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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

Primary Purpose

Respiratory Syncytial Virus Infection Prevention

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ad26.RSV.preF-based Vaccine
Placebo
Sponsored by
Janssen Vaccines & Prevention B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Syncytial Virus Infection Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alliance for Multispeciality Research
  • Research Institute of South Florida Inc
  • Heartland Research Associates, an AMR Company
  • AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
  • Meridian Clinical Research, LLC
  • Tekton Research Inc.
  • Alliance for Multispeciality Research
  • Anima
  • C.H.U. St Pierre / Maladies Infectieuses
  • Private Practice RESPISOM Namur
  • Emovis GmbH
  • Klinische Forschung Berlin GbR
  • Klinische Forschung Dresden GmbH
  • Clinical Research HamburggmbH
  • Zentrum fuer klinische Forschung
  • SIBAmed GmbH & Co. KG
  • Klinische Forschung Schwerin GmbH
  • Hosp. Reina Sofia
  • Hosp. Virgen de La Victoria
  • ProbarE i Lund AB
  • ClinSmart Sweden AB
  • ProbarE i Stockholm AB
  • Studieenheten Akademiskt Specialistcentrum Stockholm

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

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

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

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

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

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

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

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 27, 2021
Last Updated
October 3, 2023
Sponsor
Janssen Vaccines & Prevention B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT05070546
Brief Title
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
Official Title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Adults Aged 18 to 59 Years, Including Those at High-risk for Severe RSV
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
August 12, 2022 (Actual)
Study Completion Date
August 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Vaccines & Prevention B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infection Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort (C)1 Group (G)1: Healthy Adults, 18-59 Years (Respiratory Syncytial Virus [RSV] vaccine)
Arm Type
Experimental
Arm Description
Participants will receive a single intramuscular (IM) injection of study vaccine on Day 1.
Arm Title
C1 G2: Healthy Adults, 18-59 Years (Placebo)
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single IM injection of matching placebo on Day 1.
Arm Title
C2 G3: High Risk Adult, 18-59 Years (RSV Vaccine)
Arm Type
Experimental
Arm Description
Participants will receive a single IM injection of study vaccine on Day 1.
Arm Title
C2 G4: High Risk Adult, 18-59 Years (Placebo)
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single IM injection of matching placebo on Day 1.
Arm Title
C3 G5: Adults, 65 Years and Older (RSV Vaccine)
Arm Type
Experimental
Arm Description
Participants will receive a single IM injection of study vaccine on Day 1.
Arm Title
C3 G6: Adults, 65 Years and Older (Placebo)
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single IM injection of matching placebo on Day 1.
Intervention Type
Biological
Intervention Name(s)
Ad26.RSV.preF-based Vaccine
Intervention Description
Participants will receive a single IM injection of an RSV vaccine.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a single IM injection of matching placebo.
Primary Outcome Measure Information:
Title
Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs)
Description
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)
Title
Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs
Description
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)
Title
Cohorts 1 and 2: Number of Participants With Unsolicited AEs
Description
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)
Title
Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs)
Description
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)
Title
Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI)
Description
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)
Title
Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers
Description
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)
Title
Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2)
Description
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)
Secondary Outcome Measure Information:
Title
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
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Vaccines & Prevention B.V. Clinical Trial
Organizational Affiliation
Janssen Vaccines & Prevention B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Alliance for Multispeciality Research
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Research Institute of South Florida Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Heartland Research Associates, an AMR Company
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Tekton Research Inc.
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Alliance for Multispeciality Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Anima
City
Alken
ZIP/Postal Code
3570
Country
Belgium
Facility Name
C.H.U. St Pierre / Maladies Infectieuses
City
Bruxelles
Country
Belgium
Facility Name
Private Practice RESPISOM Namur
City
Namur
ZIP/Postal Code
5101
Country
Belgium
Facility Name
Emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Klinische Forschung Berlin GbR
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
ZIP/Postal Code
01069
Country
Germany
Facility Name
Clinical Research HamburggmbH
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Zentrum fuer klinische Forschung
City
Koeln
ZIP/Postal Code
51069
Country
Germany
Facility Name
SIBAmed GmbH & Co. KG
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Hosp. Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hosp. Virgen de La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
ProbarE i Lund AB
City
Lund
ZIP/Postal Code
22222
Country
Sweden
Facility Name
ClinSmart Sweden AB
City
Solna
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
ProbarE i Stockholm AB
City
Stockholm
ZIP/Postal Code
113 29
Country
Sweden
Facility Name
Studieenheten Akademiskt Specialistcentrum Stockholm
City
Stockholm
ZIP/Postal Code
11361
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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