REVEAL 1 (Evaluation of VGX-3100 and Electroporation for... | NCT03185013

ID	Type	Description	Link
2016-002761-63	EudraCT Number

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for... | NCT03185013 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VGX-3100 + EP	Experimental	Participants received three IM injections of 6 milligram (mg) (in 1 milliliter [mL]) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Biological: VGX-3100 Device: Electroporation (EP)
Placebo + EP	Placebo Comparator	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Biological: Placebo Device: Electroporation (EP)

Name	Type	Description	Arm Group Labels	Other Names
VGX-3100	Biological	1 mL VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.	VGX-3100 + EP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples	Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame, and participants in which excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.	Week 36

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study	An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. An SAE is any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged 18 years and above
Confirmed cervical infection with HPV types 16 and/or 18 at screening
Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first dose of study drug
Confirmed histologic evidence of cervical HSIL at screening
Must be judged by Investigator to be an appropriate candidate for the protocol-specified procedure required at Week 36
With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with failure rate of less than 1% per year when used consistently and correctly from screening until Week 36
Normal screening electrocardiogram (ECG)

Exclusion Criteria:

Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening
Cervical lesion(s) that cannot be fully visualized on colposcopy
History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or insufficient for diagnosis
Treatment for cervical HSIL within 4 weeks prior to screening
Pregnant, breastfeeding or considering becoming pregnant during the study
History of previous therapeutic HPV vaccination
Immunosuppression as a result of underlying illness or treatment
Receipt of any non-study, non-live vaccine within 2 weeks of Day 0
Receipt of any non-study, live vaccine within 4 weeks of Day 0
Current or history of clinically significant, medically unstable disease or condition which, in the judgment of the investigator, would jeopardize the safety of the participant, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results
Presence of acute or chronic bleeding or clotting disorder that would contraindicate IM injections, or use of blood thinners within 2 weeks of Day 0
Participation in an interventional study with an investigational compound or device within 30 days of signing informed consent
Less than two acceptable sites available for IM injection

Contacts/Locations Module

Name	Affiliation	Role
Jeffrey Skolnik, MD	Inovio Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mesa Obstetricians and Gynecologist		Mesa	Arizona	85209	United States
Women's Health Research

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 milligram (mg) (in 1 milliliter [mL]) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
FG001	Placebo + EP

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 20, 2019	Jun 30, 2023

Type	Comment	Reasons
Withdrawal by Subject		FG0005 subjects FG0013 subjects
Adverse Event		FG0001 subjects FG0010 subjects
Progressive Disease		FG0001 subjects FG0010 subjects
Lost to Follow-up		FG0008 subjects FG0012 subjects
Physician Decision		FG0001 subjects FG0010 subjects
Protocol Deviation		FG0002 subjects FG0010 subjects
Reason not Specified		FG0003 subjects FG0012 subjects
Death		FG0001 subjects FG0010 subjects

Arm/Group Information

ID	Title	Description
BG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
BG001	Placebo + EP	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00031.3± 6.53 BG00131.9± 6.08 BG00231.5± 6.38

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000138 BG00163 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00022 BG0019 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples

Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame, and participants in which excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Week 36

ID	Title	Description
OG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
OG001	Placebo + EP	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Units	Counts
Participants	OG000138 OG00163

Title

Denominators

Categories

Title	Measurements
	OG00022.5 OG00111.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Miettinen and Nurminen method		0.029		Difference in percentage	11.4			2-Sided	95	-0.4	21.2					Superiority	Superiority was concluded if the one-sided p-value was <0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).

Secondary

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. An SAE is any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.

Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.

Posted

Count of Participants

Participants

From baseline up to Week 88

ID	Title	Description
OG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
OG001

Secondary

Percentage of Participants With No Evidence of Cervical HSIL on Histology

Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL at Week 36 and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or LSIL.

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Week 36

ID	Title	Description
OG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
OG001	Placebo + EP	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Units	Counts
Participants

Secondary

Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV Testing

Participants with no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Week 36

ID	Title	Description
OG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
OG001	Placebo + EP	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Units	Counts
Participants

Secondary

Percentage of Participants With No Evidence of LSIL or HSIL on Histology

Participants with no histologic evidence of cervical HSIL, squamous atypia, or LSIL at the Week 36 time frame and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined as no evidence of cervical squamous intraepithelial neoplasia 1 (CIN1), CIN2, or CIN3 on biopsies or excisional treatment.

