Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-02 @ 9:14 AM
Study NCT ID:
NCT02643368
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity of Monovalent Type 2 Oral Poliovirus Vaccine
Sponsor:
Centers for Disease Control and Prevention
Organization:
Study Overview
Official Title:
Assessing Immunogenicity of Type 2 Monovalent Oral Poliovirus Vaccine Administered at One, Two or Four Week Intervals and When Coadministered With Inactivated Poliovirus Vaccine in an Urban Area in Bangladesh
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label phase IV, randomized controlled trial of mOPV2 alone and mOPV2 along with IPV. This trial will assess the impact on type 2 immunogenicity by reducing the interval between mOPV2 doses. The trial will also evaluate any difference in immunogenicity when the first dose of mOPV2, in a two dose schedule with a four week interval, is administered simultaneously with IPV.
Detailed Description:
The Strategic Advisory Group of Experts on Immunization (SAGE) has recommended a phased cessation of OPVs starting with serotype 2 (OPV2). This is because the last case of type 2 wild poliovirus (WPV2) was reported in 1999 and type 2 vaccine poliovirus is associated with the highest risk of causing paralysis due to reversion to vaccine derived poliovirus (VDPV), in which the reverted virus acquires not only the ability to cause paralysis but also the ability to transmit from person-to-person. Withdrawal of OPV2 will be done through the replacement worldwide of trivalent OPV (tOPV) with bivalent (types 1 and 3) OPV (bOPV) for use in routine immunization and in campaigns.
After the tOPV to bOPV switch, there will be strict biosafety requirements for the use of vaccines containing OPV2. Trivalent OPV will no longer exist and use of monovalent OPV2 (mOPV2) will be limited to responding to a type 2 outbreak. To respond to poliovirus type 2 outbreaks, the Global Polio Eradication Initiative has proposed delivering using mOPV2 in campaigns conducted in the primary zone of the outbreak and IPV in campaigns conducted in areas adjacent to outbreak zone. Therefore, mOPV2 will be a critical component of response to poliovirus type 2 outbreaks.
Typically, polio campaigns are conducted at an interval of 4 weeks. Recently, a clinical trial conducted by icddr,b and the U.S. Centers for Disease Control and Prevention (CDC) in Matlab and Mirpur in Bangladesh demonstrated non-inferiority of type 1 seroconversion after bOPV or mOPV1 at a 2 week interval compared to 4 weeks between doses. Based these findings, the Global Polio Eradication Initiative (GPEI) concluded that the immune response to "OPV is satisfactory when the interval between doses is shortened to 14 or even 7 days (in case of mOPV1)" and has used short-interval campaigns to deliver mOPV1 and bOPV in areas with security-limited access and for outbreak response. However, there are no data and no current or planned polio clinical trials are assessing the impact on immunogenicity of mOPV2 of a reduction in the interval between mOPV2 doses or of administration of mOPV2 in combination with IPV. Therefore, the findings from the trial proposed in this protocol have a direct and immediate implication on strategies to respond to type 2 polio outbreaks.
Field site: The study will be carried out in urban slums in Mirpur and Mohakahli in Dhaka.
After the tOPV to bOPV switch, there will be strict biosafety requirements for the use of vaccines containing OPV2. Trivalent OPV will no longer exist and use of monovalent OPV2 (mOPV2) will be limited to responding to a type 2 outbreak. To respond to poliovirus type 2 outbreaks, the Global Polio Eradication Initiative has proposed delivering using mOPV2 in campaigns conducted in the primary zone of the outbreak and IPV in campaigns conducted in areas adjacent to outbreak zone. Therefore, mOPV2 will be a critical component of response to poliovirus type 2 outbreaks.
Typically, polio campaigns are conducted at an interval of 4 weeks. Recently, a clinical trial conducted by icddr,b and the U.S. Centers for Disease Control and Prevention (CDC) in Matlab and Mirpur in Bangladesh demonstrated non-inferiority of type 1 seroconversion after bOPV or mOPV1 at a 2 week interval compared to 4 weeks between doses. Based these findings, the Global Polio Eradication Initiative (GPEI) concluded that the immune response to "OPV is satisfactory when the interval between doses is shortened to 14 or even 7 days (in case of mOPV1)" and has used short-interval campaigns to deliver mOPV1 and bOPV in areas with security-limited access and for outbreak response. However, there are no data and no current or planned polio clinical trials are assessing the impact on immunogenicity of mOPV2 of a reduction in the interval between mOPV2 doses or of administration of mOPV2 in combination with IPV. Therefore, the findings from the trial proposed in this protocol have a direct and immediate implication on strategies to respond to type 2 polio outbreaks.
Field site: The study will be carried out in urban slums in Mirpur and Mohakahli in Dhaka.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: