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Trial record 1 of 1 for:    NCT02593071
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Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novavax
ClinicalTrials.gov Identifier:
NCT02593071
First received: October 22, 2015
Last updated: January 16, 2017
Last verified: January 2017
  Purpose
This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season. This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV season, and the safety and immunogenicity of revaccination over two years.

Condition Intervention Phase
Respiratory Syncytial Virus (RSV)
Biological: RSV-F Vaccine
Biological: Phosphate Buffer Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine in Healthy Older Adult Subjects Previously Treated With the Same Vaccine, or Placebo, in the Prior Year; and to Estimate the Incidence Rate of RSV Disease and Vaccine Efficacy in Subjects Based on Their RSV F Vaccine Experience Over Two Consecutive Years.

Further study details as provided by Novavax:

Primary Outcome Measures:
  • Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. [ Time Frame: Day 0 to Day 364 ]

    Derived/calculated endpoints based on these data will include:

    • Geometric mean concentration as EU (GMEU)
    • Geometric mean ratio (GMR)
    • Seroresponse rate (SRR)
    • Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)

  • Numbers and percentages of subjects with solicited local and systemic AEs [ Time Frame: Day 0 to Day 364 ]
    Solicited local and systemic AEs over the seven days post-injection; and all adverse events, solicited and unsolicited, over 56 days post-dosing (Year 2). In addition, MAEs, SAEs, and SNMCs will be collected for 1 year (approximately 364 days) post-dosing


Secondary Outcome Measures:
  • Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA [ Time Frame: Day 0 to Day 182 ]

    Summarized by:

    • Geometric mean concentrations (GMC)
    • Geometric mean ratio (GMR)
    • Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)

  • Neutralizing antibody titer to at least one RSV/A and one RSV/B strain. [ Time Frame: Day 0 to Day 182 ]

    Summarized by:

    • Geometric mean titer (GMT)
    • Geometric mean ratio (GMR)
    • Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)


Other Outcome Measures:
  • Number and percentages of subjects fulfilling the definitions of RSV-associated respiratory disease and/or RSV-lower respiratory tract disease in various treatment groups. [ Time Frame: Day 0 to Day 182 ]
  • Number and percentages of subjects with respiratory illnesses for which a non-RSV viral respiratory pathogen (with or without concurrent RSV infection) is identified by RT-PCR. [ Time Frame: Day 0 to Day 182 ]

Enrollment: 1330
Study Start Date: October 2015
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group A
RSV-F Vaccine ( 0.5mL Injection)
Biological: RSV-F Vaccine
Placebo Comparator: Treatment Group B
Phosphate Buffer Placebo (0.5mL Injection)
Biological: Phosphate Buffer Placebo

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females ≥60 years of age who are veterans of the RSV-E-201 clinical trial and who are ambulatory and live in the community or in residential facilities which provide 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,
    • Absence of medical events qualifying as SAEs within two months, and
    • Absence of known, current, life-limiting diagnoses that, in the opinion of the investigator, render survival to trial completion unlikely.
  2. Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
  3. Able to comply with study requirements, including access to transportation for study visits. The investigator may use his/her discretion to assess potential ability and willingness to comply based on performance in the prior trial, RSV-E-201.
  4. Access to inbound and outbound communication by telephone with caregivers and study staff.

Exclusion Criteria:

  1. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination, with the exception of participation in the preceding study RSV-E-201.
  2. History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization, or withdrawal from the preceding RSV-E-201 clinical trial due to an adverse event deemed test article-related or at the advice of the investigator.
  3. Receipt of any vaccine other than IIV in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time unless administered in the preceding study, RSV-E-201.
  4. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
  5. 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 ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
  6. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  7. 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).
  8. 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.
  9. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
  10. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02593071

Locations
United States, California
Nothern California Clinical Research
Redding, California, United States, 96001
United States, Georgia
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
United States, Ohio
Rapid Medical Research
Cleveland, Ohio, United States, 44122
United States, Tennessee
Clinical Research Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
United States, Utah
Advanced Clinical Research
West Jordan, Utah, United States, 84088
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
United States, Wisconsin
Marshfield Clinical Research Foundation
Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
Novavax
Investigators
Study Director: D. Nigel Thomas, Ph.D. Novavax, Inc.
  More Information

Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT02593071     History of Changes
Other Study ID Numbers: RSV-E-202
Study First Received: October 22, 2015
Last Updated: January 16, 2017

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 22, 2017