Effect of Lactoferrin on Polio Seroconversion

NCT04432935 | Completed DMC

• 1 other identifier: 2019-1955-5013
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

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.

Conditions

Poliomyelitis

Keywords

Bovine Lactoferrin; Poliovirus; Routine immunization

Outcome Measures

Primary Outcomes (1)

• Assessment of humoral immunity by seroconversion

  Presence of detectable antibodies to poliovirus types 1 and 3 in serum) after receipt of two doses of OPV

  10 weeks

Secondary Outcomes (3)

• Comparison of humoral immunity represented by seroconversion

  18 weeks

• Comparison of intestinal immunity represented by shedding of poliovirus types 1 and 3

  19 weeks

• Comparison of duration of shedding among the two study arms

  20 and 22 weeks

Study Arms (2)

Bovine Lactoferrin

EXPERIMENTAL

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

Glucon D

PLACEBO COMPARATOR

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

Interventions

Bovine Lactoferrin DIETARY_SUPPLEMENT

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.

Bovine Lactoferrin

Placebo Glucon D OTHER

This group will be given 100mg Glucon-D (99.4% glucose) which will be similar in shape, color to the bLF.

Glucon D

Eligibility Criteria

• Age: 1 Hour - 23 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Kharadar Campus, Aga Khan University Hospital

Karachi, 74800, Pakistan

Location

Related Publications (8)

• Hussain SF, Boyle P, Patel P, Sullivan R. Eradicating polio in Pakistan: an analysis of the challenges and solutions to this security and health issue. Global Health. 2016 Oct 12;12(1):63. doi: 10.1186/s12992-016-0195-3.

  PMID: 27729081 BACKGROUND

• Roseanu A, Brock JH. What are the structure and the biological function of lactoferrin in human breast milk? IUBMB Life. 2006 Apr;58(4):235-7. doi: 10.1080/15216540600577897. No abstract available.

  PMID: 16754302 BACKGROUND

• Seganti L, Di Biase AM, Marchetti M, Pietrantoni A, Tinari A, Superti F. Antiviral activity of lactoferrin towards naked viruses. Biometals. 2004 Jun;17(3):295-9. doi: 10.1023/b:biom.0000027708.27142.bc.

  PMID: 15222481 BACKGROUND

• Ochoa TJ, Cleary TG. Effect of lactoferrin on enteric pathogens. Biochimie. 2009 Jan;91(1):30-4. doi: 10.1016/j.biochi.2008.04.006. Epub 2008 Apr 18.

  PMID: 18472012 BACKGROUND

• Superti F, Ammendolia MG, Valenti P, Seganti L. Antirotaviral activity of milk proteins: lactoferrin prevents rotavirus infection in the enterocyte-like cell line HT-29. Med Microbiol Immunol. 1997 Oct;186(2-3):83-91. doi: 10.1007/s004300050049.

  PMID: 9403835 BACKGROUND

• Hwang SA, Wilk KM, Budnicka M, Olsen M, Bangale YA, Hunter RL, Kruzel ML, Actor JK. Lactoferrin enhanced efficacy of the BCG vaccine to generate host protective responses against challenge with virulent Mycobacterium tuberculosis. Vaccine. 2007 Sep 17;25(37-38):6730-43. doi: 10.1016/j.vaccine.2007.07.005. Epub 2007 Jul 27.

  PMID: 17698261 BACKGROUND

• Hwang SA, Arora R, Kruzel ML, Actor JK. Lactoferrin enhances efficacy of the BCG vaccine: comparison between two inbred mice strains (C57BL/6 and BALB/c). Tuberculosis (Edinb). 2009 Dec;89 Suppl 1:S49-54. doi: 10.1016/S1472-9792(09)70012-5.

  PMID: 20006305 BACKGROUND

• Habib A, Nausheen S, Nooruddin S, Javed T, Samejo T, Hussain A, Namdev S, Amirali S, Umer M, Sheikh L, Hussain I, Ariff S, Soofi S. Effect of bovine lactoferrin on seroconversion following polio vaccine administration in children: protocol for a double-blinded randomised controlled trial. BMJ Open. 2022 May 24;12(5):e050849. doi: 10.1136/bmjopen-2021-050849.

  PMID: 35613782 DERIVED

Related Links

• Agency Response Letter GRAS Notice No. GRN 000611

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

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; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Sajid Soofi, MBBS, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be carried out by Data management unit and all investigators /dispensers and participants will be masked to the randomization.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: June 16, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

PA (1)