Lung Transplant RecipientPhase 1/2NCT05280158

High-Dose Moderna mRNA-1273 Booster Study for Lung Transplant Recipients

A Phase 1/2 study testing mRNA-1273 (Moderna COVID-19 vaccine) in people with Lung Transplant Recipient and SARS-CoV-2, run by University of California, Los Angeles at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Transplant Recipient, SARS-CoV-2, Immunosuppression
What is being tested?: mRNA-1273 (Moderna COVID-19 vaccine)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 10 Mar 2022to 27 Feb 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Previous documented COVID-19 infection.
Use of investigational agents for prophylaxis against COVID-19 within 90 days of the start of the study, including Evusheld monoclonal antibodies.
Ongoing therapy for acute cellular or antibody mediated rejection.
Intravenous immunoglobulins (IVIG) administration within the prior 3 months or ongoing IVIG therapy.
Anaphylaxis or allergic reaction to any prior vaccines.
History of anaphylaxis or other significant adverse reaction requiring medical intervention after receipt of a vaccine.

Show all 14Show fewer

Is acutely ill or febrile 24 hours prior to or at the Day 1 visit. Fever is defined as a body temperature ≥ 38.0°C/100.4°F. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
Pregnant or breastfeeding.
Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
Known history of hypertension (HTN) with systolic blood pressure (BP) > 180 mm Hg at the Day 1 visit.
Known history of hypotension with systolic blood pressure < 85 mm Hg at the Day 1 visit.
Bleeding disorder considered a contraindication to IM injection or phlebotomy.
Active malignancy diagnosed within previous 4 years (excluding non-melanoma skin cancer).
Received a major surgery including lung transplantation in the past 3 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA Clinical Translational Research Center
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Phase I/II, Open-Label Dose-Finding Trial of High-Dose mRNA-1273 Booster for Lung Transplant Recipients

Lung transplant recipients have poor outcomes after COVID-19 infection with mortality. Due to the immunosuppression, they have had poor responses to SARS-CoV-2 vaccine and remain at high risk of poor outcomes. This is a Phase I/II clinical trial to evaluate the safety and immune response from a higher dose mRNA-1273 vaccine among lung transplant recipients who have already received three or four doses of the COVID-19 vaccine.

Read the detailed description

This is a Phase I/II open-label dose-finding trial among lung transplant recipients who received three or four mRNA vaccine doses (mRNA-1273 or BNT162b2) after lung transplantation to: standard-dose (50 ug), mid-dose (100 ug) or high-dose (200 ug) mRNA-1273 booster vaccine. Sixty participants will be enrolled into three dose groups: 1) Standard-dose - 20 participants, 2) Mid-dose - 20 participants, 3) High-dose - 20 participants. The first 2 participants in both the mid-dose and high dose groups will be considered the 'sentinel' group. Participants in the sentinel group will receive the vaccine and undergo a 7-day observation period for safety and reactogenicity before additional participants are enrolled into that dose group.

Overall study enrollment will begin with the mid-dose sentinel group (n=2). During the observation period for the mid-dose sentinel group, we will enroll two participants into the standard-dose group. Once the mid-dose sentinel group completes their 7-day observation period without triggering halting rules and is approved to proceed by the DSMB, we will enroll the next 27 participants (Cohort 1) with a 2:1 randomization into the mid-dose (n=18) and standard-dose (n=9) groups.

Once all 20 participants have received their mid-dose vaccine without triggering halting rules and is approved to proceed by the DSMB, we will enroll the high-dose sentinel group (n=2). Once the high-dose sentinel group completes their 7-day observation period without triggering halting rules and is approved to proceed by the DSMB, we will enroll the next 27 participants (Cohort 2) with a 2:1 randomization into the high-dose (n=18) and standard-dose (n=9) groups. All 20 participants in the mid-dose group will be enrolled prior to the enrollment of the high-dose group.

We will perform stratified randomization for the two cohorts based on: 1) the number of prior doses, and 2) prior receipt of any BNT162b2 vaccines. Randomization with be done by the UCLA Clinical and Translational Science Institute (CTSI) statistics team based on scheduled participants prior to the study visit. The 6 participants in the sentinel (n=4) and initial (n=2) groups (Table 1) will be assigned into the 3 groups based on their scheduled visit day.

