Papilloma Viral InfectionNCT01030562
Immunogenicity of Off-Schedule Dosing of HPV Vaccine
An observational study of Papilloma Viral Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.
Trial summary
The purpose of this study is to gain a better understanding of the body's response to a human papillomavirus (HPV) (sexually transmitted disease), vaccine and booster shot. The study will also determine factors related to adolescents not following vaccination schedules. The HPV vaccine requires 3 doses (shots). Read more about this study
- Who is it for?
- Ages 9 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Papilloma Viral Infection
- How many people
- 1,321 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Jun 2010to 5 Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Girls 9-17 years old receiving third dose of HPV vaccine from primary care clinician. Parent/legal guardian will participate by answering a questionnaire to determine factors related to non-adherence to recommended vaccine schedule.
Who may be able to join
- Girls will be eligible if they are: -9 to 17 years of age (defined as between 9 years 0 days and younger than 18 years of age) at time of receipt of third HPV dose; -Receiving the third human papillomavirus (HPV) vaccine as part of routine health care; -Able and willing to complete all study visits and evaluations; -Able and willing to participate in the study by providing written informed assent/consent (as applicable); -Parent or legal guardian provides permission (as applicable). Parent/legal guardian inclusion criteria: At sites administering the survey and health literacy assessment, parent or legal guardian providing permission for their daughter to participate in the study will be eligible to participate in the parental questionnaire if they are able to provide informed consent for themselves.
Who cannot join
- Girls meeting any of the following exclusion criteria at baseline will be excluded from study participation. -Unable to comply with the study protocol. -Receipt of more than 3 doses of human papillomavirus (HPV) vaccine. -Receipt of blood and or blood products (including immunoglobulin) in the past 3 months or anticipated receipt during the study period. -History of any physical, mental, or developmental disorder that study personnel believe may hinder a participant's ability to comply with the study requirements. -History of malignancy or confirmed or suspected immunodeficient condition, such as human immunodeficiency virus infection. -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 or anticipated receipt during the study period. Specifically, potentially immunosuppressive corticosteroids or any parenteral corticosteroid, high dose (>800 mcg/day) beclomethasone dipropionate or equivalent medication; nasal and topical steroids are allowed. -Current or former participation in HPV vaccine related research. -Receipt of an investigational or alternate (Cervarix) HPV vaccine. -Receipt of a live virus vaccine (varicella virus vaccine, any measles, mumps, or rubella virus vaccine, or yellow fever vaccine but not including live attenuated influenza virus vaccine) within 4 weeks before or after the 3rd dose of HPV vaccine or anticipated receipt of a live virus vaccine within 4 weeks after the 3rd dose of HPV vaccine. However, subjects may receive any vaccine on the same day as the third dose of HPV. Parent/legal guardian exclusion criteria: If the site is actively recruiting adolescents from a clinic population, the survey and health literacy assessments are not available for the parents/legal guardians from that clinic population. Therefore they will not be asked to participate in the study. -At sites administering the survey and health literacy assessment, parents/legal guardians meeting any of the following exclusion criteria at baseline will be excluded from filling out the study questionnaire examining factors associated with adherence: -History of any physical, mental or developmental disorder that study personnel believe may hinder a participant's ability to comply with study requirements.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201-1509
Cincinnati Children?s Hospital Medical Center - Adolescent Medicine
Cincinnati, Ohio, 45229-3039
Children's Mercy Hospital and Clinics - Infectious Diseases
Kansas City, Missouri, 64108-4619
Monroe Carell Jr. Children's Hospital at Vanderbilt - Adolescent Medicine
Nashville, Tennessee, 37232-0001
Primary Physicians Research Inc. - Pittsburgh
Pittsburgh, Pennsylvania, 15241-3100
Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases
Seattle, Washington, 98101-1466
Kaiser Permanente Crescent Medical Center - Pediatrics/Adolescent Medicine
Tucker, Georgia, 30084-7047
About this study
Official title: Immunogenicity of the HPV-6, 11, 16, 18 Vaccine Among Adolescent Girls Who Receive Vaccine Doses at Non-recommended Intervals and Factors Related to Non-adherence
The purpose of this study is to gain a better understanding of the body's response to a human papillomavirus (HPV) (sexually transmitted disease), vaccine and booster shot. The study will also determine factors related to adolescents not following vaccination schedules. The HPV vaccine requires 3 doses (shots). Girls sometimes receive the 3 shots at the recommended time and sometimes girls receive the shots at non-recommended times. This study will evaluate if getting the shots at non-recommended times affects the level of protection provided by the vaccine. Participants will include about 1400 girls 9-17 years old receiving a third dose of HPV vaccine from their primary care clinician. The parent/legal guardian of each subject may answer a questionnaire related to the vaccine schedule. Study procedures include: medical history, questionnaires and blood draws. Participants will be involved in the study for about 6 months from time of enrollment.
