Anal Cancer, Nonneoplastic Condition, Penile Cancer, Precancerous Condition
Conditions
Keywords
human papilloma virus infection, anal cancer, penile cancer, HIV infection
Brief summary
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to prevent viral infection. PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.
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.
Interventions
OTHERlaboratory biomarker analysis
Sponsors
National Cancer Institute (NCI)
The Emmes Company, LLC
University of Arkansas
Merck Sharp & Dohme LLC
AIDS and Cancer Specimen Resource
AIDS Malignancy Consortium
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
13 Years to 26 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA | Post Month 7 through Month 24 | 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. |
| Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA | Post Month 7 through Month 24 | 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. |
| Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA | Post Month 7 through Month 24 | 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. |
| Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA | Post Month 7 through Month 24 | 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. |
| Incidence of Persistent Anogenital Infection With HPV 6 DNA | Post Month 7 through Month 24 | 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. |
| Incidence of Persistent Anogenital Infection With HPV 11 DNA | Post Month 7 through Month 24 | 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. |
| Incidence of Persistent Anogenital Infection With HPV 16 DNA | Post Month 7 through Month 24 | 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. |
| Incidence of Persistent Anogenital Infection With HPV 18 DNA | Post Month 7 through Month 24 | 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. |
| Incidence of HGAIN Associated With HPV 6 | Post month 7 through month 24 | 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. |
| Incidence of HGAIN Associated With HPV 11 | Post month 7 through month 24 | 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. |
| Incidence of HGAIN Associated With HPV 16 | Post month 7 through month 24 | 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. |
| Incidence of HGAIN Associated With HPV 18 | Post month 7 through month 24 | 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. |
| Incidence of Penile/Scrotal Condyloma in HPV 6 Naive and Prior Exposed Participants | Post month 7 through month 24 | Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline. |
| Incidence of Penile/Scrotal Condyloma in HPV 11 Naive and Prior Exposed Participants | Post month 7 through month 24 | Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline. |
| Incidence of Penile/Scrotal Condyloma in HPV 16 Naive and Prior Exposed Participants | Post month 7 through month 24 | Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline. |
| Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants | Post month 7 through month 24 | Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Grade ≥ 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine | Through Month 24 | Number of participants who experienced grade 3 and higher AEs that were possibly, probably or definitely related to the vaccine. |
| Geometric Mean Titers for HPV 6 | Baseline through month 24 | Geometric mean concentration of antibodies for HPV 6 at each visit |
| Geometric Mean Titers for HPV 11 | Baseline through month 24 | Geometric mean concentration of antibodies for HPV 11 at each visit |
| Geometric Mean Titers for HPV 16 | Baseline through 24 months | Geometric mean concentration of antibodies for HPV 16 at each visit |
| Geometric Mean Titers for HPV 18 | Baseline through 24 months | Geometric mean concentration of antibodies for HPV 18 at each visit |
| Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | at 7 and 24 Months | Geometric mean concentration of antibodies for HPV 6 at 7 and 24 months |
| Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | at 7 and 24 Months | Geometric mean concentration of antibodies for HPV 11 at 7 and 24 months |
| Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | at 7 and 24 Months | Geometric mean concentration of antibodies for HPV 16 at 7 and 24 months |
| Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | at 7 and 24 Months | Geometric mean concentration of antibodies for HPV 18 at 7 and 24 months |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 144 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Incarceration | 2 |
| Overall Study | Lost to Follow-up | 24 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Refusal after starting therapy | 8 |
| Overall Study | Refusal prior to therapy | 1 |
| Overall Study | Relocated | 3 |
Baseline characteristics
| Characteristic | Vaccination |
|---|---|
| Age, Continuous | 23.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 80 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Region of Enrollment Puerto Rico | 3 participants |
| Region of Enrollment United States | 141 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 144 |
| other Total, other adverse events | 59 / 144 |
| serious Total, serious adverse events | 5 / 144 |
Outcome results
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.
Time frame: Post Month 7 through Month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA | 0.0 Events per 100 person years |
| Prior Exposure to HPV 6 | Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA | 2.2 Events per 100 person years |
p-value: 0.224Exact poisson test
Comparison: This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 2.0 events per 100 PY, respectively.p-value: 0.361Exact Poisson calculation
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.
Time frame: Post Month 7 through Month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA | 0.0 Events per 100 person years |
| Prior Exposure to HPV 6 | Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA | 4.5 Events per 100 person years |
p-value: 0.079Exact poisson test
Comparison: This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.8 events per 100 PY, respectively.p-value: 0.35Exact Poisson calculation
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.
Time frame: Post Month 7 through Month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA | 0.0 Events per 100 person years |
| Prior Exposure to HPV 6 | Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA | 2.8 Events per 100 person years |
p-value: 0.162Exact poisson test
Comparison: This study's Naive to HPV 18 group was compared to the Merck 020 per-protocol historical placebo group naive to HPV 18 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.0 events per 100 PY, respectively.p-value: 0.49Exact Poisson calculation
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.
