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
NCT ID: NCT03502707
Last Updated: 2025-05-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
669 participants
INTERVENTIONAL
2018-07-06
2022-05-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Cohort (C)1 Group (G)1: Placebo for RSV preF Protein
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
C1 G2: RSV preF Protein
Participants will receive intramuscular injection of 50 microgram (mcg) RSV preF protein on Day 1, Day 57 and at Month 12.
RSV preF Protein 50 mcg
RSV preF will be administered as a solution for intramuscular injection at a dose of 50 mcg.
C1 G3: Placebo for Ad26.RSV.preF/RSV preF or RSV preF Protein
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
C1 G4: Mixture of Ad26.RSV.preF/RSV preF Protein
Participants will receive intramuscular injection of a mixture of 5\*10\^10 viral particles (vp) of Ad26.RSV.preF/RSV preF 50 mcg protein on Day 1, Day 57 and at Month 12.
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
C1 G5: RSV preF Protein
Participants will receive intramuscular injection of 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12.
RSV preF Protein 150 mcg
RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.
C1 G6: Mixture of Placebo for Ad26.RSV.preF/RSV preF Protein
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
C1 G7: Mixture of Ad26.RSV.preF/RSV preF Protein
Participants will receive intramuscular injection of a mixture of 5\*10\^10 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12.
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
C1 G8: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein
Participants will receive intramuscular injection of placebo on Day 1 and at Month 12 and in only 1 arm on Day 57.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 1\*10\^11 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and at Month 12 and placebo in another arm on Day 1 and at Month 12.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo
Participants will receive separate intramuscular injections of 1\*10\^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and at Month 12 and placebo in 1 arm on Day 57.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
RSV preF Protein 150 mcg
RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.
Ad26.RSV.preF 1*10^11 vp
Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1\*10\^11 vp.
C2 G11: Ad26.RSV.preF and Placebo
Participants will receive intramuscular injection of 1\*10\^11 vp of Ad26.RSV.preF in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Ad26.RSV.preF 1*10^11 vp
Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1\*10\^11 vp.
C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 5\*10\^10 vp Ad26.RSV.preF plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 1\*10\^11 vp Ad26.RSV.preF plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg
Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 1\*10\^11 vp Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 5\*10\^10 vp Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
Data from C1 G10 will be pooled with those of C2 G16. Participants will receive separate intramuscular injections of 1\*10\^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and placebo in 1 arm on Day 57.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
RSV preF Protein 150 mcg
RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.
Ad26.RSV.preF 1*10^11 vp
Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1\*10\^11 vp.
C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Data from C1 G9 will be pooled with those of C2 G17. Participants will receive intramuscular injection of a mixture of 1\*10\^11 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and placebo in another arm on Day 1.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
C2 G18: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein
Participants will receive intramuscular injection of placebo in separate arms on Day 1 and in only 1 arm on Day 57.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
C3 G19: Selected Regimen (SR)
If a one-dose regimen is selected, participants in this group will receive SR on Day 1 and a booster (the SR) at Month 12 and month 24. The participants who are randomized to two-dose regimen will receive SR on Day 1 and Day 57, and a booster (the selected regimen) at Month 12.
Selected Regimen
A regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.
C3 G20: SR + Placebo for SR
If a one-dose regimen is selected, participants in this group will receive SR on Day 1 and Month 24, and a placebo at Month 12. The participants who are randomized to two-dose regimen will receive selected regimen on Day 1 and Day 57, and a placebo at Month 12.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Selected Regimen
A regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.
C3 G21: Placebo for SR
If a one-dose regimen is selected, participants in this group will receive placebo for SR on Day 1 and at Month 12 and Month 24. The participants who are randomized to two-dose regimen will receive placebo for SR on Day 1, Day 57, and Month 12.
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Interventions
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Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
RSV preF Protein 50 mcg
RSV preF will be administered as a solution for intramuscular injection at a dose of 50 mcg.
RSV preF Protein 150 mcg
RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.
Ad26.RSV.preF 1*10^11 vp
Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1\*10\^11 vp.
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg
Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
Selected Regimen
A regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
60 Years
ALL
Yes
Sponsors
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Janssen Vaccines & Prevention B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Vaccines & Prevention B.V. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Vaccines & Prevention B.V.
Locations
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Optimal Research
Huntsville, Alabama, United States
Optimal Research
San Diego, California, United States
Optimal Research
Melbourne, Florida, United States
Optimal Research
Peoria, Illinois, United States
Optimal Research
Rockville, Maryland, United States
Optimal Research
Austin, Texas, United States
Countries
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References
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Comeaux CA, Bart S, Bastian AR, Klyashtornyy V, De Paepe E, Omoruyi E, van der Fits L, van Heesbeen R, Heijnen E, Callendret B, Sadoff J. Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-Based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. J Infect Dis. 2024 Jan 12;229(1):19-29. doi: 10.1093/infdis/jiad220.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VAC18193RSV1004
Identifier Type: OTHER
Identifier Source: secondary_id
CR108456
Identifier Type: -
Identifier Source: org_study_id
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