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| ID | Type | Description | Link |
|---|---|---|---|
| 10393 | Registry Identifier | DAIDS ES Registry Number | |
| ACTG A5240 |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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Human papillomavirus (HPV) is the most common sexually transmitted disease in the world. HPV infection can cause genital warts and certain cervical problems, including cervical cancer. HPV infection may be more severe and harder to treat in HIV-infected people. The purpose of this study was to determine whether the quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in HIV-infected women.
HPV is a DNA virus that affects both men and women. Approximately 90 types of HPV have been identified, 30 of which are sexually transmitted. The most common forms of HPV are types 6, 11, 16, and 18. The quadrivalent HPV vaccine that was tested in this study had been shown in previous studies to be effective in preventing infection with HPV 6, 11, 16, and 18 in healthy young women. According to a report by the Centers for Disease Control and Prevention (CDC), 80% of women will have acquired HPV by the age of 50. HIV infected women have been reported to have a higher prevalence and persistence of HPV infection, as well as an increased risk for abnormal Pap smears and cervical cancer. HPV types 16 and 18 cause the majority of cervical cancers worldwide, and types 6 and 11 are responsible for the majority of cases of genital warts. Vaccinations for preventable infections are particularly important among HIV infected people because people with HIV have compromised immune systems; therefore, any infection is very serious and can potentially be fatal. However, standard vaccination series have not been very successful because a compromised immune system may not produce the desired immune response to a vaccine. The HPV vaccine is designed to protect against infection with HPV types 6, 11, 16, and 18 and has been approved by the FDA for use in women between the ages of 9 and 26. The purpose of this study was to determine whether the quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in HIV infected females.
The study consisted of single arm evaluations of HPV vaccine immunogenicity and safety in 3 groups based on the study screening CD4 cell count as follows:
In Version 1.0 of the protocol, the target accrual was n=67 participants with screening HIV viral load <=10,000 copies/mL and n=67 participants with HIV viral load >10,000 copies/mL within each CD4 stratum, yielding n=134 in each CD4 stratum. In light of subsequent findings from completed HPV vaccine studies, the sample size was changed to n=94 participants per CD4 stratum in Version 2.0 of the protocol, and stratification by screening HIV viral load was removed. All Stratum A and Stratum B participants were enrolled under protocol Version 1.0.
The study duration was 72 weeks. All participants received HPV vaccine administered by intramuscular injection at baseline, and at Weeks 8 and 24. Following each injection, participants remained at the clinic for 30 minutes of observation for adverse events. A telephone follow-up or a home visit by study staff was performed within 2 days following each injection.
Participants returned to the clinic for visits at Weeks 4, 8, 12, 24, 28, 52, and 72. Most study visits included a physical exam, medication review, blood and urine collection, and answering questions about signs and symptoms since previous visit. Some visits included measurement of HIV viral load and CD4 cell count; collection of endocervical wick, cervical cytobrush and anal swab; and an oral exam. A subset of participants were asked to provide additional blood samples and oral cytobrush specimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratum A | Experimental | Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. |
|
| Stratum B | Experimental | Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. |
|
| Stratum C | Experimental | Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent HPV vaccine | Biological | Quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine. All participants received the vaccine via intramuscular injection at baseline, Week 8 and Week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series | Percentage of participants with HPV6 antibody development from seronegative status (HPV6 antibody titers <20 mMU/mL) at baseline to seropositive (HPV6 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. | Week 28 |
| Percentage of Participants With HPV11 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series | Percentage of participants with HPV11 antibody development from seronegative status (HPV11 antibody titers <16 mMU/mL) at baseline to seropositive (HPV11 antibody titers >=16 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. | Week 28 |
| Percentage of Participants With HPV16 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series | Percentage of participants with HPV16 antibody development from seronegative status (HPV16 antibody titers <20 mMU/mL) at baseline to seropositive (HPV16 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. | Week 28 |
| Percentage of Participants With HPV18 Antibody Development From the Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series | Percentage of participants with HPV18 antibody development from seronegative status (HPV18 antibody titers <24 mMU/mL) at baseline to seropositive (HPV18 antibody titers >=24 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. |
| Measure | Description | Time Frame |
|---|---|---|
| HPV6 Antibody Titers Among Those Seronegative for HPV6 at Baseline | HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6). Geometric mean HPV6 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV6 (<20 mMU/mL) at baseline. |
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Inclusion Criteria:
HIV infection
CD4 count obtained within 45 days prior to study entry
Karnofsky performance score >=70 on at least one occasion within 45 days prior to study entry
The following labs within 45 days prior to study entry:
Willing to use acceptable forms of contraception for the duration of the study
Written informed consent from participant or from parent or guardian, if applicable
If on HAART, then the same regimen for at least 12 weeks prior to study entry with no change within 30 days prior to study entry. (This criterion was removed in Version 2.0 of the protocol.)
HIV viral load obtained within 45 days prior to study entry (This criterion was removed in Version 2.0 of the protocol.)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erna Milunka Kojic, MD | Department of Immunology/Infectious Disease, The Miriam Hospital, Brown University | Study Chair |
| Susan Cu-Uvin, MD | Obstetrics-Gynecology and Medicine, The Miriam Hospital, Brown University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Therapeutics CRS | Birmingham | Alabama | 35294-2050 | United States | ||
| Usc La Nichd Crs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17672042 | Background | Cameron JE, Hagensee ME. Human papillomavirus infection and disease in the HIV+ individual. Cancer Treat Res. 2007;133:185-213. doi: 10.1007/978-0-387-46816-7_7. | |
| 17117025 | Background | Chaturvedi AK, Goedert JJ. Human papillomavirus genotypes among women with HIV: implications for research and prevention. AIDS. 2006 Nov 28;20(18):2381-3. doi: 10.1097/01.aids.0000253366.94072.b4. No abstract available. |
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Participants were enrolled into 3 strata based on screening CD4 cell count:
319 HIV-infected women 13-45 years of age were recruited in US, South Africa and Brazil between March 2008 and July 2011 for participation in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stratum A | Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. |
| FG001 | Stratum B | Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Entry Through Week 28 |
|
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|
| Week 28 |
| Weeks 28, 72 |
| HPV11 Antibody Titers Among Those Seronegative for HPV11 at Baseline | HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11). Geometric mean HPV11 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV11 (<16 mMU/mL) at baseline. | Weeks 28, 72 |
| HPV16 Antibody Titers Among Those Seronegative for HPV16 at Baseline | HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16). Geometric mean HPV16 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV16 (<20 mMU/mL) at baseline. | Weeks 28, 72 |
| HPV18 Antibody Titers Among Those Seronegative for HPV18 at Baseline | HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18). Geometric mean HPV18 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV18 (<24 mMU/mL) at baseline. | Weeks 28, 72 |
| Change in Log10 HPV6 Antibody Titers From Baseline Among Those Seropositive for HPV6 at Baseline | Change in log10 HPV6 antibody titers was calculated as log10 HPV6 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV6 antibody titers at baseline among those seropositive for HPV6 (>=20 mMU/mL) at baseline. HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6). | Weeks 0, 28, 72 |
| Change in Log10 HPV11 Antibody Titers From Baseline Among Those Seropositive for HPV11 at Baseline | Change in log10 HPV11 antibody titers was calculated as log10 HPV11 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV11 antibody titers at baseline among those seropositive for HPV11 (>=16 mMU/mL) at baseline. HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11). | Weeks 0, 28, 72 |
| Change in Log10 HPV16 Antibody Titers From Baseline Among Those Seropositive for HPV16 at Baseline | Change in log10 HPV16 antibody titers was calculated as log10 HPV16 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV16 antibody titers at baseline among those seropositive for HPV16 (>=20 mMU/mL) at baseline. HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16). | Weeks 0, 28, 72 |
| Change in Log10 HPV18 Antibody Titers From Baseline Among Those Seropositive for HPV18 at Baseline | Change in log10 HPV18 antibody titers was calculated as log10 HPV18 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV18 antibody titers at baseline among those seropositive for HPV18 (>=24 mMU/mL) at baseline. HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18). | Weeks 0, 28, 72 |
