Measles and Rubella Vaccine Microneedle Patch Phase 1-2 Age De-escalation Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04394689|
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : October 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Measles Rubella Vaccination Healthy||Biological: Measles Rubella Vaccine (MRV-SC) Biological: MRV-MNP Other: PLA-MNP Other: PLA-SC||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|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)|
|Masking Description:||Participant, care provider, and investigator blinding will occur through use of a double-dummy design; subjects randomized to the MNP group will also receive a placebo (PLA) saline injection, and subjects randomized to the MRV-SC group will also receive a PLA-MNP.|
|Official Title:||A Phase I/II, Double-blind, Randomized, Active-controlled, Age De-escalation Trial to Assess Safety and Immunogenicity of a Measles Rubella Vaccine (MRV) Microneedle Patch (MRV-MNP) in Adults, MRV-primed Toddlers, and MRV-naïve Infants|
|Actual Study Start Date :||May 19, 2021|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||June 2022|
Active Comparator: MRV-SC
A standard, single dose of Measles Rubella vaccine delivered subcutaneously with a needle and syringe
Biological: Measles Rubella Vaccine (MRV-SC)
One dose as subcutaneous injection of a WHO prequalified MR vaccine
One placebo dose of a dissolving microneedle patch
A single dose of Measles Rubella vaccine delivered intradermally with a microneedle patch
One standard dose of Measles and Rubella vaccine delivered intradermally as a dissolving microneedle patch
Placebo saline as subcutaneous injection
- Incidence of treatment-emergent solicited adverse events as assessed by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. [ Time Frame: 14 days ]The number, severity and relatedness of solicited local and systemic adverse events collected on the day of study product administration and daily until day 14 following study product administration.
- Incidence of pan-study unsolicited adverse events, as assessed by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. [ Time Frame: 180 days ]The number, severity and relatedness of unsolicited adverse events and serious adverse events from the day of study product administration until day 180 following study product administration.
- Incidence of treatment-emergent biochemical and hematological abnormalities as assessed by regional laboratory normal values for a given test [ Time Frame: up to 14 days ]The number, severity and relatedness of biochemical and hematological abnormalities occurring until day 14 (Adult cohort only), or day 7 (toddler and infant cohorts) following study product administration.
- Percentage of measles seroprotected participants [ Time Frame: Days 42 and 180 post vaccination ]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 ≥ 120mIU/mL.
- Percentage of rubella seroprotected participants [ Time Frame: Days 42 and 180 post vaccination ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394689
|Contact: Ed Clarke, MD||220 4495442 ext firstname.lastname@example.org|
|Contact: Sebastien Henry, MS, MBA||770 email@example.com|
|Medical Research Center The Gambia at LSHTM||Recruiting|
|Contact: Ed Clarke, MD|
|Principal Investigator:||Ed Clarke, MD||Medical Research Center, The Gambia|