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Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Infants

This study has been completed.
All India Institute of Medical Sciences, New Delhi
National Institutes of Health (NIH)
Centers for Disease Control and Prevention
Stanford University
Indian Institute of Science
Children's Hospital Medical Center, Cincinnati
Ministry of Science and Technology, India
Information provided by:
Society for Applied Studies Identifier:
First received: January 13, 2006
Last updated: July 1, 2008
Last verified: July 2008

It has been observed that in children who get a severe rotavirus infection, subsequent infections cause either no symptoms or generally only mild or moderate diarrhea. This evidence is the basis for developing a vaccine since it suggests that the first infection immunizes the child against disease upon re-infection.

It was found that neonatal avirulent strains 116E and I321 induce protective immunity and offer clinical protection for at least one year. Both these strains are well characterized and the safety studies have been done in animal models. These candidate vaccine strains have been evaluated for safety and immunogenicity in adults and children (2 to 12 years of age) by a randomized double blind placebo controlled trial in Cincinnati, USA. In India, the diversity of rotavirus strains is greater and there is greater prevalence of malnutrition and co-infection with other enteric pathogens. These vaccines have therefore, also been tested in India.

Condition Intervention Phase
Rotavirus Infections
Biological: 116E AGMK
Drug: I321
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reactogenicity and Immunogenicity of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Healthy Non-Malnourished Infants 8-12 Weeks of Age

Resource links provided by NLM:

Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:
  • - Safety [ Time Frame: 4 weeks after test article administration ]

Secondary Outcome Measures:
  • - Vaccine Take, antibody titers in subjects in vaccine and placebo groups 28 days after administration of vaccine/placebo or shedding of rotavirus vaccine strains by antigen detection ELISA on days 3, 7 and 28 post administration. [ Time Frame: 4 weeks post administration of test article ]

Enrollment: 90
Study Start Date: January 2005
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Biological: 116E AGMK
Single dose of 116E 10^5 FFu
Experimental: 2
Drug: I321
Single dose of I321 10^5 FFu
Placebo Comparator: 3
Drug: Placebo
1 crystal of potassium permanganate dissolved in the bicarbonate buffer to colour match the vaccine

Detailed Description:

This study was a phase I randomized, double blind, safety and immunogenicity study of live, attenuated neonatal rotavirus vaccine candidate strains 116E or I321 in healthy non-malnourished infants aged 8-12 weeks. Informed, written, witnessed consent was obtained from the parents before infants were screened at 6 weeks of age. Infants (n=90) were randomized (30 per group) to receive one dose of either the 116E or I321 vaccines (10^5 fluorescence focus units, FFu) or placebo at 8 weeks of age. The rotavirus vaccine was administered at a different time than DPT (Diptheria-Pertussis-Tetanus), OPV (Oral Polio Vaccine) and HBV (Hepatitis B vaccine) immunization since the trial represented the first safety study in infants with these strains. The DPT, OPV and HBV vaccines were given at the regular EPI schedule of 6, 10 and 14 weeks with the precautions and techniques routinely in place for these.

The test article was administered orally two weeks after the first DPT, OPV and HBV dose, after half an hour of administering 2.5 ml bicarbonate to buffer stomach acidity.

Evaluation of reactogenicity consisted of daily recording of symptoms reported by the mother/caregiver and twice-daily axillary temperature measurements for 14 days post administration of vaccine/placebo. Stool specimens were collected before administration of vaccine/placebo, twice during the week following administration (days 3 and 7), and at day 28 after administration to evaluate for vaccine virus shedding. Weekly recording of adverse events was also done for the next 2 weeks i.e. on days 21 and 28 post administration of vaccine/placebo. If gastrointestinal signs or symptoms occurred any time during the 4 weeks observation period, attempts were made to collect stool samples daily (maximum 2 per day) while the illness persisted, to be examined for the presence of the vaccine strains.

Immunogenicity was determined by analysis of sera obtained before immunization and 28 days after immunization for changes in titers of rotavirus antibodies.


Ages Eligible for Study:   8 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy infants
  • Consent available

Exclusion Criteria:

  • Evidence of renal, cardiovascular, liver or other reticuloendothelial, neurological, gastrointestinal, hematologic, rheumatologic or immunologic disease
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Please refer to this study by its identifier: NCT00280111

Society for Applied Studies
New Delhi, Delhi, India, 110016
Sponsors and Collaborators
Society for Applied Studies
All India Institute of Medical Sciences, New Delhi
National Institutes of Health (NIH)
Centers for Disease Control and Prevention
Stanford University
Indian Institute of Science
Children's Hospital Medical Center, Cincinnati
Ministry of Science and Technology, India
Principal Investigator: Maharaj K Bhan, MD All India Institute of Medical Sciences, New Delhi
Principal Investigator: Pratima Ray, PhD All India Institute of Medical Sciences, New Delhi
  More Information

Responsible Party: Dr. MK Bhan, Dr. Pratima Ray, All India Institute of Medical Sciences Identifier: NCT00280111     History of Changes
Other Study ID Numbers: 03-153
U01AI053719-02 ( US NIH Grant/Contract Award Number )
Study First Received: January 13, 2006
Last Updated: July 1, 2008

Keywords provided by Society for Applied Studies:

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017