A study to determine the safety, tolerability and ability to provoke an immune response of graded doses of the STX-100/Alhydrogel vaccine in healthy volunteers

• Register: ANZCTR
• Last refreshed on: 11 June 2018
• Main ID: ACTRN12617001027303
• Date of registration: 17/07/2017
• Prospective Registration: Yes
• Primary sponsor: Clinical Network Services (CNS) Pty Ltd
• Public title: A study to determine the safety, tolerability and ability to provoke an immune response of graded doses of the STX-100/Alhydrogel vaccine in healthy volunteers
• Scientific title: Randomised, Double-Blind, Controlled Phase I Trial of the Safety, Tolerability and Immunogenicity of Graded Doses of STX-100/Alhydrogel, a Recombinant Enterovirus A 71 (EV-A71) Virus-Like Particle Vaccine in Healthy Adults
• Date of first enrolment: 18/01/2018
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://www.anzctr.org.au/ACTRN12617001027303.aspx
• Study type: Interventional
• Study design: Randomised controlled trial
• Phase: Phase 1

Health Condition(s) or Problem(s) studied

Hand, foot and mouth disease

Intervention(s)

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).