NCT03982199 (CYPRESS) is a Phase 2 clinical trial of RSV Vaccine in Respiratory Syncytial Viruses, sponsored by Janssen Vaccines & Prevention B.V..

Who is sponsoring NCT03982199?

NCT03982199 is sponsored by Janssen Vaccines & Prevention B.V..

What drugs are being tested in NCT03982199?

Interventions in NCT03982199: RSV Vaccine, Placebo.

What condition does NCT03982199 study?

NCT03982199 studies Respiratory Syncytial Viruses, Respiratory Tract Diseases.

Is NCT03982199 still recruiting?

NCT03982199 is currently terminated. Last updated 25 May 2025.

Are results published for NCT03982199?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-05-25 · How we verify

NCT03982199: CYPRESS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older

Terminated Phase 2 Results posted Last updated 25 May 2025

What this trial tests

Phase 2 trial testing RSV Vaccine in Respiratory Syncytial Viruses in 5,815 participants. Terminated before completion.

Timeline

1 August 2019

Primary endpoint
6 June 2022

26 May 2023

Quick facts

Lead sponsor	Janssen Vaccines & Prevention B.V.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	5,815
Start date	1 August 2019
Primary completion	6 June 2022
Estimated completion	26 May 2023
Sites	40 locations across United States

Drugs / interventions tested

RSV Vaccine — full drug profile →
Placebo

Conditions studied

Respiratory Syncytial Viruses — all drugs for Respiratory Syncytial Viruses →
Respiratory Tract Diseases — all drugs for Respiratory Tract Diseases →

Sponsor

Janssen Vaccines & Prevention B.V. — full company profile →

Who can join

65 and older, any sex, with Respiratory Syncytial Viruses or Respiratory Tract Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD) Primary · From screening (Day 1) up to 9 months

Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to case definition-1, 2 and 3 were reported. Case definition 1 was defined as having a new onset or worsening in 3 or more symptoms of lower respiratory tract infection (LRTI) ; Case definition 2 was defined as having a new onset or worsening in greater than or equal to (\>=) 2 symptoms of LRTI; and Case definition 3 was defined as having a new onset or worsening in \>=2 OR \>=1 symptoms of LRTI with \>=1 systemic symptoms. Systemic symptoms (fatigue/malaise and fever/feverishness) and symptoms of LRTI

Case Definition-1

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	6
Arm 2: Main Cohort: Group 2: Placebo	30

Case Definition-2

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	10
Arm 2: Main Cohort: Group 2: Placebo	40

Case Definition-3

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	13
Arm 2: Main Cohort: Group 2: Placebo	43

Main Cohorts: Number of Participants With Any RT-PCR-confirmed RSV Disease Secondary · From screening (Day 1) up to 9 months

Number of participants with any RT-PCR-confirmed RSV disease were reported. The analysis was based on poisson regression model.

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	13
Arm 2: Main Cohort: Group 2: Placebo	43

Main Cohorts: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers Secondary · Days 15, 85, 169, 365

RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.

Day 15

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	6761	5478 – 8346
Arm 2: Main Cohort: Group 2: Placebo	516	443 – 602

Day 85

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	4963	4053 – 6077
Arm 2: Main Cohort: Group 2: Placebo	602	528 – 687

Day 169

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	3057	2523 – 3703
Arm 2: Main Cohort: Group 2: Placebo	552	489 – 623

Day 365

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	1546	1235 – 1936
Arm 2: Main Cohort: Group 2: Placebo	341	284 – 409

Revaccination Subcohorts: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers Secondary · Days 15, 365, 379, 393, 449, 730, 737, 744, 758

RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.

