Dose Escalation Study to Evaluate Oral Rotavirus Vaccine 116E Live Attenuated in Healthy Infants 8 to 20 Weeks Old

NCT00439660 | Completed Phase 1

• 2 other identifiers: BBIL/ROTA/014ISRCTN57452882
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a Phase I, randomized, double blind, safety and immunogenicity trial of the Vero cell based 116E neonatal rotavirus vaccine candidate strain in healthy non-malnourished infants aged 8-20 weeks at three different dosage levels i.e.10\^4.0, 10\^5.0 and 10\^6.0 FFU and for three administrations of each of these dosages given to infants at 4-week intervals. 180 infants (90 vaccinees/90 placebo) will be enrolled for each of the three dosage levels. The progression from the lower to the next higher dosage will be based on approval by the Data Safety Monitoring Board (DSMB) to be constituted by the Department of Biotechnology, New Delhi.

Conditions

Diarrhea

Keywords

Rotavirus, diarrhea, vaccine

Outcome Measures

Primary Outcomes (1)

• 116E rotavirus vaccine

  Safety

  6,10 and 14 weeks

Secondary Outcomes (1)

• 116E rotavirus vaccine

  6,10 and 14 weeks

Study Arms (2)

rotavirus vaccine 116E 1 X 10(4)

EXPERIMENTAL

vaccine dose of 1 X 10(4) focus-forming units (ffu) in three doses starting at 6 weeks : 4 weeks apart each dose

Biological: Oral Rotavirus Vaccine 116E Live Attenuated

rotavirus vaccine 116E 1 X 10(5)

EXPERIMENTAL

vaccine dose of 1 X 10(5) focus-forming units (ffu) in three doses starting at 6 weeks : 4 weeks apart each dose

Biological: Oral Rotavirus Vaccine 116E Live Attenuated

Interventions

Oral Rotavirus Vaccine 116E Live Attenuated BIOLOGICAL

rotavirus vaccine 116E 1 X 10(4); rotavirus vaccine 116E 1 X 10(5)

Eligibility Criteria

• Age: 8 Weeks - 20 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Access to telephone at home or in the immediate neighborhood.
• Healthy male and female non-malnourished (weight for length not ≤ -3 SD of WHO child growth standards) infants aged 6 weeks (till 6 weeks + 2 days).
• Parent's permission to participate in the study is available.
• No plans to travel over the next 4 months

You may not qualify if:

• Gestational age \<37 weeks.
• Any major physical congenital malformation.
• Living in a household or has contact with an individual who is immunosuppressed.
• Hospitalized once or more for the following illnesses since birth: heart disease, pneumonia, sepsis, meningitis, unconsciousness.
• Is required to take daily medications other than vitamins or herbal "tonics".
• Evidence of cardiovascular disease as indicated by any of the following:
• Central cyanosis
• Cyanotic or apnoeic spells
• Features of congestive heart failure
• Significant heart murmur detected on physical examination
• Evidence of gastrointestinal disease indicated by following:
• Diarrhea in the previous 7 days
• Blood in the stools any time since birth
• Evidence of neurological disease, as indicated by:
• History of seizures any time since birth

Sponsors & Collaborators

• Bharat Biotech International Limited: lead
• Ministry of Science and Technology, India: collaborator
• Centers for Disease Control and Prevention: collaborator
• National Institutes of Health (NIH): collaborator
• Stanford University: collaborator
• Indian Council of Medical Research: collaborator
• PATH: collaborator

Study Sites (1)

Society for Applied Studies (SAS)

New Delhi, 110 017, India

Location

Related Publications (3)

• Bhandari N, Sharma P, Glass RI, Ray P, Greenberg H, Taneja S, Saksena M, Rao CD, Gentsch JR, Parashar U, Maldonado Y, Ward RL, Bhan MK. Safety and immunogenicity of two live attenuated human rotavirus vaccine candidates, 116E and I321, in infants: results of a randomised controlled trial. Vaccine. 2006 Jul 26;24(31-32):5817-23. doi: 10.1016/j.vaccine.2006.05.001. Epub 2006 May 12.

  PMID: 16735085 BACKGROUND

• Appaiahgari MB, Glass R, Singh S, Taneja S, Rongsen-Chandola T, Bhandari N, Mishra S, Vrati S. Transplacental rotavirus IgG interferes with immune response to live oral rotavirus vaccine ORV-116E in Indian infants. Vaccine. 2014 Feb 3;32(6):651-6. doi: 10.1016/j.vaccine.2013.12.017. Epub 2013 Dec 25.

  PMID: 24374502 DERIVED

• Bhandari N, Sharma P, Taneja S, Kumar T, Rongsen-Chandola T, Appaiahgari MB, Mishra A, Singh S, Vrati S; Rotavirus Vaccine Development Group. A dose-escalation safety and immunogenicity study of live attenuated oral rotavirus vaccine 116E in infants: a randomized, double-blind, placebo-controlled trial. J Infect Dis. 2009 Aug 1;200(3):421-9. doi: 10.1086/600104.

  PMID: 19545211 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nita Bhandari, MBBS, PhD

  Society for Applied Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomised double blind placebo controlled tri
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised double blind placebo controlled tri

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 26, 2007
• Study Start: December 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

IN (1)