Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
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ClinicalTrials.gov Identifier: NCT01031069 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 14, 2009
Last Update Posted
: December 16, 2016
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Condition or disease | Intervention/treatment | Phase |
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Infections, Papillomavirus | Biological: GSK Biologicals' HPV vaccine 580299 Biological: Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 649 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Safety and Immunogenicity of Cervarix™ in Human Immunodeficiency Virus Infected Females |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | January 2016 |
Estimated Study Completion Date : | May 2017 |

Arm | Intervention/treatment |
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Experimental: Group Cervarix
3 doses of the study vaccine administered according to a Day 0, Week 6, and Month 6 vaccination schedule.
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Biological: GSK Biologicals' HPV vaccine 580299
Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Other Name: Cervarix™
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Active Comparator: Group Gardasil
3 doses of the study vaccine administered according to a Day 0, Week 6, and Month 6 vaccination schedule.
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Biological: Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Other Name: Gardasil®
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- Occurrence and intensity of solicited local symptoms in HIV+ subjects [ Time Frame: During the 7-day (Days 0 - 6) follow-up period after each and any vaccination ]
- Occurrence, intensity and relationship to vaccination of solicited general symptoms in HIV+ subjects [ Time Frame: During the 7-day (Days 0 - 6) follow-up period after each and any vaccination ]
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms in HIV+ subjects [ Time Frame: During the 30-day (Days 0 - 29) follow-up period after any vaccination ]
- Occurrence of SAEs up to 30 days after the last dose of vaccine in HIV+ subjects [ Time Frame: Throughout the active phase of the study (up to Month 7) ]
- Occurrence of medically significant conditions (including potential immune mediated diseases [pIMDs]) up to 30 days after the last dose of vaccine in HIV+ subjects [ Time Frame: Throughout the active phase of the study (up to Month 7) ]
- Occurrence and outcome of pregnancies up to 30 days after the last dose of vaccine in HIV+ subjects [ Time Frame: Throughout the active phase of the study (up to Month 7) ]
- Occurrence of clinically relevant abnormalities in hematological and biochemical parameters up to 30 days after the last dose of vaccine in HIV+ subjects [ Time Frame: Throughout the active phase of the study (up to Month 7) ]
- CD4 cell count up to 30 days after the last dose of vaccine in HIV+ subjects [ Time Frame: Throughout the active phase of the study (up to Month 7) ]
- HIV viral load up to 30 days after the last dose of vaccine in HIV+ subjects [ Time Frame: Throughout the active phase of the study (up to Month 7) ]
- HIV clinical staging up to 30 days after the last dose of vaccine in HIV+ subjects [ Time Frame: Throughout the active phase of the study (up to Month 7) ]
- HPV-16 and HPV-18 antibody titers by Pseudovirion-Based Neutralization Assay (PBNA) 30 days after the last dose of vaccine in HIV+ subjects [ Time Frame: At Month 7 ]
- Occurrence and intensity of solicited local symptoms in HIV- subjects. [ Time Frame: During the 7-day (Days 0 - 6) follow-up period after each and any vaccination ]
- Occurrence, intensity and relationship to vaccination of solicited general symptoms in HIV- subjects. [ Time Frame: During the 7-day (Days 0 - 6) follow-up period after each and any vaccination ]
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms in HIV- subjects. [ Time Frame: During the 30-day (Days 0 - 29) follow-up period after any vaccination ]
- Occurrence of SAEs up to 30 days after the last dose of vaccine in HIV- subjects [ Time Frame: Throughout the active phase of the study (up to Month 7) ]
- Occurrence of medically significant conditions (including pIMDs) up to 30 days after the last dose of vaccine in HIV- subjects [ Time Frame: Throughout the active phase of the study (up to Month 7) ]
- Occurrence and outcome of pregnancies in all subjects. [ Time Frame: Throughout the entire study (up to Month 24) ]
- Occurrence of clinically relevant abnormalities in hematological and biochemical parameters in all subjects. [ Time Frame: At Months 12, 18 and 24 ]
- Occurrence of SAEs in all subjects. [ Time Frame: Throughout the entire study (up to Month 24) ]
- Occurrence of medically significant conditions (including pIMDs) in all subjects. [ Time Frame: Up to 12 months after the last vaccine dose (up to Month 18) ]
- CD4 cell count, HIV viral load and HIV clinical staging in HIV+ subjects. [ Time Frame: At Months 12, 18 and 24 ]
- HPV-16 and HPV-18 antibody titers by Pseudovirion-Based Neutralization Assay (PBNA) in HIV- subjects [ Time Frame: At Month 7 ]
- HPV-16 and HPV-18 antibody titers and total Immunoglobulin G (IgG) titers by Enzyme-Linked ImmunoSorbent Assay (ELISA) in serum in all subjects [ Time Frame: At Day 0, Week 6, Week 10, Months 7, 12, 18 and 24 ]
- HPV-16 and HPV-18 antibody titers and total Immunoglobulin G (IgG) titers by Enzyme-Linked ImmunoSorbent Assay in cervicovaginal secretion (CVS) in post-menarcheal subjects who volunteer for this procedure [ Time Frame: At Day 0, Week 6, Week 10, Months 7, 12 and 24 ]
- Frequencies of HPV-16 and HPV-18 specific B cells and T cells in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-) [ Time Frame: At Day 0, Week 6, Week 10, Months 7 and 12 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parent(s)/legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol.