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Week 36

ID	Title	Description
OG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
OG001	Placebo + EP	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Units	Counts
Participants

Secondary

Percentage of Participants With No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18

Participants with no histologic evidence of cervical HSIL, squamous atypia, and LSIL, no evidence of HPV-16 and/or HPV-18 by type specific HPV testing at the Week 36 time, and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined as no evidence of CIN1, CIN2, or CIN3 on biopsies or excisional treatment.

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Week 36

ID	Title	Description
OG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
OG001	Placebo + EP	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Units	Counts
Participants

Secondary

Percentage of Participants With No Progression of Cervical HSIL to Cervical Carcinoma

Participants with no histologic evidence of cervical Adenocarcinoma in situ or cervical carcinoma at the Week 36 timeframe relative to baseline and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered as responders.

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Week 36

ID	Title	Description
OG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
OG001	Placebo + EP	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations

Participants with no evidence of HPV-16 and/or HPV-18 on specimens from noncervical anatomic locations (oropharynx, vagina and intra-anal) at the Week 36 time frame were considered as responder.

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Week 36

ID	Title	Description
OG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
OG001	Placebo + EP	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Units	Counts
Participants	OG000

Secondary

Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations

A standardized binding enzyme-linked immunosorbent assay (ELISA) was performed to measure the anti-HPV-16/18 antibody response induced by VGX-3100.

mITT population included all participants who received at least one dose of clinical trial treatment and who had the analysis endpoint of interest. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

Posted

Median

Full Range

reciprocal endpoint titer

Week 15 and Week 36

ID	Title	Description
OG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
OG001	Placebo + EP	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Units	Counts
Participants

Secondary

Change From Baseline in Interferon-Gamma Response Magnitude

Assessment of cellular immune activity occurred via the application of the Interferon-γ enzyme-linked immunosorbent spot (IFN-γ ELISpot). Peripheral blood mononuclear cells (PBMCs) isolated from whole blood sample were used for analysis.

Posted

Median

Full Range

spot forming units (SFU)/10^6 PBMC

Baseline; Week 15 and Week 36

ID	Title	Description
OG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
OG001	Placebo + EP	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Units	Counts

Secondary

Change From Baseline in Flow Cytometry Response Magnitude

Assessment of cellular immune activity was measured using the application flow cytometry for the purposes of performing a Lytic Granule Loading Assay. The Lytic Granule Loading assay examines the following external cellular markers: CD3, CD4, CD8 (T cell identification), CD137, CD38 and CD69 (T cell activation markers) as well as PD-1 (exhaustion/activation marker). Here change from baseline in CD8+CD137+Perforin+, CD8+CD38+Perforin+ and CD8+CD69+Perforin+ are reported.

Posted

Median

Full Range

SFU/10^6 PBMC

Baseline, Week 15

ID	Title	Description
OG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
OG001	Placebo + EP	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	VGX-3100 + Electroporation (EP)	Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	1	136	13	136	131	136
EG001	Placebo + EP	Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	0	62	6	62	61	62

