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임상시험 NCT07192458은(는) Immunization; Infection|Transplantation Infection|Influenza, 인플루엔자에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
밴더빌트 대학교High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater) 2상 60 백신 무작위 배정 이중 눈가림
Lung transplantation is a life-saving therapy for patients with advanced lung disease, and is also associated with an improvement in quality of life. However, due to the need for life-long immunosuppression to pre...
더 보기Immunogenicity and Safety of Consecutive High-Dose vs. Standard-Dose Influenza Vaccines Administered Over Successive Seasons in Lung Transplant Recipients
- 251037
Vaccination
Immunization
Lung Transplantation
High Dose
Fluzone
Standard Dose
Influenza, Human
Communicable Diseases
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Fluzone: Two Doses High Dose Inactivated Influenza Vaccine Fluzone: Two Doses of HD-IIV | Fluzone High Dose Inactivated Influenza Vaccine Fluzone High-Dose (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus- containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted...더 보기 |
실험적Fluzone: Two Doses Standard Dose Inactivated Influenza Vaccine Fluzone: Two Doses of of SD-IIV | Fluzone Standard Dose Inactivated Influenza Vaccine Fluzone Standard Dose is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Immunogenicity: Geometric Mean Titers of Influenza Vaccine Antibodies | HAI GMT to influenza antigens four-eight weeks following the second study vaccination | Four-eight weeks following the second study vaccination |
Safety - The number of participants reporting solicited injection site reactions | Solicited Injection-site Adverse Events Following each Vaccination Dose (Pain, Tenderness, Swelling/induration, Erythema/redness) | Within 7 days post vaccination |
Safety - The number of participants reporting systemic adverse events | Systemic adverse events (Fatigue/malaise, headache, nausea, body ache/myalgia (not at the injection site), general activity level, vomiting, and fever) | Within 7 days post vaccination |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
The number of participants achieving seroprotection and seroconversion for influenza virus after receiving either two doses of HD-IIV or two doses of SD-IIV over two consecutive years | Antibody titers will be measured by hemagglutination inhibition assay. Seroconversion is defined as ≥ 4-fold rise in hemagglutination inhibition assay titers. Seroprotection is defined as ≥1:40 hemagglutination inhibition assay titer. | Four to eight weeks after vaccination |
Geometric Mean Titers of Influenza Vaccine Antibodies after One or Two Doses in the Second Year | To quantify and compare the degree to which one versus two doses of either HD-IIV or SD-IIV in the subsequent season elicits enhanced immunogenicity compared to two doses of either HD-IIV or SD-IIV in the first influenza season in lung transplant recipients. Measuring GMT 4-8 weeks after 1st and 2nd vaccine. | Within four to eight weeks post vaccination after 1st and 2nd vaccine |
Lung transplant recipient who enrolled and completed Visits 1, 2, and 3 of the DMID protocol number 22-0014 during the prior 2024-2025 or 2025-2026 influenza season, respectively
- Anticipated to be available for the duration of the study
- Can be reached by telephone, text message, email, or electronic health record messaging
Recipient of multi-organ, extra-pulmonary, and/or hematopoietic stem cell transplant
Recipient of a re-do lung transplant
History of Guillain-Barre syndrome
History of receiving the current season's influenza vaccine prior to study enrollment and/or Visit 1 of this follow-up study
Pregnant person
Laboratory-confirmed influenza disease after September 1st in the current influenza season and before enrollment in this follow-up study (patient can still receive the second influenza vaccination despite proven influenza disease after enrollment)
CMVIG/IVIG/SCIG receipt within 28 days of each vaccine
Receipt of rituximab or other B-cell depleting antibody (including proteasome inhibitors) therapy within 3 months of 1st vaccine dose (Day 0)
Receipt of T-cell depleting therapies (anti-thymocyte globulin, alemtuzumab, daratumumab) between the completion of Visit 3 of the initial study and enrollment in this follow-up study
Investigator concern about study participation
Note: Criteria for temporarily delaying vaccine administration: The following conditions are temporary or self-limiting, and a participant may be included in the study once the condition has resolved, provided that the participant is otherwise eligible:
- Fever ≥100.4ºF/38.0ºC (oral measurement), or an acute severe illness within 48 hours of enrollment
- Receipt of any live vaccines within four weeks or any inactivated vaccines within two weeks prior to potential study vaccination
No children have been enrolled in the DMID protocol number 22-0014; therefore, only adults will be enrolled in this current study
밴더빌트 대학교Tennessee