| Number of Participants With Signs and Symptoms of Grade 3 or Higher | Number of participants who experienced a sign or symptom of Grade 3 or higher at any time after baseline while on study. Grading of signs and symptoms was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004. | From baseline to up to Week 72 |
| Number of Participants With Laboratory Abnormalities of Grade 3 or Higher | Number of participants who experienced a laboratory abnormality of Grade 3 or higher at any time after baseline while on study. Grading of laboratory abnormalities was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004. | From baseline to up to Week 72 |
| Change in Log10 HIV Viral Load (VL) From Baseline | A blood sample was drawn for local testing to determine the HIV VL. Change in log10 HIV VL was calculated as log10 HIV VL at a later time point (Weeks 4, 12, 28, 52 and 72) minus log10 HIV VL at baseline. | Weeks 0, 4, 12, 28, 52, and 72 |
| Change in CD4 Cell Count From Baseline | A blood sample was drawn for local testing to determine the CD4 cell count. Change in CD4 cell count was calculated as CD4 cell count at a later time point (Weeks 4, 8, 12, 24, 28, 52 and 72) minus CD4 cell count at baseline. | Weeks 0, 4, 8, 12, 24, 28, 52 and 72 |
| Alhambra |
| California |
| 90033 |
| United States |
| University of California, UC San Diego CRS | La Jolla | California | 92093-0672 | United States |
| Miller Children's Hosp. Long Beach CA NICHD CRS | Long Beach | California | 90806 | United States |
| University of Southern California CRS | Los Angeles | California | 90033-1079 | United States |
| UCLA CARE Center CRS | Los Angeles | California | 90035 | United States |
| Stanford AIDS Clinical Trials Unit CRS | Palo Alto | California | 94304-5350 | United States |
| UCSD Antiviral Research Center CRS | San Diego | California | 92103 | United States |
| Ucsf Hiv/Aids Crs | San Francisco | California | 94110 | United States |
| University of Colorado Hospital CRS | Aurora | Colorado | 80045 | United States |
| Denver Public Health CRS | Denver | Colorado | 80204 | United States |
| Georgetown University CRS (GU CRS) | Washington D.C. | District of Columbia | 20007 | United States |
| Howard Univ. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20060 | United States |
| South Florida CDTC Ft Lauderdale NICHD CRS | Fort Lauderdale | Florida | 33316 | United States |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | 32209 | United States |
| Pediatric Perinatal HIV Clinical Trials Unit CRS | Miami | Florida | 33136 | United States |
| The University of Miami AIDS Clinical Research Unit (ACRU) CRS | Miami | Florida | 33136 | United States |
| The Ponce de Leon Center CRS | Atlanta | Georgia | 30308 | United States |
| Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program | Chicago | Illinois | 60608 | United States |
| Northwestern University CRS | Chicago | Illinois | 60611 | United States |
| Rush Univ. Med. Ctr. ACTG CRS | Chicago | Illinois | 60612 | United States |
| Rush University CRS | Chicago | Illinois | 60612 | United States |
| Tulane Univ. New Orleans NICHD CRS | New Orleans | Louisiana | 70112 | United States |
| IHV Baltimore Treatment CRS | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University CRS | Baltimore | Maryland | 21205 | United States |
| Massachusetts General Hospital CRS (MGH CRS) | Boston | Massachusetts | 02114 | United States |
| Bmc Actg Crs | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hosp. CRS | Detroit | Michigan | 48202 | United States |
| Washington University Therapeutics (WT) CRS | St Louis | Missouri | 63110-1010 | United States |
| Cooper Univ. Hosp. CRS | Camden | New Jersey | 08103 | United States |
| New Jersey Medical School- Adult Clinical Research Ctr. CRS | Newark | New Jersey | 07103 | United States |
| Weill Cornell Chelsea CRS | New York | New York | 10011 | United States |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | United States |
| Columbia P&S CRS | New York | New York | 10032-3732 | United States |
| Columbia IMPAACT CRS | New York | New York | 10032 | United States |
