HIV Infection
Conditions
Keywords
Highly-active antiretroviral therapy, Human papillomavirus, HPV vaccine
Brief summary
The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.
Interventions
BIOLOGICALHPV vaccine for strains -6, -11, -16, and -18
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).
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 23 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPV-11 Antibody Level (Geometric Mean Titer of HPV-11) | Week 28 | 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. |
| HPV-6 Antibody Level (Geometric Mean Titer of HPV-6) | Week 28 | 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. |
| HPV-16 Antibody Level (Geometric Mean Titer of HPV-16) | Week 28 | 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. |
| HPV-18 Antibody Level (Geometric Mean Titer of HPV-18) | Week 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine | Entry, Week 8, and Week 24 | 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. |
| 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. | Week 48 | 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. |
| 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. | Week 48 | 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 |
| 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. | Week 48 | 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 |
| 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. | Week 48 | 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 |
| Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24). | 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. |
| Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24). | 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. |
| Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24). | 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. |
| 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 | Week 28 | 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. |
| Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48). | 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. |
| Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48). | 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. |
| Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48). | 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. |
| Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48). | 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. |
| 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 | Week 48 | 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 … 1. You feel that condom use during sex is less necessary. 2. You feel it is still just as important to have as few sexual partners as possible. 3. You feel that it is less important to talk to your sex partners about safe sex. 4. You think it is still just as important to use a condom every time you have sex. 5. 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. |
| Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the 12-item Knowledge About HPV and HPV Vaccine Measure) | Week 48 | 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. |
| Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card. | Day 1 through Week 24 | 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%. |
| Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Day 1 through Week 24 | 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. |
| Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24). | 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. |
| 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 | Week 28 | 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. |
| 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 | Week 28 | 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. |
| 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 | Week 28 | 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. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants were enrolled between 2008 and 2011 at Adolescent Trials Network for HIV/AIDS Interventions (ATN) clinical sites.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 69 |
| 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. | 30 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failure to adhere or complete study eval | 1 | 1 |
| Overall Study | Incarceration | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Moved out of area | 1 | 0 |
| Overall Study | Prem disc vaccine, completed all visits | 6 | 2 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Unable to complete Wk 48 within window | 2 | 0 |
Baseline characteristics
| Characteristic | Group A | Group B | Total |
|---|---|---|---|
| Age, Customized < 20 years | 16 Participants | 6 Participants | 22 Participants |
| Age, Customized > = 20 years | 53 Participants | 24 Participants | 77 Participants |
| Region of Enrollment Puerto Rico | 6 participants | 1 participants | 7 participants |
| Region of Enrollment United States | 63 participants | 29 participants | 92 participants |
| Sex: Female, Male Female | 69 Participants | 30 Participants | 99 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 69 | 14 / 30 |
| serious Total, serious adverse events | 0 / 69 | 0 / 30 |
Outcome results
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.
Time frame: Week 28
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | HPV-11 Antibody Level (Geometric Mean Titer of HPV-11) | 896.0 mMU/mL | Standard Deviation 1132.1 |
Primary
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.
Time frame: Week 28
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | HPV-16 Antibody Level (Geometric Mean Titer of HPV-16) | 2961.1 mMU/mL | Standard Deviation 3376.8 |
Primary
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.
Time frame: Week 28
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | HPV-18 Antibody Level (Geometric Mean Titer of HPV-18) | 576.5 mMU/mL | Standard Deviation 839.6 |
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.
Time frame: Week 28
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | HPV-6 Antibody Level (Geometric Mean Titer of HPV-6) | 738.9 Milli-Merck units/milliliter (mMU/mL) | Standard Deviation 908.7 |
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.
Time frame: Week 24
Population: 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.)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24). | No | 97.7 percentage of participants |
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24). | Yes | 2.3 percentage of participants |
| Group B | Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24). | No | 100.0 percentage of participants |
| Group B | Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24). | Yes | 0.0 percentage of participants |
p-value: 1Fisher Exact
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.
Time frame: Week 48
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48). | Yes | 5.1 percentage of participants |
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48). | No | 94.9 percentage of participants |
| Group B | Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48). | Yes | 0.0 percentage of participants |
| Group B | Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48). | No | 100.0 percentage of participants |
p-value: 1Fisher Exact
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.
Time frame: Week 24
Population: 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.)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24). | Yes | 2.8 percentage of participants |
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24). | No | 97.2 percentage of participants |
| Group B | Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24). | Yes | 0.0 percentage of participants |
| Group B | Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24). | No | 100.0 percentage of participants |
p-value: 1Fisher Exact
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.
Time frame: Week 48
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48). | Yes | 5.9 percentage of participants |
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48). | No | 94.1 percentage of participants |
| Group B | Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48). | Yes | 7.1 percentage of participants |
| Group B | Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48). | No | 92.9 percentage of participants |
p-value: 1Fisher Exact
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.
Time frame: Week 24
Population: 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.)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24). | Yes | 4.1 percentage of participants |
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24). | No | 95.9 percentage of participants |
| Group B | Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24). | Yes | 5.6 percentage of participants |
| Group B | Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24). | No | 94.4 percentage of participants |
p-value: 1Fisher Exact
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.
Time frame: Week 48
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48). | Yes | 8.7 percentage of participants |
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48). | No | 91.3 percentage of participants |
| Group B | Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48). | Yes | 6.3 percentage of participants |
| Group B | Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48). | No | 93.8 percentage of participants |
p-value: 1Fisher Exact
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.
