Respiratory Syncytial Virus Infection Prevention
Conditions
Brief summary
The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.
Detailed description
RSV is an important cause of serious respiratory infections in adults aged 60 years and older, immunocompromised individuals, and those with underlying chronic cardiopulmonary conditions. The current study assess the safety and immunogenicity of the RSV vaccine in adults 18 to 59 years of age, including those who are at risk for severe RSV disease. The study comprises screening (pre-vaccination) and vaccination for each participant on Day 1, and a 6- month safety and immunogenicity follow-up period. The study duration will be up to 6 months per participant. Assessments like immunogenicity (such as humoral and cellular immune responses), safety (such as monitoring of AEs, physical examinations, and vital signs) and reactogenicity will be performed in this study.
Interventions
BIOLOGICALAd26.RSV.preF-based Vaccine
Participants will receive a single IM injection of an RSV vaccine.
OTHERPlacebo
Participants will receive a single IM injection of matching placebo.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants must be of a) non child bearing potential or b) of child bearing potential and practicing an acceptable and effective of contraception * All participants of childbearing potential must: have a negative highly sensitive urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; and have a negative highly sensitive urine beta-hCG pregnancy test immediately prior to each study vaccination (if screening and vaccination are not performed on the same day) Cohorts 1 and 2 * Participant is aged 18 to 59 years (inclusive) on the day of signing the informed consent form (ICF) and expected to be available for the duration of the study Cohort 2 * Has an existing chronic heart or lung condition, without hospitalizations or major medication class change (that is, new or stopped medications) within 30 days prior to screening, meeting the following criteria; a) cardiac disease: at least Class II symptoms per New York Heart Association classification or similar guidelines according to local practice, b) pulmonary disease: activity-restricting symptoms or use of long-term medications Cohort 3 * Participant is aged 65 years or older on the day of signing the ICF and expected to be available for the duration of the study * Participant may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease (COPD), type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider
Exclusion criteria
* Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) * Abnormal function of immune system due to a clinical condition or treatment * History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT). * Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine * Received an respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study * History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic idiopathic demyelinating polyneuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2) | 14 days after vaccination on Day 1 (Day 15) | Percentage of participants with seroresponse as assessed by VNA-A2 strain were reported. Seroresponse was defined as a 4-fold increase from baseline in Day 15 VNA A2 antibody titers. |
| Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) | 7 days after vaccination on Day 1 (Day 8) | Number of participants with solicited local AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were predefined local events (at the injection site: erythema, pain/tenderness and swelling) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination. |
| Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs | 7 days after vaccination on Day 1 (Day 8) | Number of participants with solicited systemic AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs including pyrexia, headache, fatigue, myalgia and nausea were collected within 7 days after vaccination. |
| Cohorts 1 and 2: Number of Participants With Unsolicited AEs | 28 days after vaccination on Day 1 (Day 29) | Number of participants with unsolicited AEs post-vaccination in Cohorts 1 and 2 were reported. An AE was defined as any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were defined as all AEs for which the participant was not specifically questioned in the participant diary. |
| Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | 6 months after vaccination on Day 1 (Day 183) | Number of participants with SAEs post-vaccination were reported. An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above. |
| Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) | 6 months after vaccination on Day 1 (Day 183) | Number of participants with AESI post-vaccination were reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI. |
| Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers | 14 days after vaccination on Day 1 (Day 15) | RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay and were expressed as 50% inhibitory concentration (IC50) units. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | 14 days after vaccination on Day 1 (Day 15) | GMTs of RSV Fusion Protein (PreF) antibodies as assessed by ELISA-Pre-Fusion at Day 15 were reported. |
Countries
Belgium, Germany, Spain, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1\*10\^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1. | 319 |
| Group 2 (Cohort 1): Placebo Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1. | 68 |
| Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1. | 319 |
