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Trial record 18 of 36 for:    " June 11, 2008":" July 11, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women

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ClinicalTrials.gov Identifier: NCT00710593
Recruitment Status : Completed
First Posted : July 4, 2008
Results First Posted : May 22, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition HIV Infection
Intervention Biological: HPV vaccine for strains -6, -11, -16, and -18
Enrollment 99
Recruitment Details Participants were enrolled between 2008 and 2011 at Adolescent Trials Network for HIV/AIDS Interventions (ATN) clinical sites.
Pre-assignment Details  
Arm/Group Title ART/HAART NAIVE HAART
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 69 30
Completed 54 [1] 25 [2]
Not Completed 15 5
Reason Not Completed
Incarceration             1             0
Unable to complete Wk 48 within window             2             0
Lost to Follow-up             3             1
Moved out of area             1             0
Failure to adhere or complete study eval             1             1
Protocol Violation             1             1
Prem disc vaccine, completed all visits             6             2
[1]
54 completed study and vaccine. 6 did not receive all vaccine, but completed all study visits.
[2]
25 completed study and vaccine. 2 did not receive all vaccine, but completed all study visits.
Arm/Group Title Group A Group B Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 69 30 99
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 30 participants 99 participants
< 20 years 16 6 22
> = 20 years 53 24 77
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 30 participants 99 participants
Female
69
 100.0%
30
 100.0%
99
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 30 participants 99 participants
United States 63 29 92
Puerto Rico 6 1 7
1.Primary Outcome
Title HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Study Participants Compared w/ Historical Comparison Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 40
Geometric Mean (Standard Deviation)
Unit of Measure: Milli-Merck units/milliliter (mMU/mL)
738.9  (908.7)
2.Primary Outcome
Title HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Study Participants Compared w/ Historical Comparison Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 63
Geometric Mean (Standard Deviation)
Unit of Measure: mMU/mL
896.0  (1132.1)
3.Primary Outcome
Title HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Study Participants Compared w/ Historical Comparison Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Geometric Mean (Standard Deviation)
Unit of Measure: mMU/mL
2961.1  (3376.8)
4.Primary Outcome
Title HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Study Participants Compared w/ Historical Comparison Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 67
Geometric Mean (Standard Deviation)
Unit of Measure: mMU/mL
576.5  (839.6)
5.Secondary Outcome
Title 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
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Study Participants Compared w/ Historical Comparison Group
Hide Arm/Group Description:
The results are reported for all participants in both Group A and Group B.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
Responder 39
Non-Responder 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants Compared w/ Historical Comparison Group
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1613
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter % of participants who were responders
Estimated Value 97.5
Confidence Interval (2-Sided) 95%
86.8 to 99.9
Estimation Comments [Not Specified]
6.Secondary Outcome
Title 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
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.
Arm/Group Title All Study Participants Compared w/ Historical Comparison Group
Hide Arm/Group Description:
The results are reported for all participants in both Group A and Group B.
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: participants
Responders 61
Non-Responders 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants Compared w/ Historical Comparison Group
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0534
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter % of participants who were responders
Estimated Value 96.8
Confidence Interval (2-Sided) 95%
89.0 to 99.9
Estimation Comments [Not Specified]
7.Secondary Outcome
Title 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
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.
Arm/Group Title All Study Participants Compared w/ Historical Comparison Group
Hide Arm/Group Description:
The results are reported for all participants in both Group A and Group B.
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: participants
Responders 49
Non-Responders 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants Compared w/ Historical Comparison Group
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0427
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter % of participants who were responders
Estimated Value 96.1
Confidence Interval (2-Sided) 95%
86.5 to 99.5
Estimation Comments [Not Specified]
8.Secondary Outcome
Title 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
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.
Arm/Group Title All Study Participants Compared w/ Historical Comparison Group
Hide Arm/Group Description:
The results are reported for all participants in both Group A and Group B.
