Trial Summary
What is the purpose of this trial?
The goal of this study is to explore and evaluate whether a 2-dose schedule of Gardasil 9 among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an antibody response that is not inferior to that observed of a 3-dose schedule of Gardasil 9 among women aged 16-26 years old. The investigators thought that having a 2-dose vaccination regimen for individuals 16 to 45 would provide a more robust dataset than those of 27 to 45 years old.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications.
What data supports the idea that Gardasil 9 Vaccination Regimen for HPV is an effective treatment?
The available research shows that Gardasil 9 is effective in preventing HPV infections. It covers more HPV types than earlier vaccines, increasing protection from about 70% to 90% against cervical cancer-causing strains. Clinical trials demonstrated that the vaccine is safe and effective, with strong immune responses in both young women and younger boys and girls. The 2-dose regimen for younger individuals was found to be as effective as the 3-dose regimen for older individuals, making it a practical and efficient option.12345
What safety data is available for Gardasil 9?
Gardasil 9, a 9-valent HPV vaccine, has been evaluated for safety in multiple studies. A post-licensure study in the USA assessed its safety following routine administration. Nonclinical studies in rats showed no adverse effects, with expected immune responses and local inflammation that resolved over time. A study in Italy reported a low rate of adverse events, with only 2 serious events consistently associated with the vaccine out of 266,647 doses. Overall, Gardasil 9 has a favorable safety profile with a low rate of serious adverse events.12367
Is Gardasil 9 a promising drug for HPV?
Eligibility Criteria
This trial is for women aged 16-45 who are patients at Boston Medical Center and have not been vaccinated against HPV. They must not be pregnant, breastfeeding, have blood clotting disorders, severe allergies (especially to yeast), or a compromised immune system.Inclusion Criteria
I am a woman receiving care at Boston Medical Center.
Exclusion Criteria
You've had a severe allergic reaction before, especially to yeast, or you know you're allergic to any part of the vaccine.
I have a blood clotting disorder or low platelet count.
I have received the HPV vaccine.
See 3 more
Treatment Details
Interventions
- Gardasil 9 2 dose regimen (Cancer Vaccine)
- Gardasil 9 3 dose regimen (Cancer Vaccine)
- Gardasil 9 rescue dose (Cancer Vaccine)
Trial OverviewThe study tests if two doses of Gardasil 9 provide the same immune response in women aged 16-45 as three doses do in those aged 16-26. It also explores the safety of this reduced-dose regimen compared to the standard three-dose schedule.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment2 Interventions
240 eligible women will receive a 2-dose regimen of Gardasil 9 at (0 and 6 months, followed by a rescue 3rd dose at month 12)
Group II: Control groupActive Control1 Intervention
120 eligible women will receive the standard 3-dose regimen of Gardasil 9 at (0, 2, 6 months)
Gardasil 9 2 dose regimen is already approved in European Union, United States for the following indications:
🇪🇺 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
- Genital warts caused by HPV Types 6 and 11
🇺🇸 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
- Genital warts caused by HPV Types 6 and 11
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Medical CenterBoston, MA
Loading ...
Who Is Running the Clinical Trial?
Boston Medical CenterLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
References
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.
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.
[Nine-valent HPV vaccine - new generation of HPV vaccine]. [2018]To evaluate current knowledge about new generation of HPV vaccine - nine-valent vaccine Gardasil9.
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.
HPV16/18 Antibody Responses After a Single Dose of Nonavalent HPV Vaccine. [2023]A single dose of human papillomavirus (HPV) vaccine would simplify logistics and reduce costs of vaccination programs worldwide. We conducted a phase IIa trial to determine the stability of HPV type-specific antibody responses after a single dose of the nonavalent HPV vaccine, Gardasil9.
Evaluation of a 9-valent HPV vaccine in Sprague-Dawley rats: Nonclinical studies assessing general, reproductive, and developmental toxicity. [2019]GARDASIL®9, a 9-valent vaccine against human papillomavirus (9vHPV), was developed to prevent diseases mediated by HPV types 6/11/16/18/31/33/45/52/58. During the development of the vaccine, three nonclinical safety studies were conducted to evaluate repeat-dose toxicity and prenatal and postnatal developmental toxicity in Sprague-Dawley rats. In all studies, the vaccine was administered via intramuscular injections of 0.5 mL (the human dose) divided equally into each quadriceps muscle. In the repeat-dose toxicity study, potential local and systemic toxic effects of the 9vHPV vaccine were evaluated after 4 doses given 21 days apart and after a 21-day recovery period. In the prenatal study, virgin females were dosed at 5 and 2 weeks prior to mating and on Gestation Day [GD] 6 (3 total doses). Potential postnatal developmental toxicity of the vaccine formulation was evaluated after 4 total doses (premating to lactation). There were no treatment-related unscheduled deaths in any studies. In the 3-month repeat-dose toxicity study, no adverse effects in male or female rats were observed. Anticipated systemic effects representing immunological responses and local inflammatory reactions at the injection sites were noted in the vaccine-treated groups, with a trend toward recovery by the end of the 21-day recovery period. In the prenatal developmental toxicity study, there was no evidence of toxicity in females given the vaccine. There were no effects on fertility or reproductive performance of the parental females and no evidence of developmental toxicity. In the postnatal study, there was no evidence of toxicity in vaccine-treated females and no evidence of developmental toxicity based on standard postnatal parameters, including behavioral testing and reproductive performance. The vaccine induced antibody responses in all studies and vaccine-specific antibodies were detected in offspring in the developmental toxicity studies. These results support the favorable safety profile of GARDASIL®9.
Real-Life Safety Profile of the 9-Valent HPV Vaccine Based on Data from the Puglia Region of Southern Italy. [2022]Human Papillomavirus (HPV) is responsible for epithelial lesions and cancers in both males and females. The latest licensed HPV vaccine is Gardasil-9®, a 9-valent HPV vaccine which is effective not only against the high-risk HPV types, but also against the ones responsible for non-cancerous lesions. This report describes adverse events following Gardasil-9® administration reported in Puglia, southern Italy, from January 2018 to November 2021. This is a retrospective observational study. Data about the adverse events following immunization (AEFIs) with Gardasil-9® were collected from the Italian Drug Authority database. AEFIs were classified as serious or non-serious accordingly to World Health Organization guidelines, and serious ones underwent causality assessment. During the study period, 266,647 doses of 9vHPVv were administered in Puglia and 22 AEFIs were reported, with a reporting rate (RR) of 8.25 per 100,000 doses. The most reported symptoms were neurological ones (7/22). A total of 5 (22.7%) AEFIs were classified as serious, and 2 of these led to the patient's hospitalization. In one case, permanent impairment occurred. Following causality assessment, only 2 out of 5 serious AEFIs were deemed to be consistently associated with the vaccination (RR: 0.750 per 100,000 doses). The data gathered in our study are similar to the pre-licensure evidence as far as the nature of the AEFIs is concerned. The reporting rate, though, is far lower than the ones described in clinical trials, likely due to the different approach to data collection: in our study, data were gathered via passive surveillance, while pre-marketing studies generally employ active calls for this purpose. Gardasil-9®'s safety profile appears to be favorable, with a low rate of serious adverse events and a risk/benefits ratio pending for the latter.