Time frame: Post Month 7 through Month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA | 0.0 Events per 100 person years |
| Prior Exposure to HPV 6 | Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA | 11.1 Events per 100 person years |
p-value: 0.112Exact poisson test
Comparison: 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.p-value: 0.447Exact Poisson calculation
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.
Time frame: Post month 7 through month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of HGAIN Associated With HPV 11 | 0.0 per 100 person years |
| Prior Exposure to HPV 6 | Incidence of HGAIN Associated With HPV 11 | 1.7 per 100 person years |
p-value: 0.745Exact Poisson calculation
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.
Time frame: Post month 7 through month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of HGAIN Associated With HPV 16 | 0.0 per 100 person years |
| Prior Exposure to HPV 6 | Incidence of HGAIN Associated With HPV 16 | 8.4 per 100 person years |
p-value: 0.014Exact Poisson calculation
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.
Time frame: Post month 7 through month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of HGAIN Associated With HPV 18 | 0.0 per 100 person years |
| Prior Exposure to HPV 6 | Incidence of HGAIN Associated With HPV 18 | 2.7 per 100 person years |
p-value: 0.166Exact Poisson calculation
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.
Time frame: Post month 7 through month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of HGAIN Associated With HPV 6 | 0.0 per 100 person years |
| Prior Exposure to HPV 6 | Incidence of HGAIN Associated With HPV 6 | 10.4 per 100 person years |
p-value: 0.064Exact Poisson calculation
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.
Time frame: Post month 7 through month 24
Population: Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of Penile/Scrotal Condyloma in HPV 11 Naive and Prior Exposed Participants | 0.9 per 100 person years |
| Prior Exposure to HPV 6 | Incidence of Penile/Scrotal Condyloma in HPV 11 Naive and Prior Exposed Participants | 1.7 per 100 person years |
p-value: 0.8090.809
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.
Time frame: Post month 7 through month 24
Population: Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of Penile/Scrotal Condyloma in HPV 16 Naive and Prior Exposed Participants | 1.8 per 100 person years |
| Prior Exposure to HPV 6 | Incidence of Penile/Scrotal Condyloma in HPV 16 Naive and Prior Exposed Participants | 0.8 per 100 person years |
p-value: 0.422Exact Poisson calculation
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.
Time frame: Post month 7 through month 24
Population: Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants | 0.7 per 100 person years |
| Prior Exposure to HPV 6 | Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants | 2.3 per 100 person years |
p-value: 0.423Exact Poisson calculation
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.
Time frame: Post month 7 through month 24
Population: Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of Penile/Scrotal Condyloma in HPV 6 Naive and Prior Exposed Participants | 1.8 per 100 person years |
| Prior Exposure to HPV 6 | Incidence of Penile/Scrotal Condyloma in HPV 6 Naive and Prior Exposed Participants | 1.1 per 100 person years |
p-value: 0.789Exact Poisson calculation
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.
Time frame: Post Month 7 through Month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of Persistent Anogenital Infection With HPV 11 DNA | 0.0 events per 100 person years |
| Prior Exposure to HPV 6 | Incidence of Persistent Anogenital Infection With HPV 11 DNA | 0.0 events per 100 person years |
p-value: >0.999Exact Poisson calculation
Comparison: This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.7 events per 100 PY, respectively.p-value: 0.209Exact Poisson calculation
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.
Time frame: Post Month 7 through Month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of Persistent Anogenital Infection With HPV 16 DNA | 2.9 events per 100 person years |
| Prior Exposure to HPV 6 | Incidence of Persistent Anogenital Infection With HPV 16 DNA | 0.0 events per 100 person years |
p-value: 0.386Exact Poisson calculation
Comparison: This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 2.9 events per 100 person years (PY) versus 4.9 events per 100 PY, respectively.p-value: 0.305Exact Poisson calculation
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.
Time frame: Post Month 7 through Month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of Persistent Anogenital Infection With HPV 18 DNA | 0.7 events per 100 person years |
| Prior Exposure to HPV 6 | Incidence of Persistent Anogenital Infection With HPV 18 DNA | 0.0 events per 100 person years |
p-value: 0.622Exact Poisson calculation
Comparison: This study's Naive to HPV 18 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 18 (NCT00090285), 0.7 events per 100 person years (PY) versus 2.7 events per 100 PY, respectively.p-value: 0.15Exact Poisson calculation
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.