Day 15

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	5508	4695 – 6460
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	421	374 – 475
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	357	281 – 454
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	361	291 – 448
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	487	383 – 620

Day 365

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	1451	1275 – 1651
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	402	354 – 456
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	308	241 – 392
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	342	264 – 444
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	435	348 – 544

Day 379

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	2075	1779 – 2420
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	5416	4462 – 6573
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	4289	2739 – 6717
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	6117	4194 – 8922
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	5114	3161 – 8275

Day 393

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	2098	1760 – 2501
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	4821	3982 – 5836
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	4487	3200 – 6291
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	5008	3272 – 7664
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	4078	2524 – 6589

Day 449

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	2491	2183 – 2841
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	4136	3483 – 4912
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	3186	2290 – 4433
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	4194	3108 – 5659
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	3553	2557 – 4935

Day 730

Group	Value	95% CI
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	2260	1914 – 2669
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	1795	1319 – 2443
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	2486	1827 – 3382
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	2491	1859 – 3338

Day 737

Group	Value	95% CI
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	2073	1415 – 3036
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	2677	2125 – 3373
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	3116	2303 – 4215

Day 744

Group	Value	95% CI
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	2542	1721 – 3753
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	3115	2453 – 3954
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	3812	2772 – 5242

Revaccination Subcohorts: Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) A Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) Secondary · Day 15: Arms 3 to 7,13 and 14; Days 365, 379, 393, 449, 533: Arms 3 to 7; Day 730: Arms 4 to 7; Days 737, 744, 758: Arms 5 to 7; Day 1095, 1109: Arms 13 and 14

GMTs of preF-A antibodies after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported.

Day 15

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	4091	3540 – 4728
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	301	269 – 336
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	258	203 – 328
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	282	228 – 349
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	391	307 – 497
Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	4195	3685 – 4776
Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	279	238 – 326

Day 365

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	1003	901 – 1117
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	325	293 – 361
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	259	200 – 335
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	317	259 – 388
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	358	291 – 440

Day 379

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	1688	1487 – 1917
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	4402	3807 – 5089
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	3642	2582 – 5136
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	4827	3545 – 6572
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	4290	3069 – 5996

Day 393

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	1757	1549 – 1994
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	3793	3265 – 4405
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	3408	2578 – 4505
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	4341	3072 – 6134
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	3541	2473 – 5070

Day 449

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	1534	1376 – 1710
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	2513	2172 – 2908
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	2227	1671 – 2968
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	2999	2254 – 3991
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	2129	1509 – 3002

Day 533

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	1430	1287 – 1590
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	1818	1585 – 2086
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	1605	1132 – 2275
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	1835	1429 – 2358
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	1783	1350 – 2355

Day 730

Group	Value	95% CI
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	1270	1112 – 1451
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	992	767 – 1283
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	1467	1182 – 1822
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	1379	1099 – 1732

Day 737

Group	Value	95% CI
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	1138	850 – 1524
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	1779	1510 – 2096
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	1674	1348 – 2077

Revaccination Subcohort 2A: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot) Secondary · Days 730, 744, 758

T-cell IFN gamma responses to RSV F protein specific peptides as measured by ELISpot assay were reported. RSV F protein specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\^6 PBMCs).

Day 730

Group	Value	95% CI
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	129	34 – 320
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	198	34 – 1035
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	168	34 – 795

Day 744

Group	Value	95% CI
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	402	105 – 1420
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	498	130 – 2269
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	405	34 – 3104

Day 758

Group	Value	95% CI
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	278	84 – 443
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	484	196 – 1375
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	277	34 – 1253

Main Cohorts: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot) Secondary · Days 15, 85, 169, 365, 533

Day 15

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	444	279 – 641
Arm 2: Main Cohort: Group 2: Placebo	34	34 – 34

Day 85

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	274	173 – 471
Arm 2: Main Cohort: Group 2: Placebo	34	34 – 34

Day 169

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	201	123 – 324
Arm 2: Main Cohort: Group 2: Placebo	34	34 – 34

Day 365

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	182	110 – 297
Arm 2: Main Cohort: Group 2: Placebo	34	34 – 34

Day 533

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	143	96 – 238
Arm 2: Main Cohort: Group 2: Placebo	34	34 – 74

Main Cohorts: Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After First Vaccination Secondary · Up to Day 8 (7 days after first vaccination on Day 1)

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness. Per protocol, all solicited local AEs were considered as related to intervention.

