RSV F Dose-Ranging Study in Women

Sponsor

Novavax (Industry)

Overall Status

Completed

CT.gov ID

NCT01960686

Collaborator

(none)

720

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Actual Enrollment :

720 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups [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 [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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.
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.

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.

Exclusion Criteria:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diablo Clinical Research	Walnut Creek	California	United States	94598
2	Clincal Research of Atlanta	Stockbridge	Georgia	United States	30281
3	Advanced Clinical Research	Boise	Idaho	United States	83642
4	Johnson County Clin-Trials	Lenexa	Kansas	United States	66219
5	QPS Bio-Kinetic	Springfield	Missouri	United States	65802
6	Wake Research Associates	Raleigh	North Carolina	United States	27612
7	Coastal Carolina Research	Mt. Pleasant	South Carolina	United States	29464
8	Research Across America	Dallas	Texas	United States	75234
9	Clinical Trials of Texas	San Antonio	Texas	United States	78229
10	Jean Brown Research	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

Novavax

Investigators

Study Director: D. Nigel Thomas, Ph.D., Novavax, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novavax

ClinicalTrials.gov Identifier:

NCT01960686

Other Study ID Numbers:

NVX757.M202

First Posted:

Oct 11, 2013

Last Update Posted:

May 26, 2016

Last Verified:

Apr 1, 2016

Additional relevant MeSH terms:

Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of May 26, 2016