Vaccine Therapy in Preventing Human Papillomavirus Infect... | NCT01209325

NCT01209325

ID	Type	Description	Link
AMC-072	Other Identifier	AMC
U01CA121947	U.S. NIH Grant/Contract		View source
CDR0000685816	Other Identifier	NCI

Status Module

Sponsor/Collaborators Module

Name	Class
National Cancer Institute (NCI)	NIH
The Emmes Company, LLC	INDUSTRY
University of Arkansas	OTHER
Merck Sharp & Dohme LLC

Oversight Module

Description Module

Detailed Description

OBJECTIVES:

Primary

To determine the protective effect of the HPV-6, -11, -16, -18 vaccine in preventing penile/scrotal condyloma and HPV-6, -11, -16, -18- associated perianal/anal disease in HIV-positive males who have sex with males (MSM) age 13-26 years by comparing the incidence of these lesions among those naïve to the relevant HPV type(s) at baseline to those who are not naïve at baseline.
To determine the protective effect of the HPV-6, -11, -16, -18 vaccine in preventing persistent anogenital infection with HPV-6, -11, -16, or 18 in HIV-positive MSM age 13-26 years by comparing the incidence of persistent infection among those naïve to the relevant HPV type(s) at baseline to those who are not naïve at baseline.
To determine the protective effect of the HPV-6, -11, -16, -18 vaccine in preventing anogenital lesions associated with HPV 6,-11,-16, -18 and persistent infection with these types, in HIV-positive MSM age 13-26 years by comparing the incidence of lesions and persistent infection among those naïve to the relevant types at baseline to incident lesions and infection among MSM naïve to these HPV types who participated in the Merck 020 protocol and who received placebo as part of the protocol.

Secondary

To define the safety of the HPV-6, -11, -16, -18 vaccine in HIV-positive MSM age 13-26 years.
To evaluate the levels and persistence of HPV 6, 11, 16 and 18 Ab titers after the vaccination series among subjects who are seropositive and seronegative at baseline.
To examine whether the protective effect and antibody titers vary as a function of the following at the time of initial vaccination: subject age, HAART treatment status, HIV viral load, CD4 + T-cell count, and nadir CD4 level.

Tertiary

To quantify anogenital HPV DNA viral load prior to and after receipt of the quadrivalent HPV vaccine.
To identify and quantify HPV types in the oral cavity of HIV-positive MSM prior to and after receipt of the quadrivalent HPV vaccine.
To identify HPV strain variants among HIV-positive participants prior to and after receipt of the quadrivalent HPV vaccine.
Assess the prevalence and incidence of urinary and gonorrhea and Chlamydia trachomatis infection at baseline and their relationship with prevalent and incident anogenital HPV infection and anal condyloma or AIN.
To characterize young men's risk perceptions, sexual behaviors, and STI diagnosis after HPV vaccination.

OUTLINE: This is a multicenter study.

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccine intramuscularly on day 1 and in weeks 8 and 24.

Blood and tissue samples may be collected periodically for laboratory studies.

After completion of study treatment, patients are followed up for 2 years.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaccination	Experimental	Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.	Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine Other: laboratory biomarker analysis

Name	Type	Description	Arm Group Labels	Other Names
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine	Biological		Vaccination
laboratory biomarker analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA	Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 6 positive DNA in participants without HPV-6 related AIN at baseline.	Post Month 7 through Month 24
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA	Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 11 positive DNA in participants without HPV-11 related AIN at baseline.	Post Month 7 through Month 24
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA	Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 16 positive DNA in participants without HPV-16 related AIN at baseline.	Post Month 7 through Month 24
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA	Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 18 positive DNA in participants without HPV-18 related AIN at baseline.	Post Month 7 through Month 24
Incidence of Persistent Anogenital Infection With HPV 6 DNA	Incident events are defined as having HPV 6 positive PCR results at 2 or more consecutive visits in those who were DNA negative for HPV 6. Persistence was defined based on being persistent in the same anatomical site.	Post Month 7 through Month 24
Incidence of Persistent Anogenital Infection With HPV 11 DNA	Incident events are defined as having positive PCR results with HPV 11 at 2 or more consecutive visits in those who were DNA negative for HPV 11 at baseline. Persistence was defined based on being persistent in the same anatomical site.

