Cervical Intraepithelial NeoplasiaPhase 1/2NCT05496231
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
A Phase 1/2 study testing HPV9 High formulation, HPV9 Medium formulation and HPV9 Low formulation in people with Cervical Intraepithelial Neoplasia, run by GlaxoSmithKline at 68 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- HPV9 High formulation, HPV9 Medium formulation and HPV9 Low formulation
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 68 sitesin 8 countries
- Study dates
- 22 Aug 2022to 25 Feb 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy participants as established by medical history and clinical examination before entering into the study.
- For Step 1 only: Female between and including 18 and 26 years of age at the time of the first study intervention administration.
- For Step 2: Female between and including 16 and 26 years of age at the time of the first study intervention administration.
- 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).
- 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).
- Female participant with no more than 4 lifetime sexual partners prior to enrollment.
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- 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.
Who cannot join
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- History or current diagnosis of autoimmune disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Hypersensitivity to latex.
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- Major congenital defects, as assessed by the investigator.
- History of abnormal Papanicolaou test or abnormal cervical biopsy result.
- History of external genital/vaginal warts.
- History of positive HPV test.
- Acute or chronic clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- Previous vaccination against HPV.
- Previous exposure to monophosphoryl lipid A (MPL) or AS04 adjuvant.
- 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.
- 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.
- Administration of long-acting immune-modifying drugs at any time during the study period.
- Use of systemic cytotoxic agents within the previous 3 months prior to randomization into this study or at any time during the study period.
- 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.
- 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.
- 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.
- History of /current chronic alcohol consumption and/or drug abuse.
- Any study personnel or their immediate dependents, family, or household members.
- Child in care.
Trial locations and contacts
68 sites in 8 countries.
68 sites in 8 countries
United States39 sites
GSK Investigational Site
Albuquerque, New Mexico, 87102
GSK Investigational Site
Atlanta, Georgia, 30328
GSK Investigational Site
Carrollton, Texas, 75010
GSK Investigational Site
Chattanooga, Tennessee, 37404
GSK Investigational Site
Columbus, Ohio, 43213
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Corpus Christi, Texas, 78412
GSK Investigational Site
Covington, Louisiana, 70433
GSK Investigational Site
Dallas, Texas, 75251
GSK Investigational Site
Elkridge, Maryland, 21075
GSK Investigational Site
Evansville, Indiana, 47712
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Houston, Texas, 77065
GSK Investigational Site
Humble, Texas, 77338
GSK Investigational Site
Humble, Texas, 77346
GSK Investigational Site
Irving, Texas, 75062
GSK Investigational Site
Jefferson City, Missouri, 65109
GSK Investigational Site
Kissimmee, Florida, 34741
GSK Investigational Site
Las Vegas, Nevada, 89102
GSK Investigational Site
Lexington, Kentucky, 40509
GSK Investigational Site
Miami, Florida, 33125
GSK Investigational Site
Norfolk, Virginia, 23502
GSK Investigational Site
Norfolk, Virginia, 68701
GSK Investigational Site
Norman, Oklahoma, 73072
GSK Investigational Site
North Charleston, South Carolina, 29405
GSK Investigational Site
North Miami Beach, Florida, 33162
GSK Investigational Site
Pompano Beach, Florida, 33060
GSK Investigational Site
Raleigh, North Carolina, 27612
GSK Investigational Site
Saginaw, Michigan, 48602
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92103-6204
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
Sarasota, Florida, 34239
GSK Investigational Site
South Bend, Indiana, 46617
GSK Investigational Site
Tomball, Texas, 77375
GSK Investigational Site
Topeka, Kansas, 66606
GSK Investigational Site
West Jordan, Utah, 84088
GSK Investigational Site
Wheat Ridge, Colorado, 80033
GSK Investigational Site
Wichita, Kansas, 67205
France7 sites
GSK Investigational Site
Dijon, 21000
GSK Investigational Site
La Roche-sur-Yon, 85025
GSK Investigational Site
La Tronche, 38043
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Paris, 75679
GSK Investigational Site
Rennes, 35000
GSK Investigational Site
Tours, 37000
Lithuania5 sites
GSK Investigational Site
Kaunas, 49387
GSK Investigational Site
Kaunas, LT-48259
GSK Investigational Site
Kaunas, LT-49456
GSK Investigational Site
Kaunas, LT-50177
GSK Investigational Site
Vilnius, 8661
Poland5 sites
GSK Investigational Site
Bydgoszcz, 85-796
GSK Investigational Site
Krakow, 30-348
GSK Investigational Site
Lodz, 91-363
GSK Investigational Site
Skierniewice, 96-100
GSK Investigational Site
Warsaw, 00-215
Czechia4 sites
GSK Investigational Site
Hradec Králové, CZ-500 03
GSK Investigational Site
Olomouc, 772 00
GSK Investigational Site
Olomouc, 779 00
GSK Investigational Site
Prague, 160000
Estonia4 sites
GSK Investigational Site
Tallinn, 10128
GSK Investigational Site
Tallinn, 10617
GSK Investigational Site
Tartu, 50106