Conditions: Lung Transplant Recipient, SARS-CoV-2, Immunosuppression
Being tested: mRNA-1273 (Moderna COVID-19 vaccine)
Keywords: SARS-CoV-2, lung transplant recipient, immunosuppression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mRNA-1273 (Moderna COVID-19 vaccine)Drug
Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study.

Study groups in NCT05280158
Study group	Role	What they receive
Standard-dose	Active comparator	mRNA-1273 (Moderna COVID-19 vaccine) 50 ug Receives: Drug: mRNA-1273 (Moderna COVID-19 vaccine)
Mid-Dose	Experimental	mRNA-1273 (Moderna COVID-19 vaccine) 100 ug Receives: Drug: mRNA-1273 (Moderna COVID-19 vaccine)
High-Dose	Experimental	mRNA-1273 (Moderna COVID-19 vaccine) 200 ug Receives: Drug: mRNA-1273 (Moderna COVID-19 vaccine)

What is being measured

The primary outcome is the main question the study is designed to answer.

Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Solicited local and systemic reactogenicity adverse events were documented daily in a dedicated diary, and assigned a grade 1-3 according to the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA grading scale). Higher grades are assigned to more severe events.
Measured: Day 1 - Day 7 after study drug administration
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Comprehensive recording of occurrence and severity grade of unsolicited adverse events (AEs) daily. These events were documented in a dedicated diary starting from Day 1 of the study and continued through to Day 30. Data collection encompassed adverse events not specifically solicited, with each event's frequency recorded for analysis.
Measured: Day 1 - Day 30 after study drug administration
Participants Reporting Any Serious Adverse Experiences (SAEs) and Adverse Events of Special Interests (AESIs) Related to the Intervention From Day 1 Until Day 180.
This comprehensive data collection is intended to provide insights into the occurrence of significant adverse events and specific adverse events of interest over an extended period
Measured: Day 1 - Day 180 after study drug administration

Secondary outcomes (4)

Humoral Immunogenicity Measured by Anti-RBD and Anti-spike (S-2P) IgG Levels at Day 30.
This evaluation provides insights into the vaccine's ability to induce an immune response by quantifying specific antibody levels targeting key viral components, contributing to the understanding of vaccine efficacy and immune response dynamics.
Measured: Day 30 after study drug administration
Humoral Immunogenicity Measured by Neutralizing Antibody Titers From a Pseudovirus Neutralization Assay at Day 30.
Provide a direct measure of the vaccine-induced immune response's ability to neutralize viral infection, offering critical insights into vaccine efficacy and immune response effectiveness
Measured: Day 1, Day 30 after study drug administration
Cellular Immunogenicity (CD8+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Percent of total CD8+ T Cells to quantify vaccine-induced cellular immune response, the activation and functionality of specific immune cell populations to contribute to understanding the vaccine's ability to elicit a robust cellular immune response, which is essential for effective protection against viral infections.
Measured: Day 1, Day 30 after study drug administration
Cellular Immunogenicity (CD4+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Percent of total CD4+ T Cells to quantify vaccine-induced cellular immune response, the activation and functionality of specific immune cell populations to contribute to understanding the vaccine's ability to elicit a robust cellular immune response, which is essential for effective protection against viral infections.
Measured: Day 1, Day 30 after study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 202227 Feb 2023

First posted15 Mar 2022
Study start10 Mar 2022
Primary completion27 Feb 2023
Study completion27 Feb 2023

