Measles and Rubella Vaccine Microneedle Patch Phase 1-2 Age De-escalation Trial
Condition: Measles; Rubella; Vaccination; Healthy
MeSH terms: Measles; Rubella
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase 1/2, single-centre, double-blind, double-dummy, randomized,
      active-controlled, age de-escalation trial. Age de-escalation will be based on a review of
      the safety data from the preceding cohort (adults for toddlers and toddlers for infants) up
      to day 14 post study product administration by a data monitoring committee (DMC). All
      participants will receive either the MRV-MNP and a placebo (0.9% sodium chloride) SC
      injection (PLA-SC) or a placebo-MNP (PLA-MNP) and MRV by the SC route (MRV-SC). Only those
      study staff randomizing participants and preparing the study products for administration will
      be aware of the products administered. Those administering the study products, all other
      trial staff and the participants and parents will be blinded to treatment group. 45 adults
      (18 to 40-years-of-age) will be randomized in a 2:1 ratio. Thus, 30 adults will receive
      MRV-MNP and PLA-SC while 15 adults will receive MRV-SC and PLA-MNP. 120 toddlers (15 to 18
      months-of-age) will be randomized in a 1:1 ratio. Thus, 60 toddlers will receive MRV-MNP and
      PLA-SC while the same number of toddlers will receive MRV-SC and PLA-MNP. 120 infants (9 to
      10 months) will also be randomized in a 1:1 ratio. Thus, 60 infants will receive MRV-MNP and
      PLA-SC while the same number of infants will receive MRV-SC and PLA-MNP. Solicited local and
      systemic AE will be collected daily from all participants from the day of study product
      administration to day 13 post study product administration. Unsolicited AE and SAE will be
      collected from the day of study product administration to day 180 post study product
      administration. All participants will have laboratory investigations (hepatitis B, hepatitis
      C, hematology and biochemistry) conducted as part of screening. Adults will have safety
      laboratory investigations repeated on day seven and day 14 post study product administration.
      Toddlers and infants will have safety laboratory investigations repeated on day seven post
      study product administration. All participants will have measles- and rubella-specific SNA
      titers and measles- and rubella-specific IgG concentrations measured at baseline and day 42
      and 180 post study product administration. Other Expanded Program on Immunization (EPI)
      vaccines due in toddler (oral poliovirus vaccine, diphtheria-tetanus-pertussis) and in
      infants (oral poliovirus vaccine, yellow fever vaccine and MenAfriVac® [due at 12 months])
      will be given by the investigator team at the day 42 study visit (V4).
    


Intervention name(s): Measles Rubella Vaccine (MRV-SC); MRV-MNP; PLA-MNP; PLA-SC
Intervention type(s): Biological; Biological; Other; Other
Intervention description(s): One dose as subcutaneous injection of a WHO prequalified MR vaccine; One standard dose of Measles and Rubella vaccine delivered intradermally as a dissolving microneedle patch; One placebo dose of a dissolving microneedle patch; Placebo saline as subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to one of two arms: Active Comparator (subcutaneous measles rubella vaccine [MRV] via needle and syringe [SC]), or MRV as a microneedle patch [MNP].
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Rubella vaccine safety; Measles vaccine safety; Microneedle patch