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HPV Vaccination Immune Response Study
Study Summary
This trial will assess the immune response in different parts of the body to the HPV vaccine in order to better understand how the vaccine works.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am between 18 and 45 years old.I have had cancer other than skin cancer, but it was surgically removed and considered cured.I haven't had, nor plan to have, major surgery within 4 weeks of joining this study.I have had an organ, bone marrow, or stem cell transplant.I am willing to have needle tests on my lymph nodes and bone marrow.I have diabetes and need insulin to manage it.I have not received blood products or immunoglobulin in the last 3 months.I have a history of genital warts, an abnormal pap smear, or a positive HPV test.I have tested positive for one of the HPV types listed.I have received an HPV vaccine dose.I do not have chronic infections like HIV, TB, or hepatitis.I have a bleeding disorder or am currently on blood thinners or NSAIDs.I have a weak immune system due to a condition or medication.I believe I need sedation for certain needle procedures.I have a history of lymphoma, breast cancer, recent arm inflammation, or surgeries that might affect immune response.I haven't taken any experimental drugs in the last year and won't for the next year, except for COVID-19 vaccines.I have an infection, swollen lymph nodes, or rash in the area to be treated.I have not had a fever of 100.4 F or higher in the last 3 days.I am currently immunosuppressed due to cancer treatment.You must agree to let the researchers keep any leftover samples or specimens for future use.
- Group 1: Group 2: Lymph node sampling at D60, D74 and D90
- Group 2: Group 3: Lymph node sampling at D180, D194 and D210
- Group 3: Group 1: Lymph node sampling at D-30 to D0, D14 and D30
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this analysis a pioneering endeavor in its field?
"Since 2002, Merck Sharp & Dohme Corp. have sponsored a series of clinical trials for Gardasil; the initial study in 2002 involved 12167 participants and yielded Phase 3 drug approval. Currently, there are 149 ongoing studies located across 573 cities and 47 countries."
What are the criteria for qualification to participate in this experimental research?
"This research project is looking for 32 individuals with HPV aged 18 to 45 that meet the following requirements: general good health, availability and willingness to remain in the study until its completion, consenting to future use of residual specimens, BMI ≤ 32., INR < 1.2 (if available from recent medical records)."
To what extent has participation in this experiment been embraced?
"Affirmative. Clinicaltrials.gov records demonstrate that this research is actively enrolling patients; the study was initially published on December 21st 2021 and last updated on the same day, with a need for 32 participants at 2 sites."
In what contexts is Gardasil employed to aid individuals?
"Gardasil is commonly prescribed to treat cervical syndrome, however the medication can additionally be employed for treating minor burns, transplantation and osteoporosis."
Does the participant pool for this clinical trial encompass individuals under 30 years of age?
"In accordance with the trial's enrollment requirements, participants must fall between 18 and 45 years of age."
What other research has been conducted in regard to Gardasil's efficacy?
"Presently, 149 clinical trials related to Gardasil are being conducted. Of those active studies, 47 have progressed into Phase 3 testing. Most of those experiments are centred in Calgary, Alberta however 1336 various locations across the world offer this medication research program."
Does this experiment have any available slots for participants?
"Correct. Data hosted on clinicaltrials.gov states that this experiment, which was initially introduced on December 21st 2021, is presently looking for individuals to take part in the study. The trial requires 32 test subjects between two centres of research."
What potential risks should be considered when evaluating Gardasil as a form of medication?
"There are ample data points to indicate that Gardasil is safe, thus it received a score of 3 on our scale. This vaccine has already been approved by the authorities for Phase 4 trials."
Who else is applying?
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What site did they apply to?
What portion of applicants met pre-screening criteria?
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Why did patients apply to this trial?
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