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Clinical Trials/EUCTR2018-000228-33-BE
EUCTR2018-000228-33-BE
Active, not recruiting
Phase 1

Prospective longitudinal study on immunogenicity, induction of cellular immune responses and safety of vaccination against HPV with the 9valent vaccine in HIV-positive women - The papillon study

CHU Saint-Pierre0 sites200 target enrollmentJanuary 29, 2018
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DrugsGardasil9

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
CHU Saint-Pierre
Enrollment
200
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 29, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
CHU Saint-Pierre

Eligibility Criteria

Inclusion Criteria

  • •HIV\-positive woman
  • •Age 15\-40 years
  • •Undetectable HIV viral load (HIVRNA \<400 cp/ml) for at least 6 months (i,e: having at least two separate HIVRNA \<400 cp/ml at 6 months intervals; the most recent HIVRNA \<400 cp/ml may be the screening CV for the study).
  • •No planned pregnancy foreseen for the next 7 months and use of contraception such as condom, hormonal contraception or intrauterine device
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 20
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 180
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Previous hysterectomy or conisation
  • •Previous or current biopsy\-proven cervical, vulvar or vaginal HPV\-associated high grade lesions defined as \= CIN2, VIN2, VaIN2 or invasive carcinoma.
  • •Previous vaccination against HPV (at least one dose)
  • •Ongoing or planned pregnancy foreseen in the next 7 months
  • •Other immunodeficiency conditions such as ongoing or previous (within 6 months) chemotherapy against cancer or chronic systemic corticosteroids treatment or immunosuppressive therapy after transplantation
  • •Any condition contraindicating intramuscular injection such as warfarin therapy.

Outcomes

Primary Outcomes

Not specified

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