Clinical trial NCT05496231: A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age
Official title: A Phase 1/2 Randomized, Observer-blinded, Multi-country Study to Evaluate Safety and Immunogenicity of Investigational Adjuvanted Human Papillomavirus Vaccine in Females (16 to 26 Years of Age)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cervical Intraepithelial Neoplasia
Keywords: Human papillomavirus
Infection
Vaccine
Women's health
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 1080
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main purpose of this study was to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)'s investigational adjuvanted human papillomavirus (HPV) vaccine formulations.


Eligibility criteria: Inclusion Criteria:

1. Healthy participants as established by medical history and clinical examination before entering into the study.
2. For Step 1 only: Female between and including 18 and 26 years of age at the time of the first study intervention administration.
3. For Step 2: Female between and including 16 and 26 years of age at the time of the first study intervention administration.
4. Written informed consent obtained from the participant prior to performance of any study specific procedure (for participants below the legal age of consent as per local regulations, written informed consent must be obtained from the participant/participant's parent\[s\]/legally authorized representatives \[LAR{s}\] and, in addition, the participant should sign and personally date a written informed assent).
5. Participants and/or participants' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits).
6. Female participant with no more than 4 lifetime sexual partners prior to enrollment.
7. Female participants of non-childbearing potential may be enrolled in the study.

Female participants of childbearing potential may be enrolled in the study if the participant:

* has practiced adequate highly effective contraception for at least 1 month prior to study intervention administration, and
* has a negative pregnancy test on the day of study intervention administration, and
* has agreed to continue adequate contraception during the entire intervention period and for 2 months after completion of the study intervention administration series.

Exclusion Criteria:

1. Pregnant or lactating female.
2. Female planning to become pregnant or planning to discontinue contraceptive precautions.
3. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
4. History or current diagnosis of autoimmune disease.
5. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
6. Hypersensitivity to latex.
7. Major congenital defects, as assessed by the investigator.
8. History of abnormal Papanicolaou test or abnormal cervical biopsy result.
9. History of external genital/vaginal warts.
10. History of positive HPV test.
11. Acute or chronic clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests
12. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
13. Previous vaccination against HPV.
14. Previous exposure to monophosphoryl lipid A (MPL) or AS04 adjuvant.
15. Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their planned use during the study period.
16. Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study interventions administration\*

    \*In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is licensed and used according to its Product Information.
17. Administration of long-acting immune-modifying drugs at any time during the study period.
18. Use of systemic cytotoxic agents within the previous 3 months prior to randomization into this study or at any time during the study period.
19. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants/ ≥0.5 milligram/kilogram/day (mg/kg/day) with maximum of 20 mg/day for participants under 18 years of age. Inhaled and topical steroids are allowed.
20. Administration of systemic immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions or planned administration during the study period.
21. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational intervention.
22. History of /current chronic alcohol consumption and/or drug abuse.
23. Any study personnel or their immediate dependents, family, or household members.
24. Child in care.

Primary outcomes:
measure: Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1
timeFrame: Within 7 days after vaccine Dose 1 (administered at Day 1)
measure: Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2
timeFrame: Within 7 days after vaccine Dose 2 (administered at Month 2)
measure: Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3
timeFrame: Within 7 days after vaccine Dose 3 (administered at Month 6)
measure: Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1
timeFrame: Within 7 days after vaccine Dose 1 (administered at Day 1)
measure: Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2
timeFrame: Within 7 days after vaccine Dose 2 (administered at Month 2)
measure: Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3
timeFrame: Within 7 days after vaccine Dose 3 (administered at Month 6)
measure: Number of Participants Reporting Grade 3 Unsolicited Adverse Events (AEs) After Vaccine Dose 1
timeFrame: Within 28 days after vaccine Dose 1 (administered at Day 1)
measure: Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 2
timeFrame: Within 28 days after vaccine Dose 2 (administered at Month 2)
measure: Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 3
timeFrame: Within 28 days after vaccine Dose 3 (administered at Month 6)
measure: Number of Participants Reporting Serious Adverse Events (SAEs)
timeFrame: From first vaccination (Day 1) to study end (Month 12)
measure: Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
timeFrame: At Day 7
measure: Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
timeFrame: At Day 7
measure: Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels
timeFrame: At Day 7 compared to baseline (Day 1)
measure: Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
timeFrame: At Month 7 (one month after vaccine Dose 3 administration)
Secondary outcomes:
measure: Number of Participants Reporting Any Solicited Administration Site Events
timeFrame: Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)
measure: Number of Participants Reporting Any Solicited Systemic Events
timeFrame: Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)
measure: Number of Participants Reporting Any Unsolicited AEs
timeFrame: Within 28 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)
measure: Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs)
timeFrame: From first vaccination (Day 1) to study end (Month 12)
measure: Number of Participants Reporting Pregnancies
timeFrame: From Day 1 of pregnancy to study end (Month 12)
measure: Number of Participants With Outcomes of Reported Pregnancies
timeFrame: From Day 1 of pregnancy up to study end (Month 12)
measure: Anti-HPV IgG Antibody Concentrations
timeFrame: At Day 1, Month 2, Month 3, Month 6, Month 7 (Month 7 data was also reported in primary outcome measure 14, as pre-specified in protocol) and Month 12
measure: Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
timeFrame: At Month 2, Month 3, Month 6, Month 7 and Month 12
measure: Anti-HPV Neutralizing Titers
timeFrame: At Day 1, Month 3 and Month 7
measure: Anti-HPV Neutralizing Titers in a Subset of Participants
timeFrame: At Month 2
measure: Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
timeFrame: At Month 3 and Month 7
measure: Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
timeFrame: At Day 1, Month 2, Month 3 and Month 7
Other outcomes:
Locations:
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Wheat Ridge
country: United States
facility: GSK Investigational Site
state: Colorado
city: Coral Gables
country: United States
facility: GSK Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: North Miami Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Pompano Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: Topeka
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Covington
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Elkridge
country: United States
facility: GSK Investigational Site
state: Maryland
city: Saginaw
country: United States
facility: GSK Investigational Site
state: Michigan
city: Jefferson City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Norman
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: North Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Carrollton
country: United States
facility: GSK Investigational Site
state: Texas
city: Corpus Christi
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Humble
country: United States
facility: GSK Investigational Site
state: Texas
city: Humble
country: United States
facility: GSK Investigational Site
state: Texas
city: Irving
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Tomball
country: United States
facility: GSK Investigational Site
state: Texas
city: West Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
city: Olomouc
country: Czechia
facility: GSK Investigational Site
city: Olomouc
country: Czechia
facility: GSK Investigational Site
city: Praha
country: Czechia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Dijon cedex
country: France
facility: GSK Investigational Site
city: La Roche Sur Yon
country: France
facility: GSK Investigational Site
city: La Tronche
country: France
facility: GSK Investigational Site
city: Nantes cedex 1
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Rennes
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Schwerin
country: Germany
facility: GSK Investigational Site
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Skierniewice
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
Study officials:
References: