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Effect of Lactoferrin on Polio Seroconversion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04432935
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : April 19, 2022
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Dr Sajid Bashir Soofi, Aga Khan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Poliomyelitis Dietary Supplement: Bovine Lactoferrin Other: Placebo Glucon D Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 754 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Group 1:

Bovine lactoferrin (bLF) will be administered (300mg) from day 0 of birth to 6 weeks of life with a single daily dose mixed with milk (preferentially breast milk otherwise premature formula milk).

Group 2:

Placebo will be administered from day 0 of birth to 6 weeks of life. (Placebo will be physically identical to the bLF mixed with breast milk or premature formula milk).

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomization will be carried out by Data management unit and all investigators /dispensers and participants will be masked to the randomization.
Primary Purpose: Prevention
Official Title: Effect of Bovine Lactoferrin on Seroconversion Following Polio Vaccine Administration in Children: A Randomized Control Trial
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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.
Dietary Supplement: Bovine Lactoferrin
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.
Other: Placebo Glucon D
This group will be given 100mg Glucon-D (99.4% glucose) which will be similar in shape, color to the bLF.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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



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Ages Eligible for Study:   1 Hour to 23 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432935


Contacts
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Contact: Muhammad Atif Habib, MBBS, PhD +922134829538 ext 8049 atif.habib@aku.edu
Contact: Shanila Nooruddin, MBBS, MS +922134829538 ext 8045 shanila.nooruddin@aku.edu

Locations
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Pakistan
Kharadar Campus, Aga Khan University Hospital Recruiting
Karachi, Pakistan, 74800
Contact: Sajid B Soofi, FCPS    +923002769398    sajid.soofi@aku.edu   
Contact: sidrah nausheen, FCPS    923012338464    sidrah.nausheen@aku.edu   
Sponsors and Collaborators
Aga Khan University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Sajid Soofi, MBBS, FCPS Aga Khan University
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Sajid Bashir Soofi, Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT04432935    
Other Study ID Numbers: 2019-1955-5013
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After the manuscript has been prepared and published.
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.

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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
Keywords provided by Dr Sajid Bashir Soofi, Aga Khan University:
Bovine Lactoferrin
Poliovirus
Routine immunization
Additional relevant MeSH terms:
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Poliomyelitis
Myelitis
Central Nervous System Infections
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Lactoferrin
Anti-Infective Agents