Why it stopped: Moderna Bivalent COVID-19 Vaccine became available to the public in Sept 2022.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (30)Papers the sponsor has linked to this study.
Other trials for Lung Transplant RecipientStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Groups will be enrolled as follows: 1. Mid-dose - Sentinel group, n=2 2. Standard-dose - Initial group, n=2 3. Cohort 1: 2:1 Randomization into * Mid-dose group, n=18 * Standard-dose group, n=9 4. High-dose - Sentinel group, n=2 5. Cohort 2: 2:1 Randomization into * High-dose group, n=18 * Standard-dose group, n=9 We will perform stratified randomization for the two cohorts based on: 1) the number of prior doses, and 2) prior receipt of any BNT162b2 vaccines.
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05280158
Sponsor's protocol ID: 22-000192
Status last verified: Mar 2025
First submitted: 5 Mar 2022
Last updated: 26 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Corbett KS, Flynn B, Foulds KE, Francica JR, Boyoglu-Barnum S, Werner AP, Flach B, O'Connell S, Bock KW, Minai M, Nagata BM, Andersen H, Martinez DR, Noe AT, Douek N, Donaldson MM, Nji NN, Alvarado GS, Edwards DK, Flebbe DR, Lamb E, Doria-Rose NA, Lin BC, Louder MK, O'Dell S, Schmidt SD, Phung E, Chang LA, Yap C, Todd JM, Pessaint L, Van Ry A, Browne S, Greenhouse J, Putman-Taylor T, Strasbaugh A, Campbell TA, Cook A, Dodson A, Steingrebe K, Shi W, Zhang Y, Abiona OM, Wang L, Pegu A, Yang ES, Leung K, Zhou T, Teng IT, Widge A, Gordon I, Novik L, Gillespie RA, Loomis RJ, Moliva JI, Stewart-Jones G, Himansu S, Kong WP, Nason MC, Morabito KM, Ruckwardt TJ, Ledgerwood JE, Gaudinski MR, Kwong PD, Mascola JR, Carfi A, Lewis MG, Baric RS, McDermott A, Moore IN, Sullivan NJ, Roederer M, Seder RA, Graham BS. Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates. N Engl J Med. 2020 Oct 15;383(16):1544-1555. doi: 10.1056/NEJMoa2024671. Epub 2020 Jul 28.
PubMed 32722908
Corbett KS, Nason MC, Flach B, Gagne M, O'Connell S, Johnston TS, Shah SN, Edara VV, Floyd K, Lai L, McDanal C, Francica JR, Flynn B, Wu K, Choi A, Koch M, Abiona OM, Werner AP, Moliva JI, Andrew SF, Donaldson MM, Fintzi J, Flebbe DR, Lamb E, Noe AT, Nurmukhambetova ST, Provost SJ, Cook A, Dodson A, Faudree A, Greenhouse J, Kar S, Pessaint L, Porto M, Steingrebe K, Valentin D, Zouantcha S, Bock KW, Minai M, Nagata BM, van de Wetering R, Boyoglu-Barnum S, Leung K, Shi W, Yang ES, Zhang Y, Todd JM, Wang L, Alvarado GS, Andersen H, Foulds KE, Edwards DK, Mascola JR, Moore IN, Lewis MG, Carfi A, Montefiori D, Suthar MS, McDermott A, Roederer M, Sullivan NJ, Douek DC, Graham BS, Seder RA. Immune correlates of protection by mRNA-1273 vaccine against SARS-CoV-2 in nonhuman primates. Science. 2021 Sep 17;373(6561):eabj0299. doi: 10.1126/science.abj0299. Epub 2021 Sep 17.
PubMed 34529476
Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.
PubMed 33378609
El Sahly HM, Baden LR, Essink B, Doblecki-Lewis S, Martin JM, Anderson EJ, Campbell TB, Clark J, Jackson LA, Fichtenbaum CJ, Zervos M, Rankin B, Eder F, Feldman G, Kennelly C, Han-Conrad L, Levin M, Neuzil KM, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Polakowski L, Mascola JR, Ledgerwood JE, Graham BS, August A, Clouting H, Deng W, Han S, Leav B, Manzo D, Pajon R, Schodel F, Tomassini JE, Zhou H, Miller J; COVE Study Group. Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase. N Engl J Med. 2021 Nov 4;385(19):1774-1785. doi: 10.1056/NEJMoa2113017. Epub 2021 Sep 22.
PubMed 34551225
