RSV F Dose-Ranging Study in Women

April 27, 2016 updated by: Novavax

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

720

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Clincal Research of Atlanta
    • Idaho
      • Boise, Idaho, United States, 83642
        • Advanced Clinical Research
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clin-Trials
    • Missouri
      • Springfield, Missouri, United States, 65802
        • QPS Bio-Kinetic
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research
    • Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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: Placebo
Biological: Low dose RSV F Antigen
Biological: Dose 1 of Aluminum Adjuvant
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: Placebo
Biological: Dose 2 of Aluminum Adjuvant
Biological: High dose RSV F Antigen
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: Placebo
Biological: Dose 3 of Aluminum Adjuvant
Biological: High dose RSV F Antigen
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: Placebo
Biological: Dose 4 of Aluminum Adjuvant
Biological: High dose RSV F Antigen
PLACEBO_COMPARATOR: Placebo
Day 0: Placebo Day 28: Placebo
Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 0 to Day 56
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.
Day 0 to Day 182

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity based on neutralizing antibody titer
Time Frame: Day 0 to Day 56
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
Day 0 to Day 91
Immunogenicity based on antibodies sharing specificity with Palivizumab
Time Frame: Day 0 to 91
Day 0 to 91

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novavax

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (ESTIMATE)

October 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 26, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVX757.M202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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