RSV F Dose-Ranging Study in Women
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
1 other identifier
interventional
720
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2013
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 8, 2013
CompletedFirst Posted
Study publicly available on registry
October 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 26, 2016
April 1, 2016
6 months
October 8, 2013
April 27, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups
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)
Day 0 to Day 56
Assessment of Safety
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.
Day 0 to Day 182
Secondary Outcomes (3)
Immunogenicity based on neutralizing antibody titer
Day 0 to Day 56
Kinetics of serum IgG antibody titers specific for the F-Protein antigen across time
Day 0 to Day 91
Immunogenicity based on antibodies sharing specificity with Palivizumab
Day 0 to 91
Study Arms (8)
Low dose RSV F Vaccine with Dose 1 of Aluminum Adjuvant
EXPERIMENTALDay 0: Low dose RSV F Antigen with Dose 1 of aluminum adjuvant Day 28: Placebo
Low dose RSV F Vaccine with Dose 2 of Aluminum Adjuvant
EXPERIMENTALDay 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
Low dose RSV F Vaccine with Dose 3 of Aluminum Adjuvant
EXPERIMENTALDay 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
Low dose RSV F Vaccine with Dose 4 of Aluminum Adjuvant
EXPERIMENTALDay 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
High dose RSV F Vaccine with Dose 2 of Aluminum Adjuvant
EXPERIMENTALDay 0: High dose RSV F Antigen with Dose 2 of aluminum adjuvant Day 28: Placebo
High dose RSV F Vaccine with Dose 3 of Aluminum Adjuvant
EXPERIMENTALDay 0: High dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Placebo
High dose RSV F Vaccine with Dose 4 of Aluminum Adjuvant
EXPERIMENTALDay 0: High dose RSV F Antigen content with Dose 4 of aluminum adjuvant Day 28: Placebo
Placebo
PLACEBO COMPARATORDay 0: Placebo Day 28: Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must meet the following criteria to be eligible to participate:
- 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.
- Persons being treated for illnesses or conditions that would become acutely symptomatic or disabling in the absence of treatment are not eligible.
- Willing and able to give informed consent prior to study enrollment.
- Able to comply with study requirements.
- 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.
You may not qualify if:
- Subjects will be excluded if they fulfill any of the following criteria:
- Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
- History of a serious reaction to any prior vaccination.
- Received any vaccine in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time.
- 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 ≥10mg 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.
- Donated blood within 3 weeks of the planned date of first vaccination.
- 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.
- Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
- 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 or psychiatric conditions deemed likely to impair the quality of safety reporting).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novavaxlead
Study Sites (10)
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Clincal Research of Atlanta
Stockbridge, Georgia, 30281, United States
Advanced Clinical Research
Boise, Idaho, 83642, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
QPS Bio-Kinetic
Springfield, Missouri, 65802, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Coastal Carolina Research
Mt. Pleasant, South Carolina, 29464, United States
Research Across America
Dallas, Texas, 75234, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Related Publications (1)
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.
PMID: 28579233DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
D. Nigel Thomas, Ph.D.
Novavax, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2013
First Posted
October 11, 2013
Study Start
October 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 26, 2016
Record last verified: 2016-04