WU 345: Immune Responses to Adjuvanted and Non-adjuvanted Seasonal Influenza Vaccines in the Lymp… (NCT07386509) | Clinical Trial Compass
TerminatedEarly Phase 1
WU 345: Immune Responses to Adjuvanted and Non-adjuvanted Seasonal Influenza Vaccines in the Lymphoid Tissues.
Stopped: COVID pandemic No participant experiences (benefits, adverse events/adverse reactions)to report. There have been no safety concerns in either participant.
No minor deviations to report
United States2 participantsStarted 2020-03-17
Plain-language summary
Healthy adults (18-49 years of age) with no previous influenza virus vaccination history for at least three years prior to enrollment will be recruited to participate in this study. All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles. Blood samples collected at 9 visits (screening, baseline, days 7, 14, 28, 60, 90, 120 and 180, fine needle aspiration (FNAs) from axillary lymph nodes from both axillae at baseline, days 7, 14, 28, 60, 90, 120 and 180.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion Criteria:
* 1\. Healthy subjects aged 18-49 years. 2. Able to understand and give informed consent. 3. Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods\* for 28 days before and 28 days after rabies vaccination.
* Women of child-bearing potential using licensed hormonal methods must also use a second form of contraception.
4\. Are in good health, as determined by medical history and targeted physical exam related to this history.
5\. Willing to give FNA specimens for the study.
6\. The following laboratory values obtained within 14 days prior to entry by any US laboratory that has a CLIA certification or its equivalent.
• Absolute neutrophil count (ANC) ≥750 cells/mm3
• Hemoglobin ≥11.0 g/dL for men and ≥10.0 g/dL for women
* Platelet count ≥100,000/mm3
* Creatinine clearance ≥60 mL/min estimated by the Cockcroft-Gault equation
* NOTE: A program for calculating creatinine clearance by the Cockcroft-Gault method is available on www.fstrf.org
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (SGPT) ≤5.0 times upper limit of normal (ULN)
*…
What they're measuring
1
Comparison of antibody titers at Day 28 versus baseline