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| ID | Type | Description | Link |
|---|---|---|---|
| 200-2012-53664-002 | Other Grant/Funding Number | CDC |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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The purpose of this pilot research project is to look at the effect of the inactivated influenza vaccine (seasonal flu shot) on early signs of immune or germ-fighting response known as cytokines or signal molecules. The investigators also want to see if the timing of vaccine administration has any effect on women's reproductive hormones. The investigators hypothesis is that influenza vaccine given right before ovulation may change the hormone levels usually seen after ovulation. Thi
This study is an open-label, longitudinal study of healthy young women of reproductive age, not on hormonal contraception who receive seasonal inactivated influenza vaccine (IIV). The women will be followed for one menstrual cycle to measure luteinizing hormone surge, estradiol, and progesterone, and then vaccinated with the seasonal inactivated influenza vaccine prior to ovulation during a second month. At the investigator's discretion, or if there is active circulation of influenza virus in Baltimore, the investigators will vaccinate during the first menstrual cycle (prior to ovulation) and then follow for a second menstrual cycle for comparison. After vaccination, they will be followed for cytokine and chemokine responses as well as changes in the concentrations of steroid hormones. This study will evaluate the effect of IIV on inflammatory cytokines and hormonal responses before and after ovulation. Each woman will have 13 visits in addition to a screening visit, and will be followed for 2 complete menstrual cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy woman | Other | All women are to receive the quadrivalent influenza vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seasonal Inactivated Influenza Vaccine | Biological | Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Levels of Progesterone After Influenza Vaccination | To explore whether receipt of IIV during the second week of the menstrual cycle (i.e., the week prior to ovulation) is associated with changes in steroid hormone levels, particularly decreases in progesterone, following ovulation. | 2 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Cytokine Effect on Reproductive Hormone Levels | To explore whether inflammatory cytokine responses to IIV receipt are associated with changes in reproductive and stress hormone levels. | 2 months |
| Cytokine Responses to Influenza Vaccine |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kawsar R Talaat, MD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Karen Broder, M.D. | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Immunization Research; Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland | 21205 | United States |
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| Label | URL |
|---|---|
| Click here for information about enrolling in this study | View source |
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Study specific screening occurred prior to enrollment. 180 screens completed
103 adult female subjects enrolled and 92 completed study over 3 vaccination seasons from 2013-2017. Each participant served as her own control and followed for 2 months: an Inactivated influenza vaccination (IIV) month and a observation/comparator month.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Women | All women are to receive the quadrivalent influenza vaccine Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Women | All women are to receive the quadrivalent influenza vaccine Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Levels of Progesterone After Influenza Vaccination | To explore whether receipt of IIV during the second week of the menstrual cycle (i.e., the week prior to ovulation) is associated with changes in steroid hormone levels, particularly decreases in progesterone, following ovulation. | Posted | Mean | Standard Deviation | ng/ml | 2 months |
|
7 days after vaccination, up to 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Women | All women are to receive the quadrivalent influenza vaccine Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kawsar Talaat | Johns Hopkins University | 410-502-9627 | ktalaat@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2018 | Sep 7, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 24, 2018 | Sep 7, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Identify optimal biomarkers of the inflammatory response after vaccination.
| 2 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Other Pre-specified | Cytokine Effect on Reproductive Hormone Levels | To explore whether inflammatory cytokine responses to IIV receipt are associated with changes in reproductive and stress hormone levels. | Not Posted | 2 months | Participants |
| Other Pre-specified | Cytokine Responses to Influenza Vaccine | Identify optimal biomarkers of the inflammatory response after vaccination. | Not Posted | 2 days | Participants |
| 0 |
| 92 |
| 0 |
| 92 |
| 73 |
| 92 |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Eythema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Induration | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Malaise | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pain | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Swelling | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |