Effect of Lactoferrin on Polio Seroconversion

August 15, 2023 updated by: Dr Sajid Bashir Soofi, Aga Khan University

Effect of Bovine Lactoferrin on Seroconversion Following Polio Vaccine Administration in Children: A Randomized Control Trial

A massive decline in cases of poliomyelitis was observed worldwide since 1988; however its transmission continues in Pakistan and Afghanistan. In 2017, a total of 17 cases were reported from these countries, which represent approximately half of the cases reported in 2016. This achievement was made possible by large scale use of oral polio vaccine (OPV) and inactivated polio vaccine (IPV). Despite vigorous efforts to end poliovirus transmission in endemic areas, several challenges including illiteracy, poverty, malnutrition, difficulty to access health and immunization services adversely affect the effectiveness of the polio eradication efforts. Innovations are thus needed to accomplish the goal of eradication as due to limited funding, the sustainability of a program becomes questionable. The aim of this study is to assess the effectiveness of lactoferrin in increasing mucosal and serum immunity in children following administration of poliovirus vaccines.

Study Overview

Status

Completed

Conditions

Detailed Description

Lactoferrin was first discovered in bovine milk which was later isolated in human milk as the second most abundant protein; with high levels found in colostrum. Evidence suggests that Lactoferrin enhances a child's immunity against gastrointestinal infections by inhibiting the growth of bacteria through iron deprivation and by preventing attachment of the virus to the intestinal cells thus children become less susceptible to virus replication in the gut. Investigations of enhanced efficacy of the BCG (Bacillus Calmette-Guérin) vaccine after administration of Lactoferrin showed promising results. The use of bovine Lactoferrin in children is generally recognized as safe by the US Food and Drug Administration. Its anti-infective properties creates a new window of opportunity to assess its effects on the level of seroconversion following poliovirus vaccination in children.

This is a double-blinded two arm randomized placebo-controlled trial. A total of 377 neonates will be enrolled in each group (754 neonates in both groups). Females ages 18-45 years in their last trimester of pregnancy in Karachi, Pakistan will be recruited for the study by the study team and consent will be obtained. Participants will be newborns (on day 1 of birth) who will be followed through 6 months of age. Newborns who fulfill the inclusion criteria will be randomly assigned to the control or intervention group in 1:1 ratio on the first day of birth. Intervention group will receive a daily bovine lactoferrin supplementation whereas Control group will receive a daily placebo supplementation along with breast milk from day 0 of birth to 6 weeks of life. Newborns will be followed up daily during the course of the hospital stay.

After discharge from the hospital, mothers will be provided with a week's supply of lactoferrin or placebo along with instructions on how and when to administer it to the baby. Newborns will be followed up weekly. Compliance will be assessed by counting the used sachets of lactoferrin or placebo because mothers will be instructed to keep the empty sachets in a dedicated container issued by study staff. Mothers will be strictly advised to administer all vaccinations according to the routine immunization schedule. For both groups, a blood sample will be collected in the hospital and containers will be given to the mother for collections of stool for the newborn.

Study Type

Interventional

Enrollment (Actual)

468

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Muhammad Atif Habib, MBBS, PhD
  • Phone Number: 8049 +922134829538
  • Email: atif.habib@aku.edu

Study Contact Backup

Study Locations

      • Karachi, Pakistan, 74800
        • Kharadar Campus, Aga Khan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 23 hours (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant females aged 18 to 45 years with no underlying complications or co-morbidities
  • Residence less than 30 kms away from the study clinic and have resided there for at least 1 year. Family MUST indicate that they will not move from their current residence for the 5 months after birth of the child (study period)
  • Healthy singleton full-term births born to these mothers, regardless of birth weight and an APGAR score of 7 or higher 5 minutes after delivery with no underlying complication (randomization will take place at this stage)

Exclusion Criteria:

  • Females with health issues and high risk pregnancies
  • Neonates presenting with any morbidities and congenital anomalies will be excluded from the study
  • Preterm birth (<37 weeks of gestation)
  • Immunodeficiency disorder in immediate family member
  • Parents refusing to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bovine Lactoferrin
Intervention group will receive bovine lactoferrin supplementation daily once a day from day 0 of birth to 6 weeks of life.
Lactoferrin is a nutritional supplement which was first discovered in bovine milk which was later isolated in human milk as the second most abundant protein; with high levels found in colostrum. The use of bovine Lactoferrin in children is generally recognized as safe by the US Food and Drug Administration.
Placebo Comparator: Glucon D
Control group will receive Glucon-D supplementation daily once a day from day 0 of birth to 6 weeks of life.
This group will be given 100mg Glucon-D (99.4% glucose) which will be similar in shape, color to the bLF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of humoral immunity by seroconversion
Time Frame: 10 weeks
Presence of detectable antibodies to poliovirus types 1 and 3 in serum) after receipt of two doses of OPV
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of humoral immunity represented by seroconversion
Time Frame: 18 weeks
Presence of detectable antibodies to poliovirus types 1, 2 and 3 in serum) after completion of the routine immunization doses/schedule
18 weeks
Comparison of intestinal immunity represented by shedding of poliovirus types 1 and 3
Time Frame: 19 weeks
If lactoferrin is effective in improving intestinal immunity, shedding is expected to be lower in the lactoferrin receiving group.
19 weeks
Comparison of duration of shedding among the two study arms
Time Frame: 20 and 22 weeks
Represented by shedding at 20 weeks of age and at 22 weeks of age after the challenge dose of bOPV administered
20 and 22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sajid Soofi, MBBS, FCPS, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study findings will be disseminated through presentations at scientific conferences and educational practice workshops and will be published in an international peer-reviewed scientific journal.

IPD Sharing Time Frame

After the manuscript has been prepared and published.

IPD Sharing Access Criteria

A formal application to the PI will be required requesting him about the accessibility of the data. This should include the rationale and expected use of the study data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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