Immunogenicity of Inactivated and Live Polio Vaccines

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.

Conditions

• Poliomyelitis

Interventions

BIOLOGICAL

Group A: Trivalent Oral Polio Vaccine

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.

BIOLOGICAL

Group B: Bivalent Oral Polio Vaccine

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.

BIOLOGICAL

Group C: Inactivated Polio Vaccine

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.

BIOLOGICAL

Group D: fractional IPV (f-IPV)

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.

BIOLOGICAL

Arm E: f-IPV and bOPV

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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  lead FED

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Ministry of Health and Family Welfare, Bangladesh

  collaborator UNKNOWN

• NanoPass Technologies Ltd

  collaborator INDUSTRY

Principal Investigators

• Abhijeet Anand, MBBS, MPH · Centers for Disease Control and Prevention

• K. Zaman, MBBS, PhD · International Center for Diarrheal Disease Research, Bangladesh

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Max Age

7 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-11-30

Primary Completion

2013-11-30

Completion

2013-11-30

Countries

• Bangladesh

Study Locations