Measles and Rubella Vaccine Microneedle Patch Phase 1-2 Age De-escalation Trial
- Conditions
- Measles and Rubella
- Registration Number
- PACTR202008836432905
- Lead Sponsor
- Micron Biomedical Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 285
Adults: Be between 18 and 40 years inclusive on the day of consent.
Toddlers: Be between 15 and 18 months of age inclusive on the day of consent.
Infants: Be between 9 and 10 months of age inclusive on the day of consent.Be judged to be able to comprehend and comply with study requirement and procedures and must be willing and able to return for all scheduled follow-up visits (adult cohort).
Have a parent who is judged to be able to comprehend and comply with study requirement and procedures and is willing and able to return for all scheduled follow-up visits (toddler and infant cohort).
Be willing to avoid consumption (ingestion and topical application) of herbal or other local traditional medications throughout the course of the study.
Have a readily identifiable place of residence within a reasonable travelling distance of the clinical trial site.
Have a consistent means of telephone contact for the duration of trial participation
Have a site on one wrist that is judged to be suitable for MNP administration.
Adult female cohort only: have a negative serum pregnancy test at screening (V0) and negative urine pregnancy test on the day of vaccination (V1).
Adult female cohort only: employ an effective method of birth control for two months preceding and throughout the study
Toddler cohort only: have been parenterally vaccinated against measles and rubella at between nine and 12 months of age.
Have used any investigational product within the 90 days prior to study product administration or plan to use any investigational products during the period of study participation.
Have consumed (by ingestion or topical application) any herbal or other traditional medication within 14 days of study product administration
Have a history of serious reactions to any prior vaccination or known hypersensitivity to any component of the MRV-MNP, MRV-SC or PLA-MNP including polyethylene foam with acrylic adhesive, silicone-coated Kraft paper, stainless steel, and severe allergic reactions to cow's milk.
Have a history of anaphylactic shock or other life-threatening allergic reactions
Have any chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or haematological abnormality or illness that requires medical therapy.
Have a history of administration of any non-study vaccines within the 56 days before the administration of study products or planned vaccination during study participation, except for non-measles and rubella catch-up/national campaign administered through the Gambian Ministry of Health.
Have a history of chronic administration (defined as more than 14 consecutive days) of immunosuppressant (> 0.5mg/kg/day of prednisolone or equivalent) or other immune modifying drugs within the 12 months prior to the administration of the study vaccine including the use of glucocorticoids. The use of inhaled/per nasal glucocorticoids will be permitted. The use of topical glucocorticoids within 12 months is not permitted.
Have a history of the administration of immunoglobulins and/or any blood products within the 12 months prior to administration of the study vaccine or anticipation of such administration during the study period.
Have a history of known disturbance of coagulation or blood disorder that could cause anaemia or excess bleeding (e.g. sickle cell disorders, thalassemia, and coagulation factor deficiencies).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent solicited adverse events as assessed by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.;Incidence of pan-study unsolicited adverse events, as assessed by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.;Incidence of treatment-emergent biochemical and hematological abnormalities as assessed by regional laboratory normal values for a given test<br>
- Secondary Outcome Measures
Name Time Method Percentage of measles seroprotected participants. Measles serum neutralization antibody (SNA) titers by plaque reduction neutralization test (PRNT). Measles serum IgG binding antibody concentrations by a bead-based multiplex assay. Measles seropositivity will be defined as a standardized titer of = 200mIU/mL, using WHO/NIBSC-III reference standard;Percentage of rubella seroprotected participants. Rubella SNA titers by indirect immunocolorimetric assay (ICA). Rubella serum IgG binding antibody concentrations by a bead-based multiplex assay. Rubella seropositivity will be defined as a standardized titer of = 10IU/mL.