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Adenosquamous Carcinoma of the Cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected136 at risk EG0011 affected62 at risk
Cervix Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0003 affected136 at risk EG0012 affected62 at risk
Squamous Cell Carcinoma of the Cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0005 affected136 at risk EG0010 affected62 at risk
Ligament Injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected136 at risk EG0010 affected62 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected136 at risk EG0011 affected62 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 24.0	Systematic Assessment	EG0000 affected136 at risk EG0011 affected62 at risk
Ectopic Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 24.0	Systematic Assessment	EG0000 affected136 at risk EG0011 affected62 at risk
Diaphragmatic Hernia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected136 at risk EG0010 affected62 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected136 at risk EG0011 affected62 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected136 at risk EG0010 affected62 at risk
Bipolar Disorder	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected136 at risk EG0010 affected62 at risk
Kidney Infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected136 at risk EG0010 affected62 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected136 at risk EG0010 affected62 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00025 affected136 at risk EG00111 affected62 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0008 affected136 at risk EG0014 affected62 at risk
Injection Site Pain	General disorders	MedDRA 24.0	Systematic Assessment	EG000105 affected136 at risk EG00149 affected62 at risk
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG00040 affected136 at risk EG00118 affected62 at risk
Injection Site Pruritus	General disorders	MedDRA 24.0	Systematic Assessment	EG00034 affected136 at risk EG00114 affected62 at risk
Injection Site Erythema	General disorders	MedDRA 24.0	Systematic Assessment	EG00033 affected136 at risk EG00114 affected62 at risk
Injection Site Swelling	General disorders	MedDRA 24.0	Systematic Assessment	EG00028 affected136 at risk EG00115 affected62 at risk
Injection Site Bruising	General disorders	MedDRA 24.0	Systematic Assessment	EG00014 affected136 at risk EG0019 affected62 at risk
Injection Site Haematoma	General disorders	MedDRA 24.0	Systematic Assessment	EG0008 affected136 at risk EG0016 affected62 at risk
Malaise	General disorders	MedDRA 24.0	Systematic Assessment	EG0009 affected136 at risk EG0015 affected62 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00013 affected136 at risk EG0014 affected62 at risk
Vaginitis Bacterial	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0009 affected136 at risk EG0014 affected62 at risk
Vulvovaginal Candidiasis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0009 affected136 at risk EG0013 affected62 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0007 affected136 at risk EG0014 affected62 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG00028 affected136 at risk EG00114 affected62 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG00013 affected136 at risk EG0016 affected62 at risk
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG00046 affected136 at risk EG00119 affected62 at risk

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D065308	Morphological and Microscopic Findings
D013568	Pathological Conditions, Signs and Symptoms

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Difference in percentage	12.8			2-Sided	95	-0.6	24.5					Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Difference in percentage	18.2			2-Sided	95	5.1	29.4					Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Difference in percentage	13.5			2-Sided	95	1.7	23.5					Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Difference in percentage	11.8			2-Sided	95	1.5	20.3					Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Difference in percentage	-1.7			2-Sided	95	-11.5	10.3					Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Difference in percentage	10.8			2-Sided	95	-0.5	20.1					Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.

Title

Denominators

Categories

HPV-16 E7 at Week 15

- ParticipantsOG000128
- ParticipantsOG00161

Title	Measurements
	OG000225.0(1 to 18225) OG0011.0(1 to 6075)

HPV-16 E7 at Week 36

- ParticipantsOG000128
- ParticipantsOG00158

Title	Measurements
	OG0001.0(1 to 18225) OG001

HPV-18 E7 at Week 15

- ParticipantsOG000128
- ParticipantsOG00161

Title	Measurements
	OG0002025.0(1 to 18225) OG001

HPV-18 E7 at Week 36

- ParticipantsOG000128
- ParticipantsOG00158

Title	Measurements
	OG000225.0(1 to 18225) OG001

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Week 15: HPV-16 E7	Location shift	224.0	2-Sided	95	24.0	224.0	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.
OG000 OG001	Week 36: HPV-16 E7	Location shift	0.0	2-Sided	95	0.0	0.0	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.
OG000 OG001	Week 15: HPV-18 E7	Location Shift	2024.0	2-Sided	95	2000.0	6050.0	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.
OG000 OG001	Week 36: HPV-18 E7	Location Shift	224.0	2-Sided	95	74.0	674.0	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.

Title

Denominators

Categories

HPV-16 E6: Baseline

- ParticipantsOG000116
- ParticipantsOG00154

Title	Measurements
	OG0000.83(0.0 to 40.0) OG0010.00(0.0 to 16.7)

