PDF of Trial CTRI Website URL -
Clinical Trial Details (PDF Generation Date :- Sat, 03 Nov 2018 05:20:48 GMT) CTRI Number Last Modified On 12/12/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study
Study No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
Reactogenicity and Immunogenicity of a High-Titer Rhesus
JOURNAL OF CLINICAL MICROBIOLOGY, Sept. 1993, p. 2439-2445 Vol. 31, No. 9 0095-1137/93/092439-07$02.00/0 Copyright 1993, American Society for Microbiology Reactogenicity and Immunogenicity of a High-Titer
Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Study vaccines Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
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Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
Status of Vaccine Research and Development of Next-generation Rotavirus Vaccines Prepared for WHO PD-VAC
Status of Vaccine Research and Development of Next-generation Rotavirus Vaccines Prepared for WHO PD-VAC I. About the Disease and Pathogen Basic information on pathogen, including transmission, estimated
Meningococcal polysaccharide vaccine Group A, Group C, Group Y and Group W-135
MENOMUNE ACYW-135 Meningococcal polysaccharide vaccine Group A, Group C, Group Y and Group W-135 Description The vaccine is a freeze-dried preparation of the group specific antigens from Neisseria meningitidis,
Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
DESCRIPTION OF STUDIES AND RISK OF BIAS ASSESSMENT FOR RCTS
DESCRIPTION OF STUDIES AND RISK OF BIAS ASSESSMENT FOR RCTS ROTAVIRUS VACCINES SCHEDULES: A SYSTEMATIC REVIEW OF SAFETY AND EFFICACY FROM RANDOMIZED CONTROLLED TRIALS AND OBSERVATIONAL STUDIES OF CHILDHOOD
Clinical Studies of a Quadrivalent Rotavirus Vaccine in Venezuelan Infants
JOURNAL OF CLINICAL MICROBIOLOGY, Mar. 1990, p. 553-558 0095-1137/90/030553-06$02.00/0 Copyright 1990, American Society for Microbiology Vol. 28, No. 3 Clinical Studies of a Quadrivalent Rotavirus Vaccine
GSK Medicine: Study No.: Title: Rationale: Study Period Objectives: Indication: Study Investigators/Centers: Research Methods: Data Source:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert.
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. Name of Sponsor/ Company: Sanofi Pasteur Study Code: Study Identifier: