HIV InfectionsVACTEVIHNCT03853681
Study on the Response to Tetanus Vaccination of People Living With HIV
A study testing additional blood sampling in people with HIV Infections, run by Centre Hospitalier de Niort at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- additional blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2019to 24 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Persons with a contraindication to tetanus vaccination
- Persons under guardianship or curatorship or without civil law
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- HIV Infections
- Being tested
- additional blood sampling
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional blood samplingDiagnostic test
additional blood sampling
| Study group | Role | What they receive |
|---|---|---|
| additional blood sampling | Other | Not described Receives: Diagnostic Test: additional blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start11 Mar 2019
- Primary completion11 Sep 2019
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Niort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon SUNDER, Doctor, Study director, Centre Hospitalier de Niort - FranceSimon SUNDER, Doctor, Study director, CH Niort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853681
- Sponsor's protocol ID
- PI-2019-02
- Acronym
- VACTEVIH
- Status last verified
- Oct 2020
- First submitted
- 15 Feb 2019
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Response to Tetanus Vaccination of People Living With HIV
- ClinicalTrials.gov ID
- NCT03853681
- Acronym / sponsor ID
- VACTEVIH / PI-2019-02
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Centre Hospitalier de NiortUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| additional blood sampling | Other | Diagnostic Test: additional blood sampling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Persons with a contraindication to tetanus vaccination
- Persons under guardianship or curatorship or without civil law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| additional blood samplingadditional blood sampling | Diagnostic test | additional blood sampling |
Primary outcome
the vaccine response to tetanus vaccination
Time frame: Month 6
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon SUNDER, Doctor study director
Centre Hospitalier de Niort - France
Simon SUNDER, Doctor study director
CH Niort
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional blood sampling in people with HIV Infections, run by Centre Hospitalier de Niort at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the vaccine response to tetanus vaccination (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.