| Trillium Health ACTG CRS | Rochester | New York | 14607 | United States |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | United States |
| Chapel Hill CRS | Chapel Hill | North Carolina | 27599 | United States |
| Duke Univ. Med. Ctr. Adult CRS | Durham | North Carolina | 27710 | United States |
| Greensboro CRS | Greensboro | North Carolina | 27401 | United States |
| Cincinnati CRS | Cincinnati | Ohio | 45219 | United States |
| Case CRS | Cleveland | Ohio | 44106 | United States |
| MetroHealth CRS | Cleveland | Ohio | 44109 | United States |
| Ohio State University CRS | Columbus | Ohio | 43210 | United States |
| The Research & Education Group-Portland CRS | Portland | Oregon | 97210 | United States |
| Penn Therapeutics, CRS | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson Univ. Med. Ctr. CRS | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh CRS | Pittsburgh | Pennsylvania | 15213 | United States |
| The Miriam Hospital Clinical Research Site (TMH CRS) CRS | Providence | Rhode Island | 02906 | United States |
| Vanderbilt Therapeutics (VT) CRS | Nashville | Tennessee | 37204 | United States |
| Trinity Health and Wellness Center CRS | Dallas | Texas | 75208 | United States |
| Texas Children's Hospital CRS | Houston | Texas | 77030-2399 | United States |
| Houston AIDS Research Team CRS | Houston | Texas | 77030 | United States |
| Virginia Commonwealth Univ. Medical Ctr. CRS | Richmond | Virginia | 23298 | United States |
| University of Washington AIDS CRS | Seattle | Washington | 98104-9929 | United States |
| Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS | Rio de Janeiro | 21040-900 | Brazil |
| Puerto Rico AIDS Clinical Trials Unit CRS | San Juan | 00935 | Puerto Rico |
| University of Puerto Rico Pediatric HIV/AIDS Research Program CRS | San Juan | 00935 | Puerto Rico |
| San Juan City Hosp. PR NICHD CRS | San Juan | 00936 | Puerto Rico |
| Wits Helen Joseph Hospital CRS (Wits HJH CRS) | Johannesburg | Gauteng | 2092 | South Africa |
| 17762573 | Background | De Vuyst H, Franceschi S. Human papillomavirus vaccines in HIV-positive men and women. Curr Opin Oncol. 2007 Sep;19(5):470-5. doi: 10.1097/CCO.0b013e3282c8c8fc. |
| 17762572 | Background | Kojic EM, Cu-Uvin S. Update: human papillomavirus infection remains highly prevalent and persistent among HIV-infected individuals. Curr Opin Oncol. 2007 Sep;19(5):464-9. doi: 10.1097/CCO.0b013e3282c8c84c. |
| 17720998 | Background | Palefsky J. Human papillomavirus infection in HIV-infected persons. Top HIV Med. 2007 Aug-Sep;15(4):130-3. |
| 24723284 | Result | Kojic EM, Kang M, Cespedes MS, Umbleja T, Godfrey C, Allen RT, Firnhaber C, Grinsztejn B, Palefsky JM, Webster-Cyriaque JY, Saah A, Aberg JA, Cu-Uvin S. Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in HIV-1-infected women. Clin Infect Dis. 2014 Jul 1;59(1):127-35. doi: 10.1093/cid/ciu238. Epub 2014 Apr 9. |
| 34907980 | Derived | Kang M, Umbleja T, Ellsworth G, Aberg J, Wilkin T. Effects of Sex, Existing Antibodies, and HIV-1-Related and Other Baseline Factors on Antibody Responses to Quadrivalent HPV Vaccine in Persons With HIV. J Acquir Immune Defic Syndr. 2022 Apr 1;89(4):414-422. doi: 10.1097/QAI.0000000000002891. |
| 30118852 | Derived | Cespedes MS, Kang M, Kojic EM, Umbleja T, Godfrey C, Webster-Cyriaque JY, Masih R, Firnhaber C, Grinsztejn B, Saah A, Cu-Uvin S, Aberg JA. Anogenital human papillomavirus virus DNA and sustained response to the quadrivalent HPV vaccine in women living with HIV-1. Papillomavirus Res. 2018 Dec;6:15-21. doi: 10.1016/j.pvr.2018.08.002. Epub 2018 Aug 16. |
| FG002 | Stratum C | Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. |
| COMPLETED |
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| NOT COMPLETED |
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| Week 29 Through Week 72 |
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|
All participants, except 4: one was found to be ineligible after enrollment (Stratum A) and 3 failed to start intervention (2 in Stratum A, 1 in Stratum C).