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	132
Arm 2: Main Cohort: Group 2: Placebo	29

Main Cohorts: Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination Secondary · Up to Day 8 (7 days after first vaccination on Day 1)

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs included fatigue, headache, myalgia, arthralgia, and fever (defined as an endogenous elevation of body temperature \>=38.0°C, as recorded in at least one measurement).

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	143
Arm 2: Main Cohort: Group 2: Placebo	58

Main Cohorts: Number of Participants With Unsolicited AEs up to 28 Days After First Vaccination Secondary · Up to Day 29 (28 days after first vaccination on Day 1)

Group	Value	95% CI
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)	58
Arm 2: Main Cohort: Group 2: Placebo	50

Revaccination Subcohorts: Number of Participants With Solicited Local AEs 7 Days After Re-vaccination up to 1, 2 and 3 Years Secondary · Arms 3,4: 7 days after revacc at 1 year (up to Day 372); Arm 5,6,7,8,9: 7 days after revacc at 2 years (up to Day 737); Arms 10,11,12,13,14: 7 days after revacc at 3 year (up to Day 1102)

Number of participants with solicited local AEs 7 days after re-vaccination at 1, 2 and 3 years were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness. Per protocol, all solicited local

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	37
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	31
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	9
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	18
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	12
Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	97
Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	81
Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF	26
Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	17
Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	29
Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	93
Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	64

Revaccination Subcohorts: Number of Participants With Solicited Systemic AEs 7 Days After Re-vaccination up to 1, 2 and 3 Years Secondary · Arms 3,4: 7 days after revacc at 1 year (up to Day 372); Arm 5,6,7,8,9: 7 days after revacc at 2 years (up to Day 737); Arms 10,11,12,13,14: 7 days after revacc at 3 year (up to Day 1102)

Number of participants with solicited systemic AEs 7 days after re-vaccination up to 1, 2 and 3 years were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs included fatigue, headache, myalgia, arthralgia, and fever (defined as an endogenous elevation of body temperature \>=38.0°C, as recorded in at least one measurement).

Group	Value	95% CI
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	35
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture	36
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone	7
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	15
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	10
Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	79
Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	85
Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF	16
Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone	12
Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	25
Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	80
Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)	70

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality: Day 1 to Day 1095 (Arms 1, 2); Day 365 to Day 730 (Arms 3, 4); Day 730 to Day 1095 (Arms 5 to 9); Day 1095 to Day 1460 (Arms 10 to 14); Serious/other AEs: Day 1 to Day 1095 (Arms 1, 2), 6 months after revacc at Day 365 (Arms 3, 4): up to Day 547, 6 months after revacc at Day 730 (Arms 5 to 9): up to Day 912, 6 months after revacc at Day 1095 (Arms 10 to 14): up to Day 1277. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)

Serious: 203/2891 (7%)

Deaths: 39/2891

Arm 2: Main Cohort: Group 2: Placebo

Serious: 196/2891 (7%)

Deaths: 38/2891

Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)

Serious: 2/120 (2%)

Deaths: 1/120

Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture

Serious: 6/126 (5%)

Deaths: 0/126

Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone

Serious: 0/28 (0%)

Deaths: 0/28

Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone

Serious: 3/28 (11%)

Deaths: 0/28

Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)

Serious: 1/28 (4%)

Deaths: 0/28

Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)

Serious: 4/137 (3%)

Deaths: 0/137

Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)

Serious: 6/149 (4%)

Deaths: 2/149

Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF

Serious: 2/37 (5%)

Deaths: 0/37

Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone

Serious: 0/37 (0%)

Deaths: 0/37

Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)

Serious: 0/37 (0%)

Deaths: 0/37

Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)

Serious: 2/131 (2%)

Deaths: 0/131

Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)

Serious: 2/119 (2%)

Deaths: 1/119

Serious adverse events (248 terms)