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: participants
Responders 62
Non-Responders 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants Compared w/ Historical Comparison Group
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter % of participants who were responders
Estimated Value 92.5
Confidence Interval (2-Sided) 95%
83.4 to 97.5
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who had at least one event that was possibly, probably, or definitely related to vaccine.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
All study participants who were administered vaccine doses #1, 2, and/or 3.
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: participants
Group A Number Analyzed 69 participants
34
Group B Number Analyzed 30 participants
14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8305
Comments The p-value is to test the proportions of subjects with at least one event among Group A during the study at Entry, Week 8 and Week 24 after vaccine was administered.
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter % of participants with at least 1 event
Estimated Value 49.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Study Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8305
Comments The p-value is to test the proportions of subjects with at least one event among Group B during the study at Entry, Week 8 and Week 24 after vaccine was administered.
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter % of participants with at least 1 event
Estimated Value 46.7
Estimation Comments [Not Specified]
10.Secondary Outcome
Title 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.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects had received third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
The results are reported for all study participants in both Group A and Group B.
Overall Number of Participants Analyzed 36
Geometric Mean (Standard Deviation)
Unit of Measure: Milli-Merck units/milliliter (mMU/mL)
311.9  (346.2)
11.Secondary Outcome
Title 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.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
The results are reported for participants in both Group A and Group B.
Overall Number of Participants Analyzed 56
Geometric Mean (Standard Deviation)
Unit of Measure: Milli-Merck units/milliliter (mMU/mL)
311.8  (448.7)
12.Secondary Outcome
Title 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.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
The results are reported for participants in both Group A and Group B.
Overall Number of Participants Analyzed 48
Geometric Mean (Standard Deviation)
Unit of Measure: mMU/mL
992.5  (1471.0)
13.Secondary Outcome
Title 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.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
The results are reported for participants in both Group A and Group B.
Overall Number of Participants Analyzed 62
Geometric Mean (Standard Deviation)
Unit of Measure: mMU/mL
175.3  (324.8)
14.Secondary Outcome
Title Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B
Hide Arm/Group Description:
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.
Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
Overall Number of Participants Analyzed 26 12
Measure Type: Number
Unit of Measure: percentage of participants
Yes 7.7 8.3
No 92.3 91.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A, Group B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.
Method of Estimation Estimation Parameter Overall aquisition rate
Estimated Value 7.9
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 19
Measure Type: Number
Unit of Measure: percentage of participants
Yes 2.3 0.0
No 97.7 100.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A, Group B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall aquisition rate
Estimated Value 1.6
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 36 15
Measure Type: Number
Unit of Measure: percentage of participants
Yes 2.8 0.0
No 97.2 100.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A, Group B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall aquisition rate
Estimated Value 2.0
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 49 18
Measure Type: Number
Unit of Measure: percentage of participants
Yes 4.1 5.6
No 95.9 94.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A, Group B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall aquisition rate
Estimated Value 4.5
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 24 12
Measure Type: Number
Unit of Measure: percentage of participants
Yes 8.3 8.3
No 91.7 91.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A, Group B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall aquisition rate
Estimated Value 8.3
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 39 17
Measure Type: Number
Unit of Measure: percentage of participants
Yes 5.1 0.0
No 94.9 100.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A, Group B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall aquistion rate
Estimated Value 3.6
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).
Hide Description 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
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[Not Specified]
Arm/Group Title Group A Group B
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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.
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 Number of Participants Analyzed 34 14
Measure Type: Number
Unit of Measure: percentage of participants
Yes 5.9 7.1
No 94.1 92.9
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Statistical Analysis Overview Comparison Group Selection Group A, Group B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall aquisition rate
Estimated Value 6.3
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).
