N/A
Completed N=54
Perturbing of HIV Reservoir With Immune Stimulation
Source: ClinicalTrials.gov NCT02707692 ↗Enrolled (actual)
54
Serious AEs
0.7%
Results posted
Aug 2022
Primary outcomePrimary: Change From Vaccination (Day 0) in Mean CD4+ T Cell-associated HIV RNA Transcription at Day 7 — -471.8; -45.9; 332.3 HIV RNA copies per million cell — p=0.32
Summary
The purpose of this study is to determine the impact of Pneumococcus and Influenza vaccines on the HIV transcriptional activity in individuals who are virologically suppressed for at least 48 weeks on similar ART. The proposed study is a randomized double-blinded control trial conducted over 28 weeks. Randomized interventions will be injections of Influenza vaccine, Pneumococcal vaccine, and Placebo. Each participant will receive each injection but in a randomized order.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Vaccination (Day 0) in Mean CD4+ T Cell-associated HIV RNA Transcription at Day 7 |
-471.8; -45.9; 332.3 | 0.32 |
Eligibility Criteria
Inclusion Criteria
- Documented HIV-1 infection more than 365 days ago (HIV antibody or viral load positive).
- Capable of signing written informed consent.
- Documented viral s suppression for at least 48 weeks (≤50 copies/mL)
- Men and women between 18 and 65 years of age.
- Read and comprehend English.
- Documented CD4 count at enrollment (>250 cells/µl)
- Reported CD4 nadir >100 cells/µl.
- Received seasonal flu vaccination at least 6 weeks prior to first trial injection (and not more recently)
- Received vaccination for pneumococcal disease at least 12 months prior to first trial injection (and not more recently)
- Started ART during chronic infection (> 6 months from estimated date of injection)
Exclusion Criteria
- Uncontrolled psychiatric condition.
- Under the influence of drug(s) or alcohol at time of screening.
- Any condition that, in the opinion of the investigator, would limit follow-up and adequate consent.
- History of allergic reactions to any of the proposed vaccines or egg allergy.
- History of Gullian Barre syndrome
- Receiving immunosuppressive medications.
- Pregnancy or lactation.
Data sourced from ClinicalTrials.gov (NCT02707692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.