Immunogenicity of 1 or 2 Doses of bOPV in Chilean Infants Primed With IPV Vaccine
IPV002ABMG
A Phase 4, Randomized, Open-Label Study to Assess Humoral and Intestinal Polio Immunity Following a Three-Dose Trivalent Inactivated Polio Vaccine Schedule Relative to Two Sequential Schedules of IPV/Bivalent Oral Polio Vaccines
1 other identifier
interventional
570
1 country
1
Brief Summary
The rationale for this study (IPV 002ABMG) is to evaluate and compare three doses of IPV, two doses of IPV plus one bOPV, and one dose of IPV plus two doses of bOPV in order to provide evidence for better immunization policy making in regions of the world that must switch to use of IPV/bOPV schedules in the 2014-2015 time frame. The goal is to identify the best option optimizing humoral immune responses, intestinal immunity and thereby prevent community transmission as well as preventing VAPP. Specifically, the study seeks to show that both of the sequential regimens are equivalent (not-inferior) to the 3-dose IPV regimen in the seroconversion rates to both type 1 and type 3 poliovirus such that not more than 10% of subjects fall below the 95% confidence interval observed for the 3-dose IPV alone regimen and the geometric mean titers (GMTs) are no more than 2/3 logs less than those for the 3-dose IPV regimen. In addition, the study will evaluate by a novel method (poliovirus shedding index), the adequacy of IPV vaccines in inducing intestinal immunity, specifically by reducing the shedding of poliovirus type 2 after an OPV challenge. The hypotheses of the study are:
- A 3-dose IPV/bOPV sequential schedule including 1 or 2 doses of bOPV is non-inferior in terms of types 1 and 3 seroconversion rates and GMTs to a 3-dose IPV schedule.
- Two and possibly 1 IPV dose(s) provides significant seroconversion rates and GMTs to type 2 poliovirus and sufficient priming to induce a rapid immune response in the context of an oral challenge at 7 months of age.
- Three, 2, and possibly 1 dose of IPV will induce intestinal immunity to poliovirus type 2 as measured by a combination of quantity of virus in stools and duration of shedding (shedding index). In addition to these 3 hypotheses, the study will explore the following hypothesis:
- Co-administration of bOPV and rotavirus at 16 weeks of age (the second rotavirus dose) provides similar antirotavirus IgA seroconversion rates and GMCs compared to subjects receiving rotavirus vaccine together with IPV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 19, 2013
CompletedFirst Posted
Study publicly available on registry
April 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMay 20, 2014
April 1, 2014
1.1 years
April 19, 2013
May 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Types 1 and 3 poliovirus humoral immune response
Two primary endpoints will be used as the basis for evaluation of the IPV/OPVb sequential regimens compared to three doses of IPV: * Seroconversion to type 1 (type-specific titers ≥1:8 and \> 4-fold over expected levels of maternally-derived antibody) and GMTs achieved at 28 weeks. * Seroconversion to type 3 (type-specific titers ≥1:8 and \> 4-fold over expected levels of maternally-derived antibody) and GMTs achieved at 28 weeks.
12 months
Secondary Outcomes (1)
Poliovirus Type 2 humoral and intestinal immune response and safety
12 months (18 months for intestinal immunity)
Other Outcomes (1)
antirotavirus IgA seroconversion rates
18 months
Study Arms (3)
IPV/IPV/IPV/Rotarix/mOPV type 2
EXPERIMENTAL190 healthy infants due for their first dose of polio vaccines will be receive IPV, IPV, IPV at 8, 16 and 24 weeks of age respectively, Rotarix at 8 and 16 weeks if parents accept (optional), and mOPV type 2 at 28 weeks of age
IPV/IPV/bOPV/Rotarix/mOPV type 2
ACTIVE COMPARATOR190 healthy infants due for their first dose of polio vaccines will be receive IPV, IPV, bOPV at 8, 16 and 24 weeks of age respectively and Rotarix at 8 and 16 weeks f age (optional) and mOPV type 2 at 28 weeks of age
IPV/bOPV/bOPV/Rotarix/mOPV type 2
ACTIVE COMPARATOR190 healthy infants due for their first dose of polio vaccines will be receive IPV, bOPV, bOPV at 8, 16 and 24 weeks of age respectively and Rotarix at 8 and 16 weeks of age (optional)and mOPV type 2 at 28 weeks of age
Interventions
Blood samples for poliovirus neutralizing antibodies to be obtained as follows: Group 1 at weeks 8, 16, 28 and 29; Group 2 and 3 at 8, 24, 28 and 29. Stool samples for poliovirus cuantification, for all groups, to be obtained at weeks 28, 29, 30, 31, 32.
