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Respiratory Synctial VirusPhase 1NCT02296463

A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age

A Phase 1 study testing RSV F Vaccine with adjuvant (0.5mL injection), RSV F Vaccine (0.5mL injection) and Hepatitis A Vaccine (0.5mL injection) in people with Respiratory Synctial Virus, run by Novavax at 4 sites 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

This is a randomized, observer-blind, irrelevant comparator-controlled trial in male and female subjects ≥24 months of age and <72 months of age. Subjects will be without symptomatic chronic cardiopulmonary disease, including recurrent wheezing. Read more about this study

Who is it for?
Ages 24 to 72 monthsHealthy volunteers can take part
Conditions the study is for
Respiratory Synctial Virus
What is being tested?
RSV F Vaccine with adjuvant (0.5mL injection), RSV F Vaccine (0.5mL injection) and Hepatitis A Vaccine (0.5mL injection)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
4 sitesCanada
Study dates
Nov 2014to Apr 2016
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 24 to 72 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy males and females, ≥24 months of age and <72 months of age, without known chronic cardiopulmonary disease including especially persistent or frequently recurrent wheezing.
  • Free of other illnesses that are believed to increase the risks associated with influenza or other respiratory viral infections, including: diabetes mellitus, congenital or acquired blood dyscrasias, renal or hepatic dysfunction, and morbid obesity.
  • Parent(s)/guardian(s) willing and able to give informed consent prior to study enrollment, and assert ability to comply with study requirements.
  • Parent(s)/guardian(s) and/or other designated child care provider must have continuous capacity for telephone communication with the study site.

Who cannot join

  • Serum MN titers against RSV/A or RSV/B <1:16 (4 log2).
  • Toxicity grade ≥2 for any safety laboratory parameter.
  • Participation in research involving an investigational product (drug/biologic/device) within 45 days before planned date of first vaccination and planned participation at any time during the study.
  • History of a serious reaction to any prior vaccination, including Guillain-Barré Syndrome within six weeks following a previous influenza vaccination.
  • Receipt of any vaccine (other than the influenza vaccine specified in the protocol) in the four weeks preceding the first study vaccination and/or planned receipt of a licensed vaccine (other than the hepatitis A vaccine specified in the protocol) at any time prior to Study Day 56.
  • Receipt of an RSV vaccine at any time.
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  • Any known or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination.
  • Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥1 mg/kg of prednisone per day or equivalent. The use of topical glucocorticoids for minor cutaneous symptoms will be permitted, but the use of nasal or inhaled glucocorticoids in exclusionary (because of potential related diagnoses rather than immunosuppression).
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
  • Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever or an oral temperature >38.0°C on the planned day of vaccine administration).
  • Known disturbance of coagulation.
  • Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including social, neurologic, or psychiatric conditions in the subject or parent(s)/guardian(s) deemed likely to impair the quality of safety reporting).

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Aggarwal and Associates

    Brampton, Ontario, L6T 0G1

  • University of Calgary, Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

  • Medicore Research, Inc

    Greater Sudbury, Ontario, P3E 1H5

  • Dalhousie University, IWK Health Centre- Canadian Center for Vaccinology

    Halifax, Nova Scotia, B3K 6R8

Other trials in Canada

About this study

Official title: A Phase I Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant Fusion (F) Nanoparticle Vaccine, With or Without Aluminum Adjuvant, in Healthy Subjects 24 to <72 Months of Age

This is a randomized, observer-blind, irrelevant comparator-controlled trial in male and female subjects ≥24 months of age and <72 months of age. Subjects will be without symptomatic chronic cardiopulmonary disease, including recurrent wheezing. Subjects will be screened for seropositivity to RSV in a qualified serum microneutralization (MN) assay and will be excluded if titers for either RSV/A or RSV/B are <1:16 (4 log2).

Treatments will comprise an IM dose of saline placebo or RSV F vaccine on Day 0 and an IM dose of RSV F vaccine or a licensed hepatitis A vaccine on Day 28. Hepatitis A vaccine (and in one group placebo) will be used to maintain the study blind; all subjects will receive a complete course of hepatitis A vaccine as a study benefit.

Being tested
RSV F Vaccine with adjuvant (0.5mL injection), RSV F Vaccine (0.5mL injection), Hepatitis A Vaccine (0.5mL injection), Placebo (0.5mL injection)

What participants receive

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

  • RSV F Vaccine with adjuvant (0.5mL injection)Biological

  • RSV F Vaccine (0.5mL injection)Biological

  • Hepatitis A Vaccine (0.5mL injection)Biological

  • Placebo (0.5mL injection)Biological

Study groups in NCT02296463
Study groupRoleWhat they receive
Treatment Group AExperimentalDay 0: RSV F Vaccine with adjuvant, Day 28: RSV F Vaccine with adjuvant
Receives: Biological: RSV F Vaccine with adjuvant (0.5mL injection)
Treatment Group BExperimentalDay 0: RSV F Vaccine with adjuvant, Day 28: Hepatitis A Vaccine
Receives: Biological: RSV F Vaccine with adjuvant (0.5mL injection); Biological: Hepatitis A Vaccine (0.5mL injection)
Treatment Group CExperimentalDay 0: RSV F Vaccine, Day 28: RSV F Vaccine
Receives: Biological: RSV F Vaccine (0.5mL injection)
Treatment Group DExperimentalDay 0: RSV F Vaccine, Day 28: Hepatitis A Vaccine
Receives: Biological: RSV F Vaccine (0.5mL injection); Biological: Hepatitis A Vaccine (0.5mL injection)
Treatment Group EPlacebo comparatorDay 0: Placebo, Day 28: Hepatitis A Vaccine
Receives: Biological: Hepatitis A Vaccine (0.5mL injection); Biological: Placebo (0.5mL injection)

What is being measured

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

  1. Numbers and percentages of subjects with solicited local and systemic AEs.

    Solicited local and systemic AEs over the 7 days post injection; and all AES, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 56 days post- first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.

    Measured: Up to Day 392

  2. Immunogenicity as assessed by serum IgG antibody levels specific for the F protein antigen as detected by enzyme-linked immunosorbent assay (ELISA) providing a standardized ELISA Unit (EU) reasout based on a standard reference sample.

    Derived/ calculated endpoints based on these data will include:

    Geometric mean EU (GMEU) Geometric mean ratio (GMR) Seroresponse rate (SRR)

    Measured: Up to Day 392

Secondary outcomes (1)

  1. Epitope-specific immune responses to the RSV F protein antigen measured by serum titers in a competition ELISA assay using known-efficacious prophylactic antibody preparation, or in vitro neutralization assays using at least one prototype RSV/A and RSV/B

    Derived/ calculated endpoints based on these data will include:

    Geometric mean EU (GMEU) Geometric mean ratio (GMR) Seroconversion rate (SCR) Seroresponse rate (SRR)

    Measured: Up to Day 392

Timeline

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

  1. First posted20 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionSep 2015
  4. Study completionApr 2016

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02296463
Sponsor's protocol ID
RSV-P-101
Status last verified
Apr 2016
First submitted
8 Nov 2014
Last updated
28 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RSV F Vaccine with adjuvant (0.5mL injection), RSV F Vaccine (0.5mL injection) and Hepatitis A Vaccine (0.5mL injection) in people with Respiratory Synctial Virus, run by Novavax at 4 sites 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 4 inclusion and 12 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Numbers and percentages of subjects with solicited local and systemic AEs. (time frame: Up to Day 392). The study lists 2 primary outcomes in all. 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 NCT02296463.

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 28 Apr 2016.

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