PMID- 38006057
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231129
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 11
IP  - 11
DP  - 2023 Nov 17
TI  - Safety, Tolerability, and Immunogenicity of Measles and Rubella Vaccine Delivered 
      with a High-Density Microarray Patch: Results from a Randomized, Partially 
      Double-Blinded, Placebo-Controlled Phase I Clinical Trial.
LID - 10.3390/vaccines11111725 [doi]
LID - 1725
AB  - Microarray patches (MAPs) have the potential to be a safer, more acceptable, 
      easier-to-use, and more cost-effective means for the administration of vaccines 
      than injection by needle and syringe. Here, we report findings from a randomized, 
      partially double-blinded, placebo-controlled Phase I trial using the Vaxxas 
      high-density MAP (HD-MAP) to deliver a measles rubella (MR) vaccine. Healthy 
      adults (N = 63, age 18-50 years) were randomly assigned 1:1:1:1 to four groups: 
      uncoated (placebo) HD-MAPs, low-dose MR HD-MAPs (~3100 median cell-culture 
      infectious dose [CCID(50)] measles, ~4300 CCID(50) rubella); high-dose MR-HD-MAPs 
      (~9300 CCID(50) measles, ~12,900 CCID(50) rubella); or a sub-cutaneous (SC) 
      injection of an approved MR vaccine, MR-Vac (>/=1000 CCID(50) per virus). The MR 
      vaccines were stable and remained viable on HD-MAPs when stored at 2-8  degrees C for at 
      least 24 months. When MR HD-MAPs stored at 2-8  degrees C for 24 months were transferred 
      to 40  degrees C for 3 days in a controlled temperature excursion, loss of potency was 
      minimal, and MR HD-MAPs still met World Health Organisation (WHO) specifications. 
      MR HD-MAP vaccination was safe and well-tolerated; any systemic or local adverse 
      events (AEs) were mild or moderate. Similar levels of binding and neutralizing 
      antibodies to measles and rubella were induced by low-dose and high-dose MR 
      HD-MAPs and MR-Vac. The neutralizing antibody seroconversion rates on day 28 
      after vaccination for the low-dose HD-MAP, high-dose HD-MAP and MR-Vac groups 
      were 37.5%, 18.8% and 35.7%, respectively, for measles, and 37.5%, 25.0% and 
      35.7%, respectively, for rubella. Most participants were seropositive for measles 
      and rubella antibodies at baseline, which appeared to negatively impact the 
      number of participants that seroconverted to vaccines delivered by either route. 
      The data reported here suggest HD-MAPs could be a valuable means for delivering 
      MR-vaccine to hard-to-reach populations and support further development. Clinical 
      trial registry number: ACTRN12621000820808.
FAU - Baker, Ben
AU  - Baker B
AUID- ORCID: 0000-0003-1561-3013
AD  - Vaxxas Pty Ltd., Hamilton, QLD 4007, Australia.
FAU - Bermingham, Imogen M
AU  - Bermingham IM
AD  - Vaxxas Pty Ltd., Hamilton, QLD 4007, Australia.
FAU - Leelasena, Indika
AU  - Leelasena I
AD  - University of the Sunshine Coast Clinical Trials Centre, Sippy Downs, QLD 4556, 
      Australia.
FAU - Hickling, Julian
AU  - Hickling J
AUID- ORCID: 0000-0001-6178-1953
AD  - Working in Tandem Ltd., Cambridge CB1 7AB, UK.
FAU - Young, Paul R
AU  - Young PR
AUID- ORCID: 0000-0002-2040-5190
AD  - School of Chemistry and Molecular Biosciences, University of Queensland, St. 
      Lucia, QLD 4072, Australia.
FAU - Muller, David A
AU  - Muller DA
AUID- ORCID: 0000-0003-4375-7890
AD  - School of Chemistry and Molecular Biosciences, University of Queensland, St. 
      Lucia, QLD 4072, Australia.
FAU - Forster, Angus H
AU  - Forster AH
AD  - Vaxxas Pty Ltd., Hamilton, QLD 4007, Australia.
LA  - eng
GR  - INV-003551/GATES/Bill & Melinda Gates Foundation/United States
PT  - Journal Article
DEP - 20231117
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC10675090
OTO - NOTNLM
OT  - Phase I
OT  - clinical trial
OT  - high-density microarray patch (HD-MAP)
OT  - measles (M)
OT  - microarray patch (MAP)
OT  - rubella (R)
OT  - thermostability
OT  - vaccine
COIS- Angus H. Forster, Ben Baker, and Imogen M. Bermingham are paid employees of 
      Vaxxas Pty Ltd. David A. Muller received consulting fees from Vaxxas. Julian 
      Hickling received consulting fees from Vaxxas. Indika Leelasena is an employee of 
      the University of the Sunshine Coast, which carried out the study on a 
      contractual basis. The funders (the Bill & Melinda Gates Foundation) provided 
      thoughts and feedback when asked by Vaxxas, but had no role in the collection, 
      analyses, and interpretation of data or in the writing of the manuscript.
EDAT- 2023/11/25 12:44
MHDA- 2023/11/25 12:45
PMCR- 2023/11/17
CRDT- 2023/11/25 01:31
PHST- 2023/07/28 00:00 [received]
PHST- 2023/08/18 00:00 [revised]
PHST- 2023/08/24 00:00 [accepted]
PHST- 2023/11/25 12:45 [medline]
PHST- 2023/11/25 12:44 [pubmed]
PHST- 2023/11/25 01:31 [entrez]
PHST- 2023/11/17 00:00 [pmc-release]
AID - vaccines11111725 [pii]
AID - vaccines-11-01725 [pii]
AID - 10.3390/vaccines11111725 [doi]
PST - epublish
SO  - Vaccines (Basel). 2023 Nov 17;11(11):1725. doi: 10.3390/vaccines11111725.