- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03026348
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
December 2, 2021 updated by: Novavax
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Sydney, New South Wales, Australia
- Research Site AU004
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Queensland
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Herston, Queensland, Australia, 4006
- Research Site AU005
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South Australia
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Adelaide, South Australia, Australia, 50000
- Research Site AU002
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Victoria
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Prahran, Victoria, Australia, 3181
- Research Site AU006
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Resarch Site AU001
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment Group A
Day 0 RSV F Vaccine 135µg/0.5mL
Day 21 Phosphate Buffer
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|
Active Comparator: Treatment Group B
Day 0 Treatment / Formulation 1 Day 21 Phosphate Buffer
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Active Comparator: Treatment Group C
Day 0 Treatment / Formulation 1 Day 21 Treatment / Formulation 1
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|
Active Comparator: Treatment Group D
Day 0 Treatment / Formulation 2 Day 21 Phosphate Buffer
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Active Comparator: Treatment Group E
Day 0 Treatment / Formulation 2 Day 21 Treatment / Formulation 2
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Active Comparator: Treatment Group F
Day 0 Treatment / Formulation 3 Day 21 Phosphate Buffer
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Active Comparator: Treatment Group G
Day 0 Treatment / Formulation 3 Day 21 Treatment / Formulation 3
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Active Comparator: Treatment Group H
Day 0 Treatment / Formulation 4 Day 21 Phosphate Buffer
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Active Comparator: Treatment Group J
Day 0 Treatment / Formulation 4 Day 21 Treatment / Formulation 4
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Active Comparator: Treatment Group K
Day 0 Treatment / Formulation 5 Day 21 Phosphate Buffer
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Active Comparator: Treatment Group L
Day 0 Treatment / Formulation 5 Day 21 Treatment / Formulation 5
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Placebo Comparator: Treatment Group M
Day 0 Phosphate Buffer Day 21 Phosphate Buffer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neutralizing antibody titers to at least one RSV/A strain
Time Frame: Day 0, 21, 28
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Day 0, 21, 28
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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.
Time Frame: Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56
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Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum concentrations of antibodies competitive with palivizumab (i.e., PCA) for binding to the RSV F protein.
Time Frame: Day 0, 21, 28, 56, 119, 385
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Day 0, 21, 28, 56, 119, 385
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Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
Time Frame: Day 0, 21, 28, 56, 119, 385
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Day 0, 21, 28, 56, 119, 385
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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.
Time Frame: Day 0, 7, 28
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Day 0, 7, 28
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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.
Time Frame: Day 0, 7, 28
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Day 0, 7, 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
May 18, 2018
Study Registration Dates
First Submitted
January 17, 2017
First Submitted That Met QC Criteria
January 17, 2017
First Posted (Estimate)
January 20, 2017
Study Record Updates
Last Update Posted (Actual)
December 6, 2021
Last Update Submitted That Met QC Criteria
December 2, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSV-E-205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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