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

Rotavirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00757926
• Other study ID #: SBL/BRV-TV/PhI/2008/0100
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: September 22, 2008
• Last updated: February 2, 2010
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2010
• Source: Shantha Biotechnics Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 240
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 8 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rotavirus Infections

Intervention

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.

Other:
• Placebo
Three oral doses of the placebo (0.5 ml each)following oral administration of antacid.

Locations

Country	Name	City	State
India	Christian Medical College	Vellore	Tamil Nadu

Sponsors (2)

Lead Sponsor	Collaborator
Shantha Biotechnics Limited	PATH

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		Upto one month after each of the three doses of vaccine/ placebo	Yes
Secondary	Immunogenicity		At one month after each of the three doses of vaccine/ placebo	No
Secondary	Viral Shedding		After each of the three doses of the vaccine/placebo	No