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of Grade ≥ 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine	Number of participants who experienced grade 3 and higher AEs that were possibly, probably or definitely related to the vaccine.	Through Month 24
Geometric Mean Titers for HPV 6

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Men with a history of at least one male sexual partner
- "Men" is defined as those documented "male" at birth (including male-to-female transgendered persons)
HIV-1 infection as documented by any federally approved, licensed HIV test performed in conjunction with screening (ELISA, western blot, or other approved test)
- Alternatively, this documentation may include a record that another physician has documented that the patient has HIV based on prior ELISA and western blot, or other approved diagnostic tests
Meets one of the following sets of criteria:
- Patients receiving antiretroviral therapy:
  - Receipt of antiretroviral therapy for at least 3 months prior to entry
  - No change in antiretroviral therapy within 30 days prior to entry
- Patients not receiving antiretroviral therapy:
  - CD4-cell count ≥ 350 cells/mm³ within 90 days prior to study entry
  - No plans to start antiretroviral therapy prior to Week 28
Normal anal cytological result, LSIL/condyloma, or ASCUS result within 90 days prior to entry, and no HGAIN on biopsy
- No current or history of anal or peri-anal carcinoma
- No anal cytological result of HSIL, atypical squamous cells suggestive of HSIL (ASC-H), or suggestive of invasive carcinoma at screening; or history of these results
No presence of penile or scrotal condyloma, LGAIN (condyloma or AIN 1), HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry on biopsy
No history of HGAIN

PATIENT CHARACTERISTICS:

Karnofsky performance score ≥ 70 within 45 days prior to entry
Absolute neutrophil count (ANC) > 750 cells/mm^3
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000/mm^3
AST (SGOT), ALT (SGPT) ≤ 3 times upper limit of normal (ULN)
Total or conjugated (direct) bilirubin ≤ 2.5 times ULN within 45 days before study entry, with the exception of isolated hyperbilirubinemia that is considered due to atazanavir
Calculated creatinine clearance ≥ 60 mL/min
No hemophilia
No active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
No serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry
No serious medical or psychiatric illness that, in the opinion of the site Investigator, will interfere with the ability of the subject to give informed consent or adhere to the protocol
No allergy to yeast or any of the components of Gardasil

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior splenectomy
No prior receipt of Gardasil or other HPV vaccine
No use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry
No expected use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids used for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG during study followup
- No patients with hepatitis C who expect to initiate treatment for hepatitis C (e.g., interferons) during this trial
Not currently receiving anticoagulation therapy other than acetylsalicylic acid

Contacts/Locations Module

Name	Affiliation	Role
Joel Palefsky, MD	University of California, San Francisco	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Moores UCSD Cancer Center		La Jolla	California	92093	United States
UCLA Clinical AIDS Research and Education (CARE) Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30658128	Derived	Kahn JA, Belzer M, Chi X, Lee J, Gaur AH, Mayer K, Martinez J, Futterman DC, Stier EA, Paul ME, Chiao EY, Reirden D, Goldstone SE, Ortiz Martinez AP, Cachay ER, Barroso LF, Da Costa M, Wilson CM, Palefsky JM; AIDS Malignancy Consortium and Adolescent Medicine Trials Network for HIV/AIDS Interventions. Pre-vaccination prevalence of anogenital and oral human papillomavirus in young HIV-infected men who have sex with men. Papillomavirus Res. 2019 Jun;7:52-61. doi: 10.1016/j.pvr.2019.01.002. Epub 2019 Jan 15.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Vaccination	Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine laboratory biomarker analysis

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 2, 2014

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Eligible participants who received at least one dose of vaccine.

Arm/Group Information

ID	Title	Description
BG000	Vaccination	Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine laboratory biomarker analysis

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00023.5(18.1 to 27.0)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000
Male	BG000144

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00038
Not Hispanic or Latino	BG000106

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001
Asian	BG0003

Region of Enrollment

Number

participants

Title

Denominators

Categories

Puerto Rico

Title	Measurements
	BG0003

United States

Title	Measurements
	BG000

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

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA

Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 6 positive DNA in participants without HPV-6 related AIN at baseline.

Eligible participants without prevalent HPV 6 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Posted

Number

Events per 100 person years

Post Month 7 through Month 24

ID	Title	Description
OG000	Naive to HPV 6	HPV 6 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 6	HPV 6 positive based on serum at visit 0.

