None listed
Conditions
Brief summary
This study is designed to test the hypothesis that HD-MAP application to the skin using a small number of healthy adult subjects with a well characterised measles rubella (MR) vaccine results in comparable safety / local skin reaction to conventional subcutaneous vaccination. This study represents the first time that HD-MAPs with an active measles rubella vaccine will be applied to humans. Therefore, this study will assess both systemic and the local reaction to application of the MR HD-MAPs delivering a low and high doses measles and rubella vaccine virus, in comparison to uncoated MAPs, and SC administration of the standard adult human dose of MR vaccine (Serum Institute of India). The local skin response will be monitored for up to 56 days. On-site clinic assessments will be performed up to 2 hours post application and at day 3, 7, 28 and 56 days post application. Phone calls will be made at Day 1 and Day 14
Interventions
HD-MAP administration
HD-MAPs are approximately 1cm2. They are applied to the upper arm, over the deltoid muscle, preferably of the non-dominant arm of the participant. Following application, the HD-MAP is held in place for 60 seconds. Each HD-MAP is single use, disposable. Each participant will receive three HD-MAPs, once only in the following groups:
Group 1: 15 subjects receive (a) 1 active MR HD-MAP on the upper arm delivering ~2,000 CCID50 each of measles and rubella vaccine viruses AND (b
HD-MAP administration HD-MAPs are approximately 1cm2. They are applied to the upper arm, over the deltoid muscle, preferably of the non-dominant arm of the participant. Following application, the HD-MAP is held in place for 60 seconds. Each HD-MAP is single use, disposable. Each participant will receive three HD-MAPs, once only in the following groups: Group 1: 15 subjects receive (a) 1 active MR HD-MAP on the upper arm delivering ~2,000 CCID50 each of measles and rubella vaccine viruses AND (b) 2 placebo (uncoated) HD-MAPs. Group 2: 15 subjects receive 3 active HD-MAPs on the upper arm, delivering a total of ~6,000 CCID50 each of measles and of rubella vaccine virus (as in group 1 each having ~2,000 CCID50 each virus per HD-MAP). Group 3: 15 subjects receive three placebo uncoated HD-MAPs on the upper arm.
Sponsors
Vaxxas Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the following criteria to be eligible for participation in this study: 1. Aged 18–50 years (inclusive); 2. With a body mass index (BMI) within the range 18.0–32.0 kg/m²; 3. Satisfactory medical assessment: no clinically significant or relevant abnormalities in medical history, physical examination, vital signs (blood pressure, oral temperature, heart rate, respiratory rate) and laboratory evaluation (haematology or biochemistry); 4. Adequate venous access in their left or right arms to allow collection of a number of small volume blood samples at different time points; 5. Risk of pregnancy: Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the duration of the study or be using one of the following acceptable birth control methods: a. Surgically sterile (hysterectomy and/or bilateral oophorectomy); b. Surgically sterile (bilateral tubal ligation with surgery at least six months prior to study initiation); c. Intrauterine device (IUD) in place for at least three months; d. Stable hormonal contraceptive for at least three months prior to study through completion of study; e. Surgical sterilization (vasectomy) for female participant’s partner(s) at least six months prior to study; f. Condom for male participant; g. Menopausal women can be included, and are defined as being at least 12 months since their last menstrual period; h. Females in same sex relationship can be included. 6. Subject is able to communicate effectively with study personnel and is considered likely to be reliable, willing and cooperative in terms of compliance with the protocol requirements; 7. Subject is able and willing to provide written, personally signed, informed consent to participate in the study.
Exclusion criteria
Subjects meeting any of the following criteria will not be eligible for participation in this study: 1. Subject with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions (such as eczema) on upper arm regions (on both arms) that could be expected to obscure the observation of application-site reactions 2. Subject with known chronic spontaneous urticaria / dermographism; 3. Known anaphylactic hypersensitivity or allergy to a previous measles and/or rubella vaccination or to any of the vaccine components; 4. Recent vaccination (within 30 days prior to enrolment) with any vaccine or a plan to be vaccinated during the study period; 5. Vaccination with a measles- or rubella-containing vaccine in the past 5 years; 6. Receipt of blood, blood products, or immunoglobulins during the preceding three months; 7. Known predisposition to keloid-scar formation; 8. History of granulomatous diseases (especially sarcoidosis and granuloma annulare); 9. History of convulsions, epilepsy, other central nervous system diseases; 10. History of clinically significant hematological, gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease; 11. An acute febrile illness at the time of enrolment; 12. A clinically significant history of cancer; 13. An active medical condition that is considered clinically significant and is under evaluation or treatment; 14. A recent illness that is considered clinically significant; 15. A chronic illness that is considered clinically significant such as an autoimmune disease; 16. A history of major surgery that is considered clinically significant, for example within the past year; 17. History of illness and/or infection with hepatitis B, or hepatitis C or HIV, or, during screening, a positive test for Hepatitis B surface antigen, Hepatitis C or antibodies against HIV. 18. History of abnormal bleeding, and/or thrombophlebitis unrelated to venepuncture or intravenous cannulation; 19. Receiving chronic treatment with immune-suppressive therapy other than asthma inhalers and topical corticosteroids. All such medications will be documented and reviewed for acceptance by the investigator or other medically qualified nominee; 20. History of any psychiatric illness or psychological disorder that might impair the ability to provide written informed consent or participate in the study; 21. Subject has donated blood or plasma or has had clinically significant blood loss within 60 days before the first screening visit; 22. Subject is pregnant or breast-feeding; 23. A history of alcohol or drug abuse in the past 12 months, or current declared alcohol consumption is >4 standard drinks (equivalent to 7 units) per day; 24. Use of any prescription medication (except for contraceptives and Hormone Replacement Therapy (HRT)) within seven days of enrolment, unless approved by the principal investigator. All medications will be documented and reviewed for acceptance by the investigator or other medically qualified nominee 25. Use of any investigational drug or device within 30 days, or 5 half-lives of the drug (whichever is longer), before the Day 0 of the study.
Outcome results
None listed