Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants

Phase I/II, Randomized, Double-blind, Placebo-controlled, Staged Dosage Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Infants Concurrently With Other Standard EPI Vaccines

A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] administered to healthy Indian infants concurrently with other standard EPI vaccines would be undertaken to evaluate the study hypothesis that a 3-dose series of BRV-TV (containing the VP7 serotypes G1, G2, G3, and G4) administered orally to healthy Indian infants at 6-8, 10-12, and 14-16 weeks of age concurrently with other standard EPI vaccines would be generally well tolerated and immunogenic.

Study Overview

• Status: Withdrawn
• Conditions: Rotavirus Infections
• Intervention / Treatment: Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • Vellore, Tamil Nadu, India, 632004
      • Christian Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy infants 6-8 weeks of age of either sex;
• Born after a gestational period of 36-42 weeks with birth weight >2 kg;
• Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF);
• Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up.

Exclusion Criteria:

• History of congenital abdominal disorders, intussusception, or abdominal surgery;
• Known or suspected impairment of immunological function;
• Known hypersensitivity to any component of the rotavirus vaccine;
• Prior receipt of any rotavirus vaccine;
• Fever, with an oral temperature ≥38.1oC (≥100.5oF); presumably measured by study staff?
• History of known rotavirus disease, chronic diarrhea, or failure to thrive;
• Baseline level of ALT or AST >2.5 times the upper limit of normal;
• Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication);
• Receipt of any IM, oral, or IV corticosteroid treatment (infants on inhaled steroids may be permitted to participate in the study);
• Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids);
• Infants testing positive for HBV, HCV, or HIV infection;
• Prior receipt of a blood transfusion or blood products, including immunoglobulins;
• Any infants who can not be adequately followed for safety by telephone and/or a home visit;
• Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]; Three oral doses of the vaccine (0.5 ml each) following oral administration of antacid.
Placebo Comparator: 2	Other: Placebo; Three oral doses of the placebo (0.5 ml each)following oral administration of antacid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability	Upto one month after each of the three doses of vaccine/ placebo

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity	At one month after each of the three doses of vaccine/ placebo
Viral Shedding	After each of the three doses of the vaccine/placebo

Collaborators and Investigators

• Sponsor: Shantha Biotechnics Limited
• Collaborators: PATH
• Investigators: Study Director: Raman Rao, MD, Shantha Biotechnics Limited

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): September 1, 2010

Study Registration Dates

• First Submitted: September 22, 2008
• First Submitted That Met QC Criteria: September 22, 2008
• First Posted (Estimate): September 23, 2008

Study Record Updates

• Last Update Posted (Estimate): February 3, 2010
• Last Update Submitted That Met QC Criteria: February 2, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Reoviridae Infections; Rotavirus Infections
• Other Study ID Numbers: SBL/BRV-TV/PhI/2008/0100