search
Back to results

Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority of Intradermal Fractional Inactivated Poliovirus Vaccine

Primary Purpose

Poliomyelitis

Status
Enrolling by invitation
Phase
Phase 4
Locations
Bangladesh
Study Type
Interventional
Intervention
Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS
Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS
Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBP
Fractional (1/5) dose Sabin Inactivated Poliovirus Vaccine produced by BIBP
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis focused on measuring Sabin Inactivated Poliovirus Vaccine, poliovirus vaccines, immunization, antibodies

Eligibility Criteria

42 Days - 48 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy infants 6 weeks of age (range: 42-48 days).
  • Parents that consent for participation in the full length of the study (i.e., 34 weeks).
  • Parents that are able to understand and comply with planned study procedures.

Exclusion Criteria:

  • 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 sIPV or collection of blood by venepuncture.
  • Acute diarrhoea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital.
  • Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age).
  • Evidence of a chronic medical condition identified by a study medical officer during physical exam.
  • Receipt of any polio vaccine (OPV or IPV) before enrollment 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).

Sites / Locations

  • Icddr,B Study Clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

IMBCAMS Sabin IPV full dose at 14 weeks and 9 months

IMBCAMS Sabin IPV fractional dose at 14 weeks and 9 months

BIBP Sabin IPV full dose at 14 weeks and 9 months

BIBP Sabin IPV fractional dose at 14 weeks and 9 months

Arm Description

Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS).

Participants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS).

Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP).

Participants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP).

Outcomes

Primary Outcome Measures

Vaccine response
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 14 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.

Secondary Outcome Measures

Reciprocal antibody titers
Variable of the observed reciprocal antibody titer results.
Priming
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 14 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.

Full Information

First Posted
July 13, 2022
Last Updated
October 5, 2022
Sponsor
Centers for Disease Control and Prevention
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh, World Health Organization, Centers for Disease Control and Prevention, China
search

1. Study Identification

Unique Protocol Identification Number
NCT05460377
Brief Title
Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority of Intradermal Fractional Inactivated Poliovirus Vaccine
Official Title
Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority of Intradermal Fractional Inactivated Poliovirus Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh, World Health Organization, Centers for Disease Control and Prevention, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an open label and off label, phase IV, randomized clinical trial that will compare the immune response among infants that receive either two full doses of Sabin IPV intramuscularly or two fractional (1/5) dose of Sabin IPV intradermally at 14 weeks and 9 months of age from two different manufacturers.
Detailed Description
After OPV cessation, which is expected within a year of polio eradication certification, IPV will be the only polio vaccine used in essential immunization programs. SAGE has recommended a two-dose intramuscular IPV or intradermal fractional IPV (fIPV) schedule after OPV cessation. While it is expected that there shall be sufficient IPV available - in large part because of several manufacturers establishing production of IPV using Sabin strains (sIPV) - it is dependent on these manufacturers being able to meet promised product development and manufacturing timeline and meet WHO prequalification. It is likely that countries that have introduced intradermal fIPV pre-eradication will continue to use intradermal fIPV post-eradication. Therefore, it is important to generate evidence on immunogenicity of intradermal fractional sIPV in addition to intramuscular sIPV for the schedule recommended by SAGE. This clinical trial assesses and compares the immunogenicity of full and fractional (1/5) dose Sabin IPV given at 14 weeks and 9 months of age from two different manufacturers. Healthy infants 6 weeks of age will be enrolled in Dhaka, Bangladesh, and randomized to one of four arms: A. IMBCAMS full dose sIPV at 14 weeks and 9 months B. IMBCAMS fractional dose sIPV at 14 weeks and 9 months C. BIBP full dose sIPV at 14 weeks and 9 months D. BIBP fractional dose sIPV at 14 weeks and 9 months Participants will be followed until 10 months of age through clinic visits. Blood samples will be collected for measuring immune response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
Sabin Inactivated Poliovirus Vaccine, poliovirus vaccines, immunization, antibodies

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMBCAMS Sabin IPV full dose at 14 weeks and 9 months
Arm Type
Active Comparator
Arm Description
Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS).
Arm Title
IMBCAMS Sabin IPV fractional dose at 14 weeks and 9 months
Arm Type
Active Comparator
Arm Description
Participants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS).
Arm Title
BIBP Sabin IPV full dose at 14 weeks and 9 months
Arm Type
Active Comparator
Arm Description
Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP).
Arm Title
BIBP Sabin IPV fractional dose at 14 weeks and 9 months
Arm Type
Active Comparator
Arm Description
Participants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP).
Intervention Type
Biological
Intervention Name(s)
Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS
Intervention Description
The Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intramuscularly by needle and syringe.
Intervention Type
Biological
Intervention Name(s)
Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS
Intervention Description
The Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intradermally by needle and syringe.
Intervention Type
Biological
Intervention Name(s)
Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBP
Intervention Description
The Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intramuscularly by needle and syringe
Intervention Type
Biological
Intervention Name(s)
Fractional (1/5) dose Sabin Inactivated Poliovirus Vaccine produced by BIBP
Intervention Description
The Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intradermally by needle and syringe
Primary Outcome Measure Information:
Title
Vaccine response
Description
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 14 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.
Time Frame
Measured 4 weeks after administration of study vaccine
Secondary Outcome Measure Information:
Title
Reciprocal antibody titers
Description
Variable of the observed reciprocal antibody titer results.
Time Frame
Measured 4 weeks after administration of study Vaccine
Title
Priming
Description
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 14 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.
Time Frame
Measured 7 days after challenge dose (e.g. 9 months + 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
48 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy infants 6 weeks of age (range: 42-48 days). Parents that consent for participation in the full length of the study (i.e., 34 weeks). Parents that are able to understand and comply with planned study procedures. Exclusion Criteria: 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 sIPV or collection of blood by venepuncture. Acute diarrhoea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital. Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age). Evidence of a chronic medical condition identified by a study medical officer during physical exam. Receipt of any polio vaccine (OPV or IPV) before enrollment 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalequ Zaman, PhD
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icddr,B Study Clinics
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority of Intradermal Fractional Inactivated Poliovirus Vaccine

We'll reach out to this number within 24 hrs