Phase I Study for SynGEM, an Intranasal Respiratory Syncytial Virus (RSV) Prefusion F Subunit Candidate Vaccine (SynGEM)
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|ClinicalTrials.gov Identifier: NCT02958540|
Recruitment Status : Unknown
Verified September 2017 by Mucosis BV.
Recruitment status was: Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : September 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Syncytial Viral Infections||Biological: SynGEM Other: placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: SynGEM low dose
Group 1: 18 subjects receiving SynGEM low dose
Prime / boost vaccination in each group
Experimental: SynGEM high dose
Group 2: 18 subjects receiving SynGEM high dose
Prime / boost vaccination in each group
Placebo Comparator: placebo
12 subjects receiving placebo
prime /boost vaccination
- Safety and tolerability assessed through diaries for local and systemic tolerability and with follow up for occurrence of any adverse event [ Time Frame: 7 days post each dose / 57 days post prime ]subjects' diary
- Immunogenicity responses [ Time Frame: up to 180 day ]At baseline (day 1), Day 8, 29, 36, 57, 120, 180
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958540
|Imperial Centre for Translational and Experimental Medicine Hammersmith Hospital|
|London, United Kingdom|
|Principal Investigator:||Chris Chiu, PhD, MD||Imperial College London|