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NCT03853681 Clinical Trial

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

HIV Infections Clinical Trial

— VACTEVIH  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03853681
Other study ID # PI-2019-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 11, 2019
Est. completion date February 24, 2020

Study information
Verified date October 2020
Source Centre Hospitalier de Niort
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date February 24, 2020
Est. primary completion date September 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• additional blood sampling
additional blood sampling

Locations
Country Name City State
France Centre Hospitalier de Niort Niort

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier de Niort

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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