Clinical trial NCT04708041: Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Papillomavirus Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 700
Sex: ALL
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: 4 weeks post last vaccination (Up to ~Month 61)
measure: Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
timeFrame: Up to 5 days post vaccination
measure: Percentage of Participants With at Least 1 Systemic Adverse Event
timeFrame: Up to 15 days post vaccination
measure: Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event
timeFrame: Entire study period (Up to ~Month 96)
Secondary outcomes:
measure: Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
timeFrame: 4 weeks post last vaccination
measure: Geometric Mean Titers (Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
timeFrame: 12 months post last vaccination
measure: Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
timeFrame: 12 months post last vaccination
measure: Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
timeFrame: 24 months post last vaccination
measure: Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
timeFrame: 24 months post last vaccination
measure: Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52 , and 58
timeFrame: 36 months post last vaccination
measure: Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
timeFrame: 36 months post last vaccination
Other outcomes:
Locations:
city: Daly City
country: United States
facility: Kaiser Permanente Daly City ( Site 0044)
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland ( Site 0020)
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Roseville ( Site 0047)
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento ( Site 0043)
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento ( Site 0045)
state: California
city: San Jose
country: United States
facility: Kaiser Permanente San Jose ( Site 0046)
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara ( Site 0042)
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research ( Site 0022)
state: California
city: Naples
country: United States
facility: Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007)
state: Florida
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC ( Site 0010)
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center ( Site 0032)
state: South Carolina
city: Corpus Christi
country: United States
facility: Coastal Bend Clinical Research ( Site 0025)
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
state: Texas
city: Cheney
country: United States
facility: MultiCare Rockwood Cheney Clinic ( Site 0038)
state: Washington
city: Medellín
country: Colombia
facility: Fundación Centro de Investigación Clínica CIC ( Site 0157)
state: Antioquia
city: Chia
country: Colombia
facility: Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151)
state: Cundinamarca
city: Mexico City
country: Mexico
facility: CAIMED México ( Site 0207)
state: Distrito Federal
city: Morelia
country: Mexico
facility: AINPAD ( Site 0204)
state: Michoacan
city: Monterrey
country: Mexico
facility: Unidad biomedica avanzada monterrey ( Site 0203)
state: Nuevo Leon
city: Merida
country: Mexico
facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (
state: Yucatan
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 0556)
state: Dolnoslaskie
city: Lodz
country: Poland
facility: Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0555)
state: Lodzkie
city: Tarnow
country: Poland
facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska ( Site 0557)
state: Malopolskie
city: Debica
country: Poland
facility: Jerzy Brzostek Prywatny Gabinet Lekarski ( Site 0553)
state: Podkarpackie
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit_Do not use - Duplicate facility ( Site 0351)
state: Gauteng
city: Cape Town
country: South Africa
facility: TREAD Research ( Site 0354)
state: Western Cape
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Foundation ( Site 0355)
state: Western Cape
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 0653)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0651)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0652)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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 Trials. 2021 Jun;105:106403. doi: 10.1016/j.cct.2021.106403. Epub 2021 Apr 12.
citation: Klein NP, Wiesner A, Bautista O, Group T, Kanu K, Li ZL, McCauley J, Saxena K, Tota J, Luxembourg A, Bonawitz R. Immunogenicity and Safety of Extended-Interval 2-Dose Regimens of 9vHPV Vaccine. Pediatrics. 2024 Aug 1;154(2):e2023064693. doi: 10.1542/peds.2023-064693.