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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rotavirus Infections

Intervention / Treatment
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* Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |