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AzTrials

Respiratory Syncytial VirusesPhase 2NCT03026348

Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults

A Phase 2 study testing RSV F Vaccine with Aluminum Phosphate Adjuvant, RSV F Vaccine and Matrix-M1 Adjuvant in people with Respiratory Syncytial Viruses, run by Novavax at 5 sites in Australia.

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, trial in clinically-stable older adults. Up to 300 eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into multiple dose/formulation treatment arms. Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Viruses
What is being tested?
RSV F Vaccine with Aluminum Phosphate Adjuvant, RSV F Vaccine and Matrix-M1 Adjuvant
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
5 sitesAustralia
Study dates
Jan 2017to 18 May 2018
Phase
Phase 2
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 60 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males and females 60 through 80 years of age who are ambulatory and live in the community or in an assisted-living facility that provides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or more chronic medical diagnoses, but should be clinically stable as assessed by:
  • Absence of changes in medical therapy within one month due to treatment failure or toxicity (dose adjustments of ongoing therapies for optimal effect, or replacements within a class of drugs due to convenience or cost, will be deemed acceptable),
  • Absence of medical events qualifying as SAEs within one month of the planned vaccination on Day 0, and
  • Absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator, render survival to completion of the protocol unlikely.
  • Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment. To complete the consent process, all qualifying subjects will correctly answer at least 4 out of 5 questions of the informed consent form (ICF) comprehension assessment in no more than 2 attempts.
  • Able to comply with study requirements. As the protocol procedures involve telephone contacts for safety ascertainment, eligible subjects must have a reliable access to a telephone.

Who cannot join

  • Received any prior RSV vaccine.
  • Participation in research involving any additional investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
  • History of a serious reaction to any prior vaccination or a history of Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.
  • Receipt of inactivated influenza vaccine within 14 days prior to the Day 0 dose of test article or any other vaccine within the 4 weeks prior to the Day 0 dose of test article.
  • Any known or suspected immunosuppressive condition, acquired or congenital, as determined by 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 ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
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  • Administration of immunoglobulins and/or any blood products within the 3 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. Potential subjects receiving aspirin, clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban, or warfarin under good control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation will NOT be excluded.
  • Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
  • 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 neurologic, cognitive, or psychiatric conditions deemed likely to impair the quality of study compliance or safety reporting).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Research Site AU002

    Adelaide, South Australia, 50000

  • Research Site AU005

    Herston, Queensland, 4006

  • Resarch Site AU001

    Nedlands, Western Australia, 6009

  • Research Site AU006

    Prahran, Victoria, 3181

  • Research Site AU004

    Sydney, New South Wales

Other trials in Australia

About this study

This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300 eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions of subjects in various strata will not be pre-specified and the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the treatment groups. Serology measures consistent with the study outcomes will be reported.

Being tested
RSV F Vaccine with Aluminum Phosphate Adjuvant, RSV F Vaccine, Matrix-M1 Adjuvant, Phosphate Buffer
Keywords
RSV

What participants receive

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

  • RSV F Vaccine with Aluminum Phosphate AdjuvantBiological

  • RSV F VaccineBiological

  • Matrix-M1 AdjuvantBiological

  • Phosphate BufferOther

Study groups in NCT03026348
Study groupRoleWhat they receive
Treatment Group AActive comparatorDay 0 RSV F Vaccine 135µg/0.5mL Day 21 Phosphate Buffer
Receives: Biological: RSV F Vaccine; Other: Phosphate Buffer
Treatment Group BActive comparatorDay 0 Treatment / Formulation 1 Day 21 Phosphate Buffer
Receives: Biological: RSV F Vaccine with Aluminum Phosphate Adjuvant; Other: Phosphate Buffer
Treatment Group CActive comparatorDay 0 Treatment / Formulation 1 Day 21 Treatment / Formulation 1
Receives: Biological: RSV F Vaccine with Aluminum Phosphate Adjuvant
Treatment Group DActive comparatorDay 0 Treatment / Formulation 2 Day 21 Phosphate Buffer
Receives: Biological: RSV F Vaccine with Aluminum Phosphate Adjuvant; Other: Phosphate Buffer
Treatment Group EActive comparatorDay 0 Treatment / Formulation 2 Day 21 Treatment / Formulation 2
Receives: Biological: RSV F Vaccine with Aluminum Phosphate Adjuvant
Treatment Group FActive comparatorDay 0 Treatment / Formulation 3 Day 21 Phosphate Buffer
Receives: Biological: RSV F Vaccine; Biological: Matrix-M1 Adjuvant; Other: Phosphate Buffer
Treatment Group GActive comparatorDay 0 Treatment / Formulation 3 Day 21 Treatment / Formulation 3
Receives: Biological: RSV F Vaccine; Biological: Matrix-M1 Adjuvant
Treatment Group HActive comparatorDay 0 Treatment / Formulation 4 Day 21 Phosphate Buffer
Receives: Biological: RSV F Vaccine; Biological: Matrix-M1 Adjuvant; Other: Phosphate Buffer
Treatment Group JActive comparatorDay 0 Treatment / Formulation 4 Day 21 Treatment / Formulation 4
Receives: Biological: RSV F Vaccine; Biological: Matrix-M1 Adjuvant
Treatment Group KActive comparatorDay 0 Treatment / Formulation 5 Day 21 Phosphate Buffer
Receives: Biological: RSV F Vaccine; Biological: Matrix-M1 Adjuvant; Other: Phosphate Buffer
Treatment Group LActive comparatorDay 0 Treatment / Formulation 5 Day 21 Treatment / Formulation 5
Receives: Biological: RSV F Vaccine; Biological: Matrix-M1 Adjuvant
Treatment Group MPlacebo comparatorDay 0 Phosphate Buffer Day 21 Phosphate Buffer
Receives: Other: Phosphate Buffer

What is being measured

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

  1. Neutralizing antibody titers to at least one RSV/A strain

    Measured: Day 0, 21, 28

  2. Subjects with solicited local and systemic AEs occurring within the 7-day period following dosings on Day 0 and Day 21 and all adverse events, solicited and unsolicited, occurring within the 56-day period of Day 0.

    Measured: Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56

Secondary outcomes (4)

  1. Serum concentrations of antibodies competitive with palivizumab (i.e., PCA) for binding to the RSV F protein.

    Measured: Day 0, 21, 28, 56, 119, 385

  2. Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.

    Measured: Day 0, 21, 28, 56, 119, 385

  3. Counts of IFN-γ spot forming units following in vitro stimulation of Day 0, Day 7, and Day 28 PBMC isolates with RSV F peptides.

    Measured: Day 0, 7, 28

  4. Counts and proportions of Day 0, Day 7, and Day 28 peripheral blood T cells positive by intracellular staining for IL-2, IFN-γ, or TNF-α production (alone or any combination thereof) following in vitro stimulation with RSV F peptides.

    Measured: Day 0, 7, 28

Timeline

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

  1. First posted20 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionApr 2017
  4. Study completion18 May 2018

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03026348
Sponsor's protocol ID
RSV-E-205
Status last verified
Dec 2021
First submitted
17 Jan 2017
Last updated
6 Dec 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RSV F Vaccine with Aluminum Phosphate Adjuvant, RSV F Vaccine and Matrix-M1 Adjuvant in people with Respiratory Syncytial Viruses, run by Novavax at 5 sites in Australia.

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 6 inclusion and 11 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 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Neutralizing antibody titers to at least one RSV/A strain (time frame: Day 0, 21, 28). 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 NCT03026348.

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 6 Dec 2021.

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