NCT04711265

Brief Summary

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'.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

3.2 years

First QC Date

December 8, 2020

Last Update Submit

January 12, 2021

Conditions

HPV VaccineHPV InfectionHIV-1-infection

Keywords

HPV Vaccine, HIV infection, Adolescents, Africa

Outcome Measures

Primary Outcomes (1)

  • Human Papillomavirus Antibody Titers

    Geometric mean titers for HPV type -6, -11, -16 and -18

    48 months

Secondary Outcomes (2)

  • HIV RNA viral load

    48 months

  • CD 4 cell count

    48 months

Interventions

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

Intramuscular injection with 3 doses of QHPV

Also known as: QHPV vaccine

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

HIV-1 infected boys and girls who had received 3 doses of QHPV vaccine

You may qualify if:

  • 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

You may not qualify if:

  • decline consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Partners in Health Research and Development

Thika, Kiambu County, Kenya

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples for HPV antibody titer assessment HIV viral load CD4 cell count

MeSH Terms

Conditions

Papillomavirus InfectionsHIV Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Principal Clinical Research Scientist

Study Record Dates

First Submitted

December 8, 2020

First Posted

January 15, 2021

Study Start

September 1, 2015

Primary Completion

November 1, 2018

Study Completion

January 1, 2019

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)