Human Papillomavirus-Related Carcinoma
Conditions
Brief summary
Human papillomavirus (HPV) is a common sexually-transmitted virus which causes infections that usually last only a few months, but sometimes can last a long time and cause cancers of the cervix, vagina, vulva, anus or oropharynx over many years among adults. This phase IIA trial studies how well does the nonavalent HPV vaccine (which can prevent nine different types of HPV) work when given in an alternative dosing schedule to heathy young research participants.
Detailed description
PRIMARY OBJECTIVES: I. To determine the persistence and stability of serologic geometric mean titer (GMT) of HPV 16/18 between 6, 12, 18, and 24 months after the prime dose and prior to the administration of the second dose. SECONDARY OBJECTIVES: I. To determine the persistence and stability of serologic GMT of HPV types 6/11/31/33/45/52/58 between 6, 12, 18, and 24 months after prime dose and prior to the administration of the second dose. II. To assess safety and reactogenicity to each vaccine dose. OUTLINE: Participants receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline (priming injection) and at 24 and 30 months (booster injections). After completion of study, participants are followed up for 2 weeks.
Interventions
OTHERLaboratory Biomarker Analysis
Correlative studies
Given IM
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, medically well girls and boys * Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant * Ability to understand and the willingness to sign a written assent document by the participant
Exclusion criteria
* Previous vaccination against HPV * The use of any investigational agent within 30 days preceding the first dose of the study vaccine or subsequent participation in another clinical trial at any time during the study period, in which the subject will be exposed to an investigational product * Chronic administration of immunosuppressive agents or other immune-modifying drugs or chemotherapeutic agents within six months prior to the first vaccine dose; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed * Receiving active treatment for cancer or an autoimmune condition * Confirmed or suspected immunosuppressive or immunodeficient condition * Known bleeding disorders that preclude intramuscular injection (e.g., on anticoagulants or thrombocytopenia) * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal dysfunction, which in the opinion of the investigator precludes administration of the study vaccine * History of allergic reactions attributed to compounds of similar chemical or biologic composition of GARDASIL 9 (recombinant human papillomavirus nonavalent vaccine), including yeast allergy * Are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Human Papilloma Virus (HPV)16/18 Antibody Titer | Between 6 and 24 months after prime dose and prior to the administration of the second dose | Difference in the log-transformed HPV 16/18 antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11 | Data are not available. The study team is working on analyzing the antibody titers of other HPV types. | Difference in the log-transformed HPV type-specific antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose. |
| Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 2 weeks post-treatment | — |
| Vaccine Reactogenicity | Up to 30 months | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHsiao-Hui (Sherry) Chow
The University of Arizona Medical Center-University Campus
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prevention (Gardasil 9) Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).
Laboratory Biomarker Analysis: Correlative studies
Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM | 201 |
| Total | 201 |
Baseline characteristics
| Characteristic | Prevention (Gardasil 9) |
|---|---|
| Age, Continuous | 10 years STANDARD_DEVIATION 0.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 100 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 23 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 27 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 131 Participants |
| Region of Enrollment United States | 201 participants |
| Sex: Female, Male Female | 143 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 201 |
| other Total, other adverse events | 151 / 201 |
| serious Total, serious adverse events | 2 / 201 |
Outcome results
Primary
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer
Difference in the log-transformed HPV 16/18 antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.
Time frame: Between 6 and 24 months after prime dose and prior to the administration of the second dose
Population: Analysis on participants who provided blood samples in all study visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prevention (Gardasil 9) | Change in Human Papilloma Virus (HPV)16/18 Antibody Titer | Difference in HPV16 titers between 6 and 12 months | -0.55 Log10 IU/ml | Standard Deviation 0.54 |
| Prevention (Gardasil 9) | Change in Human Papilloma Virus (HPV)16/18 Antibody Titer | Difference in HPV16 titers between 12 and 18 months | 0.03 Log10 IU/ml | Standard Deviation 0.62 |
| Prevention (Gardasil 9) | Change in Human Papilloma Virus (HPV)16/18 Antibody Titer | Difference in HPV16 titers between 18 and 24 months | -0.002 Log10 IU/ml | Standard Deviation 0.64 |
| Prevention (Gardasil 9) | Change in Human Papilloma Virus (HPV)16/18 Antibody Titer | Difference in HPV18 titers between 6 and 12 months | -0.38 Log10 IU/ml | Standard Deviation 0.46 |
| Prevention (Gardasil 9) | Change in Human Papilloma Virus (HPV)16/18 Antibody Titer | Difference in HPV18 titers between 12 and 18 months | -0.005 Log10 IU/ml | Standard Deviation 0.53 |
| Prevention (Gardasil 9) | Change in Human Papilloma Virus (HPV)16/18 Antibody Titer | Difference in HPV18 titers between 18 and 24 months | -0.02 Log10 IU/ml | Standard Deviation 0.63 |
Secondary
Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11
Difference in the log-transformed HPV type-specific antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.
Time frame: Data are not available. The study team is working on analyzing the antibody titers of other HPV types.
Secondary
Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Time frame: Up to 2 weeks post-treatment
Secondary
Vaccine Reactogenicity
Time frame: Up to 30 months