Trial Outcomes & Findings for Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women (NCT NCT00710593)
NCT ID: NCT00710593
Last Updated: 2017-07-02
Results Overview
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.
COMPLETED
PHASE2
99 participants
Week 28
2017-07-02
Participant Flow
Participants were enrolled between 2008 and 2011 at Adolescent Trials Network for HIV/AIDS Interventions (ATN) clinical sites.
Participant milestones
| Measure |
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.
|
HAART
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.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
30
|
|
Overall Study
COMPLETED
|
54
|
25
|
|
Overall Study
NOT COMPLETED
|
15
|
5
|
Reasons for withdrawal
| Measure |
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.
|
HAART
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.
|
|---|---|---|
|
Overall Study
Incarceration
|
1
|
0
|
|
Overall Study
Unable to complete Wk 48 within window
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Moved out of area
|
1
|
0
|
|
Overall Study
Failure to adhere or complete study eval
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Prem disc vaccine, completed all visits
|
6
|
2
|
Baseline Characteristics
Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women
Baseline characteristics by cohort
| Measure |
Group A
n=69 Participants
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.
|
Group B
n=30 Participants
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.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 20 years
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Customized
> = 20 years
|
53 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
29 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 28Population: 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).
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=40 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)
|
738.9 Milli-Merck units/milliliter (mMU/mL)
Standard Deviation 908.7
|
—
|
PRIMARY outcome
Timeframe: Week 28Population: 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).
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=63 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)
|
896.0 mMU/mL
Standard Deviation 1132.1
|
—
|
PRIMARY outcome
Timeframe: Week 28Population: 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).
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=51 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)
|
2961.1 mMU/mL
Standard Deviation 3376.8
|
—
|
PRIMARY outcome
Timeframe: Week 28Population: 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).
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=67 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)
|
576.5 mMU/mL
Standard Deviation 839.6
|
—
|
SECONDARY outcome
Timeframe: Week 28Population: Subjects had received third dose of vaccination who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV Sero-Negative at baseline.
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=40 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: Week 28Population: Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=63 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: Week 28Population: Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=51 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: Week 28Population: Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=67 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: Entry, Week 8, and Week 24Population: Subjects who had at least one event that was 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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=99 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine
Group A
|
34 participants
|
—
|
|
Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine
Group B
|
14 participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Subjects had received third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=36 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
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 outcome
Timeframe: Week 48Population: Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.
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
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=56 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
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 outcome
Timeframe: Week 48Population: Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.
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
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=48 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
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 1471.0
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.
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
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=62 Participants
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.
|
Group B
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
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 outcome
Timeframe: Week 24Population: 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.)
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=26 Participants
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.
|
Group B
n=12 Participants
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).
Yes
|
7.7 percentage of participants
|
8.3 percentage of participants
|
|
Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).
No
|
92.3 percentage of participants
|
91.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: 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.)
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=43 Participants
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.
|
Group B
n=19 Participants
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).
Yes
|
2.3 percentage of participants
|
0.0 percentage of participants
|
|
Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).
No
|
97.7 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: 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.)
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=36 Participants
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.
|
Group B
n=15 Participants
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).
Yes
|
2.8 percentage of participants
|
0.0 percentage of participants
|
|
Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).
No
|
97.2 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: 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.)
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=49 Participants
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.
|
Group B
n=18 Participants
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).
Yes
|
4.1 percentage of participants
|
5.6 percentage of participants
|
|
Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).
No
|
95.9 percentage of participants
|
94.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=24 Participants
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.
|
Group B
n=12 Participants
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).
Yes
|
8.3 percentage of participants
|
8.3 percentage of participants
|
|
Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).
No
|
91.7 percentage of participants
|
91.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=39 Participants
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.
|
Group B
n=17 Participants
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).
Yes
|
5.1 percentage of participants
|
0.0 percentage of participants
|
|
Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).
No
|
94.9 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=34 Participants
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.
|
Group B
n=14 Participants
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).
Yes
|
5.9 percentage of participants
|
7.1 percentage of participants
|
|
Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).
No
|
94.1 percentage of participants
|
92.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=46 Participants
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.
|
Group B
n=16 Participants
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).
Yes
|
8.7 percentage of participants
|
6.3 percentage of participants
|
|
Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).
