Last updated: 01/27/2025 13:30:15
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
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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)
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)
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)
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)
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)
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)
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)
Number of participants reporting Grade 3 unsolicited AEs after vaccine Dose 2
Timeframe: Within 28 days after vaccine Dose 2 (administered at Month 2)
Number of participants reporting Grade 3 unsolicited AEs after vaccine Dose 3
Timeframe: Within 28 days after vaccine Dose 3 (administered at Month 6)
Number of participants reporting serious adverse events (SAEs)
Timeframe: From first vaccination (Day 1) to study end (Month 12)
Number of participants in Step 1 subset with clinically relevant biochemical abnormalities
Timeframe: At Day 7
Number of participants in Step 1 subset with clinically relevant hematological abnormalities
Timeframe: At Day 7
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)
Anti-HPV immunoglobulin G (IgG) antibody concentrations
Timeframe: At Month 7 (one month after vaccine Dose 3 administration)
Secondary outcomes:
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)
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)
Number of participants reporting any unsolicited AEs
Timeframe: Within 28 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)
Number of participants reporting potential immune-mediated diseases (pIMDs)
Timeframe: From first vaccination (Day 1) to study end (Month 12)
Number of participants reporting pregnancies
Timeframe: From Day 1 of pregnancy to study end (Month 12)
Number of participants with outcomes of reported pregnancies
Timeframe: From Day 1 of pregnancy up to study end (Month 12)
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
Number of participants with seroconversion for anti-HPV IgG antibodies
Timeframe: At Month 2, Month 3, Month 6, Month 7 and Month 12
Anti-HPV neutralizing titers
Timeframe: At Day 1, Month 3 and Month 7
Anti-HPV neutralizing titers in a subset of participants
Timeframe: At Month 2
Number of participants with seroconversion for anti-HPV neutralizing antibodies
Timeframe: At Month 3 and Month 7
Correlation between anti-HPV IgG antibody concentration and anti-HPV neutralizing antibody titers
Timeframe: At Day 1, Month 2, Month 3 and Month 7
Interventions:
Biological/vaccine: HPV9 High formulation
Biological/vaccine: HPV9 Medium formulation
Biological/vaccine: HPV9 Low formulation
Biological/vaccine: Gardasil 9
Enrollment:
1080
Observational study model:
Not applicable
Primary completion date:
2024-23-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cervical Intraepithelial Neoplasia
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2022 to February 2024
Type
Interventional
Phase
1/2
Participation criteria
Sex
Female
Age
16 - 26 Years
Accepts healthy volunteers
Yes
- 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.
- 1. Pregnant or lactating female.
- 2. Female planning to become pregnant or planning to discontinue contraceptive precautions.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Coral Gables, FL, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi, TX, United States, 78412
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, CZ-500 03
Status
Study Complete
Location
GSK Investigational Site
Jefferson City, MO, United States, 65109
Status
Study Complete
Location
GSK Investigational Site
North Charleston, SC, United States, 29405
Status
Study Complete
Location
GSK Investigational Site
North Miami Beach, FL, United States, 33162
Status
Study Complete
Location
GSK Investigational Site
Pompano Beach, FL, United States, 33060
Status
Study Complete
Location
GSK Investigational Site
San Diego, CA, United States, 92103-6204
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2024-23-02
Actual study completion date
2024-25-02
Plain language summaries
Summary of results in plain language
Available language(s): English, Bulgarian, Czech, Estonian, French, German, Haitian Creole, Lithuanian, Polish, Russian (Estonia), Spanish (United States)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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