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Virus Therapy

9vHPV Vaccine for HPV-Related Oral Infections in Men

Q: Does this research mark a new development in the field?

<p>Merck Sharp &#x26; Dohme Corp. first sponsored a study for 9vHPV <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a> in 2002. Since the initial study, which involved 12167 participants, there have been 34 live trials in 131 cities and 32 countries.</p>

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

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

Must have

Is healthy and is judged to be in good physical health based on medical history and physical examination.

Participants may continue in the Extension Study if Inclusion Criteria #1 and #4 are still met, and the participants was in either the placebo group in the Base Study or the vaccine group in the Base Study but did not complete the vaccination series.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month postdose 3 (month 7)

Awards & highlights

Study Summary

This trial will test whether the 9-valent HPV vaccine is safe and effective in preventing HPV-related oral infections in men.

Who is the study for?

Men aged 20-45 who are generally healthy, have had at least one sexual partner, and can complete an electronic vaccination report card. They must not have a history of HPV-related cancers or lesions, severe allergies to vaccine components, immune system problems, or be taking certain medications that affect the immune response.Check my eligibility

What is being tested?

The trial is testing the effectiveness of the 9-valent human papillomavirus (9vHPV) vaccine in preventing persistent oral HPV infections compared to a saline placebo. Participants will receive three doses and those initially given a placebo may later receive the actual vaccine.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site like pain and swelling, headaches, fever, nausea, dizziness. Severe allergic reactions are rare but could occur due to ingredients such as yeast or aluminum.

Eligibility Criteria

Inclusion Criteria

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

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I am healthy and in good physical condition as confirmed by a doctor.

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I can join the extended study if I was in the placebo or vaccine group but didn't finish all shots.

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I have had at least one sexual partner in my lifetime.

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I have had at least one sexual partner in my life.

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I agree to give my contact details and an alternate contact for follow-ups.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month postdose 3 (month 7)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month postdose 3 (month 7)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month postdose 3 (month 7) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Human Papillomavirus (HPV)16/18/31/33/45/52/58-related 6-month Persistent Oral Infection

Secondary outcome measures

Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies

Incidence of Human Papillomavirus (HPV) 6/11-related 6-month Persistent Oral Infection

Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)

+5 more

Side effects data

From 2022 Phase 3 trial • 614 Patients • NCT04313244

73%

Pain

44%

Myalgia

30%

Erythema

23%

Headache

21%

Swelling

20%

Malaise

19%

Asthenia

COVID-19

Fever

Pyrexia

Upper respiratory tract infection

COVID-19 pneumonia

Dermatitis contact

Diarrhoea

Nasopharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

9vHPV+TDV

9vHPV

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 9vHPV vaccineExperimental Treatment1 Intervention

Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6

Group II: PlaceboPlacebo Group1 Intervention

Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Human papillomavirus type 6 L1 capsid protein antigen

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,575,789 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,048,538 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,057,447 Total Patients Enrolled

Media Library

9vHPV Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04199689 — Phase 3

Human Papillomavirus Research Study Groups: Placebo, 9vHPV vaccine

Human Papillomavirus Clinical Trial 2023: 9vHPV Vaccine Highlights & Side Effects. Trial Name: NCT04199689 — Phase 3

9vHPV Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04199689 — Phase 3

Human Papillomavirus Patient Testimony for trial: Trial Name: NCT04199689 — Phase 3

Frequently Asked Questions

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

What are the risks associated with 9vHPV Vaccine?

"There is both efficacy and safety data from Phase 3 trials to support the use of 9vHPV Vaccine, so our team has rated it as a level 3."

Answered by AI

Are there any openings left for this clinical trial?

"This study is not recruiting patients at the moment, as seen on clinicaltrials.gov. The latest update was on August 17th, 2022 and the posting date was February 27th, 2020. There are 863 other trials for papillomavirus infections and 34 studies for 9vHPV Vaccine that are currently looking for participants."

Answered by AI

Does this research mark a new development in the field?

"Merck Sharp & Dohme Corp. first sponsored a study for 9vHPV Vaccine in 2002. Since the initial study, which involved 12167 participants, there have been 34 live trials in 131 cities and 32 countries."

Answered by AI

How many sites are running this study?

"This study is accepting patients at Rapid Medical Research, Inc. ( Site 0037) in Cleveland, Ohio, Holston Medical Group ( Site 0030) in Kingsport, Tennessee, and Solaris Clinical Research, LLC ( Site 0003) in Meridian, Idaho as well as other sites 32 other locations."

Answered by AI

Are there other ongoing research programs testing the 9vHPV Vaccine?

"34 different clinical trials are currently investigating the 9vHPV Vaccine with 16 of them being in Phase 3. Many of these studies are based in Miami, Florida, but there are 246 research sites for this project altogether."

Answered by AI

What are the requirements for joining this clinical trial?

"This particular trial is looking for 6000 individuals that have contracted papillomavirus and are between the ages of 20-45. Most importantly, candidates must meet the following criteria: Be literate and able to understand and fill out an electronic vaccination report card (eVRC), Willing to provide study personnel with a primary telephone number as well as an alternate means of contact, if available (such as an alternate telephone number or email) for follow-up purposes, Has had at least 1 lifetime sexual partner."

Answered by AI

Do you have an age limit for the people who can join this test?

"The age requirement to participate in this trial is between 20 and 45 years old."

Answered by AI

How many individuals are being asked to participate in this clinical trial?

"Currently, this clinical trial is not seeking new patients. However, it's important to note that the date of the last update was August 17th, 2022. There are 863 other trials related to papillomavirus infections and 34 for 9vHPV Vaccine that are actively recruiting participants."

Answered by AI