Study on the Response to Tetanus Vaccination of People Living With HIV
VACTEVIH
1 other identifier
interventional
210
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Mar 2019
Shorter than P25 for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 26, 2019
CompletedStudy Start
First participant enrolled
March 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2020
CompletedOctober 5, 2020
October 1, 2020
6 months
February 15, 2019
October 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
additional blood sampling
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Persons with a contraindication to tetanus vaccination
- Persons under guardianship or curatorship or without civil law
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier de Niort
Niort, 79000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Simon SUNDER, Doctor
Centre Hospitalier de Niort - France
- STUDY DIRECTOR
Simon SUNDER, Doctor
CH Niort
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2019
First Posted
February 26, 2019
Study Start
March 11, 2019
Primary Completion
September 11, 2019
Study Completion
February 24, 2020
Last Updated
October 5, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share