Persistence of IPV Immunity (NCT03723837) | Clinical Trial Compass
CompletedPhase 4
Persistence of IPV Immunity
Nepal502 participantsStarted 2018-11-21
Plain-language 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.
Who can participate
Age range
7 Months – 36 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
Exclusion Criteria:
* 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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of children with detectable immunity against type 2 poliovirus
Timeframe: 5 weeks
Trial details
NCT IDNCT03723837
SponsorTribhuvan University Teaching Hospital, Institute Of Medicine.