IPV Clinical Trial - The Gambia
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall goal of this study is to identify interference between intramuscular Inactivated
      Polio Vaccine (IPV) and other vaccines (Measles Rubella and Yellow Fever) co-administered at
      nine months of age and to confirm the safety of co-administration. In addition, the study
      will compare the immunogenicity and safety of IPV when administered via different routes.

      A total of 1504 healthy infants between the ages of nine to ten months, who have completed
      their primary immunizations, including at least three doses of trivalent Oral Polio Vaccine
      (tOPV) will be recruited for this study.
    

Detailed description: 
      In studies conducted to date, Inactivated Polio Vaccine (IPV) appears to boost the systemic
      immunity generated by Oral Polio Vaccine (OPV) priming significantly more effectively than
      the use of additional doses of OPV. The use of IPV to both enhance the immunity generated by
      OPV and also to provide protection against circulating Vaccine Derived Polio Virus type 2
      outbreaks and Vaccine Associated Paralytic Poliomyelitis has the potential to address
      concerns regarding a switch to bivalent OPV.

      Concomitant administration with Expanded Program of Immunisations(EPI) vaccines given at
      about nine months would be a feasible programmatic approach. Maternal antibodies will have
      largely waned by this point negating any inhibitory effect which they may have within the
      priming schedule. Significant interference between IPV, Measles and Rubella (MR) and Yellow
      Fever (YF) vaccines must be excluded to ensure that IPV introduction does not negatively
      impact on the immunogenicity or safety of the other vaccines in the program at the same
      point.

      Restricted manufacturing capacity in the context of a higher manufacturing cost than OPV
      would currently limit the rate at which IPV could be rolled out within a modified EPI
      schedule. The administration of a fractional dose of the vaccine by the Intradermal route
      would facilitate vaccine role out through limiting the cost and the manufacturing scale-up
      required. The proposed study is phase 4, eight-arm, open label, randomized controlled
      clinical vaccine trial. A total of 1504 randomized healthy infants between nine and ten
      months will receive IPV, MR and YF vaccines either alone, in combinations of two vaccines, or
      all three vaccines will be given together. Different routes (IM and fractional dose ID) and
      needle free jet injections devices for administration of IPV will be compared in the
      different groups. The participants will be assigned to one of eight groups using blocked
      randomization scheme in a 1:1:1:1:1:1:1:1:1 ratio.

      Non- inferiority of serological responses and median antibody titers will be the primary
      immunogenicity end points. The incidence of serious adverse events and other important
      medical events at any point during the study will be the primary safety end point in all
      groups. Following device of reference needle/syringe administration, any local adverse event
      (reactogenicity), which will be collected on day 0(day of vaccination), day 1, day 2 and day
      3 will be a second primary safety endpoint.
    

Intervention name(s): IPV IM Needle; IPV ID Needle; IPV IM Device; IPV ID Device
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Inactivated Poliovirus Vaccine Intramuscular using syringe and needle pair; Inactivated Poliovirus Vaccine Intradermal using syringe and needle pair; Intramuscular Inactivated Poliovirus Vaccine using intramuscular Jet injector device; Intradermal Inactivated Poliovirus Vaccine using intradermal device
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Inactivated Poliovirus Vaccine; Randomised Control Phase IV Study; Gambia; IPV; Safety and Immunogenicity; Non-interference study; IM Jet injector; ID Jet Injector