Your session is about to expire
← Back to Search
Virus Therapy
9vHPV Vaccine for HPV-Related Oral Infections in Men
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
Be between 18 and 65 years old
Must not have
Has previously received a marketed HPV vaccine, or has participated in a clinical trial for any HPV vaccine (receiving either active agent or placebo)
Has a history of or clinical evidence at the Day 1 external genital examination of HPV-related external lesion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month postdose 3 (month 7)
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
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.
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.
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
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received an HPV vaccine or participated in an HPV vaccine trial.
Select...
I have had or currently have HPV-related lesions on my genitals.
Select...
I have had my spleen removed.
Select...
I have received or plan to receive an immune or blood product other than IVIG in the last 3 months.
Select...
I have a condition that weakens my immune system.
Select...
I have had HPV-related anal or head and neck cancer.
Select...
I have had a fever of 100.0°F or higher in the last 24 hours.
Select...
I have a blood condition that makes injections unsafe for me.
Select...
I have visible signs of a possible STD on my genitals.
Select...
I haven't had any inactivated or recombinant vaccines in the last 14 days or live vaccines in the last 21 days.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Human Papillomavirus (HPV)16/18/31/33/45/52/58-related 6-month Persistent Oral Infection
Secondary study objectives
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 moreSide effects data
From 2022 Phase 3 trial • 614 Patients • NCT0431324473%
Pain
44%
Myalgia
30%
Erythema
23%
Headache
21%
Swelling
20%
Malaise
19%
Asthenia
8%
COVID-19
3%
Fever
1%
Upper respiratory tract infection
1%
COVID-19 pneumonia
1%
Nasopharyngitis
1%
Pyrexia
1%
Dermatitis contact
1%
Diarrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
9vHPV+TDV
9vHPV
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,576,325 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,981 Previous Clinical Trials
5,171,976 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,866 Previous Clinical Trials
8,076,549 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have allergies to any ingredients in the vaccine, like aluminum, yeast, or BENZONASE®.I am healthy and in good physical condition as confirmed by a doctor.I can read, understand, and complete the electronic vaccination report card (eVRC).I have received an HPV vaccine or participated in an HPV vaccine trial.I have had or currently have HPV-related lesions on my genitals.I have had my spleen removed.I can follow the study's schedule and won't move away during the trial.I can join the extended study if I was in the placebo or vaccine group but didn't finish all shots.I have not used strong immune system affecting drugs or high-dose steroids recently.I have received or plan to receive an immune or blood product other than IVIG in the last 3 months.I'm sorry, but the criterion "Base Study" is not clear enough for me to provide a simplified explanation. Could you please provide more information or context?I have had at least one sexual partner in my lifetime.I have a condition that weakens my immune system.I have had HPV-related anal or head and neck cancer.I have had sexual activity as defined within 48 hours before vaccination.You have experienced a severe allergic reaction in the past that needed medical help, with symptoms like swelling of the mouth and throat, trouble breathing, low blood pressure, or shock.The participant has agreed to take part in the study and may allow their data to be used for future medical research, but they are not required to do so.You currently use recreational or illegal drugs, or have had a problem with drug or alcohol abuse in the past year. This includes drinking alcohol despite having problems in your personal life or with the law.This study is only open to participants who have previously taken part in a related study.I have had a fever of 100.0°F or higher in the last 24 hours.I have a blood condition that makes injections unsafe for me.I have had at least one sexual partner in my life.I agree to give my contact details and an alternate contact for follow-ups.I have visible signs of a possible STD on my genitals.I haven't had any inactivated or recombinant vaccines in the last 14 days or live vaccines in the last 21 days.
Research Study Groups:
This trial has the following groups:- Group 1: 9vHPV vaccine
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Human Papillomavirus Patient Testimony for trial: Trial Name: NCT04199689 — Phase 3
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger