Persistence of IPV Immunity

NCT03723837 | Completed Phase 4 DMC

• 1 other identifier: 69/2018
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 3

Brief Summary

In 2015, Strategic Advisory Group of Experts in Immunization (SAGE) recommended the global switch from trivalent to bivalent oral poliovirus vaccine (OPV) that does not contain type 2 poliovirus and introduction of a single dose of inactivated poliovirus vaccine (IPV) to maintain population immunity to type 2 polio to reduce the risk of vaccine derived polio. Following SAGE recommendations, Nepal introduced one dose of IPV in routine immunization in 2015 followed by withdrawal trivalent OPV in April 2016. However, Nepal, like many other countries had to stop vaccination by the end of 2016 because of a global shortage of IPV. Single dose of IPV induces detectable antibodies in 34% to 80% of infants, compared to \>90% after three doses and most of seronegative children (84-98%) are "immunologically primed" by the first dose. Primed individuals produce protective antibody levels in serum within one week of exposure to a new dose of IPV or OPV. However, it is unknown whether seroconversion or priming responses persist, and for how long they persist after the single dose of IPV. IPV immunogenicity for vaccine delivered low-resource countries may also be inferior to that observed in clinical trials because of program factors that decrease vaccine efficacy. This cross sectional study aims to determine whether the immune response provided by a single dose of IPV delivered through routine immunization services persists for more than a year. The study will be implemented in three study sites in Kathmandu, Nepal during November 2018- July 2019. Information generated from this study is expected to allow better estimation of children partially protected (primed) or fully protected against type 2 poliovirus depending on coverage and time since last IPV vaccination. These estimates will help inform the Global Polio Eradication Initiative (GPEI) on vaccine choices for responding to type 2 vaccine derived poliovirus (VDPV) outbreaks and will help guide decisions on polio immunization schedules for Nepal and for other countries in future.

Conditions

Poliomyelitis

Keywords

IPV; Routine immunization; Single dose; Persistence of immunity

Outcome Measures

Primary Outcomes (1)

• Proportion of children with detectable immunity against type 2 poliovirus

  To compare the proportion of infants vaccinated with one dose of IPV after 14 weeks of age who are seropositive or primed against type 2 poliovirus, either \> 21 months after vaccination (study group), or one month after vaccination (control group)

  5 weeks

Secondary Outcomes (1)

• Proportion of children who seroconvert or boost antibody titers to type 2 poliovirus

  5 weeks

Study Arms (2)

Study Arm A

ACTIVE COMPARATOR

Children {Age \> 24 months and who received a single dose Inactivated Polio Vaccine (IPV) at the time of routine immunization} in this arm will receive an IPV (0.5ml) intramuscularly at the time of enrolment in the trial

Biological: Inactivated Polio Vaccine (IPV)

Study arm B

ACTIVE COMPARATOR

Children {Age 7-12 months and have not received any IPV till date of enrolment} in this arm will receive an Inactivated Polio Vaccine, IPV (0.5 ml) intramuscularly at the time of enrolment in the trial and a repeat dose of IPV (0.5 ml) after 1 month

Biological: Inactivated Polio Vaccine (IPV)

Interventions

Inactivated Polio Vaccine (IPV) BIOLOGICAL

Children receive one or two doses of IPV based on study arm they fall in

Study Arm A; Study arm B

Eligibility Criteria

• Age: 7 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• We will be including Nepali infants who fulfil the following criteria:
• Born after 30 April 2016
• Healthy infant or mild illness
• Age groups within one of the following age groups: 7-12 months or \>24 months.
• Receipt of one dose of IPV at 3- 6 months of age (if age \>24months) or zero doses (if age within 7-12 months). IPV receipt must be validated through immunization card or registry book.
• Parents that consent for participation in the full length of the study.
• Parents those are able to understand and comply with planned study procedures.

You may not qualify if:

• Parents and infants who are unable to participate in the full length of the study.
• A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
• A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of IPV or collection of blood by venipuncture.
• Acute infection or illness at the time of enrollment that would require infant's admission to a hospital.
• Evidence of a chronic medical condition identified by a study medical officer during physical exam.
• Known allergy/sensitivity or reaction to polio vaccines.
• Discontinuation Criteria
• Withdrawal of consent for participation for any reason.
• Request by parents of participant to terminate all study procedures.
• Identification of immunodeficiency disorder, bleeding disorder or another medical condition for which continued participation, in the opinion of the principal investigator, would pose a risk to the participant to continue in the study.
• Receipt of immunosuppressive medications.
• Receipt of any polio (OPV or IPV) vaccine outside of study after enrollment (as per parent's report).
• Allergic reaction to a dose of polio vaccine.
• Unable to collect or obtain blood at enrollment.
• Premature termination of the study.

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead
• World Health Organization: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (3)

Kanti Children's Hospital

Kathmandu, Nepal

Location

Patan Hospital

Kathmandu, Nepal

Location

Tribhuvan University Teaching Hospital

Kathmandu, Nepal

Location

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Related Links

• Global Polio Eradication Initiative. List of wild poliovirus by country and year.
• The Global Polio Eradication Initiative. Data and monitoring
• Hickling J, Jones R and Nundy N. Improving the affordability of intactivated poliovirus vaccine (IPV) for use in low-and middle-income countries
• Global Polio Eradication Initiative. Standard Operating Procedures: responding to a poliovirus event and outbreak, part 2: protocol for poliovirus type 2, 15 August 2016 (Original publication 20 april 2016)
• Department of Immunization Vaccines and Biologicals. WHO multi-dose vial policy (MDVP), Revision 2014. WHO/IVB/14.07

MeSH Terms

Conditions

Poliomyelitis

Interventions

Poliovirus Vaccine, Inactivated

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

Intervention Hierarchy (Ancestors)

Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Laxman P Shrestha, MD

  Tribhuvan University Teaching Hospital, Institute Of Medicine.

  PRINCIPAL INVESTIGATOR

• Concepcion Estivariz, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Harish Verma, DCH

  World Health Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co PI, Associate Professor, Department of Pediatrics

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: November 21, 2018
• Primary Completion: June 30, 2019
• Study Completion: July 30, 2019
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

NE (3)