Oliver SE, Wallace M, See I, Mbaeyi S, Godfrey M, Hadler SC, Jatlaoui TC, Twentyman E, Hughes MM, Rao AK, Fiore A, Su JR, Broder KR, Shimabukuro T, Lale A, Shay DK, Markowitz LE, Wharton M, Bell BP, Brooks O, McNally V, Lee GM, Talbot HK, Daley MF. Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021. MMWR Morb Mortal Wkly Rep. 2022 Jan 21;71(3):90-95. doi: 10.15585/mmwr.mm7103a4.
PubMed 35051137
Barda N, Dagan N, Ben-Shlomo Y, Kepten E, Waxman J, Ohana R, Hernan MA, Lipsitch M, Kohane I, Netzer D, Reis BY, Balicer RD. Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med. 2021 Sep 16;385(12):1078-1090. doi: 10.1056/NEJMoa2110475. Epub 2021 Aug 25.
PubMed 34432976
Simone A, Herald J, Chen A, Gulati N, Shen AY, Lewin B, Lee MS. Acute Myocarditis Following COVID-19 mRNA Vaccination in Adults Aged 18 Years or Older. JAMA Intern Med. 2021 Dec 1;181(12):1668-1670. doi: 10.1001/jamainternmed.2021.5511.
PubMed 34605853
Oster ME, Shay DK, Su JR, Gee J, Creech CB, Broder KR, Edwards K, Soslow JH, Dendy JM, Schlaudecker E, Lang SM, Barnett ED, Ruberg FL, Smith MJ, Campbell MJ, Lopes RD, Sperling LS, Baumblatt JA, Thompson DL, Marquez PL, Strid P, Woo J, Pugsley R, Reagan-Steiner S, DeStefano F, Shimabukuro TT. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022 Jan 25;327(4):331-340. doi: 10.1001/jama.2021.24110.
PubMed 35076665
Larson KF, Ammirati E, Adler ED, Cooper LT Jr, Hong KN, Saponara G, Couri D, Cereda A, Procopio A, Cavalotti C, Oliva F, Sanna T, Ciconte VA, Onyango G, Holmes DR, Borgeson DD. Myocarditis After BNT162b2 and mRNA-1273 Vaccination. Circulation. 2021 Aug 10;144(6):506-508. doi: 10.1161/CIRCULATIONAHA.121.055913. Epub 2021 Jun 16.
PubMed 34133884
Rosenblum HG, Hadler SC, Moulia D, Shimabukuro TT, Su JR, Tepper NK, Ess KC, Woo EJ, Mba-Jonas A, Alimchandani M, Nair N, Klein NP, Hanson KE, Markowitz LE, Wharton M, McNally VV, Romero JR, Talbot HK, Lee GM, Daley MF, Mbaeyi SA, Oliver SE. Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021. MMWR Morb Mortal Wkly Rep. 2021 Aug 13;70(32):1094-1099. doi: 10.15585/mmwr.mm7032e4.
PubMed 34383735
Marion O, Del Bello A, Abravanel F, Couat C, Faguer S, Esposito L, Hebral AL, Izopet J, Kamar N. Safety and Immunogenicity of Anti-SARS-CoV-2 Messenger RNA Vaccines in Recipients of Solid Organ Transplants. Ann Intern Med. 2021 Sep;174(9):1336-1338. doi: 10.7326/M21-1341. Epub 2021 May 25. No abstract available.
PubMed 34029487
Hall VG, Ferreira VH, Ku T, Ierullo M, Majchrzak-Kita B, Chaparro C, Selzner N, Schiff J, McDonald M, Tomlinson G, Kulasingam V, Kumar D, Humar A. Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients. N Engl J Med. 2021 Sep 23;385(13):1244-1246. doi: 10.1056/NEJMc2111462. Epub 2021 Aug 11. No abstract available.
PubMed 34379917
Boyarsky BJ, Werbel WA, Avery RK, Tobian AAR, Massie AB, Segev DL, Garonzik-Wang JM. Antibody Response to 2-Dose SARS-CoV-2 mRNA Vaccine Series in Solid Organ Transplant Recipients. JAMA. 2021 Jun 1;325(21):2204-2206. doi: 10.1001/jama.2021.7489.
PubMed 33950155
Schramm R, Costard-Jackle A, Rivinius R, Fischer B, Muller B, Boeken U, Haneya A, Provaznik Z, Knabbe C, Gummert J. Poor humoral and T-cell response to two-dose SARS-CoV-2 messenger RNA vaccine BNT162b2 in cardiothoracic transplant recipients. Clin Res Cardiol. 2021 Aug;110(8):1142-1149. doi: 10.1007/s00392-021-01880-5. Epub 2021 Jul 9.
PubMed 34241676
Shostak Y, Shafran N, Heching M, Rosengarten D, Shtraichman O, Shitenberg D, Amor SM, Yahav D, Ben Zvi H, Pertzov B, Kramer MR. Early humoral response among lung transplant recipients vaccinated with BNT162b2 vaccine. Lancet Respir Med. 2021 Jun;9(6):e52-e53. doi: 10.1016/S2213-2600(21)00184-3. Epub 2021 May 5. No abstract available.
PubMed 33964244

