Study on the Response to Tetanus Vaccination of People Li... | NCT03853681

Studies
Study on the Response to Tetanus Vaccination of People Living With HIV

NCT03853681

Sponsor

Centre Hospitalier de Niort

Status

Completed

Last Update Posted

Oct 5, 2020Actual

Enrollment

210Actual

Phase

Not Applicable

Conditions

HIV Infections

Interventions

additional blood sampling

Countries

France

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

Oct 2020

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

Mar 11, 2019Actual

Primary Completion Date

Sep 11, 2019Actual

Completion Date

Feb 24, 2020Actual

First Submitted Date

Feb 15, 2019

First Submission Date that Met QC Criteria

Feb 25, 2019

First Posted Date

Feb 26, 2019Actual

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

Oct 2, 2020

Last Update Posted Date

Oct 5, 2020Actual

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

The response to primary tetanus immunization of HIV-infected children is lower than that of uninfected children.

Response to tetanus toxoid (TT) booster doses in adults living with HIV who have received primary vaccination prior to infection is not known.

Currently, it is recommended to have a TT booster for people living with HIV (PLHIV) every 10 years. In general population, this recall is made only at 25, 45 and 65 years, then every 10 years.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

210Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
additional blood sampling	Other		Diagnostic Test: additional blood sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
additional blood sampling	Diagnostic Test	additional blood sampling	additional blood sampling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the vaccine response to tetanus vaccination	An anti-tetanus IgG level> 0.1 is considered long-term protective. An anti-tetanus IgG level between 0.01 and 0.1 is considered protective in the short term. The measurement of the vaccine response will be correlated with the age of the last VAT recall (<10 years, between 10 and 20 years,> 20 years and unknown)	Month 6

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Person aged ≥ 18 years
Person infected with HIV followed in the infectious diseases department of CH Niort
Born in France
Affiliate or beneficiary of a social security scheme
Being able to give free and informed consent to participation in research

Exclusion Criteria:

Persons with a contraindication to tetanus vaccination
Persons under guardianship or curatorship or without civil law

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Simon SUNDER, Doctor	Centre Hospitalier de Niort - France	Study Director
Simon SUNDER, Doctor	CH Niort	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de Niort		Niort		79000	France

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
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided