Antibody Response to Prophylactic QHPV Vaccine at 48 Mont... | NCT04711265

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

NCT04711265

Sponsor

Kenya Medical Research Institute

Status

Completed

Last Update Posted

Jan 15, 2021Actual

Enrollment

176Actual

Phase

Not provided

Conditions

HPV Vaccine
HPV Infection
HIV-1-infection

Interventions

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

Countries

Kenya

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Nov 2018Actual

Completion Date

Jan 2019Actual

First Submitted Date

Dec 8, 2020

First Submission Date that Met QC Criteria

Jan 12, 2021

First Posted Date

Jan 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2021

Last Update Posted Date

Jan 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nelly Rwamba Mugo, Senior Principal Clinical Research Scientist, Kenya Medical Research InstitutePrincipal Investigator

Lead Sponsor

Kenya Medical Research InstituteOTHER

Collaborators

Name	Class
University of Washington	OTHER
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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'.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

176Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine	Drug	Intramuscular injection with 3 doses of QHPV		QHPV vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Human Papillomavirus Antibody Titers	Geometric mean titers for HPV type -6, -11, -16 and -18	48 months

Secondary Outcomes

Measure	Description	Time Frame
HIV RNA viral load	Impact of HIV RNA viral load on HPV antibody response	48 months
CD 4 cell count	Impact of immune status on HPV antibody response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Partners in Health Research and Development		Thika	Kiambu County		Kenya

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D030361	Papillomavirus Infections
D015658	HIV Infections

Ancestor Terms

ID	Term
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided