Phase 2
N=386
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
Respiratory Syncytial Virus Infections
Bottom Line
View on ClinicalTrials.gov: NCT05921903 ↗Enrolled (actual)
386
Serious AEs
8.6%
Results posted
Jul 2025
Primary outcome: Primary: 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 — 1.34 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RSVPreF3 OA Investigational Vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
1.34 | — |
| PRIMARY RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group |
1.26 | — |
| SECONDARY 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 |
807.0; 814.1; 889.0; 1775.8; 2031.1; 6716.8 | — |
| SECONDARY RSV-A and RSV-B Serum Neutralizing Titers Expressed as GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups |
— | — |
| SECONDARY RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups |
6689.9; 1902.8; 6653.8; 4113.0 | — |
| SECONDARY RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups |
4041.9; 5098.4 | — |
| SECONDARY RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups |
4244.8; 5541.6 | — |
| SECONDARY RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups |
5505.3; 5615.7 | — |
| SECONDARY RSV-A Serum Neutralizing Titers Expressed as Group GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups |
— | — |
| SECONDARY RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups |
8238.7; 2442.6; 8545.5; 5106.9 | — |
| SECONDARY RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups |
4333.3; 5550.5 | — |
| SECONDARY RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups |
4632.9; 5973.5 | — |
| SECONDARY RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups |
6090.6; 6123.0 | — |
| SECONDARY RSV-B Serum Neutralizing Titers Expressed as Group GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups |
— | — |
| SECONDARY RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI |
— | — |
| SECONDARY RSV-A and RSV-B Serum Neutralizing Titers Expressed as MGI |
— | — |
| SECONDARY Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells |
86.8; 110.3; 107.8; 2932.2; 3704.3; 2959.8 | — |
| SECONDARY CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells |
33.9; 8.2; 27.7; 16.0; 8.7; 13.0 | — |
| SECONDARY CMI Response in a Subset of Participants |
— | — |
| SECONDARY Number Of Participants Reporting Any Solicited Administration Site Events |
95; 92; 95; 81; 8; 14 | — |
| SECONDARY Number Of Participants Reporting Any Solicited Systemic Events |
2; 1; 1; 2; 37; 38 | — |
| SECONDARY Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration |
21; 60; 26 | — |
| SECONDARY Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs |
12; 18; 3; 1; 0; 0 | — |
| SECONDARY Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung SOT Participants |
0; 1 | — |
| SECONDARY Number of Participants Reporting Any SAEs, SAEs Related to Study Intervention and Fatal SAEs |
— | — |
| SECONDARY Number of Participants Reporting Any pIMDs and pIMDs Related to Study Intervention |
— | — |
| SECONDARY Number of Participants Reporting Any AESIs Specific to Renal and Lung SOT Participants |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Participants and/or participant's parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.
- Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
- Female participants of nonchildbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause.
- Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception from 1 month prior to study intervention administration and agreed to continue adequate contraception until study end for this study, and has a negative pregnancy test on the day of and prior to study intervention administration.
Specific inclusion criteria for renal/lung transplant patients:
- A male or female, >=18 YoA at the time of signing the Informed consent form (ICF) or Informed assent form (IAF).
- Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than legal age of consent, or written informed consent obtained from the participant if the participant has achieved legal age of consent.
- Participant who has received an ABO compatible allogeneic renal or lung transplant (allograft) more than 12 months (365 days) prior to the first study intervention administration.
- Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection.
Specific inclusion criteria for renal transplant (RTx) patients:
- Participant with stable renal function, stability defined as less than 20% variability between last two results of eGFR or in the opinion of the investigator after investigator review of more than the last two results of eGFRs and based on medical history.
Specific inclusion criteria for lung transplant (LTx) patients:
- Participant with stable lung function, with stability defined as the stability in the FEV1 compared to post-transplant baseline FEV1 and based on medical history of the last 3 months, in the opinion of the investigator.
Specific inclusion criteria for healthy participants:
- A male or female, >=50 YoA at the time of signing the ICF.
- Healthy participants as established by medical history and clinical examination before entering the study.
- Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration.
- Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
Exclusion Criteria
Medical conditions:
- History of any reaction/ hypersensitivity likely to be exacerbated by any component of the study intervention.
- Acute or chronic clinically significant cardiovascular or hepatic functional abnormality as determined by physical examination or laboratory screening tests.
- Recurrent/uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study if their condition will allow them to comply with the requirements of the protocol, with the help of a caregiver if needed.
- Any history of dementia or any medical condition that moderately or severely impairs cognition.
- Any condition which would make IM injection unsafe.
- Significant underlying illness that would prevent completion of the study).
- Acute disease and/or f
Data sourced from ClinicalTrials.gov (NCT05921903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.