A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02472548 |
Recruitment Status :
Completed
First Posted : June 16, 2015
Last Update Posted : February 5, 2020
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Tracking Information | ||||
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First Submitted Date ICMJE | June 5, 2015 | |||
First Posted Date ICMJE | June 16, 2015 | |||
Last Update Posted Date | February 5, 2020 | |||
Study Start Date ICMJE | May 2015 | |||
Actual Primary Completion Date | March 14, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of participants with adverse events as a measure of safety and reactogenicity of the intramuscular DPX-RSV(A) [ Time Frame: Up to 28 Days after first injection. ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine | |||
Official Title ICMJE | A Phase I Randomized, Observer-blind, Controlled, Dose Escalation Trial of the Safety and Tolerability of Two Intramuscular Doses of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine Containing Respiratory Syncytial Virus (RSV) SHe Antigen and a Novel Adjuvant DepoVaxTM, or SHe A Antigen Co-administered With Aluminum Hydroxide, or Placebo to Healthy Adults ≥50-64 Years of Age | |||
Brief Summary | Administration of DPX-RSV(A), a Respiratory Syncytial Virus vaccine containing Respiratory Syncytial Virus (RSV) SHe antigen and DepoVaxTM adjuvant to healthy adults ≥50-64 years of age. | |||
Detailed Description | This is a phase 1, First in Humans, randomized (2:2:1) observer blind, controlled, dose ranging, multi-arm parallel-group clinical trial in healthy persons 50 to 64 years of age to assess the safety and immunogenicity of two dose levels of a novel vaccine formulation DPX-RSV(A) consisting of a synthetic Respiratory Syncytial Virus SHe antigen combined with a novel adjuvant DepoVaxTM, compared to the antigen combined with the commonly used adjuvant Aluminum hydroxide, and to a saline placebo control. The study will evaluate two different doses of DPX-RSV(A) and two doses of the RSV SHe antigen with aluminum hydroxide (RSV(A)-Alum), and a placebo control. The study is randomized, controlled, and observer-blinded in order that allocation to treatment is concealed from the investigative team and the participant. The inclusion of comparator groups (a placebo control group and the RSV(A)-Alum) allows for estimation of the attributable risk of adverse events. Since the study vaccines are not identical in appearance, an unblinded study nurse who has no other role in the study will administer the study vaccines. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Respiratory Syncytial Virus | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
40 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 14, 2017 | |||
Actual Primary Completion Date | March 14, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 64 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02472548 | |||
Other Study ID Numbers ICMJE | CI1204 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Joanne Langley, Dalhousie University | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Dalhousie University | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | ImmunoVaccine Technologies, Inc. (IMV Inc.) | |||
Investigators ICMJE |
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PRS Account | Dalhousie University | |||
Verification Date | January 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |