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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose RSV F Vaccine with Dose 1 of Aluminum Adjuvant | Experimental | Day 0: Low dose RSV F Antigen with Dose 1 of aluminum adjuvant Day 28: Placebo |
|
| Low dose RSV F Vaccine with Dose 2 of Aluminum Adjuvant | Experimental | 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 |
|
| Low dose RSV F Vaccine with Dose 3 of Aluminum Adjuvant | Experimental | 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 |
|
| Low dose RSV F Vaccine with Dose 4 of Aluminum Adjuvant | Experimental | 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 |
|
| High dose RSV F Vaccine with Dose 2 of Aluminum Adjuvant |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose RSV F Antigen | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Day 0 to Day 56 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| D. Nigel Thomas, Ph.D. | Novavax, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States | ||
| Clincal Research of Atlanta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28579233 | Derived | August A, Glenn GM, Kpamegan E, Hickman SP, Jani D, Lu H, Thomas DN, Wen J, Piedra PA, Fries LF. A Phase 2 randomized, observer-blind, placebo-controlled, dose-ranging trial of aluminum-adjuvanted respiratory syncytial virus F particle vaccine formulations in healthy women of childbearing age. Vaccine. 2017 Jun 27;35(30):3749-3759. doi: 10.1016/j.vaccine.2017.05.045. Epub 2017 Jun 1. |
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Day 0: High dose RSV F Antigen with Dose 2 of aluminum adjuvant Day 28: Placebo |
|
| High dose RSV F Vaccine with Dose 3 of Aluminum Adjuvant | Experimental | Day 0: High dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Placebo |
|
| High dose RSV F Vaccine with Dose 4 of Aluminum Adjuvant | Experimental | Day 0: High dose RSV F Antigen content with Dose 4 of aluminum adjuvant Day 28: Placebo |
|
| Placebo | Placebo Comparator | Day 0: Placebo Day 28: Placebo |
|
| 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 | Biological |
|
| Immunogenicity based on antibodies sharing specificity with Palivizumab |
| Day 0 to 91 |
| Stockbridge |
| Georgia |
| 30281 |
| United States |
| Advanced Clinical Research | Boise | Idaho | 83642 | United States |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | United States |
| QPS Bio-Kinetic | Springfield | Missouri | 65802 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Coastal Carolina Research | Mt. Pleasant | South Carolina | 29464 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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