Trial record 3 of 4 for:
novavax | RSV Infection
RSV F Dose-Ranging Study in Women
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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. |
| ClinicalTrials.gov Identifier: NCT01960686 |
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Recruitment Status :
Completed
First Posted : October 11, 2013
Last Update Posted : May 26, 2016
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Sponsor:
Novavax
Information provided by (Responsible Party):
Novavax
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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 Type : | Interventional (Clinical Trial) |
| 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 : | October 2013 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | April 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Respiratory Syncytial Virus Infections
| Arm | Intervention/treatment |
|---|---|
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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
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Biological: Low dose RSV F Antigen Biological: Dose 1 of Aluminum Adjuvant Biological: Placebo |
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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
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Biological: Low dose RSV F Antigen Biological: Dose 2 of Aluminum Adjuvant |
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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
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Biological: Low dose RSV F Antigen Biological: Dose 3 of Aluminum Adjuvant |
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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
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Biological: Low dose RSV F Antigen Biological: Dose 4 of Aluminum Adjuvant |
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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
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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
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Biological: High dose RSV F Antigen Biological: Dose 4 of Aluminum Adjuvant Biological: Placebo |
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Placebo Comparator: Placebo
Day 0: Placebo Day 28: Placebo
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Biological: Placebo |
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 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 [ 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.
Secondary Outcome Measures :
- Immunogenicity based on neutralizing antibody titer [ Time Frame: 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 ]
- Immunogenicity based on antibodies sharing specificity with Palivizumab [ Time Frame: Day 0 to 91 ]
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:
Subjects must meet the following criteria to be eligible to participate:
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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).
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): NCT01960686
Locations
| United States, California | |
| Diablo Clinical Research | |
| Walnut Creek, California, United States, 94598 | |
| United States, Georgia | |
| Clincal Research of Atlanta | |
| Stockbridge, Georgia, United States, 30281 | |
| United States, Idaho | |
| Advanced Clinical Research | |
| Boise, Idaho, United States, 83642 | |
| United States, Kansas | |
| Johnson County Clin-Trials | |
| Lenexa, Kansas, United States, 66219 | |
| United States, Missouri | |
| QPS Bio-Kinetic | |
| Springfield, Missouri, United States, 65802 | |
| United States, North Carolina | |
| Wake Research Associates | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, South Carolina | |
| Coastal Carolina Research | |
| Mt. Pleasant, South Carolina, United States, 29464 | |
| United States, Texas | |
| Research Across America | |
| Dallas, Texas, United States, 75234 | |
| Clinical Trials of Texas | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Jean Brown Research | |
| Salt Lake City, Utah, United States, 84124 | |
Sponsors and Collaborators
Novavax
Investigators
| Study Director: | D. Nigel Thomas, Ph.D. | Novavax, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novavax |
| ClinicalTrials.gov Identifier: | NCT01960686 |
| Other Study ID Numbers: |
NVX757.M202 |
| First Posted: | October 11, 2013 Key Record Dates |
| Last Update Posted: | May 26, 2016 |
| Last Verified: | April 2016 |
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections Virus Diseases Infections Pneumovirus Infections |
Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections |