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NCT05921903: RSV OA=ADJ-023

A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above

Completed Phase 2 Results posted Last updated 8 August 2025
What this trial tests

Phase 2 trial testing RSVPreF3 OA Investigational Vaccine in Respiratory Syncytial Virus Infections in 386 participants. Completed in 16 May 2025.

Timeline
28 July 2023
Primary endpoint
25 June 2024
16 May 2025

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment386
Start date28 July 2023
Primary completion25 June 2024
Estimated completion16 May 2025
Sites46 locations across Italy, Japan, Germany, South Korea, Canada, Australia, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Respiratory Syncytial Virus Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group Primary · At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)

MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).

GroupValue95% CI
RSV_IC_2 Group1.341.20 – 1.48
RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group Primary · At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)

MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-B post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).

GroupValue95% CI
RSV_IC_2 Group1.261.14 – 1.40
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups Secondary · At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 in a subset of participants (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)

Neutralizing titers were calculated as GMT and expressed in titers (Estimated Dilution 60 \[ED60\]).

RSV-A , Visit 1
GroupValue95% CI
RSV_IC_1 Group807.0700.9 – 929.2
RSV_IC_2 Group814.1701.3 – 945.1
RSV_HA Group889.0781.9 – 1010.6
RSV-A , Visit 2
GroupValue95% CI
RSV_IC_1 Group1775.81201.0 – 2625.6
RSV_IC_2 Group2031.11283.6 – 3213.9
RSV_HA Group6716.84907.6 – 9193.0
RSV-A , Visit 3
GroupValue95% CI
RSV_IC_1 Group3990.83219.4 – 4947.0
RSV_IC_2 Group4174.03230.7 – 5392.6
RSV_HA Group6822.55926.2 – 7854.4
RSV-A , Visit 4
GroupValue95% CI
RSV_IC_1 Group4184.73360.1 – 5211.7
RSV_IC_2 Group5377.94265.4 – 6780.6
RSV_HA Group5707.04853.6 – 6710.3
RSV-B, Visit 1
GroupValue95% CI
RSV_IC_1 Group864.2727.8 – 1026.2
RSV_IC_2 Group892.9754.1 – 1057.3
RSV_HA Group1027.3889.6 – 1186.3
RSV-B, Visit 2
GroupValue95% CI
RSV_IC_1 Group2325.31592.9 – 3394.5
RSV_IC_2 Group2603.11714.9 – 3951.3
RSV_HA Group8113.65699.9 – 11549.5
RSV-B, Visit 3
GroupValue95% CI
RSV_IC_1 Group5002.93901.7 – 6414.8
RSV_IC_2 Group4834.73736.6 – 6255.6
RSV_HA Group9140.57805.3 – 10704.1
RSV-B, Visit 4
GroupValue95% CI
RSV_IC_1 Group4461.73519.0 – 5657.0
RSV_IC_2 Group5820.84658.2 – 7273.5
RSV_HA Group6281.65377.6 – 7337.7
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups Secondary · At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)

Group GMT was assessed for RSV\_HA group over pooled RSV\_IC group (combined RSV\_IC\_1 and RSV\_IC\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_HA and Pooled RSV\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.

Visit 2
GroupValue95% CI
RSV_HA Group6689.94639.3 – 9646.7
Pooled RSV_IC Group1902.81479.6 – 2446.9
Visit 3
GroupValue95% CI
RSV_HA Group6653.85503.5 – 8044.6
Pooled RSV_IC Group4113.03595.5 – 4705.0
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups Secondary · At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Group GMT of RSV\_IC\_2 over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_IC\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.

GroupValue95% CI
RSV_IC_1 Group4041.93254.8 – 5019.3
RSV_IC_2 Group5098.44088.8 – 6357.3
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups Secondary · At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Group GMT of RSV\_HA over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.

GroupValue95% CI
RSV_IC_1 Group4244.83551.8 – 5073.0
RSV_HA Group5541.64622.0 – 6644.2
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups Secondary · At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Group GMT of RSV\_HA over RSV\_IC\_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_2 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.

GroupValue95% CI
RSV_IC_2 Group5505.34627.0 – 6550.3
RSV_HA Group5615.74719.8 – 6681.6
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups Secondary · At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)

Group GMT was assessed for RSV\_HA group over pooled RSV\_IC group (combined RSV\_IC\_1 and RSV\_IC\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_HA and Pooled RSV\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.

Visit 2
GroupValue95% CI
RSV_HA Group8238.75972.9 – 11364.1
Pooled RSV_IC Group2442.61958.3 – 3046.7
Visit 3
GroupValue95% CI
RSV_HA Group8545.57031.3 – 10385.8
Pooled RSV_IC Group5106.94448.4 – 5863.0
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups Secondary · At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Group GMT ratio of RSV\_IC\_2 over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_IC\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.

GroupValue95% CI
RSV_IC_1 Group4333.33510.0 – 5349.8
RSV_IC_2 Group5550.54478.3 – 6879.4
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups Secondary · At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Group GMT of RSV\_HA over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.

GroupValue95% CI
RSV_IC_1 Group4632.93890.8 – 5516.6
RSV_HA Group5973.55000.9 – 7135.4
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups Secondary · At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Group GMT of RSV\_HA over RSV\_IC\_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_2 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.

GroupValue95% CI
RSV_IC_2 Group6090.65184.6 – 7155.0
RSV_HA Group6123.05212.1 – 7193.0
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI Secondary · At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days), each compared to Visit 1 (Day 1)

MGI was assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV\_HA and pooled RSV\_IC (combined RSV\_IC\_1 and RSV\_IC\_2 groups), and at Visit 4 over Visit 1 in RSV\_IC\_1, RSV\_IC\_2, RSV\_HA groups.

RSV-A, Visit 2
GroupValue95% CI
RSV_IC_1 Group2.141.44 – 3.18
RSV_IC_2 Group2.201.45 – 3.34
RSV_HA Group7.595.44 – 10.58
Pooled RSV_IC Group2.171.64 – 2.87
RSV-A, Visit 3
GroupValue95% CI
RSV_IC_1 Group4.923.95 – 6.12
RSV_IC_2 Group5.014.00 – 6.27
RSV_HA Group7.826.74 – 9.06
Pooled RSV_IC Group4.964.24 – 5.80
RSV-A, Visit 4
GroupValue95% CI
RSV_IC_1 Group5.294.24 – 6.60
RSV_IC_2 Group6.535.32 – 8.01
RSV_HA Group6.555.60 – 7.6
RSV-B, Visit 2
GroupValue95% CI
RSV_IC_1 Group2.511.78 – 3.55
RSV_IC_2 Group2.541.75 – 3.67
RSV_HA Group8.596.59 – 11.20
Pooled RSV_IC Group2.531.98 – 3.23
RSV-B, Visit 3
GroupValue95% CI
RSV_IC_1 Group5.724.53 – 7.21
RSV_IC_2 Group5.344.25 – 6.72
RSV_HA Group8.807.67 – 10.11
Pooled RSV_IC Group5.534.71 – 6.51
RSV-B, Visit 4
GroupValue95% CI
RSV_IC_1 Group5.224.20 – 6.49
RSV_IC_2 Group6.525.34 – 7.97
RSV_HA Group6.355.50 – 7.33

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 4 (Visit 3 + 30-42 days).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RSV_IC_1 Group
Serious: 12/131 (9%)
Deaths: 0/131
RSV_IC_2 Group
Serious: 18/130 (14%)
Deaths: 2/130
RSV_HA Group
Serious: 3/125 (2%)
Deaths: 0/125

Serious adverse events (36 terms)

ReactionSystemRSV_IC_1 GroupRSV_IC_2 GroupRSV_HA Group
PneumoniaInfections and infestations
SepsisInfections and infestations
GastroenteritisInfections and infestations
Acute kidney injuryRenal and urinary disorders
PyrexiaGeneral disorders
COVID-19Infections and infestations
Urinary tract infectionInfections and infestations
Aspergillus infectionInfections and infestations
UrosepsisInfections and infestations
Escherichia bacteraemiaInfections and infestations
GangreneInfections and infestations
Bursitis infectiveInfections and infestations
Gastroenteritis Escherichia coliInfections and infestations
InfluenzaInfections and infestations
Oesophageal candidiasisInfections and infestations
ColitisGastrointestinal disorders
Invasive ductal breast carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome with excess blastsNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal impairmentRenal and urinary disorders
Urinary retentionRenal and urinary disorders
Chest painGeneral disorders
Acute respiratory failureRespiratory, thoracic and mediastinal disorders
Other adverse events (113 terms — click to expand)

ReactionSystemRSV_IC_1 GroupRSV_IC_2 GroupRSV_HA Group
Administration site painGeneral disorders
FatigueGeneral disorders
MyalgiaMusculoskeletal and connective tissue disorders
HeadacheNervous system disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Administration site erythemaGeneral disorders
Administration site swellingGeneral disorders
DiarrhoeaGastrointestinal disorders
DizzinessNervous system disorders
PruritusSkin and subcutaneous tissue disorders
NasopharyngitisInfections and infestations
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
NauseaGastrointestinal disorders
CoughRespiratory, thoracic and mediastinal disorders
Administration site pruritusGeneral disorders
Oedema peripheralGeneral disorders
ChillsGeneral disorders
PyrexiaGeneral disorders
Neck painMusculoskeletal and connective tissue disorders
COVID-19Infections and infestations
Urinary tract infectionInfections and infestations
SinusitisInfections and infestations
RhinorrhoeaRespiratory, thoracic and mediastinal disorders
Productive coughRespiratory, thoracic and mediastinal disorders
Chest painGeneral disorders
Back painMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
GastroenteritisInfections and infestations
BronchitisInfections and infestations
Lymph gland infectionInfections and infestations
RhinitisInfections and infestations
CystitisInfections and infestations
Enterococcal infectionInfections and infestations
Escherichia urinary tract infectionInfections and infestations
Herpes simplex reactivationInfections and infestations
Pneumonia pseudomonalInfections and infestations
Stenotrophomonas maltophilia pneumoniaInfections and infestations
Upper respiratory tract infectionInfections and infestations
Clostridium difficile colitisInfections and infestations
GingivitisInfections and infestations

Most-reported serious reactions: Pneumonia, Sepsis, Gastroenteritis, Acute kidney injury, Pyrexia, COVID-19, Urinary tract infection, Aspergillus infection.

Data from ClinicalTrials.gov NCT05921903 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The respiratory syncytial virus vaccine and monoclonal antibody landscape: the road to global access.
    Terstappen J, Hak SF, Bhan A, Bogaert D, et al · · 2024 · cited 54× · PMID 39326422 · DOI 10.1016/s1473-3099(24)00455-9
  2. Global progress in clinical research on human respiratory syncytial virus vaccines.
    Peng R, Chen C, Chen Q, Zhang Y, et al · · 2024 · cited 8× · PMID 39286350 · DOI 10.3389/fmicb.2024.1457703
  3. Respiratory Syncytial Virus Vaccines: Analysis of Pre-Marketing Clinical Trials for Immunogenicity in the Population over 50 Years of Age.
    Papazisis G, Topalidou X, Gioula G, González PA, et al · · 2024 · cited 8× · PMID 38675736 · DOI 10.3390/vaccines12040353
  4. Respiratory syncytial virus: health burden, disease prevention, and treatment-recent progress and lessons learned.
    Brüssow H. · · 2025 · cited 3× · PMID 40420998 · DOI 10.1093/femsml/uqaf003
  5. Recent advances in the prevention and treatment of respiratory syncytial virus disease.
    Sanchez-Martinez A, Moore T, Freitas TS, Benzaken TR, et al · · 2025 · cited 3× · PMID 40202895 · DOI 10.1099/jgv.0.002095
  6. Respiratory Syncytial Virus (RSV): A Comprehensive Overview From Basic Biology to Clinical Prevention and Control.
    Shi J, Huang X, Ye C, Lu Y, et al · · 2026 · PMID 41261734 · DOI 10.1002/med.70025
  7. Could more adults than just those aged 75-79 years potentially benefit from vaccination against RSV: insights from UK data.
    Vyse A, Hockey C, Wright H, Ellsbury G. · · 2025 · PMID 41199924 · DOI 10.1080/20523211.2025.2576618
  8. Immune persistence and safety of the AS01<sub>E</sub>-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in adults 50-59 years of age, including at-increased-risk adults: A randomized controlled trial.
    Ferguson M, Schwarz TF, Núñez SA, Rodríguez-García J, et al · · 2025 · PMID 41194599 · DOI 10.1080/21645515.2025.2579335

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05921903.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing