9vHPV Vaccine for Papillomavirus Infections

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
FN Motol ( Site 0402), Praha 5, Czechia
Papillomavirus Infections+2 More
9vHPV Vaccine - Biological
Eligibility
18 - 65
Male
What conditions do you have?
Select

Study Summary

This trial will test whether the 9-valent HPV vaccine is safe and effective in preventing HPV-related oral infections in men. The 9vHPV vaccine is used to treat Papillomavirus Infections and has previously been approved by the FDA for a different condition.

Eligible Conditions

  • Papillomavirus Infections

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 1 month postdose 3 (Month 7)

Month 7
Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies
Percentage of Participants who Seroconvert to Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Day 15
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
Percentage of Participants Who Report at Least 1 Systemic Adverse Event
Day 5
Percentage of Participants with Elevated Temperature (Fever)
Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE)
Up to Month 42
Incidence of Human Papillomavirus (HPV) 6/11-related 6-month Persistent Oral Infection
Incidence of Human Papillomavirus (HPV)16/18/31/33/45/52/58-related 6-month Persistent Oral Infection
Percentage of Participants who Experience at Least 1 Serious Vaccine-Related Adverse Event

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Heterosexual and MSM Males
64%Injection site pain
21%Injection site erythema
20%Injection site swelling
14%Headache
0%External ear cellulitis
0%Appendicitis perforated
0%Tibia fracture
0%Infectious mononucleosis
0%Nephrolithiasis
0%Appendicitis
0%Concussion
0%Haematoma
0%Cholecystitis
0%Ovarian cyst ruptured
0%Radius fracture
0%Renal failure acute
0%Anal abscess
0%Abortion spontaneous
0%Postoperative wound infection
0%Abortion incomplete
0%Anxiety
0%Escherichia urinary tract infection
0%Familial periodic paralysis
0%Cyst rupture
0%Device dislocation
0%Constipation
0%Atrioventricular block second degree
0%Vomiting
0%Dengue fever
0%Pilonidal cyst
0%Viral infection
0%Syncope
0%Migraine
0%Pulmonary tuberculosis
0%Exposure to communicable disease
0%Ligament disorder
0%Schizophreniform disorder
0%Subcutaneous emphysema
0%Cerebrovascular accident
0%Psychotic disorder
0%Foetal malpresentation
0%Ovarian cyst
0%Ectopic pregnancy
0%Abortion induced
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT01651949) in the Heterosexual and MSM Males ARM group. Side effects include: Injection site pain with 64%, Injection site erythema with 21%, Injection site swelling with 20%, Headache with 14%, External ear cellulitis with 0%.

Trial Design

2 Treatment Groups

9vHPV vaccine
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

6000 Total Participants · 2 Treatment Groups

Primary Treatment: 9vHPV Vaccine · Has Placebo Group · Phase 3

9vHPV vaccine
Biological
Experimental Group · 1 Intervention: 9vHPV Vaccine · Intervention Types: Biological
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo (Saline for Injection) · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human papillomavirus type 16 L1 capsid protein antigen
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month postdose 3 (month 7)
Closest Location: Solaris Clinical Research, LLC ( Site 0003) · Meridian, ID
Photo of idaho 1Photo of idaho 2Photo of idaho 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Papillomavirus Infections
0 CompletedClinical Trials

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,626 Previous Clinical Trials
4,942,428 Total Patients Enrolled
61 Trials studying Papillomavirus Infections
434,196 Patients Enrolled for Papillomavirus Infections
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,573,177 Total Patients Enrolled
36 Trials studying Papillomavirus Infections
419,967 Patients Enrolled for Papillomavirus Infections
Medical DirectorStudy DirectorMerck Sharp & Dohme Corp.
2,597 Previous Clinical Trials
8,925,345 Total Patients Enrolled
22 Trials studying Papillomavirus Infections
90,737 Patients Enrolled for Papillomavirus Infections

Eligibility Criteria

Age 18 - 65 · Male Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
I can read, understand, and complete the electronic vaccination report card (eVRC).
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.
Agrees to provide study personnel with a primary telephone number and an alternate means of contact, if available (such as an alternate telephone number or email) for follow-up purposes in the event that the study personnel are unable to reach the subject by telephone.
The person has had at least one sexual partner in their lifetime.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.