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AzTrials

HIV InfectionsPhase 2NCT00604175

Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women

A Phase 2 study testing Quadrivalent HPV vaccine in people with HIV Infections and Sexually Transmitted Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 61 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 13 to 45 years, women only
Conditions the study is for
HIV Infections, Sexually Transmitted Diseases
What is being tested?
Quadrivalent HPV vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
319 participants
Where
61 sitesin 4 countries
Study dates
Feb 2008to Nov 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 45 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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:
  • hemoglobin >8.0 g/dL
  • direct bilirubin <2.5 x upper limit of normal (ULN)
Show all 13Show fewer
  • alanine aminotransferase, ALT (SGPT) <3 xULN
  • aspartate aminotransferase, AST (SGOT) <3 xULN
  • platelet count >=100,000 /mm^3
  • 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.)

Who cannot join

  • Abnormal Pap test with confirmed biopsy results of cervical intraepithelial neoplasia (CIN) II or III or cervical cancer within 180 days prior to study entry
  • Vulval intraepithelial neoplasia (VIN) II or III or cancer confirmed by biopsy results within 180 days prior to study entry
  • Physician-diagnosed genital warts within 180 days prior to study entry
  • Previous cervical dysplasia treatment, including loop electrosurgical excision procedure (LEEP), cervical cryotherapy, cone biopsy, and cervical laser vaporization within 180 days prior to study entry
  • Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry. Participants who had received standard of care (e.g., hepatitis B, influenza, and tetanus) vaccines were not excluded.
  • Known allergy or hypersensitivity to yeast or any components of the vaccine or its formulation
Show all 13Show fewer
  • Current drug or alcohol use or dependence or any other condition that may interfere with study participation
  • Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to study entry
  • Total hysterectomy. Participants who had undergone partial hysterectomy and had a cervix were not excluded.
  • Hemophilia
  • Currently on anticoagulation therapy other than acetylsalicylic acid
  • Prior vaccination with an HPV vaccine
  • Pregnant or breastfeeding

Trial locations and contacts

61 sites in 4 countries.

61 sites in 4 countries

United States56 sites

  • Usc La Nichd Crs

    Alhambra, California, 90033

  • The Ponce de Leon Center CRS

    Atlanta, Georgia, 30308

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80045

  • IHV Baltimore Treatment CRS

    Baltimore, Maryland, 21201

  • Johns Hopkins University CRS

    Baltimore, Maryland, 21205

  • Alabama Therapeutics CRS

    Birmingham, Alabama, 35294-2050

  • Massachusetts General Hospital CRS (MGH CRS)

    Boston, Massachusetts, 02114

  • Bmc Actg Crs

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Med. Ctr., ACTG CRS

    Boston, Massachusetts, 02215

  • Cooper Univ. Hosp. CRS

    Camden, New Jersey, 08103

  • Chapel Hill CRS

    Chapel Hill, North Carolina, 27599

  • Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program

    Chicago, Illinois, 60608

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Rush Univ. Med. Ctr. ACTG CRS

