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Phase I Study for SynGEM, an Intranasal Respiratory Syncytial Virus (RSV) Prefusion F Subunit Candidate Vaccine

NCT02958540 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-09-08

No results posted yet for this study

Summary

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.

Conditions

  • Respiratory Syncytial Viral Infections

Interventions

BIOLOGICAL

SynGEM

Prime / boost vaccination in each group

OTHER

placebo

prime /boost vaccination

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Mucosis BV

    lead INDUSTRY

Principal Investigators

  • Chris Chiu, PhD, MD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-07-31
Completion
2017-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02958540 on ClinicalTrials.gov