HIV InfectionsPhase 4YF-HIVNCT03132311
Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
A Phase 4 study testing Yellow Fever vaccination (17 DD Biomanguinhos) in people with HIV Infections, run by Oswaldo Cruz Foundation at 1 site in Brazil.
Trial summary
Phase 4 study to evaluate the immunogenicity and Safety of the 17DD Yellow Fever vaccine in HIV infected individuals, compared to non-HIV-infected individuals. Main objective: To compare the proportion of seroconversion and the geometric mean of neutralizing antibodies 30 days and 365 days after vaccine. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Yellow Fever vaccination (17 DD Biomanguinhos)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBrazil
- Study dates
- 29 May 2017to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV infected adults, age >= 18 and <60 years old.
- CD4 > 200 cells/mm³ within the last 6 months prior to inclusion. Individuals with no CD4 results in the last 6 months which have undetectable HIV viral load and last CD4 count > 350 can be included.
- Healthy HIV-uninfected individuals (aged >= 18 and < 60)
- No history of Yellow Fever vaccination
- Willing to participate and to sign the consent
Who cannot join
- Individuals with chronic diseases such as: decompensated diabetes, kidney failure (in dialysis), liver failure/cirrhosis, cancer (except for non-melanoma skin cancer and in situ HIV related carcinoma), use of immunosuppressive agents (including prednisone ≥ 20mg/day, during 7 or more days in the last 30 days before inclusion).
- Pregnant women
- Hypersensitivity reaction to eggs, chicken protein. Allergy to erythomycin or kanamycin. Hereditary fructose intolerance.
- Administration of immunoglobulins or blood derivates < 3 months or life attenuated vaccine <1 month.
- History of thymic dysfunction (including thymoma and thymectomy).
- Use of anti-CCR5
- symptoms of severe acute illnesses or fever (axillary temperature ≥ 38°C)
- HIV positive rapid test for HIV negative subjects.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, 21040360
Lara Coelho, MD, +55 21 22707064, lara.coelho@ini.fiocruz.br
About this study
Phase 4 study to evaluate the immunogenicity and Safety of the 17DD Yellow Fever vaccine in HIV infected individuals, compared to non-HIV-infected individuals.
Main objective:
To compare the proportion of seroconversion and the geometric mean of neutralizing antibodies 30 days and 365 days after vaccine.
Secondary objectives:
To evaluate whether the titles of neutralizing antibodies are associated with CD4 lymphocyte counts, CD8 lymphocyte counts, CD4 nadir, HIV viral load and use of antiretroviral therapy. To assess the yellow fever vaccine viremia at day 10 after vaccine.To compare the incidence of adverse events in HIV-infected and non-HIV-infected individuals.
- Conditions
- HIV Infections
- Being tested
- Yellow Fever vaccination (17 DD Biomanguinhos)
- Keywords
- yellow fever vaccine, hiv
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yellow Fever vaccination (17 DD Biomanguinhos)Biological
One intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| HIV positive subjects | Experimental | 300 HIV positive adults with CD4 > 200 cells/mm3, stratified in 3 groups (100 patients in each group) according to CD4 counts (200-350; 351-500, >500 cells/mm3).
Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos) Receives: Biological: Yellow Fever vaccination (17 DD Biomanguinhos) |
| HIV negative subjects | Active comparator | 100 HIV negative adults.
Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos) Receives: Biological: Yellow Fever vaccination (17 DD Biomanguinhos) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
Seroconversion
Measured: 30 days after the vaccine
Immunogenicity
Neutralizing antibodies titers
Measured: 30 days after the vaccine
Immunogenicity
Seroconversion
Measured: 365 days after the vaccine
Immunogenicity
Neutralizing antibodies titers
Measured: 365 days after the vaccine
Secondary outcomes (4)
Viremia
Yellow Fever vaccine viremia
Measured: 7 days after the vaccine
Adverse events
Yellow Fever vaccine related adverse events
Measured: up to 30 days after the vaccine
Immunogenicity
Neutralizing antibodies titles
Measured: 5 years after the vaccine
Immunogenicity
Neutralizing antibodies titles
Measured: 10 years after the vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start29 May 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oswaldo Cruz Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132311
- Sponsor's protocol ID
- 001
- Acronym
- YF-HIV
- Status last verified
- Jul 2018
- First submitted
- 24 Apr 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macieira KV, Caetano DG, De Lima SMB, Wagner Giacoia-Gripp CB, Cortes FH, Da Silva Cazote A, De Souza Azevedo Soares A, Dos Santos Alves N, De Souza Borges Quintana M, Costa M, Brandao LGP, De Andrade MM, Grinsztejn B, Coelho LE, De Almeida DV. Differential gene expression of cytokines, receptors, and miRNAs in individuals living with HIV-1 and vaccinated against yellow fever. Mol Immunol. 2023 Dec;164:58-65. doi: 10.1016/j.molimm.2023.10.013. Epub 2023 Nov 10.
PubMed 37952362Motta E, Camacho LAB, Cunha M, de Filippis AMB, Lima SMB, Costa M, Pedro L, Cardoso SW, Cortes FH, Giacoia-Gripp CBW, Morata M, Nazer S, Moreira RI, de Oliveira Souza MC, Mendes YS, Souza Azevedo A, Dos Santos Alvez N, Grinsztejn B, Coelho LE. Immunogenicity and reactogenicity of yellow fever vaccine in people with HIV. AIDS. 2023 Dec 1;37(15):2319-2329. doi: 10.1097/QAD.0000000000003696. Epub 2023 Aug 23.
