Respiratory Syncytial Viral Infections Clinical Trial
Official title:
Randomized, Doubleblind, Placebo-controlled Trial in Healthy Adults of Safety and Immunogenicity of 2 Intranasal Doses of SynGEM®, an RSV Candidate Vaccine Containing F Glycoprotein Linked to a Bacterium-like-Particle (BLP) Carrier
The study is a double-blind (within dose level), placebo-controlled Phase I study to assess
the safety, reactogenicity and tolerability of two intranasal dose levels of SynGEM®: a low
dose level (140 μg F-protein/2mg BLPs) and a high dose level ( 350 μg F-protein/5mg BLPs),
each administered twice according to a prime-boost schedule 28 days apart at Day 1 and Day
29. The two dose levels will be recruited sequentially.
Immunogenicity end-points will include assessment of humoral and cellular responses at
selected time-points.
A total of 48 healthy adult volunteers aged 18 to 49 years will be recruited. The first 24
subjects will be randomized 3:1 to SynGEM® low dose level (140 μg F-protein/2mg BLPs) or
placebo administered at Day 1 and Day 29 (Group 1). After completion of recruitment of Group
1, if no pausing rule is met until 7 days post prime in all Group 1 subjects, 24 additional
subjects will be randomized 3:1 to SynGEM® high dose level (350 μg F-protein/2mg BLPs) or
placebo administered at Day 1 and Day 29 (Group 2).
Recruitment will be guided by pre-specified pausing rules. Recruitment of Group 1 will be
staggered as follows: a sentinel cohort of 2 subjects (1 subject receiving SynGEM® and 1
subject receiving placebo) will be recruited on study Day 1; subjects will be followed up to
Visit 2 (3 days post-dosing) and if no pausing rule is met, a second cohort of 2 subjects (1
subject receiving SynGEM® and 1 subject receiving placebo) will be vaccinated; subjects will
be followed up to Visit 2 (3 days post-dosing) and if no pausing rule is met, recruitment
will be extended to the remaining 20 subjects (16 on SynGEM®/4 on placebo) of Group 1.
Escalation to the high dose level will be implemented only after collection of safety data of
all subjects in Group 1 for at least 7 days post-prime if no pausing rule is met. Group 2
will also be comprised of a total of 24 subjects and recruitment will be staggered and
subjected to the same pausing rules as in Group 1.
Each subject will return to the site for study visits 3, 7 and 28 days post-prime
vaccination; 28 days after prime vaccination the boost vaccination will be administered and
subjects will return 3, 7, 28 days after boost vaccination. A primary analysis will be
carrying out on data collected up to this timepoints. Subjects will be followed up for safety
and immunogenicity thereafter up to 180 days post-prime.
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