RSV-F Vaccine Dose Ranging Study in Young Women
A Phase II Randomized, Observer-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum, in Healthy Women of Child-Bearing Age
1 other identifier
interventional
330
1 country
4
Brief Summary
The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.
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 2012
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 8, 2012
CompletedFirst Posted
Study publicly available on registry
October 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMarch 7, 2014
February 1, 2014
6 months
October 8, 2012
February 5, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups
Immunogenicity will be measured using derived / calculated endpoints based on: * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
Day 0 to Day 112
Assessment of the safety
Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post-injections; all adverse events, solicited and unsolicited over 56 days post-first injection. Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for six months
Day 0 to Day 182
Secondary Outcomes (1)
Immunogenicity based on neturalizing antibody titer
Day 0 to Day 112
Study Arms (10)
Group A
EXPERIMENTALLow dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28)
Group B
EXPERIMENTALLow dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28)
Group C
EXPERIMENTALLow dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28)
Group D
EXPERIMENTALLow dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28)
Group E
EXPERIMENTALHigh dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28)
Group F
EXPERIMENTALHigh dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28)
Group G
EXPERIMENTALHigh dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28)
Group H
EXPERIMENTALHigh dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28)
Group J
EXPERIMENTALLow dose RSV-F Vaccine with Adjuvant \[Bedside Mixing\] (Day 0 \& Day 28)
Group K
PLACEBO COMPARATORPlacebo (Day 0 and Day 28)
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- 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.
- 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
Study Sites (4)
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Accelovance Rockville
Rockville, Maryland, 20850, United States
Coastal Carolina Research
Mt. Pleasant, South Carolina, 29464, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Related Publications (1)
Glenn GM, Fries LF, Thomas DN, Smith G, Kpamegan E, Lu H, Flyer D, Jani D, Hickman SP, Piedra PA. A Randomized, Blinded, Controlled, Dose-Ranging Study of a Respiratory Syncytial Virus Recombinant Fusion (F) Nanoparticle Vaccine in Healthy Women of Childbearing Age. J Infect Dis. 2016 Feb 1;213(3):411-22. doi: 10.1093/infdis/jiv406. Epub 2015 Aug 10.
PMID: 26259809DERIVED
Related Links
MeSH Terms
Interventions
Intervention 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, 2012
First Posted
October 11, 2012
Study Start
October 1, 2012
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
March 7, 2014
Record last verified: 2014-02