Time frame: Week 24
Population: 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.)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24). | Yes | 7.7 percentage of participants |
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24). | No | 92.3 percentage of participants |
| Group B | Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24). | Yes | 8.3 percentage of participants |
| Group B | Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24). | No | 91.7 percentage of participants |
p-value: 1Fisher Exact
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.
Time frame: Week 48
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48). | Yes | 8.3 percentage of participants |
| All Study Participants Compared w/ Historical Comparison Group | Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48). | No | 91.7 percentage of participants |
| Group B | Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48). | Yes | 8.3 percentage of participants |
| Group B | Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48). | No | 91.7 percentage of participants |
p-value: 1Fisher Exact
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.
Time frame: Day 1 through Week 24
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Grade 2 | 1.19 AEs/Total Number of Participants |
| All Study Participants Compared w/ Historical Comparison Group | Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Grade 3 or above identified after evaluation | 0.07 AEs/Total Number of Participants |
| All Study Participants Compared w/ Historical Comparison Group | Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Grade 3 | 0.07 AEs/Total Number of Participants |
| All Study Participants Compared w/ Historical Comparison Group | Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Overall | 2.19 AEs/Total Number of Participants |
| All Study Participants Compared w/ Historical Comparison Group | Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Grade 4 | 0.00 AEs/Total Number of Participants |
| All Study Participants Compared w/ Historical Comparison Group | Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Grade 1 | 0.93 AEs/Total Number of Participants |
| Group B | Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Grade 3 | 0.08 AEs/Total Number of Participants |
| Group B | Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Grade 1 | 1.37 AEs/Total Number of Participants |
| Group B | Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Grade 2 | 1.37 AEs/Total Number of Participants |
| Group B | Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Grade 4 | 0.03 AEs/Total Number of Participants |
| Group B | Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Grade 3 or above identified after evaluation | 0.11 AEs/Total Number of Participants |
| Group B | Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). | Overall | 2.84 AEs/Total Number of Participants |
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.
Time frame: Week 28
Population: Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | 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 | Responders | 61 participants |
| All Study Participants Compared w/ Historical Comparison Group | 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 | Non-Responders | 2 participants |
Comparison: Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.p-value: 0.053495% CI: [89, 99.9]Fisher Exact
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.
Time frame: Week 28
Population: Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | 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 | Responders | 49 participants |
| All Study Participants Compared w/ Historical Comparison Group | 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 | Non-Responders | 2 participants |
Comparison: Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.p-value: 0.042795% CI: [86.5, 99.5]Fisher Exact
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.
Time frame: Week 28
Population: Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | 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 | Responders | 62 participants |
| All Study Participants Compared w/ Historical Comparison Group | 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 | Non-Responders | 5 participants |
Comparison: Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.p-value: 0.000695% CI: [83.4, 97.5]Fisher Exact
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.
Time frame: Week 28
Population: Subjects had received third dose of vaccination who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV Sero-Negative at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | 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 | Responder | 39 participants |
| All Study Participants Compared w/ Historical Comparison Group | 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 | Non-Responder | 1 participants |
Comparison: Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.p-value: 0.161395% CI: [86.8, 99.9]Fisher Exact
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.
Time frame: Week 48
Population: Total population analyzed was 99 participants. Percentage of participants reflects percentage of participants in both lower NSSB and higher NSSB.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the 12-item Knowledge About HPV and HPV Vaccine Measure) | 47.5 percentage of participants |
| Group B | Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the 12-item Knowledge About HPV and HPV Vaccine Measure) | 52.5 percentage of participants |
p-value: 0.001295% CI: [1, 1.1]Regression, Logistic
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.
Time frame: Entry, Week 8, and Week 24
Population: Subjects who had at least one event that was possibly, probably, or definitely related to vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine | Group B | 14 participants |
| All Study Participants Compared w/ Historical Comparison Group | Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine | Group A | 34 participants |
p-value: 0.8305Chi-squared, Corrected
p-value: 0.8305Chi-squared, Corrected
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 … 1. You feel that condom use during sex is less necessary. 2. You feel it is still just as important to have as few sexual partners as possible. 3. You feel that it is less important to talk to your sex partners about safe sex. 4. You think it is still just as important to use a condom every time you have sex. 5. 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.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | 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 | 47.5 percentage of participants |
| Group B | 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 | 52.5 percentage of participants |
p-value: 0.000495% CI: [1.02, 1.1]Regression, Logistic
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.
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
Time frame: Week 48
Population: Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | 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. | 311.8 Milli-Merck units/milliliter (mMU/mL) | Standard Deviation 448.7 |
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.
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
Time frame: Week 48
Population: Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | 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. | 992.5 mMU/mL | Standard Deviation 1471 |
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.
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
Time frame: Week 48
Population: Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | 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. | 175.3 mMU/mL | Standard Deviation 324.8 |
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.
Time frame: Week 48
Population: Subjects had received third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | 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. | 311.9 Milli-Merck units/milliliter (mMU/mL) | Standard Deviation 346.2 |
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%.
Time frame: Day 1 through Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants Compared w/ Historical Comparison Group | Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card. | 51.3 percentage of days | Standard Deviation 27.4 |
| Group B | Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card. | 96.1 percentage of days | Standard Deviation 14 |
p-value: <0.0001t-test, 2 sided