As indicated
Administered at 28 weeks of age to all study participants
Administered at 8 and 16 weeks to all study participants accepting to recive this vaccine
Eligibility Criteria
You may qualify if:
- Age: 8 weeks (-7 to +7 days).
- Healthy infants of all ethnicities and both genders without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
- Written informed consent obtained from 1 parent or legal guardian who, in the opinion of the investigator, is capable of understanding and complying with the protocol requirements.
You may not qualify if:
- Previous vaccination against poliovirus.
- Low birth weight (BW \<2,500 grams).
- Twins or multiple pregnancy infants.
- Another family or household member who has received OPV within the past 6 months or is going to receive OPV within the following 6 months.
- Any confirmed or suspected immunosuppressive or immunedeficient condition including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
- Known allergy to any component of the study vaccines.
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Chilelead
- Bill and Melinda Gates Foundationcollaborator
Study Sites (1)
Facultad de Medicina de la Universidad de Chile
Santiago, Santiago Metropolitan, 8380453, Chile
Related Publications (6)
1. Global Polio Eradication Initiative. Data and Monitoring: Polio this week. Available at http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx.http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx. Copyright 2010. Accessed 8/23/2012 2. Sixty-fifth World Health Assembly. Poliomyelitis: Intensification of the global eradication initiative. WHA 65.5, Agenda item 13.10; 26 May 2012. 3. Sabin, A B.
BACKGROUND2. Sixty-fifth World Health Assembly. Poliomyelitis: Intensification of the global eradication initiative. WHA 65.5, Agenda item 13.10; 26 May 2012.
BACKGROUNDAsturias EJ, Dueger EL, Omer SB, Melville A, Nates SV, Laassri M, Chumakov K, Halsey NA. Randomized trial of inactivated and live polio vaccine schedules in Guatemalan infants. J Infect Dis. 2007 Sep 1;196(5):692-8. doi: 10.1086/520546. Epub 2007 Jul 23.
PMID: 17674310BACKGROUNDMinor PD. Polio eradication, cessation of vaccination and re-emergence of disease. Nat Rev Microbiol. 2004 Jun;2(6):473-82. doi: 10.1038/nrmicro906. No abstract available.
PMID: 15152203BACKGROUNDBrickley EB, Wieland-Alter W, Connor RI, Ackerman ME, Boesch AW, Arita M, Weldon WC, O'Ryan MG, Bandyopadhyay AS, Wright PF. Intestinal Immunity to Poliovirus Following Sequential Trivalent Inactivated Polio Vaccine/Bivalent Oral Polio Vaccine and Trivalent Inactivated Polio Vaccine-only Immunization Schedules: Analysis of an Open-label, Randomized, Controlled Trial in Chilean Infants. Clin Infect Dis. 2018 Oct 30;67(suppl_1):S42-S50. doi: 10.1093/cid/ciy603.
PMID: 30376086DERIVEDO'Ryan M, Bandyopadhyay AS, Villena R, Espinoza M, Novoa J, Weldon WC, Oberste MS, Self S, Borate BR, Asturias EJ, Clemens R, Orenstein W, Jimeno J, Ruttimann R, Costa Clemens SA; Chilean IPV/bOPV study group. Inactivated poliovirus vaccine given alone or in a sequential schedule with bivalent oral poliovirus vaccine in Chilean infants: a randomised, controlled, open-label, phase 4, non-inferiority study. Lancet Infect Dis. 2015 Nov;15(11):1273-82. doi: 10.1016/S1473-3099(15)00219-4. Epub 2015 Aug 26.
PMID: 26318714DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel L O'Ryan, MD
University of Chile
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor and Associate Director for Innovation, Faculty of Medicine, University of Chile
Study Record Dates
First Submitted
April 19, 2013
First Posted
April 26, 2013
Study Start
April 1, 2013
Primary Completion
May 1, 2014
Study Completion
June 1, 2014
Last Updated
May 20, 2014
Record last verified: 2014-04