A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine

NCT02472548 | Completed Phase 1 DMC

• 1 other identifier: CI1204
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events as a measure of safety and reactogenicity of the intramuscular DPX-RSV(A)

  Up to 28 Days after first injection.

Secondary Outcomes (3)

• Number of participants with adverse events as a measure of safety of a second dose of the DPX-RSV(A)

  180 days after vaccination.

• The immunogenicity of the DPX-RSV(A) as measured by antibodies directed to the SHe antigen

  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

  From Day 28 to Day 180 after second vaccination

Study Arms (5)

Group A, DPX-RSV(A) low dose (Step 1)

EXPERIMENTAL

Biological: DPX-RSV(A)

Group B, RSV(A)-Alum low dose (Step 1)

EXPERIMENTAL

Biological: RSV(A)-Alum

Group D, DPX-RSV(A) high dose (Step 2)

EXPERIMENTAL

Biological: DPX-RSV(A)

Group E, RSV(A)-Alum high dose (Step 2)

EXPERIMENTAL

Biological: RSV(A)-Alum

Group C & F, Placebo control (Step 1 and 2)

PLACEBO COMPARATOR

Other: Placebo

Interventions

DPX-RSV(A) BIOLOGICAL

Prophylactic peptide vaccine targeting RSV will be administered intramuscularly.

Group A, DPX-RSV(A) low dose (Step 1); Group D, DPX-RSV(A) high dose (Step 2)

RSV(A)-Alum BIOLOGICAL

Prophylactic peptide vaccine targeting RSV will be administered intramuscularly.

Group B, RSV(A)-Alum low dose (Step 1); Group E, RSV(A)-Alum high dose (Step 2)

Placebo OTHER

Normal saline (0.9 % sodium chloride) will be administered intramuscularly.

Group C & F, Placebo control (Step 1 and 2)

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dalhousie University: lead
• ImmunoVaccine Technologies, Inc. (IMV Inc.): collaborator

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Study Officials

• Joanne M Langley, MD, MSc, FRCPC

  Dalhousie University, IWK Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 16, 2015
• Study Start: May 1, 2015
• Primary Completion: March 14, 2017
• Study Completion: March 14, 2017
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

CA (1)