| Group 4 (Cohort 2): Placebo High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1. | 69 |
| Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg on Day 1. | 313 |
| Group 6 (Cohort 3): Placebo Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1. | 30 |
| Total | 1,118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 8 | 2 | 7 | 1 | 2 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 3 | 0 |
| Overall Study | Randomized but not vaccinated | 1 | 0 | 1 | 1 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 3 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein | Group 2 (Cohort 1): Placebo | Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein | Group 4 (Cohort 2): Placebo | Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein | Group 6 (Cohort 3): Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.8 years STANDARD_DEVIATION 12.33 | 38.4 years STANDARD_DEVIATION 12.34 | 44.4 years STANDARD_DEVIATION 11.81 | 44.6 years STANDARD_DEVIATION 11.58 | 71.1 years STANDARD_DEVIATION 4.74 | 71.2 years STANDARD_DEVIATION 5.1 | 50.6 years STANDARD_DEVIATION 17.27 |
| Age, Customized Adults (18-64 years) | 319 Participants | 68 Participants | 319 Participants | 69 Participants | 0 Participants | 0 Participants | 775 Participants |
| Age, Customized From 65 and over | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 313 Participants | 30 Participants | 343 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 10 Participants | 40 Participants | 9 Participants | 19 Participants | 2 Participants | 122 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 274 Participants | 57 Participants | 276 Participants | 60 Participants | 289 Participants | 28 Participants | 984 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 3 Participants | 0 Participants | 5 Participants | 0 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 4 Participants | 7 Participants | 1 Participants | 9 Participants | 0 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 289 Participants | 64 Participants | 308 Participants | 68 Participants | 303 Participants | 29 Participants | 1061 Participants |
| Region of Enrollment BELGIUM | 178 Participants | 36 Participants | 38 Participants | 5 Participants | 18 Participants | 3 Participants | 278 Participants |
| Region of Enrollment GERMANY | 0 Participants | 0 Participants | 175 Participants | 38 Participants | 88 Participants | 11 Participants | 312 Participants |
| Region of Enrollment SPAIN | 0 Participants | 0 Participants | 15 Participants | 5 Participants | 0 Participants | 0 Participants | 20 Participants |
| Region of Enrollment SWEDEN | 33 Participants | 8 Participants | 50 Participants | 15 Participants | 160 Participants | 11 Participants | 277 Participants |
| Region of Enrollment UNITED STATES | 108 Participants | 24 Participants | 41 Participants | 6 Participants | 47 Participants | 5 Participants | 231 Participants |
| Sex: Female, Male Female | 193 Participants | 40 Participants | 174 Participants | 39 Participants | 181 Participants | 21 Participants | 648 Participants |
| Sex: Female, Male Male | 126 Participants | 28 Participants | 145 Participants | 30 Participants | 132 Participants | 9 Participants | 470 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 319 | 0 / 68 | 0 / 319 | 0 / 69 | 0 / 313 | 1 / 30 |
| other Total, other adverse events | 77 / 319 | 5 / 68 | 50 / 319 | 8 / 69 | 32 / 313 | 5 / 30 |
| serious Total, serious adverse events | 1 / 319 | 1 / 68 | 10 / 319 | 0 / 69 | 13 / 313 | 1 / 30 |
Outcome results
Primary
Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI)
Number of participants with AESI post-vaccination were reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.
Time frame: 6 months after vaccination on Day 1 (Day 183)
Population: FAS included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein | Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) | 0 Participants |
| Group 2 (Cohort 1): Placebo | Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) | 0 Participants |
| Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein | Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) | 0 Participants |
| Group 4 (Cohort 2): Placebo | Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) | 0 Participants |
| Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein | Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) | 0 Participants |
| Group 6 (Cohort 3): Placebo | Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) | 0 Participants |
Primary
Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs)
Number of participants with SAEs post-vaccination were reported. An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: 6 months after vaccination on Day 1 (Day 183)
Population: FAS included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein | Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Group 2 (Cohort 1): Placebo | Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein | Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | 10 Participants |
| Group 4 (Cohort 2): Placebo | Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein | Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | 13 Participants |
| Group 6 (Cohort 3): Placebo | Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
Primary
Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs)
Number of participants with solicited local AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were predefined local events (at the injection site: erythema, pain/tenderness and swelling) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination.