Read the detailed description
The immune response to the quadrivalent human papillomavirus (HPV) vaccine in the non-clinical trial settings is unknown. In addition, the immune response following administration of vaccine at substantially prolonged intervals is unknown. Early indications suggest that many girls will be receiving the vaccine at prolonged intervals and that this timing may affect immunogenicity. The lack of knowledge about the immunogenicity of prolonged intervals between vaccine doses precludes evidence based recommendations for patients who are substantially late for their second or third dose. Some clinicians currently restart the series while others give the doses at the incorrect interval (unpublished observation) without the ability to counsel their patients as to their expected level of immune response or protection. Examining the immune response prior to the third dose and at one and six months after the third dose will allow a better understanding of the immunogenicity of this vaccine and immune response to booster doses. Furthermore, determining factors related to non-adherence in the adolescent age group is important and timely. As an increasing number of vaccines are being recommended to the adolescent age group, elucidating factors involved with non-adherence to the recommended dosing schedule is now critical. This information can guide interventions that aim to increase adolescent adherence to the recommended schedules. Eligible girls 9 - 17 years old receiving the quadrivalent HPV vaccine from their primary care provider will be enrolled into this study on the day of, but prior to, receiving their third HPV vaccine dose or at approximately 28 days after the third HPV dose . Blood for immunogenicity testing will be obtained up to three times throughout the study: one month (Study Day 28) and six months (Study Day 180) after the third dose (Study Day 0) for all subjects and just prior to the third dose for subjects on time for their third dose (regardless of the time interval between the first and second dose). The primary analysis will be based on comparing the geometric mean titer (GMTs) and sero-response rate of subjects receiving the vaccine doses at substantially prolonged intervals to GMTs and sero-response rate of subjects receiving the second and third dose on time. In addition, on Study Day 0, patient and parent related factors known to impact health care utilization may be measured using a questionnaire given to parents/legal guardians and 14 to 17 year old subjects. Analysis based on a health care utilization model will be used to determine factors associated with non-adherence to the vaccine schedule. Initially, all subjects meeting eligibility criteria will be enrolled regardless of timing of the second and third vaccine doses. When a study arm reaches the accrual target, it will be closed to enrollment. Enrollment for the entire study will remain open until the control and three primary experimental arms have completed enrollment One or more experimental arms may be dropped from the study after monitoring of accrual rates indicates that it/they cannot be fully enrolled in a timely fashion. Monitoring will occur monthly. Assessment of accrual rates will occur semi-annually. The primary objective is to compare the GMT one month after completing the three dose vaccination series in 9 to 17 year old subjects who received the second and/or third dose at substantially prolonged intervals to subjects who receive both the second and third dose on time after adjusting for age.
- Conditions
- Papilloma Viral Infection
- Keywords
- adolescent, children, HPV, human papillomavirus, vaccine, women
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alternate Arm | Subjects who meet eligibility requirements but do not fit into any of the primary experimental arms. | |
| Control Arm | Subjects with an on-time interval between Dose 1 and 2 and an on-time interval between Dose 2 and 3. | |
| Experimental/Primary Arm 1 | This primary arm will consist of subjects receiving the second dose on time/third dose substantially late. | |
| Experimental/Primary Arm 2 | This primary arm will consist of subjects receiving the second dose substantially late/third dose on time. | |
| Experimental/Primary Arm 3 | This primary arm will consist of subjects receiving the second dose substantially late/third dose substantially late. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) to vaccine human papillomavirus (HPV) serotypes as measured by HPV4-plex IgG ELISA.
Measured: One month after the third HPV vaccine dose.
Sero-response rate (proportion of subjects developing antibody to vaccine HPV serotypes).
Measured: One month after the third HPV vaccine dose.
Secondary outcomes (2)
GMT to vaccine HPV serotypes as measured by HPV4-plex IgG ELISA
Measured: Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose.
Sero-response rate (proportion of subjects developing antibody to vaccine HPV serotypes).