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients
Vaccination, Respiratory Syncytial Virus (RSV)
RecruitingPhase 2
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All Lung Transplant Recipient trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II, Open-Label Dose-Finding Trial of High-Dose mRNA-1273 Booster for Lung Transplant Recipients
ClinicalTrials.gov ID: NCT05280158
Acronym / sponsor ID: 22-000192
Conditions: Lung Transplant Recipient, SARS-CoV-2, Immunosuppression
Keywords: SARS-CoV-2, lung transplant recipient, immunosuppression
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Moderna Bivalent COVID-19 Vaccine became available to the public in Sept 2022.
Enrolment: 19 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Collaborators: ModernaTX, Inc.
Study start: 10 Mar 2022 (actual)
Primary completion: 27 Feb 2023 (actual)
Study completion: 27 Feb 2023 (actual)
First posted: 15 Mar 2022 (actual)
Results: Posted 26 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Groups will be enrolled as follows: 1. Mid-dose - Sentinel group, n=2 2. Standard-dose - Initial group, n=2 3. Cohort 1: 2:1 Randomization into * Mid-dose group, n=18 * Standard-dose group, n=9 4. High-dose - Sentinel group, n=2 5. Cohort 2: 2:1 Randomization into * High-dose group, n=18 * Standard-dose group, n=9 We will perform stratified randomization for the two cohorts based on: 1) the number of prior doses, and 2) prior receipt of any BNT162b2 vaccines.

