Immunogenicity of Inactivated and Live Polio Vaccines
Phase III Clinical Trial to Assess the Immunogenicity of a Sequential Dose of Fractional Inactivated Polio Vaccine (f-IPV) and Oral Polio Vaccine (OPV)
1 other identifier
interventional
1,206
1 country
1
Brief Summary
This study is an open-label phase III randomized clinical trial that would compare immunogenicity after receiving one of five different combinations of polio vaccines. Infants will be enrolled and randomized at 6 weeks of age to one of five different arms: A) Three doses of trivalent oral poliovirus vaccine (tOPV) at 6, 10 and 14 weeks of age B) Three doses of bivalent OPV (bOPV) at 6, 10 and 14 weeks of age C) Two doses of intramuscular (IM) inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age D) Two doses of intra-dermal (ID) fractional IPV (f-IPV) at 6 and 14 weeks of age E) Sequential administration of ID f-IPV at 6 and 14 weeks of age with bOPV at 10 weeks of age To assess the immunogenicity of each study vaccine and vaccination schedule, antibody titers against poliovirus types 1, 2 and 3 will be determined in sera extracted from blood collected before (at 6 weeks of age) and after receiving 3 doses of study vaccine (18 weeks of age). Seroconversion will be defined as a titer 4-fold higher than the expected fall in maternally derived antibodies, assuming a half-life of 28 days. The initial antibody titer at 6 weeks of age will be used as the starting point for the expected decline in maternal antibody. This study will compare the immunogenicity of:
- 1.Sequential dose of intra-dermal f-IPV and bOPV to bOPV alone administered at 6, 10 and 14 weeks of age
- 2.tOPV to bOPV administered at 6,10 and 14 weeks of age
- 3.IM IPV to ID f-IPV administered at 6 and 14 weeks of age The answer to these questions will guide the global polio eradication program in designing new routine immunization schedule for children that eliminates the risks of paralysis due to vaccine derived poliovirus (VDPV) from type 2 vaccine poliovirus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2012
Shorter than P25 for phase_3
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
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 12, 2013
CompletedFirst Posted
Study publicly available on registry
March 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJanuary 9, 2014
March 1, 2013
1 year
March 12, 2013
January 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroconversion
The primary analytical approach will be intention-to-treat analysis on enrolled participants who have serological results available on blood specimens collected at 18 weeks of age. Reciprocal antibody titers of at least 1:8, the lowest detectable titer, is considered to indicate seropositivity with regards to the presence of poliovirus neutralizing antibodies. Seroconversion is defined as either seronegative participants (\<1:8 titers) who become seropositive (≥1:8) or participants who demonstrate a 4-fold change in titers between two specimens, e.g. a change from 1:8 to 1:32. To compare the immunogenicity across study arms, the investigators will compare the proportion of participants who seroconvert by 18 weeks of age. Chi-square tests will be used to test the statistical significance among seroconversion rates across study arms.
Change in antibody titers at 18 weeks of age compared to 6 weeks of age
Secondary Outcomes (1)
Poliovirus shedding in stool
At 19 weeks of age
Study Arms (5)
Group A: Trivalent Oral Polio Vaccine
ACTIVE COMPARATORGroup A will receive 3 doses of trivalent oral polio vaccine (tOPV) at 6, 10 and 14 weeks of age. A challenge dose of tOPV will be administered at 18 weeks of age.
Group B: Bivalent Oral Polio Vaccine
ACTIVE COMPARATORGroup B will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. A challenge dose of tOPV will be administered at 18 weeks of age.
Group C: Inactivated Polio Vaccine
ACTIVE COMPARATORGroup C will receive 2 doses of inactivated polio vaccine (IPV) at 6 and 14 weeks of age. IPV will be administered intramuscularly using standard needle and syringe. A challenge dose of tOPV will be administered at 18 weeks of age.
Group D: fractional IPV (f-IPV)
ACTIVE COMPARATORGroup D will receive 2 doses of fractional inactivated polio vaccine (f-IPV) at 6 and 14 weeks of age. f-IPV (one-fifth dose of IPV) will be administered intradermally using MicroJet 600 microneedle hub by NanoPass Technologies. A challenge dose of tOPV will be administered at 18 weeks of age.
Arm E: f-IPV and bOPV
ACTIVE COMPARATORGroup E will receive 2 doses of f-IPV at 6 and 14 weeks of age with bOPV at 10 weeks of age. f-IPV will be administered intradermally using MicroJet 600 microneedle hub by NanoPass Technologies. A challenge dose of tOPV will be administered at 18 weeks of age.
Interventions
Group A will receive 3 doses of trivalent oral polio vaccine (tOPV) at 6, 10 and 14 weeks of age. A challenge dose of tOPV will be administered at 18 weeks of age.
Group B will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. A challenge dose of tOPV will be administered at 18 weeks of age.
Group C will receive 2 doses of inactivated polio vaccine (IPV) at 6 and 14 weeks of age. IPV will be administered intramuscularly using standard needle and syringe. A challenge dose of tOPV will be administered at 18 weeks of age.
Group D will receive 2 doses of fractional inactivated polio vaccine (f-IPV) at 6 and 14 weeks of age. f-IPV (one-fifth dose of IPV) will be administered intradermally using MicroJet 600 microneedle hub by NanoPass Technologies. A challenge dose of tOPV will be administered at 18 weeks of age.
Group E will receive 2 doses of f-IPV at 6 and 14 weeks of age with bOPV at 10 weeks of age. f-IPV will be administered intradermally using MicroJet 600 microneedle hub by NanoPass Technologies. A challenge dose of tOPV will be administered at 18 weeks of age.
Eligibility Criteria
You may qualify if:
- Healthy infants 6-7 weeks of age
- Family that consents for participation in the full length of the study
- Family that is able to understand and comply with planned study procedures
You may not qualify if:
- Family that is 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 IPV or collection of blood by venipuncture
- Acute diarrhea, infection or illness at the time of enrollment (6-7 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV per country guidelines
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age)
- 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 contents of polio vaccine
- Infants from multiple births. Infants from multiple are excluded to reduce the potential for contact transmission of vaccine poliovirus. The infant from a multiple birth who is not enrolled is likely to receive routine immunization and transmit vaccine poliovirus to the enrolled infant
- Infants from premature births (\<37 weeks of gestation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mirpur Health Clinic
Dhaka, Bangladesh
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abhijeet Anand, MBBS, MPH
Centers for Disease Control and Prevention
- PRINCIPAL INVESTIGATOR
K. Zaman, MBBS, PhD
International Center for Diarrheal Disease Research, Bangladesh
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2013
First Posted
March 19, 2013
Study Start
November 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
January 9, 2014
Record last verified: 2013-03