Measured: Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study start2 Jun 2010
- Primary completion5 Mar 2014
- Study completion5 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papilloma Viral InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,321 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030562
- Sponsor's protocol ID
- 08-0012
- Status last verified
- 31 Jul 2013
- First submitted
- 10 Dec 2009
- Last updated
- 29 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Widdice LE, Hoagland R, Callahan ST, Kahn JA, Harrison CJ, Pahud BA, Frey SE, Berry AA, Kotloff KL, Edwards KM, Mulligan MJ, Sudman J, Nakamura A, Bernstein DI. Caregiver and adolescent factors associated with delayed completion of the three-dose human papillomavirus vaccination series. Vaccine. 2018 Mar 7;36(11):1491-1499. doi: 10.1016/j.vaccine.2017.12.060. Epub 2018 Feb 7.
PubMed 29428177
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of the HPV-6, 11, 16, 18 Vaccine Among Adolescent Girls Who Receive Vaccine Doses at Non-recommended Intervals and Factors Related to Non-adherence
- ClinicalTrials.gov ID
- NCT01030562
- Acronym / sponsor ID
- 08-0012
- Conditions
- Papilloma Viral Infection
- Keywords
- adolescent, children, HPV, human papillomavirus, vaccine, women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,321 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 2 Jun 2010 (actual)
- Primary completion
- 5 Mar 2014 (actual)
- Study completion
- 5 Mar 2014 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gain a better understanding of the body's response to a human papillomavirus (HPV) (sexually transmitted disease), vaccine and booster shot. The study will also determine factors related to adolescents not following vaccination schedules. The HPV vaccine requires 3 doses (shots). Girls sometimes receive the 3 shots at the recommended time and sometimes girls receive the shots at non-recommended times. This study will evaluate if getting the shots at non-recommended times affects the level of protection provided by the vaccine. Participants will include about 1400 girls 9-17 years old receiving a third dose of HPV vaccine from their primary care clinician. The parent/legal guardian of each subject may answer a questionnaire related to the vaccine schedule. Study procedures include: medical history, questionnaires and blood draws. Participants will be involved in the study for about 6 months from time of enrollment.
Detailed description
The immune response to the quadrivalent human papillomavirus (HPV) vaccine in the non-clinical trial settings is unknown. In addition, the immune response following administration of vaccine at substantially prolonged intervals is unknown. Early indications suggest that many girls will be receiving the vaccine at prolonged intervals and that this timing may affect immunogenicity. The lack of knowledge about the immunogenicity of prolonged intervals between vaccine doses precludes evidence based recommendations for patients who are substantially late for their second or third dose. Some clinicians currently restart the series while others give the doses at the incorrect interval (unpublished observation) without the ability to counsel their patients as to their expected level of immune response or protection. Examining the immune response prior to the third dose and at one and six months after the third dose will allow a better understanding of the immunogenicity of this vaccine and immune response to booster doses. Furthermore, determining factors related to non-adherence in the adolescent age group is important and timely. As an increasing number of vaccines are being recommended to the adolescent age group, elucidating factors involved with non-adherence to the recommended dosing schedule is now critical. This information can guide interventions that aim to increase adolescent adherence to the recommended schedules. Eligible girls 9 - 17 years old receiving the quadrivalent HPV vaccine from their primary care provider will be enrolled into this study on the day of, but prior to, receiving their third HPV vaccine dose or at approximately 28 days after the third HPV dose . Blood for immunogenicity testing will be obtained up to three times throughout the study: one month (Study Day 28) and six months (Study Day 180) after the third dose (Study Day 0) for all subjects and just prior to the third dose for subjects on time for their third dose (regardless of the time interval between the first and second dose). The primary analysis will be based on comparing the geometric mean titer (GMTs) and sero-response rate of subjects receiving the vaccine doses at substantially prolonged intervals to GMTs and sero-response rate of subjects receiving the second and third dose on time. In addition, on Study Day 0, patient and parent related factors known to impact health care utilization may be measured using a questionnaire given to parents/legal guardians and 14 to 17 year old subjects. Analysis based on a health care utilization model will be used to determine factors associated with non-adherence to the vaccine schedule. Initially, all subjects meeting eligibility criteria will be enrolled regardless of timing of the second and third vaccine doses. When a study arm reaches the accrual target, it will be closed to enrollment. Enrollment for the entire study will remain open until the control and three primary experimental arms have completed enrollment One or more experimental arms may be dropped from the study after monitoring of accrual rates indicates that it/they cannot be fully enrolled in a timely fashion. Monitoring will occur monthly. Assessment of accrual rates will occur semi-annually. The primary objective is to compare the GMT one month after completing the three dose vaccination series in 9 to 17 year old subjects who received the second and/or third dose at substantially prolonged intervals to subjects who receive both the second and third dose on time after adjusting for age.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Alternate Arm | – | –Subjects who meet eligibility requirements but do not fit into any of the primary experimental arms. |
| Control Arm | – | –Subjects with an on-time interval between Dose 1 and 2 and an on-time interval between Dose 2 and 3. |
| Experimental/Primary Arm 1 | – | –This primary arm will consist of subjects receiving the second dose on time/third dose substantially late. |
| Experimental/Primary Arm 2 | – | –This primary arm will consist of subjects receiving the second dose substantially late/third dose on time. |
| Experimental/Primary Arm 3 | – | –This primary arm will consist of subjects receiving the second dose substantially late/third dose substantially late. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Girls 9-17 years old receiving third dose of HPV vaccine from primary care clinician. Parent/legal guardian will participate by answering a questionnaire to determine factors related to non-adherence to recommended vaccine schedule.
