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RSV F Dose-Ranging Study in Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novavax
ClinicalTrials.gov Identifier:
NCT01960686
First received: October 8, 2013
Last updated: April 27, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Respiratory Syncytial Virus Infections 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 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novavax:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 720
Study Start Date: October 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
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
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
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
Biological: High dose RSV F Antigen Biological: Dose 4 of Aluminum Adjuvant Biological: Placebo
Placebo Comparator: Placebo
Day 0: Placebo Day 28: Placebo
Biological: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).
  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: NCT01960686

Locations
United States, California
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Georgia
Clincal Research of Atlanta
Stockbridge, Georgia, United States, 30281
United States, Idaho
Advanced Clinical Research
Boise, Idaho, United States, 83642
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
United States, Missouri
QPS Bio-Kinetic
Springfield, Missouri, United States, 65802
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, South Carolina
Coastal Carolina Research
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Novavax
Investigators
Study Director: D. Nigel Thomas, Ph.D. Novavax, Inc.
  More Information

Additional Information:
Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT01960686     History of Changes
Other Study ID Numbers: NVX757.M202
Study First Received: October 8, 2013
Last Updated: April 27, 2016

Additional relevant MeSH terms:
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2017