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Respiratory Syncytial VirusPhase 1NCT02472548

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

A Phase 1 study testing DPX-RSV(A) and RSV(A)-Alum in people with Respiratory Syncytial Virus, run by Dalhousie University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus
What is being tested?
DPX-RSV(A) and RSV(A)-Alum
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteCanada
Study dates
May 2015to 14 Mar 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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
  • Fever is defined as temperature ≥ 38° /100.4°F by any route; the preferred route for recording temperature in this study will be oral.
  • Participants with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
  • 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).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

Other trials in Canada

About this study

Official title: 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

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.

Read the 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.

Being tested
DPX-RSV(A), RSV(A)-Alum, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DPX-RSV(A)Biological

    Prophylactic peptide vaccine targeting RSV will be administered intramuscularly.

  • RSV(A)-AlumBiological

    Prophylactic peptide vaccine targeting RSV will be administered intramuscularly.

  • PlaceboOther

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

Study groups in NCT02472548
Study groupRoleWhat they receive
Group A, DPX-RSV(A) low dose (Step 1)ExperimentalNot described
Receives: Biological: DPX-RSV(A)
Group B, RSV(A)-Alum low dose (Step 1)ExperimentalNot described
Receives: Biological: RSV(A)-Alum
Group D, DPX-RSV(A) high dose (Step 2)ExperimentalNot described
Receives: Biological: DPX-RSV(A)
Group E, RSV(A)-Alum high dose (Step 2)ExperimentalNot described
Receives: Biological: RSV(A)-Alum
Group C & F, Placebo control (Step 1 and 2)Placebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 28 Days after first injection.

Secondary outcomes (3)

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

    Measured: 180 days after vaccination.

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

    Measured: 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.

  3. Persistence of the humoral immune response to two doses of the RSV investigational vaccines, as measured by anti-SHe antibodies

    Measured: From Day 28 to Day 180 after second vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2015 (estimated)
  2. Study startMay 2015
  3. Primary completion14 Mar 2017
  4. Study completion14 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02472548
Sponsor's protocol ID
CI1204
Status last verified
Jan 2020
First submitted
5 Jun 2015
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DPX-RSV(A) and RSV(A)-Alum in people with Respiratory Syncytial Virus, run by Dalhousie University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02472548.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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