Clinical trial NCT04453202: A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels of an Ad26.RSV.preF-based Vaccine in Adults Aged 60 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2020-07-01
Enrollment: 459
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).


Eligibility criteria: 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 medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)
* A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
* Agree to not donate blood from the time of vaccination until 3 months after vaccination
* Have a body mass index (BMI) less than (\<) 40 kilogram per meter square (kg/m\^2)
* Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study

Exclusion Criteria:

* Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)
* Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
* History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis
* Has hepatitis B or C infection, including history of treated hepatitis C infection
* Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization

Primary outcomes:
measure: 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
timeFrame: 14 days after vaccination on Day 1 (Day 15)
measure: Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
timeFrame: Until 7 days after Vaccination on Day 1 (Day 8)
measure: Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
timeFrame: Until 7 days after Vaccination on Day 1 (Day 8)
measure: Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
timeFrame: Until 28 days after Vaccination on Day 1 (Day 29)
Secondary outcomes:
measure: Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1
timeFrame: At 3 and 6 months after vaccination on Day 1
measure: Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
timeFrame: At 14 days and 3 and 6 months after vaccination on Day 1
measure: Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides
timeFrame: At 14 days and 3 and 6 months after vaccination on Day 1
measure: Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Baseline (Day1) up to 6 months
measure: Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
timeFrame: Until 7 days after vaccination on Day 1 (Day 8)
measure: Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
timeFrame: Until 7 days after vaccination on Day 1 (Day 8)
measure: Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
timeFrame: Until 28 days after vaccination on Day 1 (Day 29)
measure: Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1
timeFrame: At 14 days and 3 and 6 months after vaccination on Day 1
measure: Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
timeFrame: At 14 days and 3 and 6 months after vaccination on Day 1
measure: Cohort 2 and 3: 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
timeFrame: At 14 days and 3 and 6 months after vaccination on Day 1
measure: Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Baseline (Day1 ) up to 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Optimal Research
state: California
city: Coral Gables
country: United States
facility: Clinical Research of South Florida, an AMR Company
state: Florida
city: El Dorado
country: United States
facility: Heartland Research Associates, an AMR Company
state: Kansas
city: Rockville
country: United States
facility: Optimal Research
state: Maryland
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research (CPR)
state: Missouri
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research - Omaha
state: Nebraska
city: Yukon
country: United States
facility: Tekton Research Inc.
state: Oklahoma
city: Knoxville
country: United States
facility: AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
state: Tennessee
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: