Clinical trial NCT01571505: Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)
Official title: Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Poliomyelitis
Tropical Enteropathy
Keywords: Oral vaccines
Vaccine Responsiveness
Tropical Enteropathy
Lead sponsor: International Vaccine Institute
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: National Institute of Cholera and Enteric Diseases, India
name: University of Virginia
name: University of Vermont
First posted: 2012-04-05
Enrollment: 372
Sex: ALL
Minimum age (years): 42
Maximum age (years): 49
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine.
timeFrame: Birth to one year
Secondary outcomes:
measure: Systemic immune responses (neutralizing antibodies) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).
timeFrame: Birth to one year
measure: 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).
timeFrame: Birth to one year
Other outcomes:
Locations:
city: Kolkata
country: India
facility: National Institute of Cholera and Enteric Diseases
Study officials:
affiliation: International Vaccine Institute
name: Ayan Dey, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: William Petri, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Beth Kirkpatrick, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cholera and Enteric Diseases, India
name: Suman Kanungo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cholera and Enteric Diseases, India
name: Ranjan K Nandy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanungo S, Kim DR, Haldar B, Snider C, Nalavade U, Kim SA, Park JY, Sinha A, Mallick AH, Manna B, Sur D, Nandy RK, Deshpande JM, Czerkinsky C, Wierzba TF, Petri WA Jr, Ali M, Dey A. Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial. Heliyon. 2017 Jan 9;3(1):e00223. doi: 10.1016/j.heliyon.2016.e00223. eCollection 2017 Jan.