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| ID | Title | Description |
|---|---|---|
| BG000 | Stratum A | Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. |
| BG001 | Stratum B | Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. |
| BG002 | Stratum C | Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race/ethnicity, self-reported (NIH categories). | Number | Participants |
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| Region of Enrollment | Number | Participants |
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| HIV Antiretroviral Therapy (ART) Status | Number | Participants |
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| CD4 Cell Count | Median | Inter-Quartile Range | Cells/mm^3 |
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| Nadir CD4 Cell Count | Median | Inter-Quartile Range | Cells/mm^3 |
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| HIV Viral Load | A blood sample was drawn for HIV viral load testing by local laboratories. The assays used were Roche Amplicor Monitor HIV RT PCR, Roche UltraSensitive HIV RT PCR, bDNA (Versant HIV-1 RNA 3.0, 3rd), Roche COBAS AmpliPrep/Taqman HIV and Abbott RealTime HIV-1. | Number | Participants |
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| Human Papillomavirus Type 6 (HPV6) Serostatus | HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. Seronegative status was defined as HPV6 antibody titers <20 mMU/mL and seropositive as HPV6 antibody titers >=20 mMU/mL. | Number | Participants |
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| Human Papillomavirus Type 11 (HPV11) Serostatus | HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. Seronegative status was defined as HPV11 antibody titers <16 mMU/mL and seropositive as HPV11 antibody titers >=16 mMU/mL. | Number | Participants |
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| Human Papillomavirus Type 16 (HPV16) Serostatus | HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. Seronegative status was defined as HPV16 antibody titers <20 mMU/mL and seropositive as HPV16 antibody titers >=20 mMU/mL. | Number | Participants |
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| Human Papillomavirus Type 18 (HPV18) Serostatus | HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. Seronegative status was defined as HPV18 antibody titers <24 mMU/mL and seropositive as HPV18 antibody titers >=24 mMU/mL. | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series | Percentage of participants with HPV6 antibody development from seronegative status (HPV6 antibody titers <20 mMU/mL) at baseline to seropositive (HPV6 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. | Per-protocol analysis including all participants seronegative to HPV6 at baseline who completed the vaccination series per protocol and had HPV6 titer available at Week 28. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 28 |
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| Primary | Percentage of Participants With HPV11 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series | Percentage of participants with HPV11 antibody development from seronegative status (HPV11 antibody titers <16 mMU/mL) at baseline to seropositive (HPV11 antibody titers >=16 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. | Per-protocol analysis including all participants seronegative to HPV11 at baseline who completed the vaccination series per protocol and had HPV11 titer available at Week 28. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 28 |
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| Primary | Percentage of Participants With HPV16 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series | Percentage of participants with HPV16 antibody development from seronegative status (HPV16 antibody titers <20 mMU/mL) at baseline to seropositive (HPV16 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. | Per-protocol analysis including all participants seronegative to HPV16 at baseline who completed the vaccination series per protocol and had HPV16 titer available at Week 28. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 28 |
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| Primary | Percentage of Participants With HPV18 Antibody Development From the Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series | Percentage of participants with HPV18 antibody development from seronegative status (HPV18 antibody titers <24 mMU/mL) at baseline to seropositive (HPV18 antibody titers >=24 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. | Per-protocol analysis including all participants seronegative to HPV18 at baseline who completed the vaccination series per protocol and had HPV18 titer available at Week 28. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 28 |
