Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT01916759
Eligibility Criteria:
Inclusion Criteria:
1. For HIV uninfected group
* Confirmation of HIV-1 infection from medical records
2. For HIV infected on HAART group
* Confirmation of HIV-1 infection from medical records
* Participants must be on HAART for at least 6 months prior to enrollment
* A CD4 T-cell count available in the last 6 months
* CD4 T-cell count \>350 cells/μL on the eligibility blood specimen
3. Long-term non-progressor group
* HIV infected for more than 7 years
* No evidence of opportunistic infections in the medical records
* Never received antiretroviral therapy (except anti-retrovirals for prevention of mother-to-infant transmission of HIV)
* A CD4 T-cell count available in the last 6 months
* CD4+ T-cell count slop of ≥0 cells/µl blood from entry into the MU-JHU cohort until the most recent available CD4+ T-cell count.
Exclusion Criteria:
1. Current moderate or severe acute illness, history of fever or temperature ≥37.5oC within 48 hours prior to vaccination (participants can be re-evaluated at a subsequent visit)
2. History of systemic disease, including: Guillain-Barré Syndrome; known hepatitis B, or hepatitis C infection; cardiac disease; uncontrolled diabetes mellitus (including gestational diabetes); chronic liver condition; clinically significant renal impairment; clinically significant neurological disorders; active TB within the last year; Cancer. This information will be based on self-reporting and (where possible) will be confirmed by hospital medical records
3. Received immunoglobulin or other blood product within the preceding 3 months or expected receipt of blood products during the 3 months of follow-up
4. History of anaphylactic hypersensitivity reactions to egg proteins (eggs or egg products), or any other component of the vaccine including traces (formaldehyde, octoxinol 9 (Triton X-100) and neomycin)
5. History of severe reaction (including hypersensitivity) after receiving any vaccine
6. Currently pregnant
7. In the opinion of the study team it would be unsuitable for the study subjects to receive the vaccine or participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01916759
Study Brief:
Protocol Section:
NCT01916759