Time frame: Post Month 7 through Month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naive to HPV 6 | Incidence of Persistent Anogenital Infection With HPV 6 DNA | 1.8 events per 100 person years |
| Prior Exposure to HPV 6 | Incidence of Persistent Anogenital Infection With HPV 6 DNA | 0.0 events per 100 person years |
p-value: 0.671Exact Poisson calculation
Comparison: This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 1.8 events per 100 person years (PY) versus 4.5 events per 100 PY, respectively.p-value: 0.312Exact Poisson calculation
Secondary
Geometric Mean Titers for HPV 11
Geometric mean concentration of antibodies for HPV 11 at each visit
Time frame: Baseline through month 24
Population: Eligible participants who received at least one vaccination with evaluable serum assessments.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 | Month 7 | 452.4 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 | Month 18 | 89.6 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 | Month 12 | 132.0 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 | Month 24 | 84.4 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 | Baseline | 0 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 | Month 24 | 300.2 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 | Baseline | 42.7 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 | Month 7 | 976.2 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 | Month 12 | 493.7 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 | Month 18 | 373.2 mMU/mL |
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
Time frame: at 7 and 24 Months
Population: Eligible participants who received at least one vaccination and who were sero-negative for HPV 11 at baseline with evaluable serum assessments.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age<24 years | 434 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age>=24 years | 482 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load <=75 | 473 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load >75 | 365 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 <=500 | 475 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 >500 | 445 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4 <=350 | 469 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4>350 | 452 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4>350 | 82 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age<24 years | 71 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 <=500 | 98 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age>=24 years | 104 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4 <=350 | 87 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load <=75 | 86 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 >500 | 78 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load >75 | 75 mMU/mL |
Secondary
Geometric Mean Titers for HPV 16
Geometric mean concentration of antibodies for HPV 16 at each visit
Time frame: Baseline through 24 months
Population: Eligible participants who received at least one vaccination with evaluable serum assessments.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 | Month 7 | 1535.6 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 | Month 18 | 309.5 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 | Baseline | 0 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 | Month 24 | 272.4 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 | Month 12 | 451.6 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 | Month 24 | 1079.5 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 | Month 12 | 1436.6 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 | Baseline | 66.6 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 | Month 18 | 1242.9 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 | Month 7 | 2947.8 mMU/mL |
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
Time frame: at 7 and 24 Months
Population: Eligible participants who received at least one vaccination and who were sero-negative for HPV 16 at baseline with evaluable serum assessments.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age<24 years | 1572 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age>=24 years | 1467 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load <=75 | 1630 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load >75 | 914 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 <=500 | 1556 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 >500 | 1522 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4 <=350 | 1390 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4>350 | 1752 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4>350 | 313 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age<24 years | 268 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 <=500 | 359 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age>=24 years | 272 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4 <=350 | 245 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load <=75 | 282 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 >500 | 229 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load >75 | 201 mMU/mL |
Secondary
Geometric Mean Titers for HPV 18
Geometric mean concentration of antibodies for HPV 18 at each visit
Time frame: Baseline through 24 months
Population: Eligible participants who received at least one vaccination with evaluable serum assessments.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 | Month 7 | 294.2 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 | Month 18 | 39.2 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 | Month 12 | 63.1 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 | Month 24 | 39.0 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 | Baseline | 0 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 | Month 24 | 161.9 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 | Baseline | 41.3 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 | Month 7 | 482.2 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 | Month 12 | 214.6 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 | Month 18 | 244.3 mMU/mL |
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
Time frame: at 7 and 24 Months
Population: Eligible participants who received at least one vaccination and who were sero-negative for HPV 18 at baseline with evaluable serum assessments.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age<24 years | 310 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age>=24 years | 281 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load <=75 | 333 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load >75 | 123 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 <=500 | 327 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 >500 | 282 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4 <=350 | 338 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4>350 | 268 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4>350 | 36 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age<24 years | 37 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 <=500 | 45 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age>=24 years | 42 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4 <=350 | 42 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load <=75 | 42 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 >500 | 36 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load >75 | 25 mMU/mL |
Secondary
Geometric Mean Titers for HPV 6
Geometric mean concentration of antibodies for HPV 6 at each visit
Time frame: Baseline through month 24
Population: Eligible participants who received at least one vaccination with evaluable serum assessments.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 | Month 12 | 111.8 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 | Month 18 | 79.7 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 | Month 7 | 302.3 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 | Month 24 | 73.7 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 | Baseline | 0 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 | Month 24 | 356.6 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 | Month 7 | 637.8 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 | Month 12 | 420.9 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 | Baseline | 81.7 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 | Month 18 | 335.3 mMU/mL |
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
Time frame: at 7 and 24 Months
Population: Eligible participants who received at least one vaccination and who were sero-negative for HPV 6 at baseline with evaluable serum assessments.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age<24 years | 319 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age>=24 years | 304 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load <=75 | 324 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load >75 | 250 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 <=500 | 341 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 >500 | 302 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4 <=350 | 361 mMU/mL |
| Naive to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4>350 | 300 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4>350 | 75 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age<24 years | 71 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 <=500 | 97 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Age>=24 years | 77 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Nadir CD4 <=350 | 77 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load <=75 | 81 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline CD4 >500 | 66 mMU/mL |
| Prior Exposure to HPV 6 | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Baseline HIV viral load >75 | 45 mMU/mL |
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.
Time frame: Through Month 24
Population: The safety population included eligible participants who received at least one vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Naive to HPV 6 | Occurrence of Grade ≥ 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine | 0 Participants |