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| Secondary | HPV6 Antibody Titers Among Those Seronegative for HPV6 at Baseline | HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6). Geometric mean HPV6 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV6 (<20 mMU/mL) at baseline. | All eligible participants who received at least one vaccine and were seronegative for HPV6 (HPV6-) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=60; 58; 52. Week 72: n=55; 53; 53. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Weeks 28, 72 |
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| Secondary | HPV11 Antibody Titers Among Those Seronegative for HPV11 at Baseline | HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11). Geometric mean HPV11 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV11 (<16 mMU/mL) at baseline. | All eligible participants who received at least one vaccine and were seronegative for HPV11 (HPV11-) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=93; 70; 71. Week 72: n=83; 66; 69. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Weeks 28, 72 |
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| Secondary | HPV16 Antibody Titers Among Those Seronegative for HPV16 at Baseline | HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16). Geometric mean HPV16 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV16 (<20 mMU/mL) at baseline. | All eligible participants who received at least one vaccine and were seronegative for HPV16 (HPV16-) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=73; 63; 64. Week 72: n=63; 59; 64. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Weeks 28, 72 |
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| Secondary | HPV18 Antibody Titers Among Those Seronegative for HPV18 at Baseline | HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18). Geometric mean HPV18 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV18 (<24 mMU/mL) at baseline. | All eligible participants who received at least one vaccine and were seronegative for HPV18 (HPV18-) at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=86; 80; 69. Week 72: n=75; 73; 69. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Weeks 28, 72 |
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| Secondary | Change in Log10 HPV6 Antibody Titers From Baseline Among Those Seropositive for HPV6 at Baseline | Change in log10 HPV6 antibody titers was calculated as log10 HPV6 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV6 antibody titers at baseline among those seropositive for HPV6 (>=20 mMU/mL) at baseline. HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6). | All eligible participants who received at least one vaccine and were seropositive for HPV6 (HPV6+) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=52; n=33; n=36. Week 72: n=43; 31; 35. | Posted | Median | Inter-Quartile Range | Log10 mMU/mL | Weeks 0, 28, 72 |
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| Secondary | Change in Log10 HPV11 Antibody Titers From Baseline Among Those Seropositive for HPV11 at Baseline | Change in log10 HPV11 antibody titers was calculated as log10 HPV11 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV11 antibody titers at baseline among those seropositive for HPV11 (>=16 mMU/mL) at baseline. HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11). | All eligible participants who received at least one vaccine and were seropositive for HPV11 (HPV11+) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=20; 21; 17. Week 72: n=17; 18; 19. | Posted | Median | Inter-Quartile Range | Log10 mMU/mL | Weeks 0, 28, 72 |
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| Secondary | Change in Log10 HPV16 Antibody Titers From Baseline Among Those Seropositive for HPV16 at Baseline | Change in log10 HPV16 antibody titers was calculated as log10 HPV16 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV16 antibody titers at baseline among those seropositive for HPV16 (>=20 mMU/mL) at baseline. HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16). | All eligible participants who received at least one vaccine and were seropositive for HPV16 (HPV16+) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=40; 28; 24. Week 72: n=37; 25; 24. | Posted | Median | Inter-Quartile Range | Log10 mMU/mL | Weeks 0, 28, 72 |
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| Secondary | Change in Log10 HPV18 Antibody Titers From Baseline Among Those Seropositive for HPV18 at Baseline | Change in log10 HPV18 antibody titers was calculated as log10 HPV18 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV18 antibody titers at baseline among those seropositive for HPV18 (>=24 mMU/mL) at baseline. HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18). | All eligible participants who received at least one vaccine and were seropositive for HPV18 at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=27; 11; 19. Week 72: n=25; 11; 19. | Posted | Median | Inter-Quartile Range | Log10 mMU/mL | Weeks 0, 28, 72 |