HPV-16 E6: Change from Baseline at Week 15

- ParticipantsOG000102
- ParticipantsOG00145

Title	Measurements
	OG00013.33(0.0 to 446.7) OG001

HPV-16 E6: Change from Baseline at Week 36

- ParticipantsOG00090
- ParticipantsOG00141

Title	Measurements
	OG0008.33(0.0 to 780.0) OG001

HPV-16 E7: Baseline

- ParticipantsOG000116
- ParticipantsOG00154

Title	Measurements
	OG0000.00(0.0 to 53.3) OG001

HPV-16 E7: Change from Baseline at Week 15

- ParticipantsOG000102
- ParticipantsOG00145

Title	Measurements
	OG00010.83(0.0 to 213.3) OG001

HPV-16 E7: Change from Baseline at Week 36

- ParticipantsOG00090
- ParticipantsOG00141

Title	Measurements
	OG0007.50(0.0 to 81.7) OG001

HPV-18 E6: Baseline

- ParticipantsOG000116
- ParticipantsOG00154

Title	Measurements
	OG0000.00(0.0 to 10.0) OG001

HPV-18 E6: Change from Baseline at Week 15

- ParticipantsOG000102
- ParticipantsOG00145

Title	Measurements
	OG00050.83(0.0 to 1910.0) OG001

HPV-18 E6: Change from Baseline at Week 36

- ParticipantsOG00090
- ParticipantsOG00141

Title	Measurements
	OG00038.33(0.0 to 1031.7) OG001

HPV-18 E7: Baseline

- ParticipantsOG000116
- ParticipantsOG00154

Title	Measurements
	OG0000.00(0.0 to 11.7) OG001

HPV-18 E7: Change from Baseline at Week 15

- ParticipantsOG000102
- ParticipantsOG00145

Title	Measurements
	OG00014.17(0.0 to 251.7) OG001

HPV-18 E7: Change from Baseline at Week 36

- ParticipantsOG00090
- ParticipantsOG00141

Title	Measurements
	OG00010.00(0.0 to 508.3) OG001

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	HPV-16 E6: Week 15	Location shift	11.67	2-Sided	95	8.33	20.00	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.
OG000 OG001	HPV-16 E6: Week 36	Difference in median	8.33	2-Sided	95	3.33	11.67	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.
OG000 OG001	HPV-16 E7: Week 15	Difference in median	10.83	2-Sided	95	5.00	15.00	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.
OG000 OG001	HPV-16 E7: Week 36	Difference in median	7.50	2-Sided	95	1.67	10.00	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.
OG000 OG001	HPV-18 E6: Week 15	Difference in median	50.83	2-Sided	95	31.67	66.67	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.
OG000 OG001	HPV-18 E6: Week 36	Difference in median	38.33	2-Sided	95	18.33	51.67	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.
OG000 OG001	HPV-18 E7: Week 15	Difference in median	14.17	2-Sided	95	6.67	18.33	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.
OG000 OG001	HPV-18 E7: Week 36	Difference in median	10.00	2-Sided	95	5.00	15.00	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.

Title

Denominators

Categories

CD8+CD137+Perforin+: Baseline

- ParticipantsOG000114
- ParticipantsOG00148

Title	Measurements
	OG0000.004(0.00 to 0.15) OG0010.001(0.00 to 0.22)

CD8+CD137+Perforin+: Change from Baseline at Week 15

- ParticipantsOG000106
- ParticipantsOG00142

Title	Measurements
	OG0000.035(0.00 to 0.44) OG001

CD8+CD38+Perforin+: Baseline

- ParticipantsOG000114
- ParticipantsOG00148

Title	Measurements
	OG0000.000(0.00 to 0.21) OG001

CD8+CD38+Perforin+: Change from Baseline at Week 15

- ParticipantsOG000106
- ParticipantsOG00142

Title	Measurements
	OG0000.011(0.00 to 0.23) OG001

CD8+CD69+Perforin+: Baseline

- ParticipantsOG000114
- ParticipantsOG00148

Title	Measurements
	OG0000.009(0.00 to 0.11) OG001

CD8+CD69+Perforin+: Change from Baseline at Week 15

- ParticipantsOG000106
- ParticipantsOG00142

Title	Measurements
	OG0000.044(0.00 to 0.37) OG001

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Parameter: CD8+CD137+Perforin+	Difference in median	0.025	2-Sided	95	0.002	0.046	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.
OG000 OG001	Parameter: CD8+CD38+Perforin+	Difference in median	0.011	2-Sided	95	0.000	0.014	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.
OG000 OG001	Parameter: CD8+CD69+Perforin+	Difference in median	0.044	2-Sided	95	0.017	0.058	Superiority	Superiority was concluded if the lower bound of the 95% CI exceeded 0.

ID	Term
D002578	Uterine Cervical Dysplasia
D000081483	Squamous Intraepithelial Lesions

ID	Term
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D008919	Investigative Techniques
D055664	Electrochemical Techniques