None listed
Conditions
Brief summary
STX-100/Alhydrogel, the study drug being researched in this project, is an experimental vaccine being developed by Sentinext Therapeutics. This means that it is not an approved treatment in Australia, and is not yet approved anywhere else in the world. STX-100/Alhydrogel is a vaccine that is intended to prevent hand, foot and mouth disease. The primary objective of this study is to determine the safety and tolerability of STX-100/Alhydrogel vaccine compared to placebo controls when administered to healthy adults.
Interventions
A First-in-Human, Randomised, Double-Blind, Controlled, Dose-Ranging, Phase 1 Study in Healthy Volunteers aged 18 to 39 years.
A total of 20 healthy male and female participants will receive two intramuscular doses of STX-100/Alhydrogel vaccine (dose level 4.6 mcg, and 18.4 mcg) or control (Placebo EV71VLP/Alhydrogel which is Bis-Tris sterile buffer solution, 150 mM NaCl, at pH 6.5 mixed with aluminium hydroxide) at Day 1 and Day 28.
Participants will be recruited in two sequential dosing group
A First-in-Human, Randomised, Double-Blind, Controlled, Dose-Ranging, Phase 1 Study in Healthy Volunteers aged 18 to 39 years. A total of 20 healthy male and female participants will receive two intramuscular doses of STX-100/Alhydrogel vaccine (dose level 4.6 mcg, and 18.4 mcg) or control (Placebo EV71VLP/Alhydrogel which is Bis-Tris sterile buffer solution, 150 mM NaCl, at pH 6.5 mixed with aluminium hydroxide) at Day 1 and Day 28. Participants will be recruited in two sequential dosing groups: Cohort 1: 8 participants will receive 4.6mcg STX-100/Alhydrogel vaccine and 2 participants will receive placebo Cohort 2: 8 participants will receive 18.4mcg STX-100/Alhydrogel vaccine and 2 participants will receive placebo The investigational study vaccine, the STX-100/Alhydrogel vaccine will consist of two fractions: one, the liquid fraction containing the recombinant EV-A71 VLP (labeled “EV71 VLP DP”), and two, the adjuvant, aluminium hydroxide, Al(OH)3 (diluted Alhydrogel). The recombinant EV-A71 VLP will be absorbed to the adjuvant to prepare the finished product for injection. The study control will be a Placebo, comprising of the Placebo product mixed with the adjuvant Aluminium Hydroxide (Placebo EV71 VLP/Alhydrogel). As this is a first-in-human study, 2 sentinel participants (1 placebo and 1 STX-100/Alhydrogel vaccine) in each cohort, will receive the first dose and be monitored for 24hrs. If dosing of the sentinels proceeds with no clinically significant adverse events, the remaining participants will be dosed. Following the first vaccination, all participants will be monitored at the clinic for at least 60-90 minutes, after which they will return to the clinic on day 7 and day 28 to be monitored. At day 28, the 2nd vaccination will be given and participants will be monitored at the clinic for 60-90 minutes. Participants will return to the clinic at day 7 and 28 after the 2nd vaccination (study day 35 and 56) for monitoring. A soft-lock will be placed on the database after the Day 56 visit at which point the data will be unblinded and an interim preliminary report will be written. All participants will attend the clinic at 3 months and 6 months post-vaccination for follow-up visits (open-label).
