Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study (mOPV1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03722004
Recruitment Status : Unknown
Verified December 2018 by Centers for Disease Control and Prevention.
Recruitment status was:  Recruiting
First Posted : October 26, 2018
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Brief Summary:
This is an open-label phase IV randomized clinical trial that will assess intestinal and humoral immunity among infants who receive a combination of monovalent oral poliovirus vaccine type 1 and fractional dose of inactivated poliovirus vaccine, monovalent oral poliovirus vaccine type 1 only, and bivalent oral poliovirus vaccine only.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: mOPV1 Biological: bOPV Biological: fIPV Phase 4

Detailed Description:

The risk for circulating vaccine-derived poliovirus (cVDPV) will increase in the years immediately after the cessation of oral poliovirus vaccine (OPV) use in routine immunization programs. Judicious use of type-specific monovalent OPV (mOPV) will be necessary for outbreak response to prevent further paralytic infections and transmission; however, data on the intestinal and humoral immunity induced by mOPV1 are very limited. Furthermore, the additional benefit of fractional dose inactivated poliovirus vaccine (fIPV) on type 1 immunity when given with mOPV1 is unclear. Data on intestinal and humoral immunity of mOPV type 1 (mOPV1) and combination use of mOPV1 and fractional dose of IPV (fIPV) are urgently needed and would be used to inform guidelines for type 1 outbreak response in a post-OPV world. In the immediate future, a strategy of shifting from bivalent OPV (bOPV) to mOPV1 as part of supplemental immunization activities in endemic countries is under consideration but data on intestinal and humoral immunity to support this change does not exist. This trial is designed to address both areas in which data are lacking.

Healthy infants 5 weeks of age will be enrolled at two study clinics in Dhaka, Bangladesh, and randomized to one of four study arms: mOPV1 + fIPV at 6 weeks, mOPV1 + fIPV at 14 weeks, mOPV1 only, and bOPV only. Infants will be followed-up until 18 weeks of age by clinic and household visits. Blood and stool specimens will be collected to test for vaccine response (humoral immunity) and vaccine virus shedding (intestinal immunity).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Intestinal and Humoral Immunity of Monovalent Oral Poliovirus Vaccine Type 1 When Administered With and Without Fractional Inactivated Poliovirus Vaccine
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: mOPV1 + fIPV 6 weeks
mOPV1 administered at 6, 10, and 14 weeks and fIPV at 6 weeks.
Biological: mOPV1
Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.

Biological: fIPV
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal injection in lieu of the full 0.5mL dose that is given intramuscularly.

Active Comparator: mOPV1 + fIPV 10 weeks
mOPV1 administered at 6, 10, and 14 weeks and fIPV at10 weeks.
Biological: mOPV1
Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.

Biological: fIPV
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal injection in lieu of the full 0.5mL dose that is given intramuscularly.

Active Comparator: mOPV1 only
mOPV1 administered at 6, 10, and 14 weeks.
Biological: mOPV1
Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.

Active Comparator: bOPV only
bOPV administered at 6, 10, and 14 weeks.
Biological: bOPV
Bivalent oral poliovirus vaccine is a live, attenuated oral poliovirus vaccine that protects against poliovirus types 1 and 3.




Primary Outcome Measures :
  1. Vaccine response [ Time Frame: Measured four weeks after administration of study vaccine(s). Vaccine response will be measured at 10 weeks, 14 weeks, and 18 weeks of age after 1, 2, and 3 doses of OPV, respectively. ]
    Dichotomous (yes/no) variable defined as participants who are either seronegative (<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 6 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.

  2. Vaccine virus particles [ Time Frame: Measured 7 and 14 days after administration of the study vaccine. For Arms B, C, and D, this will be after administration of the first mOPV1 or bOPV dose. For Arms A, B, and C, this will be after the mOPV1 challenge dose at 14 weeks of age. ]
    Presence or absence of vaccine virus particles in stool specimens.


Secondary Outcome Measures :
  1. Reciprocal antibody titers [ Time Frame: Measured four weeks after administration of study vaccine(s). Vaccine response will be measured at 10 weeks, 14 weeks, and 18 weeks of age after 1, 2, and 3 doses of OPV, respectively. ]
    Variable of the observed reciprocal antibody titer results.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Days to 41 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants 5 weeks of age (range: 35-41 days).
  • Parents that consent for participation in the full length of the study.
  • Parents that 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 fIPV or collection of blood by venipuncture.
  • Evidence of a chronic medical condition identified by a study medical officer during physical exam.
  • Infection or illness at the enrolment visit (i.e., 5 weeks of age) that a study medical officer judges would prevent the start of study activities at 6 weeks of age (i.e., blood collection and vaccination).
  • Receipt of any polio vaccine (OPV or IPV/fIPV) before enrolment based upon documentation or parental recall.
  • Known allergy/sensitivity or reaction to polio vaccine, or its contents.
  • Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant.
  • Infants from premature births (<37 weeks of gestation).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722004


Contacts
Layout table for location contacts
Contact: Cindi Snider, PhD 404.718.6328 csnider@cdc.gov

Locations
Layout table for location information
Bangladesh
icddr,b study clinics (Mirpur and CTU Dhaka) Recruiting
Dhaka, Bangladesh
Contact: Md. Khalequzzaman, MBBS, PhD       kzaman@icddrb.org   
Sponsors and Collaborators
Centers for Disease Control and Prevention
International Centre for Diarrhoeal Disease Research, Bangladesh
Layout table for additonal information
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT03722004    
Other Study ID Numbers: PR-18045
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centers for Disease Control and Prevention:
monovalent oral poliovirus vaccine type 1
bivalent oral poliovirus vaccine
inactivated poliovirus vaccine
fractional inactivated poliovirus vaccine
humoral immunity
intestinal immunity
Bangladesh
Additional relevant MeSH terms:
Layout table for MeSH terms
Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases