Cargando…

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-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]

BACKGROUND: New strategies to increase measles and rubella vaccine coverage, particularly in low- and middle-income countries, are needed if elimination goals are to be achieved. With this regard, measles and rubella vaccine microneedle patches (MRV-MNP), in which the vaccine is embedded in dissolvi...

Descripción completa

Detalles Bibliográficos
Autores principales: Adigweme, Ikechukwu, Akpalu, Edem, Yisa, Mohammed, Donkor, Simon, Jarju, Lamin B., Danso, Baba, Mendy, Anthony, Jeffries, David, Njie, Abdoulie, Bruce, Andrew, Royals, Michael, Goodson, James L., Prausnitz, Mark R., McAllister, Devin, Rota, Paul A., Henry, Sebastien, Clarke, Ed
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9472726/
https://www.ncbi.nlm.nih.gov/pubmed/36104719
http://dx.doi.org/10.1186/s13063-022-06493-5
_version_ 1784789356618186752
author Adigweme, Ikechukwu
Akpalu, Edem
Yisa, Mohammed
Donkor, Simon
Jarju, Lamin B.
Danso, Baba
Mendy, Anthony
Jeffries, David
Njie, Abdoulie
Bruce, Andrew
Royals, Michael
Goodson, James L.
Prausnitz, Mark R.
McAllister, Devin
Rota, Paul A.
Henry, Sebastien
Clarke, Ed
author_facet Adigweme, Ikechukwu
Akpalu, Edem
Yisa, Mohammed
Donkor, Simon
Jarju, Lamin B.
Danso, Baba
Mendy, Anthony
Jeffries, David
Njie, Abdoulie
Bruce, Andrew
Royals, Michael
Goodson, James L.
Prausnitz, Mark R.
McAllister, Devin
Rota, Paul A.
Henry, Sebastien
Clarke, Ed
author_sort Adigweme, Ikechukwu
collection PubMed
description BACKGROUND: New strategies to increase measles and rubella vaccine coverage, particularly in low- and middle-income countries, are needed if elimination goals are to be achieved. With this regard, measles and rubella vaccine microneedle patches (MRV-MNP), in which the vaccine is embedded in dissolving microneedles, offer several potential advantages over subcutaneous delivery. These include ease of administration, increased thermostability, an absence of sharps waste, reduced overall costs and pain-free administration. This trial will provide the first clinical trial data on MRV-MNP use and the first clinical vaccine trial of MNP technology in children and infants. METHODS: This is a phase 1/2, randomized, active-controlled, double-blind, double-dummy, age de-escalation trial. Based on the defined eligibility criteria for the trial, including screening laboratory investigations, 45 adults [18–40 years] followed by 120 toddlers [15–18 months] and 120 infants [9–10 months] will be enrolled in series. To allow double-blinding, participants will receive either the MRV-MNP and a placebo (0.9% sodium chloride) subcutaneous (SC) injection or a placebo MNP and the MRV by SC injection (MRV-SC). Local and systemic adverse event data will be collected for 14 days following study product administration. Safety laboratories will be repeated on day 7 and, in the adult cohort alone, on day 14. Unsolicited adverse events including serious adverse events will be collected until the final study visit for each participant on day 180. Measles and rubella serum neutralizing antibodies will be measured at baseline, on day 42 and on day 180. Cohort progression will be dependent on review of the unblinded safety data by an independent data monitoring committee. DISCUSSION: This trial will provide the first clinical data on the use of a MNP to deliver the MRV and the first data on the use of MNPs in a paediatric population. It will guide future product development decisions for what may be a key technology for future measles and rubella elimination. TRIAL REGISTRATION: Pan-African Clinical Trials Registry 202008836432905. ClinicalTrials.govNCT04394689
format Online
Article
Text
id pubmed-9472726
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-94727262022-09-15 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-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial] Adigweme, Ikechukwu Akpalu, Edem Yisa, Mohammed Donkor, Simon Jarju, Lamin B. Danso, Baba Mendy, Anthony Jeffries, David Njie, Abdoulie Bruce, Andrew Royals, Michael Goodson, James L. Prausnitz, Mark R. McAllister, Devin Rota, Paul A. Henry, Sebastien Clarke, Ed Trials Study Protocol BACKGROUND: New strategies to increase measles and rubella vaccine coverage, particularly in low- and middle-income countries, are needed if elimination goals are to be achieved. With this regard, measles and rubella vaccine microneedle patches (MRV-MNP), in which the vaccine is embedded in dissolving microneedles, offer several potential advantages over subcutaneous delivery. These include ease of administration, increased thermostability, an absence of sharps waste, reduced overall costs and pain-free administration. This trial will provide the first clinical trial data on MRV-MNP use and the first clinical vaccine trial of MNP technology in children and infants. METHODS: This is a phase 1/2, randomized, active-controlled, double-blind, double-dummy, age de-escalation trial. Based on the defined eligibility criteria for the trial, including screening laboratory investigations, 45 adults [18–40 years] followed by 120 toddlers [15–18 months] and 120 infants [9–10 months] will be enrolled in series. To allow double-blinding, participants will receive either the MRV-MNP and a placebo (0.9% sodium chloride) subcutaneous (SC) injection or a placebo MNP and the MRV by SC injection (MRV-SC). Local and systemic adverse event data will be collected for 14 days following study product administration. Safety laboratories will be repeated on day 7 and, in the adult cohort alone, on day 14. Unsolicited adverse events including serious adverse events will be collected until the final study visit for each participant on day 180. Measles and rubella serum neutralizing antibodies will be measured at baseline, on day 42 and on day 180. Cohort progression will be dependent on review of the unblinded safety data by an independent data monitoring committee. DISCUSSION: This trial will provide the first clinical data on the use of a MNP to deliver the MRV and the first data on the use of MNPs in a paediatric population. It will guide future product development decisions for what may be a key technology for future measles and rubella elimination. TRIAL REGISTRATION: Pan-African Clinical Trials Registry 202008836432905. ClinicalTrials.govNCT04394689 BioMed Central 2022-09-14 /pmc/articles/PMC9472726/ /pubmed/36104719 http://dx.doi.org/10.1186/s13063-022-06493-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Adigweme, Ikechukwu
Akpalu, Edem
Yisa, Mohammed
Donkor, Simon
Jarju, Lamin B.
Danso, Baba
Mendy, Anthony
Jeffries, David
Njie, Abdoulie
Bruce, Andrew
Royals, Michael
Goodson, James L.
Prausnitz, Mark R.
McAllister, Devin
Rota, Paul A.
Henry, Sebastien
Clarke, Ed
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-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]
title 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-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]
title_full 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-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]
title_fullStr 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-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]
title_full_unstemmed 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-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]
title_short 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-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]
title_sort 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-naïve infants (9 to 10 months) in the gambia [measles and rubella vaccine microneedle patch phase 1/2 age de-escalation trial]
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9472726/
https://www.ncbi.nlm.nih.gov/pubmed/36104719
http://dx.doi.org/10.1186/s13063-022-06493-5
work_keys_str_mv AT adigwemeikechukwu studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT akpaluedem studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT yisamohammed studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT donkorsimon studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT jarjulaminb studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT dansobaba studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT mendyanthony studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT jeffriesdavid studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT njieabdoulie studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT bruceandrew studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT royalsmichael studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT goodsonjamesl studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT prausnitzmarkr studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT mcallisterdevin studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT rotapaula studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT henrysebastien studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine
AT clarkeed studyprotocolforaphase12singlecentredoubleblinddoubledummyrandomizedactivecontrolledagedeescalationtrialtoassessthesafetytolerabilityandimmunogenicityofameaslesandrubellavaccinedeliveredbyamicroneedlepatchinhealthyadults18to40yearsmeaslesandrubellavaccine