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Phase 2 N=669 Randomized Quadruple-blind Prevention

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

Healthy

Enrolled (actual)
669
Serious AEs
11.1%
Results posted
Sep 2023
Primary outcome: Primary: Cohort 1: Number of Participants With Serious Adverse Events (SAEs) — 3; 0; 0; 2 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Placebo (Biological); RSV preF Protein 50 mcg (Biological); RSV preF Protein 150 mcg (Biological); Ad26.RSV.preF 1*10^11 vp (Biological); Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg (Biological); Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg (Biological); Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg (Biological); Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg (Biological); Selected Regimen (Biological)
Age
Adult, Older Adult · 60+ yrs
Sex
All
Sponsor
Janssen Vaccines & Prevention B.V.
Primary completion
May 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
3; 0; 0; 2; 3; 0
PRIMARY
Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs)
0; 5; 5; 7; 3; 4
PRIMARY
Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs)
4; 5
PRIMARY
Cohort 3: Number of Participants With Serious Adverse Events (SAEs)
14; 16; 3
PRIMARY
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
3; 2; 4; 0; 5; 6
PRIMARY
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
5; 1; 3; 2; 3; 7
PRIMARY
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
1; 0; 3; 2; 4; 5
PRIMARY
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
14; 24; 26; 29; 25; 20
PRIMARY
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
1; 0; 3; 3; 3; 2
PRIMARY
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
95; 94; 9; 95; 88; 12
PRIMARY
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
74; 23; 6; 56; 38; 10
PRIMARY
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
42; 48; 4; 32; 46; 6
PRIMARY
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
2; 5; 0; 1; 3; 4
PRIMARY
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
2; 1; 2; 0; 2; 4
PRIMARY
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
1; 0; 0; 1; 0; 1
PRIMARY
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
8; 11; 10; 12; 8; 10
PRIMARY
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
6; 5; 5; 6; 2; 3
PRIMARY
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
32; 23; 7
PRIMARY
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
9; 10; 4
PRIMARY
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
8; 8; 2
PRIMARY
Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29
1642; 2869; 4813; 5189; 4855
SECONDARY
Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints
553; 600; 917; 434; 457; 577
SECONDARY
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints
546; 552; 582; 6739; 4982; 525
SECONDARY
Cohort 2 (Group 16): RSV A2 Strain Neutralization Antibody Titers on Day 29
6053
SECONDARY
Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85
4616
SECONDARY
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
245; 263; 360; 215; 274; 301
SECONDARY
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
436; 354; 278; 274; 318; 314
SECONDARY
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
222; 206; 316; 197; 210; 239
SECONDARY
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
270; 260; 228; 202; 237; 246
SECONDARY
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
48; 39; 16; 26; 71; 34
SECONDARY
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
56; 73; 39; 515; 566; 17
SECONDARY
Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29
320; 354; 315; 290; 390; 298
SECONDARY
Cohort 2 (Group 17): Breadth of IFN-gamma T-Cells Responses Analyzed by ELISpot Assay on Day 85
495

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03502707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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