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 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT02707692
Eligibility Criteria:
Inclusion Criteria
1. Documented HIV-1 infection more than 365 days ago (HIV antibody or viral load positive).
2. Capable of signing written informed consent.
3. Documented viral s suppression for at least 48 weeks (≤50 copies/mL)
4. Men and women between 18 and 65 years of age.
5. Read and comprehend English.
6. Documented CD4 count at enrollment (\>250 cells/µl)
7. Reported CD4 nadir \>100 cells/µl.
8. Received seasonal flu vaccination at least 6 weeks prior to first trial injection (and not more recently)
9. Received vaccination for pneumococcal disease at least 12 months prior to first trial injection (and not more recently)
10. Started ART during chronic infection (\> 6 months from estimated date of injection)
Exclusion Criteria
1. Uncontrolled psychiatric condition.
2. Under the influence of drug(s) or alcohol at time of screening.
3. Any condition that, in the opinion of the investigator, would limit follow-up and adequate consent.
4. History of allergic reactions to any of the proposed vaccines or egg allergy.
5. History of Gullian Barre syndrome
6. Receiving immunosuppressive medications.
7. Pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02707692
Study Brief:
Protocol Section:
NCT02707692