Units	Counts
Participants	OG00015 OG00134

Title

Denominators

Categories

Title	Measurements
	OG0000.0 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		Exact poisson test		0.112	Two-sided p-value													Superiority
OG000	This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 0.0 events per 100 person years (PY) versus 3.4 events per 100 PY, respectively.

Primary

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA

Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 11 positive DNA in participants without HPV-11 related AIN at baseline.

Eligible participants without prevalent HPV 11 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Posted

Number

Events per 100 person years

Post Month 7 through Month 24

ID	Title	Description
OG000	Naive to HPV 11	HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 11	HPV 11 positive based on serum at visit 0.

Units	Counts
Participants	OG000

Primary

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA

Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 16 positive DNA in participants without HPV-16 related AIN at baseline.

Eligible participants without prevalent HPV 16 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Posted

Number

Events per 100 person years

Post Month 7 through Month 24

ID	Title	Description
OG000	Naive to HPV 16	HPV 16 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 16	HPV 16 positive based on serum at visit 0.

Units	Counts
Participants	OG000

Primary

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA

Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 18 positive DNA in participants without HPV-18 related AIN at baseline.

Eligible participants without prevalent HPV 18 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Posted

Number

Events per 100 person years

Post Month 7 through Month 24

ID	Title	Description
OG000	Naive to HPV 18	HPV 18 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 18	HPV 18 positive based on serum at visit 0.

Units	Counts
Participants	OG000

Primary

Incidence of Persistent Anogenital Infection With HPV 6 DNA

Incident events are defined as having HPV 6 positive PCR results at 2 or more consecutive visits in those who were DNA negative for HPV 6. Persistence was defined based on being persistent in the same anatomical site.

All eligible participants who were HPV 6 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.

Posted

Number

events per 100 person years

Post Month 7 through Month 24

ID	Title	Description
OG000	Naive to HPV 6	HPV 6 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure HPV 6	HPV 6 positive based on serum at visit 0 from any anatomical site.

Units	Counts
Participants	OG000

Primary

Incidence of Persistent Anogenital Infection With HPV 11 DNA

Incident events are defined as having positive PCR results with HPV 11 at 2 or more consecutive visits in those who were DNA negative for HPV 11 at baseline. Persistence was defined based on being persistent in the same anatomical site.

All eligible participants who were HPV 11 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.

Posted

Number

events per 100 person years

Post Month 7 through Month 24

ID	Title	Description
OG000	Naive to HPV 11	HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 11	HPV 11 positive based on serum at visit 0 from any anatomical site.

Units	Counts
Participants	OG000

Primary

Incidence of Persistent Anogenital Infection With HPV 16 DNA

Incident events are defined as having positive PCR results with HPV 16 at 2 or more consecutive visits in those who were DNA negative for HPV 16 at baseline. Persistence was defined based on being persistent in the same anatomical site.

All eligible participants who were HPV 16 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.

Posted

Number

events per 100 person years

Post Month 7 through Month 24

ID	Title	Description
OG000	Naive to HPV 16	HPV 16 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 16	HPV 16 positive based on serum at visit 0 from any anatomical site.

Units	Counts
Participants	OG000

Primary

Incidence of Persistent Anogenital Infection With HPV 18 DNA

Incident events are defined as having positive PCR results with HPV 18 at 2 or more consecutive visits in those who were DNA negative for HPV 18. Persistence was defined based on being persistent in the same anatomical site.

All eligible participants who were HPV 18 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.

Posted

Number

events per 100 person years

Post Month 7 through Month 24

ID	Title	Description
OG000	Naive to HPV 18	HPV 18 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 18	HPV 18 positive based on serum at visit 0 from any anatomical site.

Units	Counts
Participants	OG000

Primary

Incidence of HGAIN Associated With HPV 6

Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 6 positive DNA in participants without HPV 6 related HGAIN at baseline.

Eligible participants without prevalent HPV 6 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Posted

Number

per 100 person years

Post month 7 through month 24

ID	Title	Description
OG000	Naive to HPV 6	HPV 6 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 6	HPV 6 positive based on serum at visit 0.

