Human papillomavirus (HPV) vaccine in human immunodeficiency virus (HIV) positive girls and wome

Not Applicable

Completed

• Conditions: Human immunodeficiency virus, human papillomavirus; Infections and Infestations; Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases

• Registration Number: ISRCTN33674451
• Lead Sponsor: Women's Health Research Institute (WHRI) (Canada)

Brief Summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27544584 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29278613

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-21
• Study Completion: 2017-02-17
• Last Update Posted: 29 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 500

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

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The seroresponsiveness of HIV positive girls and women to an HPV VLP quadrivalent vaccine.

Secondary Outcome Measures

Name	Time	Method
<br> 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)<br> 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<br> 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<br>