Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label phase IV randomized clinical trial that will assess intestinal and
      humoral immunity among infants who receive a combination of monovalent oral poliovirus
      vaccine type 1 and fractional dose of inactivated poliovirus vaccine, monovalent oral
      poliovirus vaccine type 1 only, and bivalent oral poliovirus vaccine only.
    

Detailed description: 
      The risk for circulating vaccine-derived poliovirus (cVDPV) will increase in the years
      immediately after the cessation of oral poliovirus vaccine (OPV) use in routine immunization
      programs. Judicious use of type-specific monovalent OPV (mOPV) will be necessary for outbreak
      response to prevent further paralytic infections and transmission; however, data on the
      intestinal and humoral immunity induced by mOPV1 are very limited. Furthermore, the
      additional benefit of fractional dose inactivated poliovirus vaccine (fIPV) on type 1
      immunity when given with mOPV1 is unclear. Data on intestinal and humoral immunity of mOPV
      type 1 (mOPV1) and combination use of mOPV1 and fractional dose of IPV (fIPV) are urgently
      needed and would be used to inform guidelines for type 1 outbreak response in a post-OPV
      world. In the immediate future, a strategy of shifting from bivalent OPV (bOPV) to mOPV1 as
      part of supplemental immunization activities in endemic countries is under consideration but
      data on intestinal and humoral immunity to support this change does not exist. This trial is
      designed to address both areas in which data are lacking.

      Healthy infants 5 weeks of age will be enrolled at two study clinics in Dhaka, Bangladesh,
      and randomized to one of four study arms: mOPV1 + fIPV at 6 weeks, mOPV1 + fIPV at 14 weeks,
      mOPV1 only, and bOPV only. Infants will be followed-up until 18 weeks of age by clinic and
      household visits. Blood and stool specimens will be collected to test for vaccine response
      (humoral immunity) and vaccine virus shedding (intestinal immunity).
    

Intervention name(s): mOPV1; bOPV; fIPV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.; Bivalent oral poliovirus vaccine is a live, attenuated oral poliovirus vaccine that protects against poliovirus types 1 and 3.; Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal injection in lieu of the full 0.5mL dose that is given intramuscularly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: monovalent oral poliovirus vaccine type 1; bivalent oral poliovirus vaccine; inactivated poliovirus vaccine; fractional inactivated poliovirus vaccine; humoral immunity; intestinal immunity; Bangladesh