Units	Counts
Participants	OG000

Primary

Incidence of HGAIN Associated With HPV 11

Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 11 positive DNA in participants without HPV 11 related HGAIN at baseline.

Eligible participants without prevalent HPV 11 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Posted

Number

per 100 person years

Post month 7 through month 24

ID	Title	Description
OG000	Naive to HPV 11	HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 11	HPV 11 positive based on serum at visit 0.

Units	Counts
Participants	OG000

Primary

Incidence of HGAIN Associated With HPV 16

Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 16 positive DNA in participants without HPV 16 related HGAIN at baseline.

Eligible participants without prevalent HPV 16 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Posted

Number

per 100 person years

Post month 7 through month 24

ID	Title	Description
OG000	Naive to HPV 16	HPV 16 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 16	HPV 16 positive based on serum at visit 0.

Units	Counts
Participants	OG000

Primary

Incidence of HGAIN Associated With HPV 18

Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 18 positive DNA in participants without HPV 18 related HGAIN at baseline.

Eligible participants without prevalent HPV 18 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Posted

Number

per 100 person years

Post month 7 through month 24

ID	Title	Description
OG000	Naive to HPV 18	HPV 18 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 18	HPV 18 positive based on serum at visit 0.

Units	Counts
Participants	OG000

Primary

Incidence of Penile/Scrotal Condyloma in HPV 6 Naive and Prior Exposed Participants

Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.

Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.

Posted

Number

per 100 person years

Post month 7 through month 24

ID	Title	Description
OG000	Naive to HPV 6	HPV 6 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 6	HPV 6 positive based on serum at visit 0.

Units	Counts
Participants	OG000

Primary

Incidence of Penile/Scrotal Condyloma in HPV 11 Naive and Prior Exposed Participants

Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.

Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.

Posted

Number

per 100 person years

Post month 7 through month 24

ID	Title	Description
OG000	Naive to HPV 11	HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 11	HPV 11 positive based on serum at visit 0.

Units	Counts
Participants	OG000

Primary

Incidence of Penile/Scrotal Condyloma in HPV 16 Naive and Prior Exposed Participants

Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.

Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.

Posted

Number

per 100 person years

Post month 7 through month 24

ID	Title	Description
OG000	Naive to HPV 16	HPV 16 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 16	HPV 16 positive based on serum at visit 0.

Units	Counts
Participants	OG000

Primary

Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants

Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.

Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.

Posted

Number

per 100 person years

Post month 7 through month 24

ID	Title	Description
OG000	Naive to HPV 18	HPV 18 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
OG001	Prior Exposure to HPV 18	HPV 18 positive based on serum at visit 0.

Units	Counts
Participants	OG000

Secondary

Occurrence of Grade ≥ 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine

Number of participants who experienced grade 3 and higher AEs that were possibly, probably or definitely related to the vaccine.

The safety population included eligible participants who received at least one vaccination.

Posted

Count of Participants

Participants

Through Month 24

ID	Title	Description
OG000	Vaccination	Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine laboratory biomarker analysis

Units	Counts
Participants	OG000

Secondary

Geometric Mean Titers for HPV 6

Geometric mean concentration of antibodies for HPV 6 at each visit

Eligible participants who received at least one vaccination with evaluable serum assessments.

Posted

Geometric Mean

95% Confidence Interval

mMU/mL

Baseline through month 24

ID	Title	Description
OG000	HPV 6 Sero-negative at Baseline	Sero-negative for HPV 6 at baseline.
OG001	HPV 6 Sero-positive at Baseline	Sero-positive for HPV 6 at baseline

Units	Counts
Participants	OG000

Secondary

Geometric Mean Titers for HPV 11

Geometric mean concentration of antibodies for HPV 11 at each visit

Eligible participants who received at least one vaccination with evaluable serum assessments.

Posted

Geometric Mean

95% Confidence Interval

mMU/mL

Baseline through month 24

ID	Title	Description
OG000	HPV 11 Sero-negative at Baseline	Sero-negative for HPV 11 at baseline.
OG001	HPV 11 Sero-positive at Baseline	Sero-positive for HPV 11 at baseline

Units	Counts
Participants	OG000

Secondary

Geometric Mean Titers for HPV 16

Geometric mean concentration of antibodies for HPV 16 at each visit

Eligible participants who received at least one vaccination with evaluable serum assessments.

Posted

Geometric Mean

95% Confidence Interval

mMU/mL

Baseline through 24 months

ID	Title	Description
OG000	HPV 16 Sero-negative at Baseline	Sero-negative for HPV 16 at baseline.
OG001	HPV 16 Sero-positive at Baseline	Sero-positive for HPV 16 at baseline

Units	Counts
Participants	OG000

Secondary

Geometric Mean Titers for HPV 18

Geometric mean concentration of antibodies for HPV 18 at each visit

Eligible participants who received at least one vaccination with evaluable serum assessments.

Posted

Geometric Mean

95% Confidence Interval

mMU/mL

Baseline through 24 months

ID	Title	Description
OG000	HPV 18 Sero-negative at Baseline	Sero-negative for HPV 18 at baseline.
OG001	HPV 18 Sero-positive at Baseline	Sero-positive for HPV 18 at baseline

Units	Counts
Participants	OG000

Secondary

Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level

Geometric mean concentration of antibodies for HPV 6 at 7 and 24 months

Eligible participants who received at least one vaccination and who were sero-negative for HPV 6 at baseline with evaluable serum assessments.

Posted

Geometric Mean

95% Confidence Interval

mMU/mL

at 7 and 24 Months

ID	Title	Description
OG000	Month 7 Visit	Month 7 visit after enrollment
OG001	Month 24 Visit	Month 24 visit after enrollment

Units	Counts
Participants	OG000

Secondary

Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level

Geometric mean concentration of antibodies for HPV 11 at 7 and 24 months

Eligible participants who received at least one vaccination and who were sero-negative for HPV 11 at baseline with evaluable serum assessments.

Posted

Geometric Mean

95% Confidence Interval

mMU/mL

at 7 and 24 Months

ID	Title	Description
OG000	Month 7 Visit	Month 7 visit after enrollment
OG001	Month 24 Visit	Month 24 visit after enrollment

Units	Counts
Participants	OG000

Secondary

Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level

Geometric mean concentration of antibodies for HPV 16 at 7 and 24 months

Eligible participants who received at least one vaccination and who were sero-negative for HPV 16 at baseline with evaluable serum assessments.

Posted

Geometric Mean

95% Confidence Interval

mMU/mL

at 7 and 24 Months

ID	Title	Description
OG000	Month 7 Visit	Month 7 visit after enrollment
OG001	Month 24 Visit	Month 24 visit after enrollment

Units	Counts
Participants	OG000

Secondary

Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level

Geometric mean concentration of antibodies for HPV 18 at 7 and 24 months

Eligible participants who received at least one vaccination and who were sero-negative for HPV 18 at baseline with evaluable serum assessments.

Posted

Geometric Mean

95% Confidence Interval

mMU/mL

at 7 and 24 Months

ID	Title	Description
OG000	Month 7 Visit	Month 7 visit after enrollment
OG001	Month 24 Visit	Month 24 visit after enrollment

Units	Counts
Participants	OG000

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	Vaccination	Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine laboratory biomarker analysis	0	144	5	144	59	144

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Skin infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment		EG0002 events2 affected144 at risk
Gum infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected144 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected144 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected144 at risk
Psychiatric disorders - other, specify	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	Homicidal ideation	EG0001 events1 affected144 at risk
Suicidal ideation	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment		EG0003 events1 affected144 at risk
Suicide attempt	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events1 affected144 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0008 affected144 at risk
Injection site reaction	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG00037 affected144 at risk
Neutrophil count decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG00010 affected144 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG00010 affected144 at risk
Skin and subcutaneous tissue disorder - other, specify	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG00013 affected144 at risk

ID	Term
D001005	Anus Neoplasms
D010412	Penile Neoplasms
D011230	Precancerous Conditions
D030361	Papillomavirus Infections
D015658	HIV Infections

Ancestor Terms

ID	Term
D012004	Rectal Neoplasms
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D007410	Intestinal Diseases
D001004	Anus Diseases
D012002	Rectal Diseases
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D010409	Penile Diseases
D052801	Male Urogenital Diseases
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D007239	Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D014412	Tumor Virus Infections
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000086982	Blood-Borne Infections
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D000068857	Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

ID	Term
D017778	Vaccines, Combined
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D053918	Papillomavirus Vaccines
D014765	Viral Vaccines