PubMed 37650759
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
- ClinicalTrials.gov ID
- NCT03132311
- Acronym / sponsor ID
- YF-HIV / 001
- Conditions
- HIV Infections
- Keywords
- yellow fever vaccine, hiv
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Oswaldo Cruz FoundationUniversity, hospital or other
- Study start
- 29 May 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Apr 2017 (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.
Phase 4 study to evaluate the immunogenicity and Safety of the 17DD Yellow Fever vaccine in HIV infected individuals, compared to non-HIV-infected individuals.
Main objective:
To compare the proportion of seroconversion and the geometric mean of neutralizing antibodies 30 days and 365 days after vaccine.
Secondary objectives:
To evaluate whether the titles of neutralizing antibodies are associated with CD4 lymphocyte counts, CD8 lymphocyte counts, CD4 nadir, HIV viral load and use of antiretroviral therapy. To assess the yellow fever vaccine viremia at day 10 after vaccine.To compare the incidence of adverse events in HIV-infected and non-HIV-infected individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV positive subjects | Experimental | Biological: Yellow Fever vaccination (17 DD Biomanguinhos)300 HIV positive adults with CD4 > 200 cells/mm3, stratified in 3 groups (100 patients in each group) according to CD4 counts (200-350; 351-500, >500 cells/mm3). Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos) |
| HIV negative subjects | Active comparator | Biological: Yellow Fever vaccination (17 DD Biomanguinhos)100 HIV negative adults. Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos) |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- HIV infected adults, age >= 18 and <60 years old.
- CD4 > 200 cells/mm³ within the last 6 months prior to inclusion. Individuals with no CD4 results in the last 6 months which have undetectable HIV viral load and last CD4 count > 350 can be included.
- Healthy HIV-uninfected individuals (aged >= 18 and < 60)
- No history of Yellow Fever vaccination
- Willing to participate and to sign the consent
Key exclusion criteria (8 listed)
- Individuals with chronic diseases such as: decompensated diabetes, kidney failure (in dialysis), liver failure/cirrhosis, cancer (except for non-melanoma skin cancer and in situ HIV related carcinoma), use of immunosuppressive agents (including prednisone ≥ 20mg/day, during 7 or more days in the last 30 days before inclusion).
- Pregnant women
- Hypersensitivity reaction to eggs, chicken protein. Allergy to erythomycin or kanamycin. Hereditary fructose intolerance.
- Administration of immunoglobulins or blood derivates < 3 months or life attenuated vaccine <1 month.
- History of thymic dysfunction (including thymoma and thymectomy).
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 |
|---|---|---|
| Yellow Fever vaccination (17 DD Biomanguinhos)One intramuscular injection | Biological | HIV negative subjects, HIV positive subjects |
Primary outcome
Immunogenicity
Time frame: 30 days after the vaccine
Seroconversion
Immunogenicity
Time frame: 30 days after the vaccine
Neutralizing antibodies titers
Immunogenicity
Time frame: 365 days after the vaccine
Seroconversion
Immunogenicity
Time frame: 365 days after the vaccine
Neutralizing antibodies titers
4 secondary outcomes
Viremia
Time frame: 7 days after the vaccine
Adverse events
Time frame: up to 30 days after the vaccine
Immunogenicity
Time frame: 5 years after the vaccine
Immunogenicity
Time frame: 10 years after the vaccine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Derived from this study: PubMed 37952362Macieira KV, Caetano DG, De Lima SMB, Wagner Giacoia-Gripp CB, Cortes FH, Da Silva Cazote A, De Souza Azevedo Soares A, Dos Santos Alves N, De Souza Borges Quintana M, Costa M, Brandao LGP, De Andrade MM, Grinsztejn B, Coelho LE, De Almeida DV. Differential gene expression of cytokines, receptors, and miRNAs in individuals living with HIV-1 and vaccinated against yellow fever. Mol Immunol. 2023 Dec;164:58-65. doi: 10.1016/j.molimm.2023.10.013. Epub 2023 Nov 10.
- Derived from this study: PubMed 37650759Motta E, Camacho LAB, Cunha M, de Filippis AMB, Lima SMB, Costa M, Pedro L, Cardoso SW, Cortes FH, Giacoia-Gripp CBW, Morata M, Nazer S, Moreira RI, de Oliveira Souza MC, Mendes YS, Souza Azevedo A, Dos Santos Alvez N, Grinsztejn B, Coelho LE. Immunogenicity and reactogenicity of yellow fever vaccine in people with HIV. AIDS. 2023 Dec 1;37(15):2319-2329. doi: 10.1097/QAD.0000000000003696. Epub 2023 Aug 23.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yellow Fever vaccination (17 DD Biomanguinhos) in people with HIV Infections, run by Oswaldo Cruz Foundation at 1 site in Brazil.
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 8 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: looking for participants now, as of the sponsor's last update on 30 Jul 2018. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lara E Coelho, MD (+552122707064, lara.coelho@ini.fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity (time frame: 30 days after the vaccine). The study lists 4 primary outcomes in all. 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 NCT03132311, which also lists 2 linked publications.
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 30 Jul 2018.