Time frame: 7 days after vaccination on Day 1 (Day 8)
Population: Full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo). Here 'N' (number of participants analysed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was planned to be analysed for specified cohorts only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein | Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) | 273 Participants |
| Group 2 (Cohort 1): Placebo | Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) | 10 Participants |
| Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein | Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) | 276 Participants |
| Group 4 (Cohort 2): Placebo | Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) | 15 Participants |
Primary
Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs
Number of participants with solicited systemic AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs including pyrexia, headache, fatigue, myalgia and nausea were collected within 7 days after vaccination.
Time frame: 7 days after vaccination on Day 1 (Day 8)
Population: FAS included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo). Here 'N' (number of participants analysed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was planned to be analysed for specified cohorts only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein | Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs | 277 Participants |
| Group 2 (Cohort 1): Placebo | Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs | 33 Participants |
| Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein | Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs | 275 Participants |
| Group 4 (Cohort 2): Placebo | Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs | 40 Participants |
Primary
Cohorts 1 and 2: Number of Participants With Unsolicited AEs
Number of participants with unsolicited AEs post-vaccination in Cohorts 1 and 2 were reported. An AE was defined as any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were defined as all AEs for which the participant was not specifically questioned in the participant diary.
Time frame: 28 days after vaccination on Day 1 (Day 29)
Population: FAS included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo). This outcome measure was planned to be analysed for specified cohorts only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein | Cohorts 1 and 2: Number of Participants With Unsolicited AEs | 111 Participants |
| Group 2 (Cohort 1): Placebo | Cohorts 1 and 2: Number of Participants With Unsolicited AEs | 13 Participants |
| Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein | Cohorts 1 and 2: Number of Participants With Unsolicited AEs | 85 Participants |
| Group 4 (Cohort 2): Placebo | Cohorts 1 and 2: Number of Participants With Unsolicited AEs | 12 Participants |
Primary
Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2)
Percentage of participants with seroresponse as assessed by VNA-A2 strain were reported. Seroresponse was defined as a 4-fold increase from baseline in Day 15 VNA A2 antibody titers.
Time frame: 14 days after vaccination on Day 1 (Day 15)
Population: PPI set included all randomized participants who received study vaccine and for whom immunogenicity data were available. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was planned to be analysed for specified arms only. As planned, combined data of participants aged 18-59 years Cohorts 1 (Group 1) and 2 (Group 3) has been reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein | Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2) | 88 percentage of participants |
| Group 2 (Cohort 1): Placebo | Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2) | 82.41 percentage of participants |
| Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein | Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2) | 89.37 percentage of participants |
95% CI: [0.3, 10.9]Difference in Seroresponse rate
95% CI: [-1.6, 10.5]Difference in Seroresponse rate
Primary
Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay and were expressed as 50% inhibitory concentration (IC50) units.
Time frame: 14 days after vaccination on Day 1 (Day 15)
Population: The Per-protocol Immunogenicity (PPI) set included all randomised participants on Day 15 who received study vaccine and for whom immunogenicity data were available. Here 'N' (number of participants analysed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was planned to be analysed for specified arms only. As planned, combined data of participants aged 18-59 years Cohorts 1 (Group 1) and 2 (Group 3) has been reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein | Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers | 7095 Titers |
| Group 2 (Cohort 1): Placebo | Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers | 4596 Titers |
| Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein | Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers | 6491 Titers |
95% CI: [1.25, 1.6]Geometric Mean Ratio
95% CI: [1.34, 1.78]Geometric Mean Ratio
Secondary
Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion
GMTs of RSV Fusion Protein (PreF) antibodies as assessed by ELISA-Pre-Fusion at Day 15 were reported.
Time frame: 14 days after vaccination on Day 1 (Day 15)
Population: PPI set included all randomised participants who received study vaccine and for whom immunogenicity data were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein | Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | 4662 ELISA units per liter (EU/L) |
| Group 2 (Cohort 1): Placebo | Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | 246 ELISA units per liter (EU/L) |
| Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein | Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | 5175 ELISA units per liter (EU/L) |
| Group 4 (Cohort 2): Placebo | Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | 283 ELISA units per liter (EU/L) |
| Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein | Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | 3864 ELISA units per liter (EU/L) |
| Group 6 (Cohort 3): Placebo | Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | 240 ELISA units per liter (EU/L) |