Rota Virus Vaccine Study

Title: A phase III, 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.

Period:  Aug 2010 to Sept2013 (ongoing)

Collaborators:  DBT, PATH,

Sponsor:  BBIL

Investigator/s:  Dr. Ashish Bavdekar.

Study Design:

  • Phase III randomized, double-blind, placebo-controlled trial
  • Randomization at a ratio of 2:1, Vaccine : Placebo

            Three doses of ORV 116E were co-administered with childhood vaccines which  include Tetravalent vaccine (i.e. combined vaccine against Diphtheria, Tetanus, Pertussis and Hepatitis B), vaccine against Haemophilus influenza and Oral Polio Vaccine at 6 to 7 weeks, ≥10 weeks and ≥ 14 weeks of age with minimum 4 weeks gap between two doses

Trial Sites:

  • Centre of Health Research and Development, Society for Applied Studies, New Delhi
  • Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre, Vadu (BK), Pune
  • Christian Medical College, Vellore

Number of Subjects:

Total Number of Targeted Subjects: 6800 enrolled subjects

  • Delhi Site: 3800
  • Pune Site: 1500
  • Vellore Site: 1500

Three trial sites are included to ensure that the trial is conducted within a reasonable timeframe and the vaccine works in different geographical settings in India. The subjects to be included from these sites would be representative of the majority population of India

 

Trial  Purpose:

The data generated from this pivotal study would be used to obtain licensure of the vaccine in India and World Health Organization (WHO) prequalification           

Hypothesis:

Three doses of the ORV 116E vaccine will be safe when co administered to children with childhood vaccines

The ORV 116E vaccine will have a protective efficacy of at least 60% against severe rotavirus gastroenteritis in subjects who receive the vaccine as compared to subjects in the placebo group

Efficacy

To evaluate the efficacy of three doses of ORV 116E, 105.0 ffu given concomitantly with childhood vaccines against severe rotavirus gastroenteritis (11 on the 20-point Vesikari scoring scale) caused by non vaccine rotavirus, in comparison with a placebo, occurring at least 14 days following the third dose till the age of 2 years (24 months) + up to 14 days

Safety

a. To assess the safety of a 3-dose regimen of ORV 116E, 105.0 ffu given concomitantly with childhood vaccines, for serious adverse events occurring during the study period in all subjects

b. To assess the safety of a 3-dose regimen of ORV 116E, 105.0 ffu given  concomitantly with childhood vaccines, for adverse events in the 2-week period following administration of each of the three doses of the vaccine/placebo in the first one third of enrolled subjects at each of the three sites

c. To assess the safety of a 3-dose regimen of ORV 116E, 105.0 ffu given concomitantly with childhood vaccines, for intussusception events occurring during the study period in all subjects

Immunogenicity

To examine the immunogenicity of a 3-dose regimen of ORV 116E, 105.0 ffu as assessed through a four fold rise in rotavirus-specific serum IgA antibody titers 28 (+/-) 5 days after the third dose in comparison to baseline levels in a subset of approximately 150 subjects at each of the three sites

Viral shedding

To assess shedding of rotavirus strains in stools collected from subjects on day 0, 3 and 7 post administration of each dose of the ORV 116E, 105.0 ffu in a subset of approximately 150 subjects at each of the three sites through antigen detection ELISA and if positive by ELISA, genotype by multiplex PCR for G and P types

Study Endpoints:

            Efficacy

  • Efficacy of ORV 116E in comparison to a placebo against severe rotavirus gastroenteritis (≥11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus will be assessed in all subjects from 14 days following the 3rd dose till the age of 2 years (24 months) + up to 14 days

Safety

  • Safety of ORV 116E for serious adverse events in comparison to a placebo will be assessed in all the subjects, from day of 1st dose till the age of 2 years (24 months) + up to 14 days
  • Safety of ORV 116E for adverse events assessed daily in the 2 week period following each dose in comparison to a placebo in first one third of the enrolled subjects in all the three sites
  • Safety of ORV 116E for intussusception events in comparison to a placebo will be assessed in all subjects, from day of 1st dose till the age of 2 years (24 months) + up to 14 days

Immunogenicity and Viral Shedding

  • Immunogenicity rates to three doses of the ORV 116E and vaccine virus shedding rates after each of the three doses of the ORV 116E in comparison to a placebo will be ascertained in approximately 150 subjects at each site

 

 

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