GSK Investigational Site
Tartu, 50708
Bulgaria2 sites
GSK Investigational Site
Sofia, 1431
GSK Investigational Site
Sofia, 1606
Germany2 sites
GSK Investigational Site
Schwerin, 19055
GSK Investigational Site
Würzburg, 97074
About this study
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)
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.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- HPV9 High formulation, HPV9 Medium formulation, HPV9 Low formulation, Gardasil 9
- Keywords
- Human papillomavirus, Infection, Vaccine, Women's health
- Medical subject headings
- Uterine Cervical Dysplasia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV9 High formulationBiological
3 doses of the high formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
HPV9 Medium formulationBiological
3 doses of the medium formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
HPV9 Low formulationBiological
3 doses of the low formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
Gardasil 9Biological
3 doses of the marketed HPV vaccine (Gardasil 9) were administered intramuscularly at Day 1, Month 2 and Month 6.
| Study group | Role | What they receive |
|---|---|---|
| HPV9 High Group | Experimental | Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6. Receives: Biological: HPV9 High formulation |
| HPV9 Med Group | Experimental | Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6. Receives: Biological: HPV9 Medium formulation |
| HPV9 Low Group | Experimental | Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6. Receives: Biological: HPV9 Low formulation |
| Gar9 Group | Active comparator | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. Receives: Biological: Gardasil 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter greater than (>) 50 millimeters (mm).
Measured: 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
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter >50 mm.
Measured: 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
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter >50 mm.
Measured: Within 7 days after vaccine Dose 3 (administered at Month 6)
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1
Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature >39.0 degrees Celsius (°C) or 102.2 Fahrenheit (°F). The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activities.
Measured: Within 7 days after vaccine Dose 1 (administered at Day 1)
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2
Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature >39.0°C or 102.2°F. The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activity.
Measured: Within 7 days after vaccine Dose 2 (administered at Month 2)
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3
Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature >39.0°C or 102.2°F. The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activity.
Measured: 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
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/legally acceptable representative(s) [LAR(s)] who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities.
Measured: Within 28 days after vaccine Dose 1 (administered at Day 1)
Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 2
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities.
Measured: Within 28 days after vaccine Dose 2 (administered at Month 2)
Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 3
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/ participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities.
Measured: Within 28 days after vaccine Dose 3 (administered at Month 6)
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or in other situations that were considered serious per medical or scientific judgment.
Measured: From first vaccination (Day 1) to study end (Month 12)
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
As pre-specified in the protocol, the assessed biochemical parameters were blood urea nitrogen (BUN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Unknown = parameter value missing for the specified parameter.
Measured: At Day 7
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
As pre-specified in the protocol, the assessed hematological parameters were hemoglobin, white blood cells (WBC) increase, WBC decrease, lymphocyte decrease, neutrophils decrease, eosinophils, and platelets decrease. Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard FDA Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening; Unknown = parameter value missing for the specified parameter.
Measured: At Day 7
Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels
The number of participants with clinically relevant abnormalities in hemoglobin change from baseline levels is reported. Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard FDA Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening; Unknown = parameter value missing for the specified parameter. Change from baseline = the difference between a participant's baseline (pre-intervention) parameter values and their follow-up (post-intervention) parameter values.
Measured: At Day 7 compared to baseline (Day 1)
Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
Anti-HPV IgG antibody concentrations were determined by electrochemiluminescence (ECL) assay and expressed as geometric mean concentrations (GMCs) in arbitrary units per milliliter (AU/mL). The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
Measured: At Month 7 (one month after vaccine Dose 3 administration)
Secondary outcomes (12)
Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade.
