ClinicalTrials.Veeva

Menu

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

Janssen (J&J Innovative Medicine) logo

Janssen (J&J Innovative Medicine)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Healthy

Treatments

Biological: RSV preF Protein 150 mcg
Biological: Placebo
Biological: RSV preF Protein 50 mcg
Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
Biological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg
Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
Biological: Ad26.RSV.preF 1*10^11 vp
Biological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
Biological: Selected Regimen

Study type

Interventional

Funder types

Industry

Identifiers

NCT03502707
CR108456
VAC18193RSV1004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

669 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

669 participants in 21 patient groups, including a placebo group

Cohort (C)1 Group (G)1: Placebo for RSV preF Protein
Placebo Comparator group
Description:
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
Treatment:
Biological: Placebo
C1 G2: RSV preF Protein
Experimental group
Description:
Participants will receive intramuscular injection of 50 microgram (mcg) RSV preF protein on Day 1, Day 57 and at Month 12.
Treatment:
Biological: RSV preF Protein 50 mcg
C1 G3: Placebo for Ad26.RSV.preF/RSV preF or RSV preF Protein
Placebo Comparator group
Description:
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
Treatment:
Biological: Placebo
C1 G4: Mixture of Ad26.RSV.preF/RSV preF Protein
Experimental group
Description:
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.
Treatment:
Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
C1 G5: RSV preF Protein
Experimental group
Description:
Participants will receive intramuscular injection of 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12.
Treatment:
Biological: RSV preF Protein 150 mcg
C1 G6: Mixture of Placebo for Ad26.RSV.preF/RSV preF Protein
Placebo Comparator group
Description:
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
Treatment:
Biological: Placebo
C1 G7: Mixture of Ad26.RSV.preF/RSV preF Protein
Experimental group
Description:
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.
Treatment:
Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
C1 G8: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein
Placebo Comparator group
Description:
Participants will receive intramuscular injection of placebo on Day 1 and at Month 12 and in only 1 arm on Day 57.
Treatment:
Biological: Placebo
C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Experimental group
Description:
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.
Treatment:
Biological: Placebo
Biological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo
Experimental group
Description:
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.
Treatment:
Biological: Placebo
Biological: Ad26.RSV.preF 1*10^11 vp
Biological: RSV preF Protein 150 mcg
C2 G11: Ad26.RSV.preF and Placebo
Experimental group
Description:
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.
Treatment:
Biological: Placebo
Biological: Ad26.RSV.preF 1*10^11 vp
C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Experimental group
Description:
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.
Treatment:
Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
Biological: Placebo
C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Experimental group
Description:
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.
Treatment:
Biological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg
Biological: Placebo
C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Experimental group
Description:
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.
Treatment:
Biological: Placebo
Biological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Experimental group
Description:
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.
Treatment:
Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
Biological: Placebo
C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
Experimental group
Description:
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.
Treatment:
Biological: Placebo
Biological: Ad26.RSV.preF 1*10^11 vp
Biological: RSV preF Protein 150 mcg
C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Experimental group
Description:
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.
Treatment:
Biological: Placebo
Biological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
C2 G18: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein
Placebo Comparator group
Description:
Participants will receive intramuscular injection of placebo in separate arms on Day 1 and in only 1 arm on Day 57.
Treatment:
Biological: Placebo
C3 G19: Selected Regimen (SR)
Experimental group
Description:
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.
Treatment:
Biological: Selected Regimen
C3 G20: SR + Placebo for SR
Experimental group
Description:
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.
Treatment:
Biological: Placebo
Biological: Selected Regimen
C3 G21: Placebo for SR
Placebo Comparator group
Description:
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.
Treatment:
Biological: Placebo

Trial documents
2

Trial contacts and locations

6

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems