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RSV-F Vaccine Dose Ranging Study in Young Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01704365
First Posted: October 11, 2012
Last Update Posted: March 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
PATH
Information provided by (Responsible Party):
Novavax
  Purpose
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.

Condition Intervention Phase
Respiratory Syncytial Virus (RSV) Biological: Low dose RSV-F Vaccine with Adjuvant Biological: Low dose RSV-F Vaccine without Adjuvant Biological: High dose RSV-F Vaccine with Adjuvant Biological: High dose RSV-F Vaccine without Adjuvant Biological: Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing] Biological: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Novavax:

Primary Outcome Measures:
  • Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups [ Time Frame: Day 0 to Day 112 ]

    Immunogenicity will be measured using derived / calculated endpoints based on:

    • Geometric mean titer (GMT)
    • Geometric mean ratio (GMR)
    • Seroconversion rate (SCR)
    • Seroresponse rate (SRR)

  • Assessment of the safety [ Time Frame: Day 0 to Day 182 ]

    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



Secondary Outcome Measures:
  • Immunogenicity based on neturalizing antibody titer [ Time Frame: Day 0 to Day 112 ]

Enrollment: 330
Study Start Date: October 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Low dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28)
Biological: Low dose RSV-F Vaccine with Adjuvant
0.5mL IM Injection
Experimental: Group B
Low dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28)
Biological: Low dose RSV-F Vaccine with Adjuvant
0.5mL IM Injection
Biological: Placebo
0.5mL IM Injection
Experimental: Group C
Low dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28)
Biological: Low dose RSV-F Vaccine without Adjuvant
0.5ml IM Injection
Experimental: Group D
Low dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28)
Biological: Low dose RSV-F Vaccine without Adjuvant
0.5ml IM Injection
Biological: Placebo
0.5mL IM Injection
Experimental: Group E
High dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28)
Biological: High dose RSV-F Vaccine with Adjuvant
0.5mL IM Injection
Experimental: Group F
High dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28)
Biological: High dose RSV-F Vaccine with Adjuvant
0.5mL IM Injection
Biological: Placebo
0.5mL IM Injection
Experimental: Group G
High dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28)
Biological: High dose RSV-F Vaccine without Adjuvant
0.5mL IM Injection
Experimental: Group H
High dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28)
Biological: High dose RSV-F Vaccine without Adjuvant
0.5mL IM Injection
Biological: Placebo
0.5mL IM Injection
Experimental: Group J
Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing] (Day 0 & Day 28)
Biological: Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]
0.5mL IM Injection
Placebo Comparator: Group K
Placebo (Day 0 and Day 28)
Biological: Placebo
0.5mL IM Injection

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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:

  • 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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704365


Locations
United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
United States, Maryland
Accelovance Rockville
Rockville, Maryland, United States, 20850
United States, South Carolina
Coastal Carolina Research
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novavax
PATH
Investigators
Study Director: D. Nigel Thomas, Ph.D. Novavax, Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT01704365     History of Changes
Other Study ID Numbers: NVX757.201
First Submitted: October 8, 2012
First Posted: October 11, 2012
Last Update Posted: March 7, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs