Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-In... | NCT00710593

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A: HAART naive or no HAART in past 6 months	Active Comparator	Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).	Biological: HPV vaccine for strains -6, -11, -16, and -18
B: HAART atleast 6 months/ 2 viral loads <400 in last 6 months	Active Comparator	Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).	Biological: HPV vaccine for strains -6, -11, -16, and -18

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HPV vaccine for strains -6, -11, -16, and -18	Biological	All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)	The outcome measure for the primary objective is immunogenicity as measured by the GMT of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.	Week 28
HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)	The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine Dose #3 was administered at Week 24.	Week 28
HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)	The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.	Week 28
HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)	The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.	Week 28

Secondary Outcomes

Measure	Description	Time Frame
Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-6	Subjects who had a greater than or equal to (>=) 20 Milli-Merck units (mMU)/milliliter (mL) response were classified as responders; subjects who had a less than (<) 20 mMU/mL response were classified as non-responders.	Week 28

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Young women age 16 years and 0 days to 23 years and 364 days
HIV-infection after the age of 9 years as documented by a positive result on any of the following licensed tests: any antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA polymerase chain reaction (PCR), or plasma HIV-1 RNA > 1,000 copies/ml
HIV treatment history that falls in one of the following categories:

Group A: ART naïve or if ART-exposed, has not received HAART for at least the six months prior to study entry Group B: Has been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry

Willingness to avoid pregnancy from study entry through the Week 28 visit for subjects of child-bearing potential, i.e., use of at least one barrier or hormonal method; e.g., condoms, Depo-Provera, oral contraceptive pills, etc. Subjects on antiretroviral (ARV) medications must use a barrier contraceptive method because ARV medications can make hormonal birth control less effective.
Anticipated ability and willingness to complete all study vaccines and evaluations
Ability and willingness to participate in the study by providing written informed consent

Exclusion Criteria:

History of any prior vaccination with an HPV vaccine
Active anogenital warts within three months prior to study entry) or history of cervical intraepithelial neoplasia (CIN) 2/3 (ever, must be documented by colposcopy)
Previous allergic reaction to any constituents of the HPV vaccine
Pregnancy
Active substance use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study
Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the time of study entry
Presence of any known > Grade 3 clinical or laboratory toxicity at the time of study entry (per the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Toxicity Tables, see ATN MOGO) with the exception of isolated Grade 3 serum total hyperbilirubinemia that is considered due to atazanavir (see Section 9.6 for definition of isolated total hyperbilirubinemia).
Receipt of any routine vaccine within four weeks prior to study entry
Receipt of any immune globulin or plasma product within six months prior study entry
Receipt of any blood product or transfusion, other than immune globulin or plasma as noted above, within four weeks prior to study entry
Receipt of any restricted medication listed in Section 5.3.2 within the four weeks preceding study entry
Receipt of any other disallowed medication listed in Section 5.3.3 within the three months preceding study entry
Thrombocytopenia or coagulation disorder that would contraindicate intramuscular injection
Anticipation of long-term systemic corticosteroid therapy (more than 10 mg/day of prednisone or equivalent for > 2 consecutive weeks)
Receipt of corticosteroid therapy at the above dose and duration within 3 months preceding study entry. Use of non-steroidal anti-inflammatory agents and inhaled or topical corticosteroids are not exclusion criteria
Known or suspected disease of the immune system (other than HIV), i.e., malignancy, current or prior treatment for malignancy
If other serious, acute or chronic medical or surgical conditions or contraindications are present during screening, the Protocol Team must be consulted to determine whether enrollment may interfere with the evaluation of the protocol objectives and for permission to proceed with the enrollment

Name	Affiliation	Role
Jessica A. Kahn, M.D., M.P.H.	Adolescent Trials Network	Study Chair
Kathleen Squires, M.D.	Adolescent Trials Network	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Childrens Hospital of Los Angeles		Los Angeles	California	90027	United States
Childrens National Medical Center

PubMed Identifier	Type	Citation	Retractions
22525109	Result	Kahn JA, Xu J, Zimet GD, Liu N, Gonin R, Dillard ME, Squires K; Adolescent Trials Network for HIV/AIDS Interventions. Risk perceptions after human papillomavirus vaccination in HIV-infected adolescents and young adult women. J Adolesc Health. 2012 May;50(5):464-70. doi: 10.1016/j.jadohealth.2011.09.005. Epub 2011 Nov 4.
22820809

Label	URL
Website for the Adolescent Trials Network for HIV/AIDS Interventions	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ART/HAART NAIVE	Participants who are antiretroviral (ART) naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
FG001	HAART

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)

The outcome measure for the primary objective is immunogenicity as measured by the GMT of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.

Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-6 sero-negative at baseline (BL).

Posted

Geometric Mean

Standard Deviation

Milli-Merck units/milliliter (mMU/mL)

Week 28

ID	Title	Description
OG000	All Study Participants Compared w/ Historical Comparison Group	This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-6 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials. Comparing data collected from this study to results from a historical comparison group is part of the protocol design.

Units	Counts
Participants	OG00040

Title

Denominators

Categories

Title	Measurements
	OG000738.9± 908.7

Secondary

Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-6

Subjects who had a greater than or equal to (>=) 20 Milli-Merck units (mMU)/milliliter (mL) response were classified as responders; subjects who had a less than (<) 20 mMU/mL response were classified as non-responders.

Subjects had received third dose of vaccination who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV Sero-Negative at baseline.

Posted

Number

participants

Week 28

ID	Title	Description
OG000	All Study Participants Compared w/ Historical Comparison Group	The results are reported for all participants in both Group A and Group B.

Units	Counts
Participants	OG000

Secondary

Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-11

Subjects who had a >= 16 mMU/mL were classified as responders; subjects who had a less than < 16 mMU/mL response were classified as non-responders.

Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.

Posted

Number

participants

Week 28

ID	Title	Description
OG000	All Study Participants Compared w/ Historical Comparison Group	The results are reported for all participants in both Group A and Group B.

Units	Counts
Participants	OG000

Secondary

Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-16

Subjects who had a >= 20 mMU/mL were classified as responders; subjects who had a less than < 20 mMU/mL response were classified as non-responders.

Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.

Posted

Number

participants

Week 28

ID	Title	Description
OG000	All Study Participants Compared w/ Historical Comparison Group	The results are reported for all participants in both Group A and Group B.

Units	Counts
Participants	OG000

Secondary

Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-18

Subjects who had a >= 24 mMU/mL were classified as responders; subjects who had a less than < 24 mMU/mL response were classified as non-responders.

Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.

Posted

Number

participants

Week 28

ID	Title	Description
OG000	All Study Participants Compared w/ Historical Comparison Group	The results are reported for all participants in both Group A and Group B.

Units	Counts
Participants	OG000

Secondary

Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine

When a subject had at least one adverse event or sign/symptom during the study after doses 1, 2 or 3, and the event was possibly, probably, or definitely related to vaccine, this subject was considered to have had a vaccine-associated adverse event, sign and/or symptom.

Subjects who had at least one event that was possibly, probably, or definitely related to vaccine.

Posted

Number

participants

Entry, Week 8, and Week 24

ID	Title	Description
OG000	All Study Participants	All study participants who were administered vaccine doses #1, 2, and/or 3.

Units	Counts
Participants	OG000

Secondary

Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-6.

Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.

Subjects had received third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.

Posted

Geometric Mean

Standard Deviation

Milli-Merck units/milliliter (mMU/mL)

Week 48

ID	Title	Description
OG000	All Study Participants	The results are reported for all study participants in both Group A and Group B.

Units	Counts
Participants	OG000

Secondary

Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-11.

Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.

Posted

Geometric Mean

Standard Deviation

Milli-Merck units/milliliter (mMU/mL)

Week 48

ID	Title	Description
OG000	All Study Participants	The results are reported for participants in both Group A and Group B.

Units	Counts
Participants	OG000

Secondary

Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-16.

Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.

Posted

Geometric Mean

Standard Deviation

mMU/mL

Week 48

ID	Title	Description
OG000	All Study Participants	The results are reported for participants in both Group A and Group B.

Units	Counts
Participants	OG000

Secondary

Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-18.

Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.

Posted

Geometric Mean

Standard Deviation

mMU/mL

Week 48

ID	Title	Description
OG000	All Study Participants	The results are reported for participants in both Group A and Group B.

Units	Counts
Participants	OG000

Primary

HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)

The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine Dose #3 was administered at Week 24.

Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-11 sero-negative at baseline (BL).

Posted

Geometric Mean

Standard Deviation

mMU/mL

Week 28

ID	Title	Description
OG000	All Study Participants Compared w/ Historical Comparison Group	This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-11 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials. Comparing data collected from this study to results from a historical comparison group is part of the protocol design.

Units	Counts
Participants	OG000

Primary

HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)

Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-16 sero-negative at baseline (BL).

Posted

Geometric Mean

Standard Deviation

mMU/mL

Week 28

ID	Title	Description
OG000	All Study Participants Compared w/ Historical Comparison Group	This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-16 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials. Comparing data collected from this study to results from a historical comparison group is part of the protocol design.

Units	Counts
Participants	OG000

Primary

HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)

Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-18 sero-negative at baseline (BL).

Posted

Geometric Mean

Standard Deviation

mMU/mL

Week 28

ID	Title	Description
OG000	All Study Participants Compared w/ Historical Comparison Group	This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-18 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials. Comparing data collected from this study to results from a historical comparison group is part of the protocol design.

Units	Counts
Participants	OG000

Secondary

Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).

Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-6 sero-negative by study group and study visit at Week 24.

Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-6 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	Group A	Antiretroviral therapy (ART) naïve or if ART exposed, have not received highlight active antiretroviral (HAART) for at least the six months prior to study entry.
OG001	Group B	Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.

Units	Counts
Participants	OG000

Secondary

Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).

Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-11 sero-negative by study group and study visit at Week 24.

Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-11 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	Group A	Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
OG001	Group B	Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.

Units	Counts
Participants

Secondary

Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).

Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-16 sero-negative by study group and study visit at Week 24.

Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-16 sero-negative for at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	Group A	Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
OG001	Group B	Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.

Units	Counts
Participants

Secondary

Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).

Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-18 sero-negative by study group and study visit at Week 24.

Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-18 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	Group A	Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
OG001	Group B	Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.

Units	Counts
Participants

Secondary

Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).

Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Group A	Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
OG001	Group B	Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.

Units	Counts
Participants	OG000

Secondary

Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).

Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Group A	Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
OG001	Group B	Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.

Units	Counts
Participants	OG000

Secondary

Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).

Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Group A	Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
OG001	Group B	Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.

Units	Counts
Participants	OG000

Secondary

Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).

Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Group A	Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
OG001	Group B	Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Reported a Lower Need to Practice Safe Sex Following HPV Vaccination and the Percentage of Participants That Reported a Higher Need to Practice Safe Sex Following HPV Vaccination

Participants' perceptions for the need to practice safe sex following HPV vaccination was measured using a safer sexual behaviors subscale, which was comprised of the following five questions:

After getting vaccinated against HPV …

You feel that condom use during sex is less necessary.
You feel it is still just as important to have as few sexual partners as possible.
You feel that it is less important to talk to your sex partners about safe sex.
You think it is still just as important to use a condom every time you have sex.
You will be less worried about having unprotected sex. Those who were categorized in the "lower need for safer sexual behaviors (NSSB)" group had a summary score that was less than the median and those in the "higher NSSB" group had a summary score that was equal to or higher than the median.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Lower NSSB	Lower NSSB is defined as participants who had a lower need for safer sexual behaviors (summary score is less than the median).
OG001	Higher NSSB	Higher NSSB is defined as participants who had a higher need for safer sexual behaviors (summary score is equal to or greater than the median).

Secondary

Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the "12-item Knowledge About HPV and HPV Vaccine" Measure)

To characterize young women's risk perceptions, sexual behaviors, and sexually transmitted infections (STI) diagnoses over the 48 weeks after initial vaccination, the relationship of baseline "12-item Knowledge About HPV and HPV Vaccine" measure was used to evaluate the need for safer sexual behaviors.

Total population analyzed was 99 participants. Percentage of participants reflects percentage of participants in both lower NSSB and higher NSSB.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Lower NSSB	Lower NSSB is defined as participants who had a lower need for safer sexual behaviors (summary score is less than the median).
OG001	Higher NSSB	Higher NSSB is defined as participants who had a higher need for safer sexual behaviors (summary score is equal to or greater than the median).

Units	Counts
Participants

Secondary

Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card.

Visit compliance is the total number of days participants actually called the TRS or completed the VRC divided by the total number of days expected to call the TRS or complete the VRC, multiplied by 100%.

Posted

Mean

Standard Deviation

percentage of days

Day 1 through Week 24

ID	Title	Description
OG000	Telephone Response System (TRS)	Participants at sites randomized to the TRS called the TRS once a day to report any side effects they were experiencing.
OG001	Vaccine Report Card (VRC)	Participants at sites randomized to the VRC recorded any of their side effects. Participants were directed to call the clinical site staff or return to the clinic for evaluation if they were concerned about their signs or symptoms or if any symptoms appeared severe. Participants brought their VRC with them to all of their study visits. The completed cards were collected after all vaccine study visits were completed.

Units	Counts
Participants

Secondary

Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC).

Rate of AEs is the total number of AEs divided by the total number of participants. The rate is not a percentage bur rather it could be above 1 or less than 1. This outcome measure looked at number of AEs reported, by grade; number of AEs > Grade 3 identified; and number of AEs > Grade 3 evaluated within 24 or 48 hours.

Posted

Number

AEs/Total Number of Participants

Day 1 through Week 24

ID	Title	Description
OG000	Telephone Response System (TRS)	Participants at sites randomized to the TRS called the TRS once a day to report any side effects they were experiencing.
OG001	Vaccine Report Card (VRC)	Participants at sites randomized to the VRC recorded any of their side effects.

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	Group A: HAART naïve or, if HAART Exposed, Has Not Received HA	Participants who are ART naïve or, if ART-exposed, have not received HAART for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).			0	69	34	69
EG001	Group B: Has Been Receiving HAART for > 6 Months, With Two HIV	Participants who have been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).			0	30	14	30

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Fever	General disorders	MedDRA (10.0)	Systematic Assessment		EG00018 events9 affected69 at risk EG0015 events3 affected30 at risk
Local reactions	General disorders	MedDRA (10.0)	Systematic Assessment	Local reactions include pain and induration.	EG00025 events19 affected69 at risk EG00110 events7 affected30 at risk
Systemic Reactions	General disorders	MedDRA (10.0)	Systematic Assessment	Systemic reactions include: headache, fatigue, malaise, anorexia, arthralgia/myalgia and weakness.	EG00035 events15 affected69 at risk EG00114 events9 affected30 at risk
Other Reactions	General disorders	MedDRA (10.0)	Systematic Assessment		EG0005 events5 affected69 at risk EG0019 events8 affected30 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

ID	Title	Description
BG000	Group A	Participants who are antiretroviral (ART) naïve or, if ART-exposed, have not received highly active antiretroviral therapy(HAART) for at least the six months prior to study entry.
BG001	Group B	Participants who have been receiving highly active retroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
BG002	Total	Total of all reporting groups