Clinical trial NCT03502707: A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
Official title: A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2018-04-19
Enrollment: 669
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 for:

Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3.

Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing antibody levels of the regimens containing RSV pre-fusion (preF) protein compared to the one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF) regimen.

Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.


Eligibility criteria: Inclusion Criteria:

* Before randomization, a woman must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
* In the investigator's clinical judgment, participant 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 symptoms and signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
* For participants in Cohorts 1 and 2 only: Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the United States (US) Food and Drug Administration (FDA) toxicity, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* From the time of each vaccination through 3 months after each vaccination, participant agrees not to donate blood
* Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

Exclusion Criteria:

* Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
* Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
* Participant has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
* Participant has a 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)
* Participant has received respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study at any time prior to randomization

Primary outcomes:
measure: Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 730
measure: Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 730
measure: Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 1095
measure: Cohort 3: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 1095
measure: Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
timeFrame: 7 days post-vaccination 1 on Day 1 (Day 8)
measure: Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
timeFrame: 7 days post-vaccination 2 on Day 57 (Day 64)
measure: Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
timeFrame: 7 days post-vaccination 3 on Day 365 (Day 372)
measure: Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
timeFrame: 7 days post-vaccination 1 on Day 1 (Day 8)
measure: Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
timeFrame: 7 days post-vaccination 2 on Day 57 (Day 64)
measure: Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
timeFrame: 7 days post-vaccination 1 on Day 1 (Day 8)
measure: Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
timeFrame: 7 days post-vaccination 2 on Day 365 (Day 372)
measure: Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
timeFrame: 7 days post-vaccination 3 on Day 730 (Day 737)
measure: Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
timeFrame: 28 days post-vaccination 1 on Day 1 (Day 29)
measure: Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
timeFrame: 28 days post-vaccination 2 on Day 57 (Day 85)
measure: Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
timeFrame: 28 days post-vaccination 3 on Day 365 (Day 393)
measure: Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
timeFrame: 28 days post-vaccination 1 on Day 1 (Day 29)
measure: Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
timeFrame: 28 days post-vaccination 2 on Day 57 (Day 85)
measure: Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
timeFrame: 28 days post-vaccination 1 on Day 1 (Day 29)
measure: Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
timeFrame: 28 days post-vaccination 2 on Day 365 (Day 393)
measure: Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
timeFrame: 28 days post-vaccination 3 on Day 730 (Day 758)
measure: Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29
timeFrame: Day 29
Secondary outcomes:
measure: Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints
timeFrame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
measure: Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints
timeFrame: Days 1, 15, 29, 57, 85, 183, 365, 393, 547, 730, 744, 758
measure: Cohort 2 (Group 16): RSV A2 Strain Neutralization Antibody Titers on Day 29
timeFrame: Day 29
measure: Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85
timeFrame: Day 85
measure: Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
timeFrame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
measure: Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
timeFrame: Days 1, 15, 29, 57, 85, 183, 365, and 547
measure: Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
timeFrame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
measure: Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
timeFrame: Days 1, 15, 29, 57, 85, 183, 365, and 547
measure: Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
timeFrame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
measure: Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
timeFrame: Days 1, 15, 29, 57, 85, 183, 365, 393, 730, 744, and 758
measure: Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29
timeFrame: Day 29
measure: Cohort 2 (Group 17): Breadth of IFN-gamma T-Cells Responses Analyzed by ELISpot Assay on Day 85
timeFrame: Day 85
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Optimal Research
state: Alabama
city: San Diego
country: United States
facility: Optimal Research
state: California
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Rockville
country: United States
facility: Optimal Research
state: Maryland
city: Austin
country: United States
facility: Optimal Research
state: Texas
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: