Safety and Immunogenicity of 1 or 2 Doses of IPV in Latin American Infants Primed With Bivalent OPV Vaccine

Fidec

Status and phase: Completed; Phase 4

Conditions: Poliomyelitis

Treatments: Biological: Glaxo SmithKline IPV (GSK IPV); Biological: Trivalent Oral Polio Vaccine (tOPV); Biological: Sanofi-Pasteur IPV (Sanofi IPV); Biological: Serum Institute of India IPV (SII IPV); Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2); Biological: Bivalent Oral Polio Vaccine (bOPV)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01831050

12-1460

Details and patient eligibility

About

This study is a Phase IV, open, randomized, multi-center, controlled vaccine trial conducted in healthy Latin American infants, utilizing one or two supplemental doses of IPV in children previously vaccinated with 3 doses of bOPV. We will examine the impact of supplemental IPV on stool shedding and humoral immunity, as well as intra-IPV manufacturer comparability, and safety.

Full description

The world polio eradication effort is near its goal of reducing the number of new cases of polio to zero. However, final and definitive eradication of the disease will require stopping the use of oral polio vaccines (OPV's) which contain live virus and can rarely revert back to disease producing strains. This period will result in a risk of polio re-emergence as immunity will wane while some vaccine poliovirus will still be circulating. Inactivated polio vaccine (IPV) could potentially play a central role during this process but at present barriers of cost and logistics prevent its routine use in resource limited countries, and concerns exist as to whether IPV provides enough immunity in the intestine to reduce the spread of polioviruses in communities once OPV's are stopped. We plan a multi-center trial in Latin America in which we will administer 1 or 2 doses of IPV to children previously vaccinated with an OPV containing type 1 and 3 poliovirus (bOPV), and then assess the shedding in the stool of a type 2 OPV virus administered later. A decrease in the amount of virus shed compared to children not given IPV would indicate that the IPV boosted intestinal immunity, and would suggest that spread of virus in communities could be reduced using this strategy. We will also measure the impact of supplemental IPV's on antibody formation in the blood, which is a marker of protection of the individual from polio disease. A secondary aim will be to compare the immunogenicity and safety of three IPV's produced by different manufacturers. The overall goal will be to inform policy makers in polio eradication regarding the potential role that one or two doses of IPV might play in the final steps toward polio eradication.

Enrollment: 1,420 estimated patients

Sex: All

Ages: 5+ weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age: 6 weeks (-7 to +14 days).
2. Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
3. Written informed consent obtained from 1 or 2 parents or legal guardian as per country regulations

Exclusion criteria

1. Previous vaccination against poliovirus.
2. Low birth weight (BW <2,500 gm).
3. Multiple pregnancy (twins, triplets, etc.),
4. Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection.
5. Family history of congenital or hereditary immunodeficiency.
6. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
7. Known allergy to any component of the study vaccines.
8. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
9. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
10. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination.
11. Member of the subject's household (living in the same house or apartment unit) who has received OPV vaccine in the last 3 months.
12. Subject who, in the opinion of the Investigator or sub-Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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1,420 participants in 9 patient groups

G1: Sanofi bOPV Control

Experimental group

Description:

210 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks

Treatment:

Biological: Bivalent Oral Polio Vaccine (bOPV)

Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2)

G2: Sanofi bOPV Control

Experimental group

Description:

210 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 40 weeks

Treatment:

Biological: Bivalent Oral Polio Vaccine (bOPV)

Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2)

G3: Trivalent OPV Control

Experimental group

Description:

100 infants receiving Trivalent Oral Polio Vaccine (tOPV)' at 6, 10 and 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks

Treatment:

Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2)

Biological: Trivalent Oral Polio Vaccine (tOPV)

G4: Sanofi bOPV, Sanofi IPV

Experimental group

Description:

210 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 1 dose of Sanofi-Pasteur IPV (Sanofi IPV) at 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks

Treatment:

Biological: Bivalent Oral Polio Vaccine (bOPV)

Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2)

Biological: Sanofi-Pasteur IPV (Sanofi IPV)

G5: Sanofi bOPV, Sanofi 2 IPV

Experimental group

Description:

210 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 2 dose of Sanofi-Pasteur IPV (Sanofi IPV) at 14 and 36 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 40 weeks

Treatment:

Biological: Bivalent Oral Polio Vaccine (bOPV)

Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2)

Biological: Sanofi-Pasteur IPV (Sanofi IPV)

G6: Sanofi bOPV, GSK IPV

Experimental group

Description:

50 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 1 dose of Glaxo SmithKline IPV (GSK IPV) at 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks

Treatment:

Biological: Bivalent Oral Polio Vaccine (bOPV)

Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2)

Biological: Glaxo SmithKline IPV (GSK IPV)

G7: Sanofi bOPV, GSK 2 IPV

Experimental group

Description:

190 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 2 doses of Glaxo SmithKline IPV (GSK IPV) at 14 and 36 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 40 weeks

Treatment:

Biological: Bivalent Oral Polio Vaccine (bOPV)

Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2)

Biological: Glaxo SmithKline IPV (GSK IPV)

G8: Sanofi bOPV, SII IPV

Experimental group

Description:

50 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 1 dose of Serum Institute of India IPV (SII IPV) at 14 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 18 weeks

Treatment:

Biological: Serum Institute of India IPV (SII IPV)

Biological: Bivalent Oral Polio Vaccine (bOPV)

Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2)

G9: Sanofi bOPV, SII 2 IPV

Experimental group

Description:

190 infants receiving Bivalent Oral Polio Vaccine (bOPV) at 6, 10 and 14 weeks and 2 doses of Serum Institute of India IPV (SII IPV) at 14 and 36 weeks with Monovalent Oral Polio Vaccine Type 2 (mOPV2) challenge at 40 weeks

Treatment:

Biological: Serum Institute of India IPV (SII IPV)

Biological: Bivalent Oral Polio Vaccine (bOPV)

Biological: Monovalent Oral Polio Vaccine Type 2 (mOPV2)