Washington University School of Medicine Infectious Disease Clinical Research Unit
St Louis, Missouri, 63110, United States
NCT Number: NCT07493460
This study is being done to understand and measure how the immune system responds to and remembers different types of vaccines. To do this, four vaccines approved by the U.S. Food and Drug Administration (FDA) will be given simultaneously to participants. Participants will be volumteers who are healthy adults (18 years old or older) and willing to receive the yearly trivalent inactivated influenza vaccine (TIV), the tetanus, diphtheria, and acellular pertussis vaccine (Tdap), the nonvalent HPV (HPV) vaccine, hepatitis A virus (HAV) vaccine and undergo study procedures.
Procedures will include:
* medical history relevant to the study, including medications and vaccines received. * Vitals (blood pressure, pulse) and temperature * Height and weight. * Physical exams. * Receive the TIV, Tdap, HPV, and HAV vaccines. * Blood samples collected for immunologic tests and genetic analysis. * Donate bone marrow by needle aspiration at a maximum of seven visits. * Complete memory aid every evening for 7 days after vaccination
Optional Procedures include:
* Donate bone marrow core biopsies at the same visits * Ultrasound of lymph nodes and fine needle aspirates of lymph nodes in both arm pits at a maximum of eight separate visits
There will be a screening visit and and a Day 1 where vaccinations will occur and subsequent visits at Day 8, Day 14, Day 29, Day 57, Day 121, Day 181, Day 366, Day 546, and Day 731.
At each of these visits health status, vital signs and blood collection will occur.
A bone marrow aspirate and lymph node aspirate will be collected at screening.
The six additional bone marrow aspirates will be repeated at D29, D91, D181, D366, D546, and D731. The optional bone marrow core biopsy will also be repeated at that time.
Up to seven separate visits will be scheduled for the follow-up lymph node aspirates (D29, D57, D91, D181, D366, D546, and D731)
Study participation will be 24 months.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 4
St Louis, Missouri, 63110, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
give FNA specimens OR give BMCB specimens OR give both FNA and BMCB specimens
Exclusion criteria
TIV
HPV
HAV
Tdap
Time frame: day 29
The antibody titer for influenza strains at d29 when compared to baseline
Time frame: at days 29, 57, 91, 181, 366, 546, and 731
Frequency of serious adverse events
Washington University School of Medicine
Other
Acronym: WU 445
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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