- A female between, and including, 15 and 25 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject and/or from the subject's parent or LAR.
- Subjects willing to undergo HIV Voluntary Counseling and Testing (VCT) and willing to be informed of their HIV infection status.
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For HIV seropositive subjects:
- Subjects must be HIV seropositive according to World Health Organization (WHO) case definition.
- Subject must be asymptomatic (or only have persistent generalized lymphadenopathy).
- Subjects should have a CD4 cell count > 350 cells/mm3.
- If currently taking antiretrovirals (ARVs), subjects must be on compliant to triple therapy (highly active ART) and have undetectable viral load on two previous clinical visits within the six months prior to study entry.
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For HIV seronegative subjects:
- Subjects confirmed as HIV seronegative at the screening visit.
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For non-virgin female subjects:
- Subjects must have no history of abnormal cytology or CIN 1/2/3.
- Subjects must have had no more than six life-time sexual partners prior to enrollment.
- Subjects must have no history of congenital malformations of the uterine cervix, or history of cauterization or surgical procedures involving damage to the transformation zone of the cervix or stenosis.
- Female subjects of non-childbearing potential may be enrolled in the study.
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Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test at screening and on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.
Exclusion Criteria:
- Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 24).
- ART not compliant with the National Guidelines.
- Active tuberculosis (TB) visit (criteria mandatory only for HIV+ subjects).
- Current TB therapy.
- Hemoglobin < 8.0 g/dL at the screening visit.
- Creatinine > 1.5-fold the upper limit of normal (ULN) at the screening visit.
- Alanine aminotransferase (ALT) > 2.5-fold ULN at the screening visit.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period (Day 0 to Month 24).
- Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs (with the exception of ART) within six months prior to the first vaccine dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days (Days 0 - 29) before the first dose of study vaccine/control. Enrollment will be postponed until the subject is outside the specified window.
- Planned administration of a vaccine not foreseen by the study protocol within 30 days before or 30 days after (i.e., Days 0 - 29) any dose of study vaccine.
- Previous administration of components of the investigational vaccine.
- Cancer or autoimmune disease under treatment.
- Hypersensitivity to latex.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control.
- Acute disease and/or fever at the time of enrollment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit.
- History of any neurological disorders or seizures.
- Pregnant or breastfeeding female.
- A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose (i.e., up to Month 8).
- Concurrently participating in another clinical study, at any time during the study period (Day 0 to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Any medically diagnosed or suspected immunodeficient condition (other than HIV for HIV seropositive subjects), based on medical history, physical examination and/or laboratory tests results.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine/control or planned administration during the study period. Enrollment will be postponed until the subject is outside the specified window.
- Administration of trimethoprim/sulphamethoxazole within seven days before the first dose of study vaccine/control, or planned administration of trimethoprim/sulphamethoxazole within seven days after the first dose of study vaccine/control.
- Current drugs or alcohol abuse.
- Child in care.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031069
Brazil | |
GSK Investigational Site | |
Porto Alegre, Rio Grande Do Sul, Brazil, 90035003 | |
GSK Investigational Site | |
Ribeirão Preto, São Paulo, Brazil, 14049-900 | |
GSK Investigational Site | |
Campinas, Brazil, 13083-970 | |
GSK Investigational Site | |
Rio de Janeiro, Brazil, 21040-360 | |
GSK Investigational Site | |
São Paulo, Brazil, 03015000 | |
Estonia | |
GSK Investigational Site | |
Kohtla-Järve, Estonia, 30322 | |
GSK Investigational Site | |
Tallinn, Estonia, 10617 | |
India | |
GSK Investigational Site | |
Chennai, India, 600113 | |
GSK Investigational Site | |
Kolkata, India, 700026 | |
GSK Investigational Site | |
Mumbai, India, 400014 | |
GSK Investigational Site | |
Pune, India, 411001 | |
Thailand | |
GSK Investigational Site | |
Bangkok, Thailand, 10330 | |
GSK Investigational Site | |
Bangkok, Thailand, 10400 | |
GSK Investigational Site | |
Chiangmai, Thailand, 50200 | |
GSK Investigational Site | |
Khon Kaen, Thailand, 40002 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01031069 History of Changes |
Other Study ID Numbers: |
109823 2013-003429-28 ( EudraCT Number ) |
First Posted: | December 14, 2009 Key Record Dates |
Last Update Posted: | December 16, 2016 |
Last Verified: | December 2016 |
Keywords provided by GlaxoSmithKline:
Cervarix Gardasil Immunogenicity |
Cervical cancer Safety HPV vaccine |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |