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RSV Vaccine

Phase 2

Healthy | Monoclonal antibody | Other |Johnson & Johnson|Last Updated: May 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment495
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04453202A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older AdultsPHASE2 COMPLETED 459Jul 16, 2020Apr 9, 2021May 25, 20259 United States
NCT04354480A Study to Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncytial Virus (RSV) Vaccine in Japanese Adults Aged 60 Years and OlderPHASE1 COMPLETED 36May 15, 2020Jan 20, 2021Feb 3, 20251 Japan
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Study Endpoints
Primary Endpoints
Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination
14 days after vaccination on Day 1 (Day 15)

Geometric mean antibody titers (ELISA units per liter \[EU/L\]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.

Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Until 7 days after Vaccination on Day 1 (Day 8)

Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was 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 pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.

Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Until 7 days after Vaccination on Day 1 (Day 8)

Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree celsius).

Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
Until 28 days after Vaccination on Day 1 (Day 29)

Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was 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. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).

Number of Participants with Solicited Local Adverse Events (AEs) After Vaccination
7 days after vaccination (Day 1 to Day 8)

Number of participants with solicited local AE's will be evaluated. Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.

Number of Participants with Solicited Systemic Adverse Events (AEs) After Vaccination
7 days after vaccination (Day 1 to Day 8)

Number of participants with solicited systemic AEs will be evaluated. Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.

Number of Participants with Unsolicited AEs
28 days after vaccination (Day 1 to Day 29)

Number of participants with unsolicited AEs will be evaluated. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.

Number of Participants with Serious Adverse Events (SAEs)
First vaccination (Day 1) to the end of the study (up to Day 183)

Number of participants with SAEs will be evaluated. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.

Secondary Endpoints
Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1
At 3 and 6 months after vaccination on Day 1
Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides
At 14 days and 3 and 6 months after vaccination on Day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Cohort 1 Group 1: RSV VaccineEXPERIMENTALParticipants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1.
Cohort 1 Group 2: RSV VaccineEXPERIMENTALParticipants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1.
Cohort 1 Group 3: RSV VaccineEXPERIMENTALParticipants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1.
Cohort 1 Group 4: RSV VaccineEXPERIMENTALParticipants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1.
Cohort 1 Group 5: PlaceboPLACEBO_COMPARATORParticipants will receive IM injection of placebo on Day 1.
Cohort 2 Group 6: RSV VaccineEXPERIMENTALParticipants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
Cohort 2 Group 7: RSV VaccineEXPERIMENTALParticipants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1.
Cohort 2 Group 8: PlaceboPLACEBO_COMPARATORParticipants will receive IM injection of placebo on Day 1.
Cohort 3 Group 9: RSV VaccineEXPERIMENTALParticipants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
Cohort 3 Group 10: RSV VaccineEXPERIMENTALParticipants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1.
Cohort 3 Group 11: PlaceboEXPERIMENTALParticipants will receive IM injection of placebo on Day 1.
RSV VaccineEXPERIMENTALParticipants will receive a single intramuscular (IM) injection of an adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV) vaccine at a single dose level on Day 1.
PlaceboPLACEBO_COMPARATORParticipants will receive single IM injection in the deltoid muscle of matching placebo on Day 1.
Interventions
NameTypeDescription
RSV VaccineBIOLOGICALParticipants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
PlaceboOTHERParticipants will receive a single IM injection of placebo on Day 1.
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites9

Inclusion Criteria: * In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and...

Countries:United StatesJapan
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