Sponsors
Clinical Network Services (CNS) Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult volunteers, aged 18–39 years (at the time of Screening). 2. Seronegative (PRNT50 less than1:20) or low level antibodies (PRNT50 less than or equal to 1:40) for neutralising antibodies to EV-A71. 3. In general good health, in the opinion of the Investigator, with no significant medical history or abnormal findings at Screening. Particular attention will be paid to: a) A drug history identifying any known drug allergies and the presence of drug abuse. b) Any chronic use of medication(s); and c) Thorough review of body systems. 4. WOCBP must use highly effective, double barrier contraception for at least one month prior to Visit 1 (first vaccination) and up to Visit 7 (28 days after second vaccination; i.e. during Part A). Double barrier contraception is defined as a condom AND one other form of the following: a) Established hormonal contraception (with approved oral, injected or depot regimen) for at least 2 months prior to Screening. b) Depot or injectable birth control. c) Intrauterine device or intrauterine system in place for at least 2 months prior to Screening. Documented evidence of surgical sterilisation at least 6 months prior to Screening visit. i.e., tubal ligation or hysterectomy for women or vasectomy for men (with appropriate post-vasectomy documentation of the absence of sperm in semen) provided the male partner is a sole partner. 5. Males must not donate sperm for at least 1-month post-dose of the last study treatment. Male partners of female participants and female partners of male participants must also use contraception, if they are of childbearing potential. WOCBP must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1, Day 28. Women not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle stimulating hormone (FSH) level more than 40 mIU/mL if in doubt. 6. Rhythm methods will not be considered as highly effective methods of birth control. Participant abstinence for the duration of the study and 1 month after the last study treatment is acceptable. 7. Adequate venous access in their left or right arms to allow collection of a number of blood samples. 8. No birthmarks, tattoos, wounds or other skin conditions on both forearms which could reasonably obscure injection site reactions. 9. Able to communicate effectively with study personnel and is considered reliable, willing and cooperative in terms of compliance with the protocol requirements. 10. Participant does not intend to start or change an existing physical conditioning regimen prior to or during the treatment period (Part A). 11. Have voluntarily given written informed consent to participate in the study (prior study entry). 12. Participant is available for the duration of the study.
Exclusion criteria
1. Immunodeficiency or autoimmune disorder, or is currently taking drugs or was undergoing a form of treatment within 6 weeks prior to Screening that affects the immune system. (Treatment of asthma with low dose corticosteroids equivalent to prednisone less than 10 mg per day, is permitted). 2. Received blood or blood products in the 3 months’ days prior to Screening. 3. Received another vaccine within 30 days before Screening and/or received any other vaccine during Part A of the study (until Visit 7, 28 days after second vaccination). 4. Participates in another clinical trial (involving an investigational product or device) within 60 days before Screening or during Part A of the study (until Visit 7, 28 days after second vaccination). 5. No donation of blood, blood fractions and plasma within 30 days before the first vaccination until 4 weeks after the second vaccination (Day 56, i.e. Visit 7). 6. Suffered previous anaphylactic reaction to foods, vaccines, drugs or hymenoptera stings, or has a history of severe allergic reactions (e.g. clinically severe urticaria). 7. If female is pregnant, planning to become pregnant, or lactating. 8. Participant is seropositive for neutralising antibodies to EV-A71 (PRNT50 more than 1:40). 9. Participant has a history of, or current evidence at the time of Screening of abuse of alcohol or any drug substance, licit or illicit, or current alcohol consumption is more than 4 standard drinks (or equivalent) per day. 10. History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study. 11. Current or history of significant neurological, cardiovascular, pulmonary, hepatic, rheumatic, autoimmune, haematological, metabolic or renal disorder. 12. Clinically significant abnormal laboratory value at Screening as determined by the Investigator. 13. Unusual dietary habits and excessive or unusual vitamin intake likely, in the opinion of the Investigator, to affect safety pathology parameters. 14. Participant is seropositive to HIV, HCV or HBsAg. 15. Body temperature (oral) more than or equal to 38.0ºC (100.4ºF) or acute illness within 3 days prior to vaccination (participant may be rescheduled to a later cohort). 16. Any skin marking, tattoo or blemish precluding injection site inspection. 17. Any other significant finding that, in the opinion of the Investigator, would increase the risk of the individual having an adverse outcome from participating in this study. 18. Participant is a member of the team or is related or in a dependent relationship with a member of the study team, as defined as the Sponsor or study site personnel.
Outcome results
None listed