A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection

NCT05070546 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CR1090382021-001909-77VAC18193RSV3006
• Study Type: interventional
• Target: 1,124
• Locations: 5 countries
• Sites: 23

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.

Conditions

Respiratory Syncytial Virus Infection Prevention

Outcome Measures

Primary Outcomes (7)

• 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.

  7 days after vaccination on Day 1 (Day 8)

• 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.

  7 days after vaccination on Day 1 (Day 8)

• 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.

  28 days after vaccination on Day 1 (Day 29)

• 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.

  6 months after vaccination on Day 1 (Day 183)

• 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.

  6 months after vaccination on Day 1 (Day 183)

• 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.

  14 days after vaccination on Day 1 (Day 15)

• 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.

  14 days after vaccination on Day 1 (Day 15)

Secondary Outcomes (1)

• 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)

Study Arms (6)

Cohort (C)1 Group (G)1: Healthy Adults, 18-59 Years (Respiratory Syncytial Virus [RSV] vaccine)

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection of study vaccine on Day 1.

Biological: Ad26.RSV.preF-based Vaccine

C1 G2: Healthy Adults, 18-59 Years (Placebo)

PLACEBO COMPARATOR

Participants will receive a single IM injection of matching placebo on Day 1.

Other: Placebo

C2 G3: High Risk Adult, 18-59 Years (RSV Vaccine)

EXPERIMENTAL

Participants will receive a single IM injection of study vaccine on Day 1.

Biological: Ad26.RSV.preF-based Vaccine

C2 G4: High Risk Adult, 18-59 Years (Placebo)

PLACEBO COMPARATOR

Participants will receive a single IM injection of matching placebo on Day 1.

Other: Placebo

C3 G5: Adults, 65 Years and Older (RSV Vaccine)

EXPERIMENTAL

Participants will receive a single IM injection of study vaccine on Day 1.

Biological: Ad26.RSV.preF-based Vaccine

C3 G6: Adults, 65 Years and Older (Placebo)

PLACEBO COMPARATOR

Participants will receive a single IM injection of matching placebo on Day 1.

Other: Placebo

Interventions

Ad26.RSV.preF-based Vaccine BIOLOGICAL

Participants will receive a single IM injection of an RSV vaccine.

C2 G3: High Risk Adult, 18-59 Years (RSV Vaccine); C3 G5: Adults, 65 Years and Older (RSV Vaccine); Cohort (C)1 Group (G)1: Healthy Adults, 18-59 Years (Respiratory Syncytial Virus [RSV] vaccine)

Placebo OTHER

Participants will receive a single IM injection of matching placebo.

C1 G2: Healthy Adults, 18-59 Years (Placebo); C2 G4: High Risk Adult, 18-59 Years (Placebo); C3 G6: Adults, 65 Years and Older (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (23)

Alliance for Multispeciality Research

Coral Gables, Florida, 33134, United States

Location

Research Institute of South Florida Inc

Miami, Florida, 33173, United States

Location

Heartland Research Associates, an AMR Company

El Dorado, Kansas, 67042, United States

Location

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

New Orleans, Louisiana, 70119, United States

Location

Meridian Clinical Research, LLC

Rockville, Maryland, 20854, United States

Location

Tekton Research Inc.

Yukon, Oklahoma, 73099, United States

Location

Alliance for Multispeciality Research

Knoxville, Tennessee, 37909, United States

Location

Anima

Alken, 3570, Belgium

Location

C.H.U. St Pierre / Maladies Infectieuses

Brussels, Belgium

Location

Private Practice RESPISOM Namur

Namur, 5101, Belgium

Location

Emovis GmbH

Berlin, 10629, Germany

Location

Klinische Forschung Berlin GbR

Berlin, 10787, Germany

Location

Zentrum fuer klinische Forschung

Cologne, 51069, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Clinical Research HamburggmbH

Hamburg, 22143, Germany

Location

SIBAmed GmbH & Co. KG

Leipzig, 04103, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Hosp Reina Sofia

Córdoba, 14004, Spain

Location

Hosp Virgen de La Victoria

Málaga, 29010, Spain

Location

ProbarE i Lund AB

Lund, 22222, Sweden

Location

ClinSmart Sweden AB

Solna, 171 64, Sweden

Location

ProbarE i Stockholm AB

Stockholm, 113 29, Sweden

Location

Studieenheten Akademiskt Specialistcentrum Stockholm

Stockholm, 11361, Sweden

Location

Related Publications (2)

• LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.

  PMID: 39971605 DERIVED

• Jastorff A, Gymnopoulou E, Salas J, Merrall E, Buntinx E, Martin C, Askling HH, Schenkenberger I, Yuste AC, Smith W, Sotolongo R, Von Engelhardt C, Bastian AR, Comeaux C, Ligtenberg N, Callendret B, Heijnen E. Safety and immunogenicity of the Ad26/protein preF RSV vaccine in adults aged 18 to 59 years with and without at-risk comorbidities for severe respiratory syncytial virus disease: A phase 3, randomized, controlled, immunobridging trial. Vaccine. 2025 Jan 1;43(Pt 1):126514. doi: 10.1016/j.vaccine.2024.126514. Epub 2024 Nov 12.

  PMID: 39536455 DERIVED

Results Point of Contact

• Title: Director Biomarkers Viral Vaccines
• Organization: Janssen Vaccines & Prevention B.V.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: September 29, 2021
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: May 25, 2025
• Results First Posted: October 4, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

SE (4); US (7); BE (3); ES (2); DE (7)