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RSV F Dose-Ranging Study in Women

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ClinicalTrials.gov Identifier: NCT01960686
Recruitment Status : Completed
First Posted : October 11, 2013
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Novavax

Tracking Information
First Submitted Date  ICMJE October 8, 2013
First Posted Date  ICMJE October 11, 2013
Last Update Posted Date May 26, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
  • Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups [ Time Frame: Day 0 to Day 56 ]
    Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. Derived/calculated endpoints based on these data will include:
    • Geometric mean concentrations as EU (GMEU)
    • Geometric mean ratio (GMR)
    • Geometric mean fold-rise (GMFR)
    • Seroconversion rate (SCR)
    • Seroresponse rate (SRR)
  • Assessment of Safety [ Time Frame: Day 0 to Day 182 ]
    Numbers and percentages of subjects with solicited local and systemic adverse events over the seven days post-injection; and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters. In addition, Medically Attended Events, Serious Adverse Events, and Significant New Medical Conditions will be collected for six months.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
  • Immunogenicity based on neutralizing antibody titer [ Time Frame: Day 0 to Day 56 ]
  • Kinetics of serum IgG antibody titers specific for the F-Protein antigen across time [ Time Frame: Day 0 to Day 91 ]
  • Immunogenicity based on antibodies sharing specificity with Palivizumab [ Time Frame: Day 0 to 91 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RSV F Dose-Ranging Study in Women
Official Title  ICMJE A Phase II Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Multiple Formulations of an RSV F Particle Vaccine With Aluminum, in Healthy Women of Child-Bearing Age
Brief Summary The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing age.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Syncytial Virus Infections
Intervention  ICMJE
  • Biological: Low dose RSV F Antigen
  • Biological: High dose RSV F Antigen
  • Biological: Dose 1 of Aluminum Adjuvant
  • Biological: Dose 2 of Aluminum Adjuvant
  • Biological: Dose 3 of Aluminum Adjuvant
  • Biological: Dose 4 of Aluminum Adjuvant
  • Biological: Placebo
Study Arms  ICMJE
  • Experimental: Low dose RSV F Vaccine with Dose 1 of Aluminum Adjuvant
    Day 0: Low dose RSV F Antigen with Dose 1 of aluminum adjuvant Day 28: Placebo
    Interventions:
    • Biological: Low dose RSV F Antigen
    • Biological: Dose 1 of Aluminum Adjuvant
    • Biological: Placebo
  • Experimental: Low dose RSV F Vaccine with Dose 2 of Aluminum Adjuvant
    Day 0: Low dose RSV F Antigen content with Dose 2 of aluminum adjuvant Day 28: Low dose RSV F Antigen content with Dose 2 of aluminum adjuvant
    Interventions:
    • Biological: Low dose RSV F Antigen
    • Biological: Dose 2 of Aluminum Adjuvant
  • Experimental: Low dose RSV F Vaccine with Dose 3 of Aluminum Adjuvant
    Day 0: Low dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Low dose RSV F Antigen with Dose 3 of aluminum adjuvant
    Interventions:
    • Biological: Low dose RSV F Antigen
    • Biological: Dose 3 of Aluminum Adjuvant
  • Experimental: Low dose RSV F Vaccine with Dose 4 of Aluminum Adjuvant
    Day 0: Low dose RSV F Antigen with Dose 4 of aluminum adjuvant Day 28: Low dose RSV F Antigen with Dose 4 of aluminum adjuvant
    Interventions:
    • Biological: Low dose RSV F Antigen
    • Biological: Dose 4 of Aluminum Adjuvant
  • Experimental: High dose RSV F Vaccine with Dose 2 of Aluminum Adjuvant
    Day 0: High dose RSV F Antigen with Dose 2 of aluminum adjuvant Day 28: Placebo
    Interventions:
    • Biological: High dose RSV F Antigen
    • Biological: Dose 2 of Aluminum Adjuvant
    • Biological: Placebo
  • Experimental: High dose RSV F Vaccine with Dose 3 of Aluminum Adjuvant
    Day 0: High dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Placebo
    Interventions:
    • Biological: High dose RSV F Antigen
    • Biological: Dose 3 of Aluminum Adjuvant
    • Biological: Placebo
  • Experimental: High dose RSV F Vaccine with Dose 4 of Aluminum Adjuvant
    Day 0: High dose RSV F Antigen content with Dose 4 of aluminum adjuvant Day 28: Placebo
    Interventions:
    • Biological: High dose RSV F Antigen
    • Biological: Dose 4 of Aluminum Adjuvant
    • Biological: Placebo
  • Placebo Comparator: Placebo
    Day 0: Placebo Day 28: Placebo
    Intervention: Biological: Placebo
Publications * August A, Glenn GM, Kpamegan E, Hickman SP, Jani D, Lu H, Thomas DN, Wen J, Piedra PA, Fries LF. A Phase 2 randomized, observer-blind, placebo-controlled, dose-ranging trial of aluminum-adjuvanted respiratory syncytial virus F particle vaccine formulations in healthy women of childbearing age. Vaccine. 2017 Jun 27;35(30):3749-3759. doi: 10.1016/j.vaccine.2017.05.045. Epub 2017 Jun 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2013)
720
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects must meet the following criteria to be eligible to participate:

  1. Healthy adult females, ≥ 18 and ≤ 35 years of age. "Healthy" shall be defined by the absence of any illness, acute or chronic, that requires ongoing systemic therapy for the control of symptoms or prevention of disability.

    • Subjects on stable (no change in ≥ 3 months) therapy for findings (e.g., hypertension or hyperlipidemia) that are not associated with symptoms or disability are eligible, as are users of hormonal contraceptives.
    • Subjects who receive intermittent prophylaxis for risks associated with asymptomatic findings (e.g., antibiotic prophylaxis prior to dental procedures in a subject with mitral valve prolapse) are eligible.
    • Ongoing therapy will be defined as continuous or, if intermittent, more frequent than once every 3 months (e.g., use of an inhaled bronchodilator for exercise-induced bronchospasm more than once every 3 months). Immunosuppressives are subject to exclusion criterion #5 below.
    • Persons being treated for illnesses or conditions that would become acutely symptomatic or disabling in the absence of treatment are not eligible.
  2. Willing and able to give informed consent prior to study enrollment.
  3. Able to comply with study requirements.
  4. Women who are not surgically sterile must have a negative urine pregnancy test prior to each vaccination; will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD.

Exclusion Criteria:

Subjects will be excluded if they fulfill any of the following criteria:

  1. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
  2. History of a serious reaction to any prior vaccination.
  3. Received any vaccine in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time.
  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. Donated blood within 3 weeks of the planned date of first vaccination.
  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.
  10. Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
  11. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
  12. 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 or psychiatric conditions deemed likely to impair the quality of safety reporting).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01960686
Other Study ID Numbers  ICMJE NVX757.M202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Novavax
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novavax
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: D. Nigel Thomas, Ph.D. Novavax, Inc.
PRS Account Novavax
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP