Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)

Papillomavirus Infections Clinical Trial

Official title:

A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen With Extended Dosing Intervals in 9- to 14-Year Old Boys and Girls Compared With a Standard 3-dose Regimen in 16- to 26-Year Old Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04708041
• Other study ID #: V503-069
• Secondary ID: V503-0692022-500
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 15, 2021
• Est. completion date: June 18, 2029

Study information

• Verified date: December 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen used to establish 9vHPV vaccine efficacy).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: June 18, 2029
• Est. primary completion date: June 18, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 26 Years

Eligibility

Inclusion Criteria:

Boys and Girls 9 to 15 Years:

• Must not have had coitarche and does not plan on becoming sexually active during the vaccination period

Women 16 to 26 Years:

• Has never had a Papanicolaou (Pap) test or only had normal Pap test results
• A lifetime history of 0 to 4 male and/or female sexual partners

Cohort 0 Participants:

• Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine Exclusion Criteria:

All Participants:

• Known allergy to any vaccine component
• History of severe allergic reaction that required medical intervention
• Thrombocytopenia or any coagulation disorder
• Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
• Currently immunocompromised, or been diagnosed with immunodeficiency
• Had a splenectomy
• Receiving or has received immunosuppressive therapies within the last year
• Received any immunoglobulin product or blood-derived product within 3 months
• Has received more than 1 dose of an HPV vaccine (Cohort 0)
• Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)

Related Conditions & MeSH terms

• Papillomavirus Infections

Intervention

Biological:
• 9vHPV vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

Locations

Country	Name	City	State
Colombia	Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151)	Chia	Cundinamarca
Colombia	Fundación Centro de Investigación Clínica CIC ( Site 0157)	Medellín	Antioquia
Mexico	Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (	Merida	Yucatan
Mexico	CAIMED México ( Site 0207)	Mexico City	Distrito Federal
Mexico	Unidad biomedica avanzada monterrey ( Site 0203)	Monterrey	Nuevo Leon
Mexico	AINPAD ( Site 0204)	Morelia	Michoacan
Poland	Jerzy Brzostek Prywatny Gabinet Lekarski ( Site 0553)	Debica	Podkarpackie
Poland	Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0555)	Lodz	Lodzkie
Poland	ALERGO-MED Specjalistyczna Przychodnia Lekarska ( Site 0557)	Tarnow	Malopolskie
Poland	Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 0556)	Wroclaw	Dolnoslaskie
South Africa	Desmond Tutu HIV Foundation ( Site 0355)	Cape Town	Western Cape
South Africa	TREAD Research ( Site 0354)	Cape Town	Western Cape
South Africa	Perinatal HIV Research Unit_Do not use - Duplicate facility ( Site 0351)	Johannesburg	Gauteng
Taiwan	Taichung Veterans General Hospital ( Site 0653)	Taichung
Taiwan	National Taiwan University Hospital ( Site 0651)	Taipei
Taiwan	Chang Gung Medical Foundation.Linkou Branch ( Site 0652)	Taoyuan
United States	MultiCare Rockwood Cheney Clinic ( Site 0038)	Cheney	Washington
United States	Coastal Bend Clinical Research ( Site 0025)	Corpus Christi	Texas
United States	Kaiser Permanente Daly City ( Site 0044)	Daly City	California
United States	University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si	Galveston	Texas
United States	Tribe Clinical Research, LLC ( Site 0010)	Greenville	South Carolina
United States	Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007)	Naples	Florida
United States	Coastal Carolina Research Center ( Site 0032)	North Charleston	South Carolina
United States	Kaiser Permanente Oakland ( Site 0020)	Oakland	California
United States	Kaiser Permanente Roseville ( Site 0047)	Roseville	California
United States	Kaiser Permanente Sacramento ( Site 0043)	Sacramento	California
United States	Kaiser Permanente South Sacramento ( Site 0045)	Sacramento	California
United States	Kaiser Permanente San Jose ( Site 0046)	San Jose	California
United States	Kaiser Permanente Santa Clara ( Site 0042)	Santa Clara	California
United States	Encompass Clinical Research ( Site 0022)	Spring Valley	California

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Colombia,  Mexico,  Poland,  South Africa,  Taiwan, 

References & Publications (1)

Teppler H, Bautista O; Thomas Group; Flores S, McCauley J, Luxembourg A. Design of a Phase III immunogenicity and safety study evaluating two-dose regimens of 9-valent human papillomavirus (9vHPV) vaccine with extended dosing intervals. Contemp Clin Trial — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay	Serum antibody titers for human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using competitive luminex immunoassay (cLIA). The geometric mean titer (GMT) for each HPV type will be reported in milli Merck units/mL (mMU/mL).	4 weeks post last vaccination (Up to ~Month 61)
Primary	Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with injection-site AEs (erythema/redness, pain and swelling) will be assessed.	Up to 5 days post vaccination
Primary	Percentage of Participants With at Least 1 Systemic Adverse Event	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with a systemic AE will be assessed.	Up to 15 days post vaccination
Primary	Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event	A serious adverse event (SAE) is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. An SAE that is judged by the investigator to be related to the study vaccine is defined as a vaccine-related SAE.	Entire study period (Up to ~Month 96)
Secondary	Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58	Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.	4 weeks post last vaccination
Secondary	Geometric Mean Titers (Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58	Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL.	12 months post last vaccination
Secondary	Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58	Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.	12 months post last vaccination
Secondary	Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58	Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL.	24 months post last vaccination
Secondary	Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58	Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.	24 months post last vaccination
Secondary	Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52 , and 58	Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL.	36 months post last vaccination
Secondary	Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58	Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.	36 months post last vaccination

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary