Phase 3
N=1,533
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above
Respiratory Syncytial Virus Infections
Bottom Line
View on ClinicalTrials.gov: NCT05590403 ↗Enrolled (actual)
1,533
Serious AEs
2.3%
Results posted
May 2024
Primary outcome: Primary: RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group — 7906.0; 7518.9 Titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RSVPreF3 OA investigational vaccine (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group |
7906.0; 7518.9 | — |
| PRIMARY RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group |
82.8; 80.2 | — |
| PRIMARY RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group |
9024.8; 8070.3 | — |
| PRIMARY RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group |
78.2; 74.3 | — |
| PRIMARY RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group |
8925.1; 7460.7 | — |
| PRIMARY RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group |
86.8; 80.2 | — |
| PRIMARY RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group |
10048.6; 8073.4 | — |
| PRIMARY RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group |
81.6; 74.3 | — |
| SECONDARY Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) |
11.9; 0.5; 14.5; 0.5; 12.1; 76.7 | — |
| SECONDARY Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) |
26.0; 5.8; 20.8; 10.0; 12.9; 44.0 | — |
| SECONDARY Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs) |
13.6; 13.5; 15.3; 10.5; 16.3 | — |
| SECONDARY Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination |
0.8; 2.1; 3.9; 2.1; 2.4 | — |
| SECONDARY Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination |
0; 0; 1.0; 0.5; 0.8 | — |
| SECONDARY Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination |
0; 0; 0; 0; 0.3 | — |
| SECONDARY Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination |
0; 0; 0; 0; 0.3 | — |
| SECONDARY Percentage of Participants Reporting Any Fatal SAEs |
0; 0; 1.0; 0.5; 0 | — |
| SECONDARY RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention |
768.8; 772.0; 779.5; 729.8; 775.7; 7925.4 | — |
| SECONDARY RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention |
3850.7; 849.6; 3980.6; 854.2; 3846.3; 3192.9 | — |
| SECONDARY RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention |
1091.1; 1197.7; 1141.4; 1167.2; 1109.1; 8971.9 | — |
| SECONDARY RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention |
3880.7; 1003.2; 4020.8; 942.1; 3710.4; 3562.8 | — |
| SECONDARY Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention |
102.7; 125.6; 161.5; 114.7; 111.3; 1282.5 | — |
| SECONDARY Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention |
825.6; 140.5; 662.9; 39.2; 763.5; 492.0 | — |
| SECONDARY Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention |
10.1; 6.0; 15.5; 10.8; 12.0; 15.2 | — |
| SECONDARY Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 |
23.1; 12.2; 27.6; 14.0; 14.8; 15.2 | — |
Summary
The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults >=60 YOA
Eligibility Criteria
Inclusion Criteria
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
- Specific inclusion criteria for all participants in Cohort 1 (Adults HA-RSV Group, Adults HA-Placebo Group, Adults AIR-RSV Group & Adults AIR-Placebo Group)
- A male or female participant 50-59 YOA at the time of the study intervention administration.
- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy or 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 until study end for this study, and
- has a negative pregnancy test on the day of study intervention administration.
Specific inclusion criteria for participants in the Adults-HA Sub-cohort
- Healthy participants as established by medical history and clinical examination before entering into the study.
- Participants with chronic stable medical conditions with or without specific treatment, such as hypertension, hypercholesterolemia, or hypothyroidism, and who are not at increased risk for RSV-LRTD , are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).
Specific inclusion criteria for participants in the Adults-AIR Sub cohort
Participants should be diagnosed with at least 1 of the following medical conditions and have a stable condition (no changes in the treatment or disease severity in the past 3 months):
- Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication
- Chronic cardiovascular disease
- Diabetes mellitus: types 1 and 2
- Other diseases at increased risk for RSV-LRTD disease
- Chronic kidney disease
- Chronic liver disease 2. Specific inclusion criteria for Cohort 2 (OA-RSV Group)
- A male or female participant ≥60 YOA at the time of the study intervention administration.
- Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).
- Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
Exclusion Criteria
Medical conditions
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
- Hypersensitivity to latex.
- Unstable chronic illness.
- Any history of dementia or any medical condition that moderately or severely impairs cognition.
- Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. Study participants may decide to assign a caregiver to help them complete the study procedures.
- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Prior/Concomitant therapy
- Use of a
Data sourced from ClinicalTrials.gov (NCT05590403). 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.