Arm	Type	Receives
Standard-dose	Active comparator	Drug: mRNA-1273 (Moderna COVID-19 vaccine)mRNA-1273 (Moderna COVID-19 vaccine) 50 ug
Mid-Dose	Experimental	Drug: mRNA-1273 (Moderna COVID-19 vaccine)mRNA-1273 (Moderna COVID-19 vaccine) 100 ug
High-Dose	Experimental	Drug: mRNA-1273 (Moderna COVID-19 vaccine)mRNA-1273 (Moderna COVID-19 vaccine) 200 ug

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (14 listed)

Previous documented COVID-19 infection.
Use of investigational agents for prophylaxis against COVID-19 within 90 days of the start of the study, including Evusheld monoclonal antibodies.
Ongoing therapy for acute cellular or antibody mediated rejection.
Intravenous immunoglobulins (IVIG) administration within the prior 3 months or ongoing IVIG therapy.
Anaphylaxis or allergic reaction to any prior vaccines.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mRNA-1273 (Moderna COVID-19 vaccine)Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study.	Drug	High-Dose, Mid-Dose, Standard-dose

Primary outcome

Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)
Time frame: Day 1 - Day 7 after study drug administration
Solicited local and systemic reactogenicity adverse events were documented daily in a dedicated diary, and assigned a grade 1-3 according to the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA grading scale). Higher grades are assigned to more severe events.
Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary
Time frame: Day 1 - Day 30 after study drug administration
Comprehensive recording of occurrence and severity grade of unsolicited adverse events (AEs) daily. These events were documented in a dedicated diary starting from Day 1 of the study and continued through to Day 30. Data collection encompassed adverse events not specifically solicited, with each event's frequency recorded for analysis.
Participants Reporting Any Serious Adverse Experiences (SAEs) and Adverse Events of Special Interests (AESIs) Related to the Intervention From Day 1 Until Day 180.
Time frame: Day 1 - Day 180 after study drug administration
This comprehensive data collection is intended to provide insights into the occurrence of significant adverse events and specific adverse events of interest over an extended period

4 secondary outcomes

Humoral Immunogenicity Measured by Anti-RBD and Anti-spike (S-2P) IgG Levels at Day 30.
Time frame: Day 30 after study drug administration
Humoral Immunogenicity Measured by Neutralizing Antibody Titers From a Pseudovirus Neutralization Assay at Day 30.
Time frame: Day 1, Day 30 after study drug administration
Cellular Immunogenicity (CD8+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Time frame: Day 1, Day 30 after study drug administration
Cellular Immunogenicity (CD4+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.
Time frame: Day 1, Day 30 after study drug administration

Results and safety

Results posted to the registry on 26 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Dose Group	8	8
Mid Dose Group	11	11

Primary outcome: Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)

Time frame: Day 1 - Day 7 after study drug administration. Number. Unit: participants

Measure	Standard-dose n = 8	Mid-Dose n = 11
Any Local AR	5	9
Injection site pain -Grade 1	4	7
Injection site pain -Grade 2	2	4
Injection Site Swelling-Grade 1	0	1
Injection site swelling, Grade 2	0	1
Any Systemic AR	3	3
Fatigue - grade 1	1	1
Fatigue - Grade 2	2	1

