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Completed

NCT Number: NCT01571505

Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)

Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breast milk antibodies, changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus vaccines is associated with the presence of tropical enteropathy.

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Key information

Conditions

Poliomyelitis Central Nervous System Diseases Central Nervous System Infections Digestive System Diseases Enterovirus Infections Gastrointestinal Diseases Infections Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Picornaviridae Infections RNA Virus Infections Spinal Cord Diseases Sprue, Tropical Tropical Enteropathy Virus Diseases

Age range

42 day–49 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Institute of Cholera and Enteric Diseases

Kolkata, India

About this study

Intervention of this study is to vaccinate oral poliovirus vaccine and oral rotavirus vaccine to the child with two group; with inactivated poliovirus vaccine and without inactivated poliovirus vaccine. Rotavirus vaccines give to the child at 10 weeks of age and 17 weeks of age.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mother willing to sign informed consent form.
  • Infant aged 0 to 49 days old.
  • No obvious congenital abnormalities or birth defects.

Exclusion criteria

  • Parents are not willing to have child's blood drawn.
  • Parents are planning to enroll child into another clinical study during the time period of this trial.
  • Mother not willing to have blood drawn and breast milk extracted.
  • Parents not willing to have field research assistant in home.
  • History of seizures or other apparent neurologic disorders.
  • Infant does not have proof of BCG and OPV since birth by immunization card.
  • History of acute illness and/or immunocompromised state of the child.
  • Immunocompromised or chronically ill mother

Treatment and study plan

IPV vaccination

Biological

Randomized IPV or OPV to children aged at 39weeks.

Other names: Rotavirus vaccination to children at 10 and 17 weeks of age.

Primary outcomes

  1. Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine.

    Time frame: Birth to one year

    Responsiveness of oral vaccines compare with Tropical Enteropathy and without Tropical Enteropathy; using lactose/mannitol ratio.

Secondary outcomes

  1. Systemic immune responses (neutralizing antibodies) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).

    Time frame: Birth to one year

  2. Mucosal immune responses (shedding OPV vaccine virus) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).

    Time frame: Birth to one year

Sponsors and collaborators

Lead sponsor

International Vaccine Institute

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • National Institute of Cholera and Enteric Diseases, India
  • University of Vermont
  • University of Virginia

Registry information

Official study title

Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2012
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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