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Cancer Vaccine

HPV Vaccine for HPV Prevention

Q: Is this the inaugural research endeavor of its kind?

<p>Since 2002, Merck Sharp &#x26; Dohme Corp. has been researching the efficacy of Recombinant Human Papillomavirus Nonavalent <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a>. The initial trial in 2002 saw 12167 participants, leading to its eventual Phase 3 drug approval. Currently there are 32 clinicial trials for this vaccine being conducted across 129 cities and 32 countries.</p>

Phase 2

Waitlist Available

Led By Yi Zeng

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between 6 and 24 months after prime dose and prior to the administration of the second dose

Awards & highlights

Study Summary

This trial is testing how well a new HPV vaccine works in preventing HPV infections.

Who is the study for?

This trial is for healthy, medically well boys and girls who can understand and agree to participate. They must not have had an HPV vaccine before, be on immunosuppressive drugs, or have significant health issues like heart or kidney problems. Pregnant individuals or those with a history of allergic reactions to similar vaccines are excluded.Check my eligibility

What is being tested?

The study is testing the effectiveness of the nonavalent HPV vaccine given in a different dosing schedule to prevent nine types of HPV in young participants. It also involves laboratory analysis to monitor biomarkers related to the vaccine's effect.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones for vaccines like this may include pain at injection site, fever, headache, fatigue, muscle or joint pain. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I (or my legal representative) can understand and am willing to sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between 6 and 24 months after prime dose and prior to the administration of the second dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between 6 and 24 months after prime dose and prior to the administration of the second dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and between 6 and 24 months after prime dose and prior to the administration of the second dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Human Papilloma Virus (HPV)16/18 Antibody Titer

Secondary outcome measures

Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11

Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Vaccine Reactogenicity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (Gardasil 9)Experimental Treatment2 Interventions

Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,658 Previous Clinical Trials

40,924,288 Total Patients Enrolled

1,394 Trials studying Carcinoma

387,317 Patients Enrolled for Carcinoma

Yi ZengPrincipal InvestigatorThe University of Arizona Medical Center-University Campus

1 Previous Clinical Trials

56 Total Patients Enrolled

Media Library

Recombinant Human Papillomavirus Nonavalent Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02568566 — Phase 2

Carcinoma Research Study Groups: Prevention (Gardasil 9)

Carcinoma Clinical Trial 2023: Recombinant Human Papillomavirus Nonavalent Vaccine Highlights & Side Effects. Trial Name: NCT02568566 — Phase 2

Recombinant Human Papillomavirus Nonavalent Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02568566 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What diseases is the Recombinant Human Papillomavirus Nonavalent Vaccine designed to combat?

"The Recombinant Human Papillomavirus Nonavalent Vaccine is effective against HPV-58, HPV-31 and other generalized forms of the virus."

Answered by AI

To what extent are geriatric patients being considered for this research endeavor?

"According to the stipulations of this trial, participants must be between 9 and 11 years old. Additionally, there are 20 trials for minors under 18 as well 14 trials available for those over 65."

Answered by AI

How many research participants are being recruited for this investigation?

"At this moment, recruitment for the trial is suspended. Initially posted on March 30th 2016 and last updated October 18th 2022, there are presently 8 studies recruiting patients with human papillomavirus and 32 trials for Recombinant Human Papillomavirus Nonavalent Vaccine actively seeking participants."

Answered by AI

Are there any opportunities to participate in this experiment currently available?

"At present, this research is not recruiting new participants. Initially posted on March 30th 2016, the trial was last updated on October 18th 2022. If searching for other studies related to human papillomavirus, 8 trials are enrolling and 32 clinical trials are actively seeking individuals eligible to participate in a Recombinant Human Papillomavirus Nonavalent Vaccine study."

Answered by AI

Is this the inaugural research endeavor of its kind?

"Since 2002, Merck Sharp & Dohme Corp. has been researching the efficacy of Recombinant Human Papillomavirus Nonavalent Vaccine. The initial trial in 2002 saw 12167 participants, leading to its eventual Phase 3 drug approval. Currently there are 32 clinicial trials for this vaccine being conducted across 129 cities and 32 countries."

Answered by AI

Could you inform me of the trial history with regards to Recombinant Human Papillomavirus Nonavalent Vaccine?

"Currently, there are 32 ongoing studies related to Recombinant Human Papillomavirus Nonavalent Vaccine with 16 of those trials in its third phase. The majority of these medical programmes originate from Bangkok and Chang Wat Nonthaburi but can be found across 244 different locations worldwide."

Answered by AI

Has the Recombinant Human Papillomavirus Nonavalent Vaccine received authorization from the Food and Drug Administration?

"There is some evidence to suggest the safety of Recombinant Human Papillomavirus Nonavalent Vaccine, so it was given a grade 2. However, there are no data points supporting its efficacy yet since this is only in phase two clinical trials."

Answered by AI

Who is eligible to take part in this research experiment?

"This trial is searching for 201 minors, aged 9-11 years old, who have contracted human papillomavirus. Furthermore, the applicants must possess a rudimentary understanding of the study and be willing to sign an assent document before enrollment."

Answered by AI