HPV Vaccine Dosing Schedules for Human Papillomavirus
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: The University of Texas Medical Branch, Galveston
Must not be taking: Immunosuppressants, Chemotherapy, Corticosteroids, others
Disqualifiers: Pregnancy, Immunodeficiency, Autoimmune diseases, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response. Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked to provide 4 blood samples over a period of 12 months. All 2-dose participants will be offered a 3rd dose after the final blood draw,12 months after their initial vaccination.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on treatments that suppress the immune system, like chemotherapy or certain immune-suppressing drugs.
What data supports the effectiveness of the drug Gardasil 9?
The 9-valent HPV vaccine, Gardasil 9, is shown to increase protection against cervical cancer from about 70% to 90% by covering additional HPV types compared to the earlier version. Clinical trials demonstrated that it is safe and effective, with strong immune responses in both young women and younger boys and girls.
12345Is the 9-valent HPV vaccine safe for humans?
The 9-valent HPV vaccine, also known as Gardasil 9, has been shown to be generally safe in humans. Studies found that the most common side effects were mild reactions at the injection site, and serious side effects were rare.
12367How is the 9-valent HPV vaccine different from other HPV vaccines?
The 9-valent HPV vaccine (Gardasil 9) is unique because it protects against nine different types of HPV, including five more types than the earlier quadrivalent vaccine, potentially offering broader protection against HPV-related diseases.
12389Eligibility Criteria
This trial is for females aged 27-45 who haven't had the HPV vaccine, use reliable birth control, and can consent. They must have a way to pay for the vaccine, speak English or Spanish, and have phone access. Pregnant women or those planning pregnancy soon, with suppressed immune systems or certain medical conditions are excluded.Inclusion Criteria
Identified source of funding for vaccine such as Medicaid, private health insurance, Texas Healthy Women program, etc.
Reports consistent use of reliable birth control and plans to continue its use through study month 13
Ability to give informed consent
+4 more
Exclusion Criteria
Plans to move out of the Galveston/Houston area in the 13 months following study entry
I have had more than 10 sexual partners in my lifetime.
Currently pregnant or plans to become pregnant or donate eggs in the next 13 months
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive either 2 or 3 doses of the 9-valent HPV vaccine over 6 months
6 months
4 visits (in-person) for blood draws and vaccinations
Follow-up
Participants are monitored for immune response through blood samples
12 months
4 visits (in-person) for blood draws
Open-label extension (optional)
Participants in the 2-dose group are offered a 3rd dose after the final blood draw
Post 12-month follow-up
Participant Groups
The study compares two schedules of the HPV vaccine: one group will receive two doses at different times while another gets three doses at standard intervals. The goal is to see if fewer doses still provide strong immunity against HPV over a year.
2Treatment groups
Experimental Treatment
Active Control
Group I: Females, 2-dose alternativeExperimental Treatment1 Intervention
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (27-45 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
Group II: Females, 3-dose standardActive Control1 Intervention
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (27-45 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine is already approved in United States, European Union, Canada, Switzerland for the following indications:
🇺🇸 Approved in United States as Gardasil 9 for:
- Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58
- Cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
- Genital warts caused by HPV Types 6 and 11
🇪🇺 Approved in European Union as Gardasil 9 for:
- Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58
- Cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
- Genital warts caused by HPV Types 6 and 11
🇨🇦 Approved in Canada as Gardasil 9 for:
- Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58
- Cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
- Genital warts caused by HPV Types 6 and 11
🇨🇭 Approved in Switzerland as Gardasil 9 for:
- Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58
- Cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
- Genital warts caused by HPV Types 6 and 11
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas Medical BranchGalveston, TX
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Who Is Running the Clinical Trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
Cancer Prevention Research Institute of TexasCollaborator
References
Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. [2016]To assess the safety and immunogenicity of the investigational 9-valent (6/11/16/18/31/33/45/52/58) HPV (9vHPV) vaccine in prior recipients of a 3-dose regimen of quadrivalent (6/11/16/18) HPV (qHPV) vaccine.
Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. [2023]The nine-valent human papillomavirus vaccine (HPV9, Gardasil®9) was licensed in the USA in December 2014. This study was a multiyear post-licensure study to assess HPV9 safety following routine administration.
[Nine-valent HPV vaccine - new generation of HPV vaccine]. [2018]To evaluate current knowledge about new generation of HPV vaccine - nine-valent vaccine Gardasil9.
Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. [2021]A 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine.
Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. [2019]Human papillomavirus is considered the causative factor for cervical cancer, which accounts for approximately 5% of the global cancer burden and more than 600,000 new cases annually that are attributable to HPV infection worldwide. The first-generation prophylactic HPV vaccines, Gardasil® and Cervarix®, were licensed approximately a decade ago. Both vaccines contain the most prevalent high-risk types, HPV16 and 18, which are associated with 70% of cervical cancer. To further increase the type coverage, 5 additional oncogenic HPV types (31, 33, 45, 52 and 58) were added to the existing Gardasil-4 to develop a 9-valent HPV vaccine (9vHPV), Gardasil 9®, increasing the potential level of protection from ∼70% to ∼90%. The efficacy of the vaccine lies primarily in its ability to elicit type-specific and neutralizing antibodies to fend off the viral infection. Therefore, type-specific and neutralizing murine monoclonal antibodies (mAbs) were used to quantitate the antigenicity of the individual vaccine antigens and to measure the antibody levels in the serum samples from vaccinees in a type- and epitope-specific manner in a competitive immunoassay. Assays for 9vHPV are extended from the proven platform used for 4vHPV by developing and adding new mAbs against the additional types. In Phase III clinical trials, comparable safety profile and immunogenicity against the original 4 types were demonstrated for the 9vHPV vaccine, and these were comparable to the 4vHPV vaccine. The efficacy of the 9vHPV vaccine was established in trials with young women. Immunobridging for younger boys and girls was performed, and the results showed higher immunogenicity in the younger age group. In a subsequent clinical trial, the 2-dose regimen of the 9vHPV vaccine used among girls and boys aged 9-14 y showed non-inferior immunogenicity to the regular 3-dose regimen for young women (aged 16-26 years). Overall, the clinical data and cost-effectiveness analysis for the 9vHPV vaccine support its widespread use to maximize the impact of this important, life-saving vaccine.
Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. [2019]A 9-valent HPV (9vHPV) vaccine has been developed to protect against HPV type 6/11/16/18/31/33/45/52/58-related infection and disease. Previous safety analyses from 7 clinical trials conducted in 9vHPV vaccine recipients 9-26 years of age, including comparisons of 9vHPV and quadrivalent HPV (qHPV) vaccines in girls and women 16-26 years of age, showed that the 9vHPV vaccine was generally well tolerated. Additional safety analyses were conducted to include the results of new clinical studies. The safety profile of the 9vHPV vaccine in prior qHPV vaccine recipients (n = 3756 from 1 randomized controlled trial and 2 open-label extension studies) and young men (n = 248 9vHPV and n = 248 qHPV vaccine recipients from 1 randomized controlled trial) was evaluated. Vaccine was administered as a 3-dose regimen (at Day 1 and Months 2 and 6), and adverse events (AEs) were monitored. The most common AEs were injection-site events (91.1% and 79.0% in prior qHPV vaccine recipients and young men, respectively), the majority of which were mild. Discontinuations due to an AE were rare (0.2% and 0.0% among prior qHPV vaccine recipients and young men, respectively). In young men, the AE profile of the 9vHPV vaccine was generally similar to that of the qHPV vaccine. Overall, the 9vHPV vaccine was generally well tolerated in prior qHPV vaccine recipients and in young men, with an AE profile generally consistent with that previously reported with the broader clinical program.
Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. [2019]The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine was evaluated across 7 Phase III studies, conducted in males and females (nonpregnant at entry), 9 to 26 years of age.
Randomized controlled trial of two dosing schedules for human papillomavirus vaccination among college age males. [2021]Quadrivalent human papillomavirus (HPV) vaccine, for protection against sexually transmitted HPV infection, is licensed for females and males 9-26 years on a 3-dose schedule (0, 2, and 6 months; Standard schedule). Vaccine uptake has been low and catch-up vaccination of older adolescents using an alternate dosing schedule may increase coverage. This study tested the non-inferiority of the immunogenicity of an alternate dosing schedule (0, 2, 12 months) among college age males.
Immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccine versus two doses of nonavalent vaccine - A randomized clinical trial. [2020]Limited data is available on the use of different HPV vaccines in the same subjects. We evaluated the immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent (9vHPV) and one dose of bivalent vaccine (2vHPV) administered in different order versus two doses of 9vHPV vaccine.