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Immunogenicity of 1 or 2 Doses of bOPV in Chilean Infants Primed With IPV Vaccine

NCT01841671 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2014-05-20

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

IPV

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.

BIOLOGICAL

bOPV

As indicated

BIOLOGICAL

mOPV type 2

Administered at 28 weeks of age to all study participants

BIOLOGICAL

Rotarix

Administered at 8 and 16 weeks to all study participants accepting to recive this vaccine

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of Chile

    lead OTHER

Principal Investigators

  • Miguel L O'Ryan, MD · University of Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Weeks
Max Age
9 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-05-31
Completion
2014-06-30

Countries

  • Chile

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01841671 on ClinicalTrials.gov