No
|
91.3 percentage of participants
|
93.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Participants' 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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=47 Participants
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.
|
Group B
n=52 Participants
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
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
|
52.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Total population analyzed was 99 participants. Percentage of participants reflects percentage of participants in both lower NSSB and higher NSSB.
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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=47 Participants
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.
|
Group B
n=52 Participants
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the "12-item Knowledge About HPV and HPV Vaccine" Measure)
|
47.5 percentage of participants
|
52.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 through Week 24Visit 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%.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=59 Participants
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.
|
Group B
n=38 Participants
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card.
|
51.3 percentage of days
Standard Deviation 27.4
|
96.1 percentage of days
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Day 1 through Week 24Rate 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.
Outcome measures
| Measure |
All Study Participants Compared w/ Historical Comparison Group
n=59 Participants
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.
|
Group B
n=38 Participants
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
|
|---|---|---|
|
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
|
0.03 AEs/Total Number of Participants
|
|
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
|
0.11 AEs/Total Number of Participants
|
|
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
|
2.84 AEs/Total Number of Participants
|
|
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
|
1.37 AEs/Total Number of Participants
|
|
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
|
1.37 AEs/Total Number of Participants
|
|
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
|
0.08 AEs/Total Number of Participants
|
Adverse Events
Group A: HAART naïve or, if HAART Exposed, Has Not Received HA
Group B: Has Been Receiving HAART for > 6 Months, With Two HIV
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: HAART naïve or, if HAART Exposed, Has Not Received HA
n=69 participants at risk
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).
|
Group B: Has Been Receiving HAART for > 6 Months, With Two HIV
n=30 participants at risk
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).
|
|---|---|---|
|
General disorders
Fever
|
13.0%
9/69 • Number of events 18 • 24 Weeks
Participants were considered to have a vaccine-associated sign and/or symptom if they had at least one sign/symptom during the study after each vaccination, and the sign/symptom is possibly, probably, or definitely related to vaccine.
|
10.0%
3/30 • Number of events 5 • 24 Weeks
Participants were considered to have a vaccine-associated sign and/or symptom if they had at least one sign/symptom during the study after each vaccination, and the sign/symptom is possibly, probably, or definitely related to vaccine.
|
|
General disorders
Local reactions
|
27.5%
19/69 • Number of events 25 • 24 Weeks
Participants were considered to have a vaccine-associated sign and/or symptom if they had at least one sign/symptom during the study after each vaccination, and the sign/symptom is possibly, probably, or definitely related to vaccine.
|
23.3%
7/30 • Number of events 10 • 24 Weeks
Participants were considered to have a vaccine-associated sign and/or symptom if they had at least one sign/symptom during the study after each vaccination, and the sign/symptom is possibly, probably, or definitely related to vaccine.
|
|
General disorders
Systemic Reactions
|
21.7%
15/69 • Number of events 35 • 24 Weeks
Participants were considered to have a vaccine-associated sign and/or symptom if they had at least one sign/symptom during the study after each vaccination, and the sign/symptom is possibly, probably, or definitely related to vaccine.
|
30.0%
9/30 • Number of events 14 • 24 Weeks
Participants were considered to have a vaccine-associated sign and/or symptom if they had at least one sign/symptom during the study after each vaccination, and the sign/symptom is possibly, probably, or definitely related to vaccine.
|
|
General disorders
Other Reactions
|
7.2%
5/69 • Number of events 5 • 24 Weeks
Participants were considered to have a vaccine-associated sign and/or symptom if they had at least one sign/symptom during the study after each vaccination, and the sign/symptom is possibly, probably, or definitely related to vaccine.
|
26.7%
8/30 • Number of events 9 • 24 Weeks
Participants were considered to have a vaccine-associated sign and/or symptom if they had at least one sign/symptom during the study after each vaccination, and the sign/symptom is possibly, probably, or definitely related to vaccine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions Publication Policy outlines procedures for the development and review of abstracts, publications and presentations. The Adolescent Medicine Leadership Group (AMLG) retains custody of and primary rights to the data. Use of data must be approved by the protocol team and AMLG.
- Publication restrictions are in place
Restriction type: OTHER