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Tests treatment safety and results for HIV Infections
Official title Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
ClinicalTrials.gov ID: NCT03132311
What this study is testing
What is Yellow Fever vaccination (17 DD Biomanguinhos)?
Yellow Fever vaccination (17 DD Biomanguinhos) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hiv infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 59. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Healthy HIV-uninfected individuals (aged \>= 18 and \< 60)
- No history of Yellow Fever vaccination
- Willing to participate and to sign the consent
You likely can't join if
- Individuals with chronic diseases such as: decompensated diabetes, kidney failure (in dialysis), liver failure/cirrhosis, cancer (except for...
- 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
See the full eligibility criteria
- 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
- 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...
- 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 people.
The study team makes the final eligibility decision.
Where it's taking place
- Rio de Janeiro, Brazil
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 59 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rio de Janeiro, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.