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MeaslesPhase 1/2NCT04394689

Measles and Rubella Vaccine Microneedle Patch Phase 1-2 Age De-escalation Trial

A Phase 1/2 study testing Measles Rubella Vaccine (MRV-SC), MRV-MNP and PLA-MNP in people with Measles and Rubella, run by Micron Biomedical, Inc at 1 site in The Gambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 9 months to 40 yearsHealthy volunteers can take part
Conditions the study is for
Measles, Rubella, Vaccination
What is being tested?
Measles Rubella Vaccine (MRV-SC), MRV-MNP and PLA-MNP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
281 participants
Where
1 siteThe Gambia
Study dates
19 May 2021to 31 Dec 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 months to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).
  • Have a history of keloid formation.
  • Have significant scars, tattoos, rashes or other dermatologic condition in the area of the vaccination site which will interfere with the application of the MNP and assessment of local solicited AE.
  • Have human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection based on screening laboratory investigations.
  • Have any medical or social condition that in the opinion of the study clinician may interfere with the study objectives, pose a risk to the participant, or prevent the participant from completing the study follow-up.
  • Be an employee of, or direct descendant (child or grandchild) of any person employed by the investigator or sponsor.
  • Have plans to travel outside the study area for an extended duration during the period of study participation.
  • Have any screening laboratory test with a toxicity score of ≥ 2 or with a toxicity score of 1 which is nonetheless judged to be clinically significant by the trial clinician.
  • Have any vital sign (heart rate, respiratory rate, non-invasive blood pressure [adult cohort only]) with a toxicity score of > 1.
  • Have an axillary temperature of > 37.5°C and have had a documented fever at the same level in the 72 hours preceding randomization and vaccination.
  • Have a history of an illness with a fever and rash suggestive of measles in the preceding two months.
  • Have any acute illness (severity grade > 2).
  • Have a positive rapid diagnostic test (RDT) (or blood film) for malaria.
  • Adult cohort only: Have been vaccinated against measles or rubella in the preceding four years.
  • Adult cohort only: Have a BMI of < 18.5kg/m2 (underweight) or > 35kg/m2 (severely obese).
  • Adults cohort only: Have a recent history (within the past year) or signs of alcohol or substance abuse.
  • Adult cohort only: Have a history of major psychiatric disorder.
  • Adult cohort only: Have a history of blood donation within three months of study enrollment or plans to donate blood during participation in the study.
  • Adult female cohort only: Be pregnant or breast-feeding.
  • Toddler and infant cohort only: Have been vertically exposed to HIV based on maternal history.
  • Toddler and infant cohorts only: Have a weight for height z-score below -2SD (moderate malnutrition).
  • Infant cohort only: Have been vaccinated against measles or rubella.

Trial locations and contacts

1 site in 1 country.

The Gambia1 site

  • Medical Research Center The Gambia at LSHTM

    Fajara

Other trials in The Gambia

About this study

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

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).

Being tested
Measles Rubella Vaccine (MRV-SC), MRV-MNP, PLA-MNP, PLA-SC
Keywords
Rubella vaccine safety, Measles vaccine safety, Microneedle patch
Medical subject headings
Measles, Rubella

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Measles Rubella Vaccine (MRV-SC)Biological

    One dose as subcutaneous injection of a WHO prequalified MR vaccine

  • MRV-MNPBiological

    One standard dose of Measles and Rubella vaccine delivered intradermally as a dissolving microneedle patch

  • PLA-MNPOther

    One placebo dose of a dissolving microneedle patch

  • PLA-SCOther

    Placebo saline as subcutaneous injection

Study groups in NCT04394689
Study groupRoleWhat they receive
MRV-SCActive comparatorA standard, single dose of Measles Rubella vaccine delivered subcutaneously with a needle and syringe
Receives: Biological: Measles Rubella Vaccine (MRV-SC); Other: PLA-MNP
MRV-MNPExperimentalA single dose of Measles Rubella vaccine delivered intradermally with a microneedle patch
Receives: Biological: MRV-MNP; Other: PLA-SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 14 days

  2. 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.

    Measured: 180 days

  3. 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.

    Measured: up to 14 days

Secondary outcomes (2)

  1. 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.

    Measured: Days 42 and 180 post vaccination

  2. 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.

    Measured: Days 42 and 180 post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start19 May 2021
  3. Primary completion23 Nov 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04394689
Sponsor's protocol ID
SCC22420
Status last verified
Mar 2023
First submitted
6 May 2020
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36104719

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Measles Rubella Vaccine (MRV-SC), MRV-MNP and PLA-MNP in people with Measles and Rubella, run by Micron Biomedical, Inc at 1 site in The Gambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04394689, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.

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