Cervical Cancer, Genital Warts
Conditions
Keywords
Human papillomavirus, Cervical cancer, Genital warts, Vaccine, Immunogenicity
Brief summary
To determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls elicits an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine delivered according to the recommended dosing schedule. This is a prospective observational study of healthy 9-18 year old female patients receiving either a second or third dose of HPV vaccine as part of their well child care. Immune responses to HPV types 6, 11, 16 and 18 will be measured both before and 1 month after the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV vaccine when administered at naturally occurring longer dosing intervals to the immune response to HPV vaccine when administered as routinely recommended. Girls receiving a 3rd dose of HPV vaccine in addition to concomitantly administered vaccines by injection were randomized to receive either the HPV vaccine first or their concomitantly administered vaccines first. Pain following vaccination was assessed in each arm using the Faces Pain Scale - Revised. Please note: This record refers only to the randomized portion of the study where pain following vaccination was assessed. Please refer to NCT02280642 for the observational portion of the study.
Interventions
BIOLOGICALReceived HPV vaccine first
BIOLOGICALReceived concomitant vaccines first
Sponsors
Centers for Disease Control and Prevention
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. A healthy, medically well female between the ages of 9 - 18 years. (Must be between 9 years and younger than 19 years of age) at time of enrollment 2. Must be receiving either a 3rd dose of HPV vaccine (All Groups) or a 2nd dose of HPV vaccine (Group 2 only) * For Group 1 - EITHER 1) The second dose of HPV vaccine must not have been administered and it must be within the specified dosing interval for the second dose of HPV vaccine (\> 90 days since the first dose of HPV vaccine) OR 2) The second dose of HPV vaccine must have been administered \> 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose of HPV vaccine (\> 60 days - \< 180 days since the second dose of HPV) * For Group 2 - The second dose of HPV vaccine must have been administered \> 30 days and \< 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose (\> 180 days since the second dose of HPV) * For Group 3 - The second dose of HPV vaccine must have been administered \> 30 days and \< 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose (\> 60 days - \< 180 days since the second dose of HPV) * For Group 4- The second dose of HPV vaccine must have been administered \> 90 days after the first dose of HPV of HPV vaccine and it must be within the specified dosing interval for the third dose (\> 180 days since the second dose of HPV) 3. Ability and willingness to participate in the study by providing written informed assent. Verbal assent is acceptable for subjects less than 12 years of age. 4. Parent/guardian provides informed consent 5. Anticipated ability and willingness to complete all study visits and evaluations
Exclusion criteria
1. Unable to comply with the study protocol 2. Receipt of three or more doses of HPV vaccine or receipt of doses of HPV vaccine outside the pre-specified time windows 3. Receipt of blood and or blood products (including immunoglobulin) in the past 3 months or anticipated receipt during the study period 4. Receipt of a live virus vaccine (varicella virus containing vaccine, any measles, mumps, or rubella virus containing vaccine such as MMR, or yellow fever vaccine but not including live attenuated influenza virus vaccine) within 4 weeks of receipt of the 3rd dose of HPV vaccine or anticipated receipt of a live virus vaccine within 4 weeks after the 3rd dose of HPV vaccine 5. History of any physical, mental, or developmental disorder that study personnel believe may hinder a participant's ability to comply with the study requirements 6. History of malignancy or confirmed or suspected immunodeficient condition such as HIV infection 7. Receipt of or history of receipt of any medications or treatments that affect the immune system, such as immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity since six months prior to the first HPV vaccine dose. Receipt of long-term (greater than or equal to 2 weeks) potentially immunosuppressive corticosteroid use within six months prior to HPV vaccine dose 1 and enrollment or anticipated receipt during the study period. Specifically, potentially immunosuppressive corticosteroids are any parenteral corticosteroid, high dose (\>800 mcg/day) beclomethasone dipropionate or equivalent medication. Nasal and topical steroids are allowed. 8. Current or former participation in HPV vaccine related research. 9. Receipt of an investigational or alternate HPV vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Following HPV Vaccine | 10 minutes following vaccination | Participants with Faces Pain Scale - Revised (FPS-R) score higher in arm where HPV received compared to arm where concomitant vaccines received. The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Received HPV Vaccine First Received HPV vaccine first | 33 |
| Received Concomitant Vaccines First Received concomitant vaccines first | 39 |
| Total | 72 |
Baseline characteristics
| Characteristic | Received HPV Vaccine First | Received Concomitant Vaccines First | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 33 Participants | 39 Participants | 72 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 33 participants | 39 participants | 72 participants |
| Sex: Female, Male Female | 33 Participants | 39 Participants | 72 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 39 |
| serious Total, serious adverse events | 0 / 33 | 0 / 39 |
Outcome results
Primary
Pain Following HPV Vaccine
Participants with Faces Pain Scale - Revised (FPS-R) score higher in arm where HPV received compared to arm where concomitant vaccines received. The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.
Time frame: 10 minutes following vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Received HPV Vaccine First | Pain Following HPV Vaccine | 17 participants |
| Received Concomitant Vaccines First | Pain Following HPV Vaccine | 32 participants |