Measured: Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)
Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included fever (defined as body temperature >=37.5°C/99.5°F), headache, myalgia, arthralgia and fatigue. The preferred location for measuring temperature was the axilla. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.
Measured: Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)
Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.
Measured: 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)
pIMDs are defined as a subset of AEs of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Measured: From first vaccination (Day 1) to study end (Month 12)
Number of Participants Reporting Pregnancies
The number of participants who experienced pregnancy while participating in this study is reported.
Measured: From Day 1 of pregnancy to study end (Month 12)
Number of Participants With Outcomes of Reported Pregnancies
The participants with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. Pregnancy outcomes were live infant, no apparent congenital anomaly; elective termination, no apparent congenital anomaly, and ectopic pregnancy.
Measured: From Day 1 of pregnancy up to study end (Month 12)
Anti-HPV IgG Antibody Concentrations
Anti-HPV IgG antibody concentrations were determined by ECL assay and expressed as GMCs in AU/mL. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
Measured: 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
Seroconversion is defined as the appearance of antibodies [i.e., concentration greater than or equal to (>=) the lower limit of quantification (LLOQ) value] in the serum of participants seronegative [i.e, concentrations less than (<) the LLOQ value] before vaccination.
The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
The LLOQ values specific to each antigen are as follows: HPV 6 type: LLOQ = 5100 AU/mL; HPV 11 type: LLOQ = 2480 AU/mL; HPV 16 type: LLOQ = 404 AU/mL; HPV 18 type: LLOQ = 1234 AU/mL; HPV 31 type: LLOQ = 3849 AU/mL; HPV 33 type: LLOQ = 617 AU/mL; HPV 45 type: LLOQ = 4079 AU/mL; HPV 52 type: LLOQ = 2352 AU/mL and HPV 58 type: LLOQ = 660 AU/mL.
Measured: At Month 2, Month 3, Month 6, Month 7 and Month 12
Anti-HPV Neutralizing Titers
Anti-HPV neutralizing titers were determined by pseudovirion-based neutralization (PBNA) assay and expressed as geometric mean titers (GMTs). The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
Measured: At Day 1, Month 3 and Month 7
Anti-HPV Neutralizing Titers in a Subset of Participants
Anti-HPV neutralizing titers were determined by PBNA assay and expressed as GMTs. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
Measured: At Month 2
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
Seroconversion is defined as the appearance of antibodies (i.e., titer >=LLOQ value) in the serum of participants seronegative (i.e, titer <LLOQ value) before vaccination.
The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
The LLOQ values specific to each antigen are as follows: HPV 6 type: LLOQ = 269 titers; HPV 11 type: LLOQ = 279 titers; HPV 16 type: LLOQ = 339 titers; HPV 18 type: LLOQ = 84 titers; HPV 31 type: LLOQ = 96 titers; HPV 33 type: LLOQ = 323 titers; HPV 45 type: LLOQ = 76 titers; HPV 52 type: LLOQ = 104 titers and HPV 58 type: LLOQ = 95 titers.
Measured: At Month 3 and Month 7
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
The Pearson coefficient of correlation between anti-HPV IgG antibody concentration and anti-HPV neutralizing antibody titers was calculated for each study group and for each antigen. The Pearson correlation was computed by the log10-transformation of specific antibody concentrations.
Measured: At Day 1, Month 2, Month 3 and Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start22 Aug 2022
- Primary completion23 Feb 2024
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496231
- Sponsor's protocol ID
- 213749
- Other IDs
- 2022-000090-15
- Status last verified
- Jan 2025
- First submitted
- 3 Aug 2022
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05496231
- Acronym / sponsor ID
- 213749
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- Human papillomavirus, Infection, Vaccine, Women's health
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HPV9 High Group | Experimental | Biological: HPV9 High formulationParticipants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6. |
| HPV9 Med Group | Experimental | Biological: HPV9 Medium formulationParticipants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6. |
| HPV9 Low Group | Experimental | Biological: HPV9 Low formulationParticipants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6. |
| Gar9 Group | Active comparator | Biological: Gardasil 9Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Healthy participants as established by medical history and clinical examination before entering into the study.
- For Step 1 only: Female between and including 18 and 26 years of age at the time of the first study intervention administration.
- For Step 2: Female between and including 16 and 26 years of age at the time of the first study intervention administration.
- 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).
- 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).
Key exclusion criteria (25 listed)
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- History or current diagnosis of autoimmune disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV9 High formulation3 doses of the high formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6. | Biological | HPV9 High Group |
| HPV9 Medium formulation3 doses of the medium formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6. | Biological | HPV9 Med Group |
| HPV9 Low formulation3 doses of the low formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6. | Biological | HPV9 Low Group |
| Gardasil 93 doses of the marketed HPV vaccine (Gardasil 9) were administered intramuscularly at Day 1, Month 2 and Month 6. | Biological | Gar9 Group |
Primary outcome
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1
Time frame: Within 7 days after vaccine Dose 1 (administered at Day 1)
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter greater than (>) 50 millimeters (mm).
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2
Time frame: Within 7 days after vaccine Dose 2 (administered at Month 2)
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter >50 mm.
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3
Time frame: Within 7 days after vaccine Dose 3 (administered at Month 6)
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter >50 mm.
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1
Time frame: Within 7 days after vaccine Dose 1 (administered at Day 1)
Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature >39.0 degrees Celsius (°C) or 102.2 Fahrenheit (°F). The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activities.
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2
Time frame: Within 7 days after vaccine Dose 2 (administered at Month 2)
Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature >39.0°C or 102.2°F. The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activity.
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3
Time frame: Within 7 days after vaccine Dose 3 (administered at Month 6)
Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature >39.0°C or 102.2°F. The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activity.
Number of Participants Reporting Grade 3 Unsolicited Adverse Events (AEs) After Vaccine Dose 1
Time frame: Within 28 days after vaccine Dose 1 (administered at Day 1)
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/legally acceptable representative(s) [LAR(s)] who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities.
Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 2
Time frame: Within 28 days after vaccine Dose 2 (administered at Month 2)
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities.
Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 3
Time frame: Within 28 days after vaccine Dose 3 (administered at Month 6)
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/ participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities.
Number of Participants Reporting Serious Adverse Events (SAEs)
Time frame: From first vaccination (Day 1) to study end (Month 12)
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or in other situations that were considered serious per medical or scientific judgment.
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
Time frame: At Day 7
As pre-specified in the protocol, the assessed biochemical parameters were blood urea nitrogen (BUN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Unknown = parameter value missing for the specified parameter.
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Time frame: At Day 7
As pre-specified in the protocol, the assessed hematological parameters were hemoglobin, white blood cells (WBC) increase, WBC decrease, lymphocyte decrease, neutrophils decrease, eosinophils, and platelets decrease. Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard FDA Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening; Unknown = parameter value missing for the specified parameter.
Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels
Time frame: At Day 7 compared to baseline (Day 1)
The number of participants with clinically relevant abnormalities in hemoglobin change from baseline levels is reported. Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard FDA Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening; Unknown = parameter value missing for the specified parameter. Change from baseline = the difference between a participant's baseline (pre-intervention) parameter values and their follow-up (post-intervention) parameter values.
Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
Time frame: At Month 7 (one month after vaccine Dose 3 administration)
Anti-HPV IgG antibody concentrations were determined by electrochemiluminescence (ECL) assay and expressed as geometric mean concentrations (GMCs) in arbitrary units per milliliter (AU/mL). The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
12 secondary outcomes
Number of Participants Reporting Any Solicited Administration Site Events
Time frame: Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)
Number of Participants Reporting Any Solicited Systemic Events
Time frame: Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)
Number of Participants Reporting Any Unsolicited AEs
Time frame: 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)
Time frame: From first vaccination (Day 1) to study end (Month 12)
Number of Participants Reporting Pregnancies
Time frame: From Day 1 of pregnancy to study end (Month 12)
Number of Participants With Outcomes of Reported Pregnancies
Time frame: From Day 1 of pregnancy up to study end (Month 12)
Anti-HPV IgG Antibody Concentrations
Time frame: 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
Time frame: At Month 2, Month 3, Month 6, Month 7 and Month 12
Anti-HPV Neutralizing Titers
Time frame: At Day 1, Month 3 and Month 7
Anti-HPV Neutralizing Titers in a Subset of Participants
Time frame: At Month 2
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
Time frame: At Month 3 and Month 7
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
Time frame: At Day 1, Month 2, Month 3 and Month 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
68 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HPV9 High formulation, HPV9 Medium formulation and HPV9 Low formulation in people with Cervical Intraepithelial Neoplasia, run by GlaxoSmithKline at 68 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, France, Lithuania, Poland, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 (time frame: Within 7 days after vaccine Dose 1 (administered at Day 1)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.