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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

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ClinicalTrials.gov Identifier: NCT03026348
Recruitment Status : Active, not recruiting
First Posted : January 20, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Novavax

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Viruses Biological: RSV F Vaccine with Aluminum Phosphate Adjuvant Biological: RSV F Vaccine Biological: Matrix-M1 Adjuvant Other: Phosphate Buffer Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : January 2017
Actual Primary Completion Date : April 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment Group A
Day 0 RSV F Vaccine 135µg/0.5mL Day 21 Phosphate Buffer
 Biological: RSV F Vaccine
Other: Phosphate Buffer
Active Comparator: Treatment Group B
Day 0 Treatment / Formulation 1 Day 21 Phosphate Buffer
 Biological: RSV F Vaccine with Aluminum Phosphate Adjuvant
Other: Phosphate Buffer
Active Comparator: Treatment Group C
Day 0 Treatment / Formulation 1 Day 21 Treatment / Formulation 1
 Biological: RSV F Vaccine with Aluminum Phosphate Adjuvant
Active Comparator: Treatment Group D
Day 0 Treatment / Formulation 2 Day 21 Phosphate Buffer
 Biological: RSV F Vaccine with Aluminum Phosphate Adjuvant
Other: Phosphate Buffer
Active Comparator: Treatment Group E
Day 0 Treatment / Formulation 2 Day 21 Treatment / Formulation 2
 Biological: RSV F Vaccine with Aluminum Phosphate Adjuvant
Active Comparator: Treatment Group F
Day 0 Treatment / Formulation 3 Day 21 Phosphate Buffer
 Biological: RSV F Vaccine
Biological: Matrix-M1 Adjuvant
Other: Phosphate Buffer
Active Comparator: Treatment Group G
Day 0 Treatment / Formulation 3 Day 21 Treatment / Formulation 3
 Biological: RSV F Vaccine
Biological: Matrix-M1 Adjuvant
Active Comparator: Treatment Group H
Day 0 Treatment / Formulation 4 Day 21 Phosphate Buffer
 Biological: RSV F Vaccine
Biological: Matrix-M1 Adjuvant
Other: Phosphate Buffer
Active Comparator: Treatment Group J
Day 0 Treatment / Formulation 4 Day 21 Treatment / Formulation 4
 Biological: RSV F Vaccine
Biological: Matrix-M1 Adjuvant
Active Comparator: Treatment Group K
Day 0 Treatment / Formulation 5 Day 21 Phosphate Buffer
 Biological: RSV F Vaccine
Biological: Matrix-M1 Adjuvant
Other: Phosphate Buffer
Active Comparator: Treatment Group L
Day 0 Treatment / Formulation 5 Day 21 Treatment / Formulation 5
 Biological: RSV F Vaccine
Biological: Matrix-M1 Adjuvant
Placebo Comparator: Treatment Group M
Day 0 Phosphate Buffer Day 21 Phosphate Buffer
 Other: Phosphate Buffer


Outcome Measures
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Primary Outcome Measures :
  1. Neutralizing antibody titers to at least one RSV/A strain [ Time Frame: 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. [ Time Frame: Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Day 0, 7, 28 ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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:

  1. Received any prior RSV vaccine.
  2. Participation in research involving any additional investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
  3. 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.
  4. 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.
  5. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
  6. 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.
  7. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  8. 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).
  9. 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.
  10. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
  11. 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026348


Locations
Australia, New South Wales
Research Site AU004
Sydney, New South Wales, Australia
Australia, Queensland
Research Site AU005
Herston, Queensland, Australia, 4006
Australia, South Australia
Research Site AU002
Adelaide, South Australia, Australia, 50000
Australia, Victoria
Research Site AU006
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Resarch Site AU001
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Novavax
Investigators
Study Director: Vivek Shinde, MD Novavax
More Information
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Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT03026348     History of Changes
Other Study ID Numbers: RSV-E-205
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Novavax:
RSV

Additional relevant MeSH terms:
Vaccines
Aluminum phosphate
Immunologic Factors
Physiological Effects of Drugs
 Adjuvants, Immunologic
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents