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

NCT00757926 | Withdrawn Phase 1 DMC

• 1 other identifier: SBL/BRV-TV/PhI/2008/0100
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotavirus Infections

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Upto one month after each of the three doses of vaccine/ placebo

Secondary Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]

2

PLACEBO COMPARATOR

Other: Placebo

Interventions

Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] BIOLOGICAL

Three oral doses of the vaccine (0.5 ml each) following oral administration of antacid.

1

Placebo OTHER

Three oral doses of the placebo (0.5 ml each)following oral administration of antacid.

2

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shantha Biotechnics Limited: lead
• PATH: collaborator

Study Sites (1)

Christian Medical College

Vellore, Tamil Nadu, 632004, India

Location

MeSH Terms

Conditions

Rotavirus Infections

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Raman Rao, MD

  Shantha Biotechnics Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 23, 2008
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 3, 2010

Record last verified: 2010-02

Locations

IN (1)