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Study on the Response to Tetanus Vaccination of People Living With HIV (VACTEVIH)

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
additional blood sampling
Sponsored by
Centre Hospitalier de Niort
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de Niort

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

additional blood sampling

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
February 15, 2019
Last Updated
October 2, 2020
Sponsor
Centre Hospitalier de Niort
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1. Study Identification

Unique Protocol Identification Number
NCT03853681
Brief Title
Study on the Response to Tetanus Vaccination of People Living With HIV
Acronym
VACTEVIH
Official Title
Study on the Response to Tetanus Vaccination of People Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
September 11, 2019 (Actual)
Study Completion Date
February 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de Niort

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
additional blood sampling
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
additional blood sampling
Intervention Description
additional blood sampling
Primary Outcome Measure Information:
Title
the vaccine response to tetanus vaccination
Description
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)
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon SUNDER, Doctor
Organizational Affiliation
Centre Hospitalier de Niort - France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Simon SUNDER, Doctor
Organizational Affiliation
CH Niort
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier de Niort
City
Niort
ZIP/Postal Code
79000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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