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Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys

K

Kenya Medical Research Institute (KEMRI)

Status

Completed

Conditions

HIV-1-infection
HPV Infection
HPV Vaccine

Treatments

Drug: Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04711265
KENYAMRI

Details and patient eligibility

About

Longitudinal observational cohort study and extension of the MISP ID: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in HIV-infected pre-adolescent girls and boys in Kenya'.

Full description

We evaluated for persistence of HPV antibody by measuring titers to specific HPV types 6, 11, 16 and 18 at re-enrollment month 24 , 36 and 48 months in addition to month 7 and 12, after initial vaccination. This provided data for immunogenicity among HIV-infected children for approximately 48 months after initial vaccination. We assessed decline over study intervals in HPV type-specific antibodies.

Enrollment

176 patients

Sex

All

Ages

9 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • receipt of 3 doses of QHPV vaccine
  • participated in primary immunogenicity study
  • consent/assent with parental consent for participants age <18 years
  • willing to continue extended follow up for 36 months

Exclusion criteria

  • decline consent

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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