Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008836432905 Date of Approval: 07/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Measles and Rubella Vaccine Microneedle Patch Phase 1-2 Age De-escalation Trial
Official scientific 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
Brief summary describing the background and objectives of the trial 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 administrat
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Measles and Rubella
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 16/11/2020
Actual trial start date 18/05/2021
Anticipated date of last follow up 23/11/2022
Actual Last follow-up date 31/12/2022
Anticipated target sample size (number of participants) 285
Actual target sample size (number of participants) 282
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group MR Vaccine Single dose of MR vaccine dose one dose per subject, final subject visit @ d 180 subcutaneous measles rubella vaccine via needle and syringe 135 Active-Treatment of Control Group
Experimental Group MRMAP Single dose of MR vaccine 1 dose/subject, final subject visit d 180 measles rubella vaccine delivered topically as a degradable microarray patch (MAP) 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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). Adult: 19 Year-44 Year,Infant: 0 Month-23 Month 9 Month(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/07/2020 The Gambia Government MRC Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 273, Banjul, The Gambia, West Africa Banjul 000000 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of treatment-emergent solicited adverse events as assessed by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Daily until 14 days
Primary Outcome Incidence of pan-study unsolicited adverse events, as assessed by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. From day of study product administration until day 180 following study product administration
Primary Outcome Incidence of treatment-emergent biochemical and hematological abnormalities as assessed by regional laboratory normal values for a given test Until day 14, adult cohort. Until day 7, toddler and infant cohorts
Secondary Outcome 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 Days 42 and 180 post vaccination
Secondary Outcome 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
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Center The Gambia Atlantic Boulevard Serrekunda Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 440 5th Ave. N. Seattle 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Micron Biomedical Inc 575 Fourteenth Street, NW Atlanta GA 30318 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ed Clarke ed.clarke@lshtm.ac.uk +2204495442 MRC, Atlantic Blvd
City Postal code Country Position/Affiliation
Banjul Gambia Staff
Role Name Email Phone Street address
Public Enquiries Sebastien Henry shenry@micronbiomedical.com +17707220306 575 Fourteenth Street, NW
City Postal code Country Position/Affiliation
Atlanta GA United States of America Director
Role Name Email Phone Street address
Scientific Enquiries Michael Royals pjglobal4@gmail.com +1970213035 1051 Obenchain Rd
City Postal code Country Position/Affiliation
Laporte 80535 United States of America Advisor and Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results will be made available Study Protocol Within 12 months of study completion Will be posted in the PACTR database
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information