RSV F Dose-Ranging Study in Women

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960686
• Other study ID #: NVX757.M202
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2013
• Last updated: October 15, 2015
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: October 2015
• Source: Novavax
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Biological:
• Low dose RSV F Antigen

• High dose RSV F Antigen

• Dose 1 of Adjuvant

• Dose 2 of Adjuvant

• Dose 3 of Adjuvant

• Dose 4 of Adjuvant

• Placebo

Locations

Country	Name	City	State
United States	Advanced Clinical Research	Boise	Idaho
United States	Research Across America	Dallas	Texas
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Coastal Carolina Research	Mt. Pleasant	South Carolina
United States	Wake Research Associates	Raleigh	North Carolina
United States	Jean Brown Research	Salt Lake City	Utah
United States	Clinical Trials of Texas	San Antonio	Texas
United States	QPS Bio-Kinetic	Springfield	Missouri
United States	Clincal Research of Atlanta	Stockbridge	Georgia
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Novavax

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	Immunogenicity based on neutralizing antibody titer		Day 0 to Day 56	No
Secondary	Kinetics of serum IgG antibody titers specific for the F-Protein antigen across time		Day 0 to Day 91	No
Secondary	Immunogenicity based on antibodies sharing specificity with Palivizumab		Day 0 to 91	No

External Links

•   Novavax, Inc