Primary outcome: Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary

Time frame: Day 1 - Day 30 after study drug administration. Count of participants. Unit: Participants

Measure	Standard Dose Group n = 8	Mid Dose Group n = 11
Any unsolicited AE	1	7
Pain in extremity - left foot, Moderate	0	1
Pain in extremity - bilateral shoulder pain, Mild	0	1
Fatigue, Mild	0	1
Fatigue, Moderate	0	1
Hyperkalemia, Moderate	0	1
Creatinine increased, Mild	0	1
COVID-19 infection - Mild	1	2

Primary outcome: Participants Reporting Any Serious Adverse Experiences (SAEs) and Adverse Events of Special Interests (AESIs) Related to the Intervention From Day 1 Until Day 180.

Time frame: Day 1 - Day 180 after study drug administration. Count of participants. Unit: Participants

Measure	Standard Dose Group n = 8	Mid Dose Group n = 11
Value	0	0

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard-dose	1 of 8 (12.5%)	5 of 8 (62.5%)	0 of 8
Mid-Dose	2 of 11 (18.2%)	10 of 11 (90.9%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32722908Corbett KS, Flynn B, Foulds KE, Francica JR, Boyoglu-Barnum S, Werner AP, Flach B, O'Connell S, Bock KW, Minai M, Nagata BM, Andersen H, Martinez DR, Noe AT, Douek N, Donaldson MM, Nji NN, Alvarado GS, Edwards DK, Flebbe DR, Lamb E, Doria-Rose NA, Lin BC, Louder MK, O'Dell S, Schmidt SD, Phung E, Chang LA, Yap C, Todd JM, Pessaint L, Van Ry A, Browne S, Greenhouse J, Putman-Taylor T, Strasbaugh A, Campbell TA, Cook A, Dodson A, Steingrebe K, Shi W, Zhang Y, Abiona OM, Wang L, Pegu A, Yang ES, Leung K, Zhou T, Teng IT, Widge A, Gordon I, Novik L, Gillespie RA, Loomis RJ, Moliva JI, Stewart-Jones G, Himansu S, Kong WP, Nason MC, Morabito KM, Ruckwardt TJ, Ledgerwood JE, Gaudinski MR, Kwong PD, Mascola JR, Carfi A, Lewis MG, Baric RS, McDermott A, Moore IN, Sullivan NJ, Roederer M, Seder RA, Graham BS. Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates. N Engl J Med. 2020 Oct 15;383(16):1544-1555. doi: 10.1056/NEJMoa2024671. Epub 2020 Jul 28.
Background: PubMed 34529476Corbett KS, Nason MC, Flach B, Gagne M, O'Connell S, Johnston TS, Shah SN, Edara VV, Floyd K, Lai L, McDanal C, Francica JR, Flynn B, Wu K, Choi A, Koch M, Abiona OM, Werner AP, Moliva JI, Andrew SF, Donaldson MM, Fintzi J, Flebbe DR, Lamb E, Noe AT, Nurmukhambetova ST, Provost SJ, Cook A, Dodson A, Faudree A, Greenhouse J, Kar S, Pessaint L, Porto M, Steingrebe K, Valentin D, Zouantcha S, Bock KW, Minai M, Nagata BM, van de Wetering R, Boyoglu-Barnum S, Leung K, Shi W, Yang ES, Zhang Y, Todd JM, Wang L, Alvarado GS, Andersen H, Foulds KE, Edwards DK, Mascola JR, Moore IN, Lewis MG, Carfi A, Montefiori D, Suthar MS, McDermott A, Roederer M, Sullivan NJ, Douek DC, Graham BS, Seder RA. Immune correlates of protection by mRNA-1273 vaccine against SARS-CoV-2 in nonhuman primates. Science. 2021 Sep 17;373(6561):eabj0299. doi: 10.1126/science.abj0299. Epub 2021 Sep 17.
Background: PubMed 33378609Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.
Background: PubMed 34551225El Sahly HM, Baden LR, Essink B, Doblecki-Lewis S, Martin JM, Anderson EJ, Campbell TB, Clark J, Jackson LA, Fichtenbaum CJ, Zervos M, Rankin B, Eder F, Feldman G, Kennelly C, Han-Conrad L, Levin M, Neuzil KM, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Polakowski L, Mascola JR, Ledgerwood JE, Graham BS, August A, Clouting H, Deng W, Han S, Leav B, Manzo D, Pajon R, Schodel F, Tomassini JE, Zhou H, Miller J; COVE Study Group. Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase. N Engl J Med. 2021 Nov 4;385(19):1774-1785. doi: 10.1056/NEJMoa2113017. Epub 2021 Sep 22.
Background: PubMed 35051137Oliver SE, Wallace M, See I, Mbaeyi S, Godfrey M, Hadler SC, Jatlaoui TC, Twentyman E, Hughes MM, Rao AK, Fiore A, Su JR, Broder KR, Shimabukuro T, Lale A, Shay DK, Markowitz LE, Wharton M, Bell BP, Brooks O, McNally V, Lee GM, Talbot HK, Daley MF. Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021. MMWR Morb Mortal Wkly Rep. 2022 Jan 21;71(3):90-95. doi: 10.15585/mmwr.mm7103a4.
Background: PubMed 34432976Barda N, Dagan N, Ben-Shlomo Y, Kepten E, Waxman J, Ohana R, Hernan MA, Lipsitch M, Kohane I, Netzer D, Reis BY, Balicer RD. Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med. 2021 Sep 16;385(12):1078-1090. doi: 10.1056/NEJMoa2110475. Epub 2021 Aug 25.
Background: PubMed 34605853Simone A, Herald J, Chen A, Gulati N, Shen AY, Lewin B, Lee MS. Acute Myocarditis Following COVID-19 mRNA Vaccination in Adults Aged 18 Years or Older. JAMA Intern Med. 2021 Dec 1;181(12):1668-1670. doi: 10.1001/jamainternmed.2021.5511.
Background: PubMed 35076665Oster ME, Shay DK, Su JR, Gee J, Creech CB, Broder KR, Edwards K, Soslow JH, Dendy JM, Schlaudecker E, Lang SM, Barnett ED, Ruberg FL, Smith MJ, Campbell MJ, Lopes RD, Sperling LS, Baumblatt JA, Thompson DL, Marquez PL, Strid P, Woo J, Pugsley R, Reagan-Steiner S, DeStefano F, Shimabukuro TT. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022 Jan 25;327(4):331-340. doi: 10.1001/jama.2021.24110.
Background: PubMed 34133884Larson KF, Ammirati E, Adler ED, Cooper LT Jr, Hong KN, Saponara G, Couri D, Cereda A, Procopio A, Cavalotti C, Oliva F, Sanna T, Ciconte VA, Onyango G, Holmes DR, Borgeson DD. Myocarditis After BNT162b2 and mRNA-1273 Vaccination. Circulation. 2021 Aug 10;144(6):506-508. doi: 10.1161/CIRCULATIONAHA.121.055913. Epub 2021 Jun 16.
Background: PubMed 34383735Rosenblum HG, Hadler SC, Moulia D, Shimabukuro TT, Su JR, Tepper NK, Ess KC, Woo EJ, Mba-Jonas A, Alimchandani M, Nair N, Klein NP, Hanson KE, Markowitz LE, Wharton M, McNally VV, Romero JR, Talbot HK, Lee GM, Daley MF, Mbaeyi SA, Oliver SE. Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021. MMWR Morb Mortal Wkly Rep. 2021 Aug 13;70(32):1094-1099. doi: 10.15585/mmwr.mm7032e4.
Background: PubMed 34029487Marion O, Del Bello A, Abravanel F, Couat C, Faguer S, Esposito L, Hebral AL, Izopet J, Kamar N. Safety and Immunogenicity of Anti-SARS-CoV-2 Messenger RNA Vaccines in Recipients of Solid Organ Transplants. Ann Intern Med. 2021 Sep;174(9):1336-1338. doi: 10.7326/M21-1341. Epub 2021 May 25. No abstract available.
Background: PubMed 34379917Hall VG, Ferreira VH, Ku T, Ierullo M, Majchrzak-Kita B, Chaparro C, Selzner N, Schiff J, McDonald M, Tomlinson G, Kulasingam V, Kumar D, Humar A. Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients. N Engl J Med. 2021 Sep 23;385(13):1244-1246. doi: 10.1056/NEJMc2111462. Epub 2021 Aug 11. No abstract available.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yusaku Michael Shino, MD principal investigator

University of California, Los Angeles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing mRNA-1273 (Moderna COVID-19 vaccine) in people with Lung Transplant Recipient and SARS-CoV-2, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR) (time frame: Day 1 - Day 7 after study drug administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05280158, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.