    Chicago, Illinois, 60612

  • Rush University CRS

    Chicago, Illinois, 60612

  • Cincinnati CRS

    Cincinnati, Ohio, 45219

  • Case CRS

    Cleveland, Ohio, 44106

  • MetroHealth CRS

    Cleveland, Ohio, 44109

  • Ohio State University CRS

    Columbus, Ohio, 43210

  • Trinity Health and Wellness Center CRS

    Dallas, Texas, 75208

  • Denver Public Health CRS

    Denver, Colorado, 80204

  • Henry Ford Hosp. CRS

    Detroit, Michigan, 48202

  • Duke Univ. Med. Ctr. Adult CRS

    Durham, North Carolina, 27710

  • South Florida CDTC Ft Lauderdale NICHD CRS

    Fort Lauderdale, Florida, 33316

  • Greensboro CRS

    Greensboro, North Carolina, 27401

  • Texas Children's Hospital CRS

    Houston, Texas, 77030-2399

  • Houston AIDS Research Team CRS

    Houston, Texas, 77030

  • Univ. of Florida Jacksonville NICHD CRS

    Jacksonville, Florida, 32209

  • University of California, UC San Diego CRS

    La Jolla, California, 92093-0672

  • Miller Children's Hosp. Long Beach CA NICHD CRS

    Long Beach, California, 90806

  • University of Southern California CRS

    Los Angeles, California, 90033-1079

  • UCLA CARE Center CRS

    Los Angeles, California, 90035

  • Pediatric Perinatal HIV Clinical Trials Unit CRS

    Miami, Florida, 33136

  • The University of Miami AIDS Clinical Research Unit (ACRU) CRS

    Miami, Florida, 33136

  • Vanderbilt Therapeutics (VT) CRS

    Nashville, Tennessee, 37204

  • Tulane Univ. New Orleans NICHD CRS

    New Orleans, Louisiana, 70112

  • Weill Cornell Chelsea CRS

    New York, New York, 10011

  • NY Univ. HIV/AIDS CRS

    New York, New York, 10016

  • Columbia P&S CRS

    New York, New York, 10032-3732

  • Columbia IMPAACT CRS

    New York, New York, 10032

  • New Jersey Medical School- Adult Clinical Research Ctr. CRS

    Newark, New Jersey, 07103

  • Stanford AIDS Clinical Trials Unit CRS

    Palo Alto, California, 94304-5350

  • Penn Therapeutics, CRS

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson Univ. Med. Ctr. CRS

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh CRS

    Pittsburgh, Pennsylvania, 15213

  • The Research & Education Group-Portland CRS

    Portland, Oregon, 97210

  • The Miriam Hospital Clinical Research Site (TMH CRS) CRS

    Providence, Rhode Island, 02906

  • Virginia Commonwealth Univ. Medical Ctr. CRS

    Richmond, Virginia, 23298

  • Trillium Health ACTG CRS

    Rochester, New York, 14607

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • UCSD Antiviral Research Center CRS

    San Diego, California, 92103

  • Ucsf Hiv/Aids Crs

    San Francisco, California, 94110

  • University of Washington AIDS CRS

    Seattle, Washington, 98104-9929

  • Washington University Therapeutics (WT) CRS

    St Louis, Missouri, 63110-1010

  • Georgetown University CRS (GU CRS)

    Washington D.C., District of Columbia, 20007

  • Howard Univ. Washington DC NICHD CRS

    Washington D.C., District of Columbia, 20060

Other trials in United States

Puerto Rico3 sites

  • Puerto Rico AIDS Clinical Trials Unit CRS

    San Juan, 00935

  • University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

    San Juan, 00935

  • San Juan City Hosp. PR NICHD CRS

    San Juan, 00936

Other trials in Puerto Rico

Brazil1 site

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

    Rio de Janeiro, 21040-900

Other trials in Brazil

South Africa1 site

  • Wits Helen Joseph Hospital CRS (Wits HJH CRS)

    Johannesburg, Gauteng, 2092

Other trials in South Africa

About this study

Official title: A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females

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.

Read the detailed description

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:

  • Stratum A: CD4 cell count >350 cells/mm^3
  • Stratum B: CD4 cell count >200 to <=350 cells/mm^3
  • Stratum C: CD4 cell count <=200 cells/mm^3

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.

Being tested
Quadrivalent HPV vaccine
Keywords
HIV, HPV 6, HPV 11, HPV 16, HPV 18, Vaccine
Medical subject headings
HIV Infections, Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quadrivalent HPV vaccineBiological

    Also called GARDASIL

    Quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine. All participants received the vaccine via intramuscular injection at baseline, Week 8 and Week 24.

Study groups in NCT00604175
Study groupRoleWhat they receive
Stratum AExperimentalParticipants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Receives: Biological: Quadrivalent HPV vaccine
Stratum BExperimentalParticipants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Receives: Biological: Quadrivalent HPV vaccine
Stratum CExperimentalParticipants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Receives: Biological: Quadrivalent HPV vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 28

  2. 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.

    Measured: Week 28

  3. 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.

    Measured: Week 28

  4. 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.

    Measured: Week 28

Secondary outcomes (12)

  1. 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.

    Measured: Weeks 28, 72

  2. 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.

    Measured: Weeks 28, 72

  3. 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.

    Measured: Weeks 28, 72

  4. 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.

    Measured: Weeks 28, 72

  5. 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).

    Measured: Weeks 0, 28, 72

  6. 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).

    Measured: Weeks 0, 28, 72

  7. 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).

    Measured: Weeks 0, 28, 72

  8. 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).

    Measured: Weeks 0, 28, 72

  9. 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.

    Measured: From baseline to up to Week 72

  10. 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.

    Measured: From baseline to up to Week 72

  11. 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.

    Measured: Weeks 0, 4, 12, 28, 52, and 72

  12. 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.

    Measured: Weeks 0, 4, 8, 12, 24, 28, 52 and 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionJan 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00604175
Sponsor's protocol ID
A5240
Other IDs
10393, ACTG A5240
Status last verified
Aug 2015
First submitted
17 Jan 2008
Last updated
4 Nov 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17672042

  • 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.

    PubMed 17117025

  • 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.

    PubMed 17762573

  • 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.

    PubMed 17762572

  • Palefsky J. Human papillomavirus infection in HIV-infected persons. Top HIV Med. 2007 Aug-Sep;15(4):130-3.

    PubMed 17720998

  • 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.

    PubMed 24723284

  • 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.

    PubMed 34907980

  • 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.

    PubMed 30118852

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Quadrivalent HPV vaccine in people with HIV Infections and Sexually Transmitted Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 61 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Puerto Rico, Brazil, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series (time frame: Week 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00604175, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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