Human immunodeficiency virus, human papillomavirus Infections and Infestations Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases
Conditions
Interventions
Following informed consent/assent, subjects will have a baseline visit to assess eligibility and to obtain baseline assessments (clinical labs, physical assessment, medical history, baseline study sam
Sponsors
Women's Health Research Institute (WHRI) (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. HIV positive 2. Aged greater than or equal to 9 years 3. Able to give fully informed consent or assent 4. Not pregnant (as determined by a negative urine pregnancy test) and willing to avoid pregnancy for the duration of the vaccination phase. Subjects at the time of the study entry must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination and throughout the study up to one month following the last vaccination. Effective methods of birth control include: birth control pill, intra-uterine device (IUD), depo provera, male or female condom and spermicidal, diaphragm or sponge with spermicidal, abstinence. 5. Able to attend the clinic for all of the study visits
Exclusion criteria
Exclusion criteria: 1. Allergy to the vaccine or its components 2. Prior use of an HPV vaccine 3. Current enrolment in any clinical trial which used an investigational vaccine or drug 4. Female planning to become pregnant or likely to become pregnant prior to 30 days post-last vaccine (visit 4) 5. Any condition (physical or psychosocial) that the site investigator deems exclusionary (for example, poor prognosis, extreme immunocompromisation; an individual may be enrolled into the study after the above have resolved)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The seroresponsiveness of HIV positive girls and women to an HPV VLP quadrivalent vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the effectiveness of an HPV quadrivalent vaccine in preventing infection and disease due to HPV 6, 11, 16 and/or 18 (types contained in vaccine) 2. To compare the level of circulating antibody to specific vaccine containing HPV genotypes in vaccinated girls and women by a proprietary assay and two independent laboratory assays 3. To determine the rate of adverse events in HIV infected girls and women given an HPV VLP vaccine compared to their baseline rate of adverse signs and symptoms | — |
Countries
Canada
Outcome results
None listed