Key inclusion criteria (1 listed)
- Girls will be eligible if they are: -9 to 17 years of age (defined as between 9 years 0 days and younger than 18 years of age) at time of receipt of third HPV dose; -Receiving the third human papillomavirus (HPV) vaccine as part of routine health care; -Able and willing to complete all study visits and evaluations; -Able and willing to participate in the study by providing written informed assent/consent (as applicable); -Parent or legal guardian provides permission (as applicable). Parent/legal guardian inclusion criteria: At sites administering the survey and health literacy assessment, parent or legal guardian providing permission for their daughter to participate in the study will be eligible to participate in the parental questionnaire if they are able to provide informed consent for themselves.
Key exclusion criteria (1 listed)
- Girls meeting any of the following exclusion criteria at baseline will be excluded from study participation. -Unable to comply with the study protocol. -Receipt of more than 3 doses of human papillomavirus (HPV) vaccine. -Receipt of blood and or blood products (including immunoglobulin) in the past 3 months or anticipated receipt during the study period. -History of any physical, mental, or developmental disorder that study personnel believe may hinder a participant's ability to comply with the study requirements. -History of malignancy or confirmed or suspected immunodeficient condition, such as human immunodeficiency virus infection. -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 or anticipated receipt during the study period. Specifically, potentially immunosuppressive corticosteroids or any parenteral corticosteroid, high dose (>800 mcg/day) beclomethasone dipropionate or equivalent medication; nasal and topical steroids are allowed. -Current or former participation in HPV vaccine related research. -Receipt of an investigational or alternate (Cervarix) HPV vaccine. -Receipt of a live virus vaccine (varicella virus vaccine, any measles, mumps, or rubella virus vaccine, or yellow fever vaccine but not including live attenuated influenza virus vaccine) within 4 weeks before or after the 3rd dose of HPV vaccine or anticipated receipt of a live virus vaccine within 4 weeks after the 3rd dose of HPV vaccine. However, subjects may receive any vaccine on the same day as the third dose of HPV. Parent/legal guardian exclusion criteria: If the site is actively recruiting adolescents from a clinic population, the survey and health literacy assessments are not available for the parents/legal guardians from that clinic population. Therefore they will not be asked to participate in the study. -At sites administering the survey and health literacy assessment, parents/legal guardians meeting any of the following exclusion criteria at baseline will be excluded from filling out the study questionnaire examining factors associated with adherence: -History of any physical, mental or developmental disorder that study personnel believe may hinder a participant's ability to comply with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Geometric mean titer (GMT) to vaccine human papillomavirus (HPV) serotypes as measured by HPV4-plex IgG ELISA.
Time frame: One month after the third HPV vaccine dose.
Sero-response rate (proportion of subjects developing antibody to vaccine HPV serotypes).
Time frame: One month after the third HPV vaccine dose.
2 secondary outcomes
GMT to vaccine HPV serotypes as measured by HPV4-plex IgG ELISA
Time frame: Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose.
Sero-response rate (proportion of subjects developing antibody to vaccine HPV serotypes).
Time frame: Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Derived from this study: PubMed 29428177Widdice LE, Hoagland R, Callahan ST, Kahn JA, Harrison CJ, Pahud BA, Frey SE, Berry AA, Kotloff KL, Edwards KM, Mulligan MJ, Sudman J, Nakamura A, Bernstein DI. Caregiver and adolescent factors associated with delayed completion of the three-dose human papillomavirus vaccination series. Vaccine. 2018 Mar 7;36(11):1491-1499. doi: 10.1016/j.vaccine.2017.12.060. Epub 2018 Feb 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papilloma Viral Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titer (GMT) to vaccine human papillomavirus (HPV) serotypes as measured by HPV4-plex IgG ELISA. (time frame: One month after the third HPV vaccine dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01030562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.