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| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
| Centers for Disease Control and Prevention | FED |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRV-SC | Active Comparator | A standard, single dose of Measles Rubella vaccine delivered subcutaneously with a needle and syringe |
|
| MRV-MNP | Experimental | A single dose of Measles Rubella vaccine delivered intradermally with a microneedle patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measles Rubella Vaccine (MRV-SC) | Biological | One dose as subcutaneous injection of a WHO prequalified MR vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent solicited adverse events as assessed by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1 Jul 2017) | 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. | 14 days |
| Incidence of pan-study unsolicited adverse events, as assessed by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. | 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. | 180 days |
| Incidence of treatment-emergent biochemical and hematological abnormalities as assessed by regional laboratory normal values for a given test | 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. | up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 42 and 180 post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ed Clarke, MD | Medical Research Center, The Gambia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Center The Gambia at LSHTM | Fajara | The Gambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36104719 | Derived | Adigweme I, Akpalu E, Yisa M, Donkor S, Jarju LB, Danso B, Mendy A, Jeffries D, Njie A, Bruce A, Royals M, Goodson JL, Prausnitz MR, McAllister D, Rota PA, Henry S, Clarke E. Study protocol for a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-naive infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]. Trials. 2022 Sep 14;23(1):775. doi: 10.1186/s13063-022-06493-5. |
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| ID | Term |
|---|---|
| D008457 | Measles |
| D012409 | Rubella |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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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].
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Participant, care provider, and investigator blinding will occur through use of a double-dummy design; subjects randomized to the MRV-MNP group will also receive a placebo (PLA) saline injection, and subjects randomized to the MRV-SC group will also receive a PLA-MNP.
| MRV-MNP | Biological | One standard dose of Measles and Rubella vaccine delivered intradermally as a dissolving microneedle patch |
|
| PLA-MNP | Other | One placebo dose of a dissolving microneedle patch |
|
| PLA-SC | Other | Placebo saline as subcutaneous injection |
|
| 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. | Days 42 and 180 post vaccination |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |