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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Diagnostic test: additional blood sampling

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Niort, France, 79000
    • Centre Hospitalier de Niort

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: additional blood sampling	Diagnostic test: additional blood sampling; additional blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Niort
• Investigators: Study Director: Simon SUNDER, Doctor, Centre Hospitalier de Niort - France; Study Director: Simon SUNDER, Doctor, CH Niort

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): September 11, 2019
• Study Completion (Actual): February 24, 2020

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections; HIV Infections; Tetanus
• Other Study ID Numbers: PI-2019-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No