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| Secondary | Number of Participants With Signs and Symptoms of Grade 3 or Higher | Number of participants who experienced a sign or symptom of Grade 3 or higher at any time after baseline while on study. Grading of signs and symptoms was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004. | All eligible participants who received at least one vaccine. | Posted | Number | Participants | From baseline to up to Week 72 |
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| Secondary | Number of Participants With Laboratory Abnormalities of Grade 3 or Higher | Number of participants who experienced a laboratory abnormality of Grade 3 or higher at any time after baseline while on study. Grading of laboratory abnormalities was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004. | All eligible participants who received at least one vaccine. | Posted | Number | Participants | From baseline to up to Week 72 |
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| Secondary | Change in Log10 HIV Viral Load (VL) From Baseline | A blood sample was drawn for local testing to determine the HIV VL. Change in log10 HIV VL was calculated as log10 HIV VL at a later time point (Weeks 4, 12, 28, 52 and 72) minus log10 HIV VL at baseline. | N=315 eligible participants who initiated intervention and had HIV VL available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=123; 89; 88. Week 12: n=118; 89; 90. Week 28: n=118; 91; 87. Week 52: n=109; 85; 82. Week 72: n=105; 81; 83. | Posted | Median | Inter-Quartile Range | Log10 copies/mL | Weeks 0, 4, 12, 28, 52, and 72 |
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| Secondary | Change in CD4 Cell Count From Baseline | A blood sample was drawn for local testing to determine the CD4 cell count. Change in CD4 cell count was calculated as CD4 cell count at a later time point (Weeks 4, 8, 12, 24, 28, 52 and 72) minus CD4 cell count at baseline. | N=315 eligible participants who initiated intervention and had data available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=122; 92; 88. Week 8: n=119; 92; 90. Week 12: n=115; 87; 90. Week 24: n=117; 85; 88. Week 28: n=114; 89; 87. Week 52: n=108; 85; 87. Week 72: 105; 85; 88. | Posted | Median | Inter-Quartile Range | Cells/mm^3 | Weeks 0, 4, 8, 12, 24, 28, 52 and 72 |
|
From baseline to up to Week 72
The protocol required reporting of signs and symptoms and laboratory abnormalities of >=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stratum A | Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. | 6 | 127 | 96 | 127 | ||
| EG001 | Stratum B | Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. | 2 | 95 | 71 | 95 | ||
| EG002 | Stratum C | Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. | 6 | 93 | 82 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Leukoplakia oral | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Vaginitis bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Vulvovaginitis trichomonal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 16.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG Clinicaltrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems, Inc. | (301)-628-3313 | ACTGCT.Gov@s-3.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D053918 | Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
Not provided
Not provided
| Site closure |
|
| Non-adherence to study requirements |
|
| 18 - 24 years |
|
| 25 - 29 years |
|
| 30 - 34 years |
|
| 35 - 39 years |
|
| 40 - 45 years |
|
| Male |
|
| Black, Non-Hispanic |
|
| Hispanic (Regardless of Race) |
|
| Asian, Pacific Islander |
|
| Unknown |
|
| Brazil |
|
| South Africa |
|
| Not on ART |
|
| >10,000 copies/mL |
|
| Unknown |
|
| Seropositive |
|
| Unknown |
|
| Seropositive |
|
| Unknown |
|
| Seropositive |
|
| Unknown |
|
| Seropositive |
|
| Unknown |
|
|
|
|
|
|
|
Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV6 at baseline.
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|
|
|
|
|
|
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Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV6 at baseline. |
|
|
Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV11 at baseline. |
|
|
Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV16 at baseline. |
|
|
Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV18 at baseline. |
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