The goal of this study is to provide information on immunogenicity at short and medium term for hexavalent with different schedules, which will be useful for the global polio program and countries, including Bangladesh.
Primary objectives are
1. To compare the proportion of participants who seroconvert to all poliovirus serotypes four weeks after a primary immunization series. 2. To compare the proportion of participants seropositive against all poliovirus serotypes at 18 months of age.
This is an open-label randomized clinical trial. Participants will be enrolled and randomized at 6 weeks of age to one of three arms. Target enrolment is 330 infants per arm and 200 controls; 990 in the main study and \~ 800 in the sub-study.
A total of 4-5 blood samples will be collected from each infant before and after the primary vaccination series, and at 18 months of age, to assess systemic immune response to different antigens.
Outcome measures/variables:
Neutralizing antibody titers in serum will be quantified for poliovirus types 1, 2, and 3 using a microneutralization test; for diphtheria toxoid, tetanus toxoid, and pertussis toxin using a Multiplex bead assay; and for antibodies to hepatitis B surface antigen (anti-HBs) using serologic assay. The presence of poliovirus types 1 and 3 in oropharyngeal swabs and stools following the bOPV challenge will be tested using a real-time reverse transcription PCR (rRT-PCR) assay.
Healthy infants 6 weeks of age (range: 42-48 days).
Parents that consent for participation in the full length of the study.
Parents that can understand and comply with planned study procedures.
Parents and infants are unable to participate in the full length of the study (e.g., plan to move away from the study area during the study period).
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 administration of IPV, wP Penta or wP-Hexa, or collection of blood by venepuncture.
Acute diarrhoea, infection, or illness at the time of first study vaccination that would require infant's admission to a hospital.
Sequential
Pentavalent vaccine
Biological/VaccineWhole-cell pertussis pentavalent vaccine (wP-Penta): Each 0.5 ml dose contains diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen, Haemophilus influenzae type b conjugate
Hexavalent vaccine
Biological/VaccineWhole-cell pertussis hexavalent vaccine (wP-Hexa): Each 0.5 ml dose contains diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen, Haemophilus influenzae type b conjugate, and inactivated polioviruses to all three poliovirus types: type 1 , 2 and 3
Inactivated poliovirus vaccine (IPV)
Biological/Vaccineone dose of IPV (0.5 mL) contains inactivated polioviruses to all three poliovirus types: type 1, 2 and 3
Bivalent oral polio vaccine (bOPV)
Biological/VaccineContain two poliovirus types: type 1 and 3
Fractional IPV( fIPV)
Biological/VaccineThe dose of fIPV is 0.1 mL or 1/5th of a full dose
Proportion of participants with seroconversion to all poliovirus serotypes four weeks after a primary immunization series with two doses of IPV or three doses of wP-Hexa
Seroconversion will be defined as seronegative participants (\<1:8 titers) becoming seropositive (≥1:8) or seropositive participants with ≥ 4-fold increase in titers between pre vaccination and four weeks after the third vaccine dose (adjusted for the expected decline of maternal antibodies). For assessing immunity to polio, seropositivity is defined as reciprocal polio neutralizing antibody titers of at least 1:8. Baseline maternally-related antibody titers will be determined in the pre-vaccination sample and estimated maternal antibody level after the vaccination series will be calculated assuming an exponential decline with a half-life of 28 days
Proportion of participants seropositive to all polio types at 18 months of age (9-14 months after the last dose of IPV for each schedule).
Seroconversion will be defined as seronegative participants (\<1:8 titers) becoming seropositive (≥1:8) or seropositive participants with ≥ 4-fold increase in titers between pre vaccination and four weeks after the third vaccine dose (adjusted for the expected decline of maternal antibodies). For assessing immunity to polio, seropositivity is defined as reciprocal polio neutralizing antibody titers of at least 1:8. Baseline maternally-related antibody titers will be determined in the pre-vaccination sample and estimated maternal antibody level after the vaccination series will be calculated assuming an exponential decline with a half-life of 28 days
Proportion of participants with seroprotection/vaccine response for non-polio antigens (Pertussis, Hepatitis B, Diphtheria, Tetanus) contained in wP-Hexa or wP-Penta four weeks after the last dose of wP-Hexa or wP-Penta
Thresholds for seroprotection for other antigens will be: ≥0.1 IU for anti-diphtheria toxoid and anti-tetanus toxoid, ≥4-fold increase from baseline for pertussis toxin (and filamentous hemoglobin) and ≥ 10 mIU/mL for anti-HBs.
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