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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
Sponsor:
Collaborator:
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Information provided by (Responsible Party):
Joanne Langley, Dalhousie University

Tracking Information
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
 (submitted: June 15, 2015)
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
 (submitted: June 15, 2015)
  • Number of participants with adverse events as a measure of safety of a second dose of the DPX-RSV(A) [ Time Frame: 180 days after vaccination. ]
  • The immunogenicity of the DPX-RSV(A) as measured by antibodies directed to the SHe antigen [ Time Frame: 28 days after one dose of vaccine and 28 days after a the second dose of a two-dose vaccine schedule as measured by antibodies directed to the SHe antigen. ]
  • Persistence of the humoral immune response to two doses of the RSV investigational vaccines, as measured by anti-SHe antibodies [ Time Frame: From Day 28 to Day 180 after second vaccination ]
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.

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
Condition  ICMJE Respiratory Syncytial Virus
Intervention  ICMJE
  • Biological: DPX-RSV(A)
    Prophylactic peptide vaccine targeting RSV will be administered intramuscularly.
  • Biological: RSV(A)-Alum
    Prophylactic peptide vaccine targeting RSV will be administered intramuscularly.
  • Other: Placebo
    Normal saline (0.9 % sodium chloride) will be administered intramuscularly.
Study Arms  ICMJE
  • Experimental: Group A, DPX-RSV(A) low dose (Step 1)
    Intervention: Biological: DPX-RSV(A)
  • Experimental: Group B, RSV(A)-Alum low dose (Step 1)
    Intervention: Biological: RSV(A)-Alum
  • Experimental: Group D, DPX-RSV(A) high dose (Step 2)
    Intervention: Biological: DPX-RSV(A)
  • Experimental: Group E, RSV(A)-Alum high dose (Step 2)
    Intervention: Biological: RSV(A)-Alum
  • Placebo Comparator: Group C & F, Placebo control (Step 1 and 2)
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2015)
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:

  • Age 50-64 years, inclusive.
  • Good general health status, as determined by history and physical examination no greater than 30 days prior to administration of the test article.
  • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of Diary Cards, return for follow-up visits).
  • Written informed consent obtained from the participant.
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 180 days after injection. (Please refer to the glossary for the definition of child-bearing potential and adequate contraception).

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study product within 28 days preceding the dose of study product, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
  • Planned administration/ administration of a vaccine/product not foreseen by the study protocol within the period starting 28 days before injection of a study vaccine and ending 84 days after.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study product or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. (Laboratory testing for HIV, Hepatitis C and Hepatitis B will be performed during the screening visit).
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drug within 6 months prior to the product dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent). Inhaled and topical steroids are allowed.
  • Family history of congenital or hereditary immunodeficiency.
  • History of or current autoimmune disease.
  • History of hypersensitivity to any test article constituent or products used during the course of study procedures.
  • Known or suspected hypersensitivity to any ingredient in the formulation or component of the container.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within 180 days of study vaccine receipt.
  • Any hematological (hemoglobin level, white blood cell [WBC], and platelet count) and biochemical (alanine aminotransferase [ALT], aspartate aminotransferase [AST], blood urea nitrogen [BUN] and creatinine) abnormality as per local laboratory normal values considered clinically significant by the investigator.
  • Transient mild laboratory abnormalities may be rescreened and the participant will be deemed eligible if the laboratory repeat test is normal as per local laboratory normal values and investigator assessment.
  • Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.
  • Malignancies within previous 5 years (excluding non-melanic skin cancer) and lymphoproliferative disorders.
  • Current alcoholism and/or drug abuse.
  • Acute disease and/or fever at the time of Screening ≥ 38°C

    1. Fever is defined as temperature ≥ 38° /100.4°F by any route; the preferred route for recording temperature in this study will be oral.
    2. Participants with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
    3. Participants with acute disease and/ or fever at the time of Screening may be re-screened at a later date.
  • Planned move to a location that will prohibit participating in the trial until study end.
  • Any other condition that the investigator judges may interfere with study procedures (e.g. drawing blood) or findings (e.g. immune response).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Responsible Party Joanne Langley, Dalhousie University
Study Sponsor  ICMJE Dalhousie University
Collaborators  ICMJE ImmunoVaccine Technologies, Inc. (IMV Inc.)
Investigators  ICMJE
Principal Investigator: Joanne M Langley, MD, MSc, FRCPC Dalhousie University, IWK Health Centre
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