Hide Description 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 46 16
Measure Type: Number
Unit of Measure: percentage of participants
Yes 8.7 6.3
No 91.3 93.8
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Statistical Analysis Overview Comparison Group Selection Group A, Group B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall aquisition rate
Estimated Value 8.1
Estimation Comments [Not Specified]
22.Secondary Outcome
Title 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
Hide Description

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
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[Not Specified]
Arm/Group Title Lower NSSB Higher NSSB
Hide Arm/Group Description:
Lower NSSB is defined as participants who had a lower need for safer sexual behaviors (summary score is less than the median).
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).
Overall Number of Participants Analyzed 47 52
Measure Type: Number
Unit of Measure: percentage of participants
47.5 52.5
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Statistical Analysis Overview Comparison Group Selection Lower NSSB, Higher NSSB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
1.02 to 1.1
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the "12-item Knowledge About HPV and HPV Vaccine" Measure)
Hide Description 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
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Total population analyzed was 99 participants. Percentage of participants reflects percentage of participants in both lower NSSB and higher NSSB.
Arm/Group Title Lower NSSB Higher NSSB
Hide Arm/Group Description:
Lower NSSB is defined as participants who had a lower need for safer sexual behaviors (summary score is less than the median).
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).
Overall Number of Participants Analyzed 47 52
Measure Type: Number
Unit of Measure: percentage of participants
47.5 52.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lower NSSB, Higher NSSB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
1.0 to 1.1
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card.
Hide Description 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
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[Not Specified]
Arm/Group Title Telephone Response System (TRS) Vaccine Report Card (VRC)
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Participants at sites randomized to the TRS called the TRS once a day to report any side effects they were experiencing.
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.
Overall Number of Participants Analyzed 59 38
Mean (Standard Deviation)
Unit of Measure: percentage of days
51.3  (27.4) 96.1  (14.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telephone Response System (TRS), Vaccine Report Card (VRC)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
25.Secondary Outcome
Title Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC).
Hide Description 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telephone Response System (TRS) Vaccine Report Card (VRC)
Hide Arm/Group Description:
Participants at sites randomized to the TRS called the TRS once a day to report any side effects they were experiencing.
Participants at sites randomized to the VRC recorded any of their side effects.
Overall Number of Participants Analyzed 59 38
Measure Type: Number
Unit of Measure: AEs/Total Number of Participants
Grade 1 0.93 1.37
Grade 2 1.19 1.37
Grade 3 0.07 0.08
Grade 4 0.00 0.03
Grade 3 or above identified after evaluation 0.07 0.11
Overall 2.19 2.84
Time Frame 24 Weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title Group A: HAART naïve or, if HAART Exposed, Has Not Received HA Group B: Has Been Receiving HAART for > 6 Months, With Two HIV
Hide Arm/Group Description 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). 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).
All-Cause Mortality
Group A: HAART naïve or, if HAART Exposed, Has Not Received HA Group B: Has Been Receiving HAART for > 6 Months, With Two HIV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious 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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/69 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A: HAART naïve or, if HAART Exposed, Has Not Received HA Group B: Has Been Receiving HAART for > 6 Months, With Two HIV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/69 (49.28%)      14/30 (46.67%)    
General disorders     
Fever  1  9/69 (13.04%)  18 3/30 (10.00%)  5
Local reactions  1 [1]  19/69 (27.54%)  25 7/30 (23.33%)  10
Systemic Reactions  1 [2]  15/69 (21.74%)  35 9/30 (30.00%)  14
Other Reactions  1  5/69 (7.25%)  5 8/30 (26.67%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Local reactions include pain and induration.
[2]
Systemic reactions include: headache, fatigue, malaise, anorexia, arthralgia/myalgia and weakness.
The small number of participants (99 started and 79 completed the study) limits generalizability of safety/tolerability data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Dr. Bob Harris
Organization: Westat
Phone: 301-251-1500
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00710593     History of Changes
Other Study ID Numbers: ATN 064
First Submitted: July 2, 2008
First Posted: July 4, 2008
Results First Submitted: November 15, 2013
Results First Posted: May 22, 2017
Last Update Posted: July 2, 2017