Phase 2
N=319
Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women
HIV Infections · Sexually Transmitted Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00604175 ↗Enrolled (actual)
319
Serious AEs
4.4%
Results posted
Oct 2013
Primary outcome: Primary: Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series — 96.3; 100.0; 84.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Quadrivalent HPV vaccine (Biological)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- Female
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series |
96.3; 100.0; 84.4 | — |
| PRIMARY Percentage of Participants With HPV11 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series |
97.7; 98.3; 91.9 | — |
| PRIMARY Percentage of Participants With HPV16 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series |
98.5; 98.2; 92.9 | — |
| 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 |
91.0; 84.5; 75.4 | — |
| SECONDARY HPV6 Antibody Titers Among Those Seronegative for HPV6 at Baseline |
462.3; 349.2; 137.1; 112.8; 79.9; 43.0 | — |
| SECONDARY HPV11 Antibody Titers Among Those Seronegative for HPV11 at Baseline |
476.5; 417.2; 205.1; 122.3; 85.1; 52.9 | — |
| SECONDARY HPV16 Antibody Titers Among Those Seronegative for HPV16 at Baseline |
1199.9; 1117.1; 570.8; 248.9; 170.4; 98.3 | — |
| SECONDARY HPV18 Antibody Titers Among Those Seronegative for HPV18 at Baseline |
175.0; 170.8; 93.6; 41.9; 40.6; 20.8 | — |
| SECONDARY Change in Log10 HPV6 Antibody Titers From Baseline Among Those Seropositive for HPV6 at Baseline |
1.12; 1.10; 0.97; 0.73; 0.70; 0.44 | — |
| SECONDARY Change in Log10 HPV11 Antibody Titers From Baseline Among Those Seropositive for HPV11 at Baseline |
1.32; 1.42; 0.60; 0.93; 0.89; 0.43 | — |
| SECONDARY Change in Log10 HPV16 Antibody Titers From Baseline Among Those Seropositive for HPV16 at Baseline |
1.65; 1.29; 1.06; 1.28; 0.97; 0.53 | — |
| SECONDARY Change in Log10 HPV18 Antibody Titers From Baseline Among Those Seropositive for HPV18 at Baseline |
1.02; 0.89; 0.85; 0.57; 0.20; 0.14 | — |
| SECONDARY Number of Participants With Signs and Symptoms of Grade 3 or Higher |
20; 20; 16 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities of Grade 3 or Higher |
10; 7; 12 | — |
| SECONDARY Change in Log10 HIV Viral Load (VL) From Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in CD4 Cell Count From Baseline |
31; -3; 5; 21; -8; 13 | — |
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. 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.
Eligibility Criteria
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:
- hemoglobin >8.0 g/dL
- direct bilirubin =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.)
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00604175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.