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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

France1 site

Centre Hospitalier de Niort
Niort, 79000

Other trials in France

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 groups in NCT03853681
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.

11 Mar 201924 Feb 2020

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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?

On the ClinicalTrials.gov record for NCT03853681.

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.