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

Summary

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.

Conditions

• Rotavirus Infections

Interventions

BIOLOGICAL

116E AGMK

Single dose of 116E 10\^5 FFu

DRUG

I321

Single dose of I321 10\^5 FFu

DRUG

Placebo

1 crystal of potassium permanganate dissolved in the bicarbonate buffer to colour match the vaccine

Sponsors & Collaborators

• All India Institute of Medical Sciences

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• Centers for Disease Control and Prevention

  collaborator FED

• Stanford University

  collaborator OTHER

• Indian Institute of Science

  collaborator OTHER_GOV

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Ministry of Science and Technology, India

  collaborator OTHER_GOV

• PATH

  collaborator OTHER

• Society for Applied Studies

  lead OTHER

Principal Investigators

• Maharaj K Bhan, MD · All India Institute of Medical Sciences

• Pratima Ray, PhD · All India Institute of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

8 Weeks

Max Age

12 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-01-31

Primary Completion

2005-05-31

Completion

2005-05-31

Countries

• India

Study Locations