Reaction	System	Arm 1: Main Cohort: Group …	Arm 2: Main Cohort: Group …	Arm 3: Revaccination (ReVa…	Arm 4: ReVacc Subcohort 2A…	Arm 5: ReVacc Subcohort 2A…	Arm 6: ReVacc Subcohort 2A…	Arm 7: ReVacc Subcohort 2A…	Arm 8: ReVacc Subcohort 1B…	Arm 9: ReVacc Subcohort 2B…	Arm 10: ReVacc Subcohort 2…	Arm 11: ReVacc Subcohort 2…	Arm 12: ReVacc Subcohort 2…	Arm 13: ReVacc Subcohort 1…	Arm 14: ReVacc Subcohort 2…
Covid-19 Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Covid-19	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrial Fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardiac Failure Congestive	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myocardial Infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Death	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Coronary Artery Disease	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Transient Ischaemic Attack	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardiac Arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Intestinal Obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chest Pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hip Fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Subdural Haematoma	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Intraductal Proliferative Breast Lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ischaemic Stroke	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (50 terms — click to expand)

Reaction	System	Arm 1: Main Cohort: Group …	Arm 2: Main Cohort: Group …	Arm 3: Revaccination (ReVa…	Arm 4: ReVacc Subcohort 2A…	Arm 5: ReVacc Subcohort 2A…	Arm 6: ReVacc Subcohort 2A…	Arm 7: ReVacc Subcohort 2A…	Arm 8: ReVacc Subcohort 1B…	Arm 9: ReVacc Subcohort 2B…	Arm 10: ReVacc Subcohort 2…	Arm 11: ReVacc Subcohort 2…	Arm 12: ReVacc Subcohort 2…	Arm 13: ReVacc Subcohort 1…	Arm 14: ReVacc Subcohort 2…
Vaccination Site Pain (Solicited)	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue (Solicited)	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia (Solicited)	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache (Solicited)	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea (Solicited)	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vaccination Site Erythema (Solicited)	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vaccination Site Swelling (Solicited)	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia (Solicited)	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Angina Pectoris	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Covid-19	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Iron Deficiency Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Aortic Valve Incompetence	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrial Fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrial Flutter	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Mitral Valve Incompetence	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tricuspid Valve Incompetence	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dental Caries	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Plicated Tongue	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema Peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Candida Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oral Candidiasis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tooth Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thermal Burn	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper Limb Fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Heart Rate Irregular	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Covid-19 Pneumonia, Pneumonia, Covid-19, Atrial Fibrillation, Chronic Obstructive Pulmonary Disease, Cardiac Failure Congestive, Myocardial Infarction, Death.

Data from ClinicalTrials.gov NCT03982199 adverse events section.

Sponsor's own description

The purpose of this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory tract disease (LRTD), when compared to placebo.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Respiratory syncytial virus prevention within reach: the vaccine and monoclonal antibody landscape.
Mazur NI, Terstappen J, Baral R, Bardají A, et al · · 2023 · cited 294× · PMID 35952703 · DOI 10.1016/s1473-3099(22)00291-2
Efficacy and Safety of an Ad26.RSV.preF-RSV preF Protein Vaccine in Older Adults.
Falsey AR, Williams K, Gymnopoulou E, Bart S, et al · · 2023 · cited 110× · PMID 36791161 · DOI 10.1056/nejmoa2207566
The Future of Respiratory Syncytial Virus Disease Prevention and Treatment.
Domachowske JB, Anderson EJ, Goldstein M. · · 2021 · cited 90× · PMID 33656652 · DOI 10.1007/s40121-020-00383-6
Respiratory syncytial virus: from pathogenesis to potential therapeutic strategies.
Shang Z, Tan S, Ma D. · · 2021 · cited 74× · PMID 34671221 · DOI 10.7150/ijbs.64762
The road to approved vaccines for respiratory syncytial virus.
Ruckwardt TJ. · · 2023 · cited 60× · PMID 37749081 · DOI 10.1038/s41541-023-00734-7
Current State and Challenges in Developing Respiratory Syncytial Virus Vaccines.
Biagi C, Dondi A, Scarpini S, Rocca A, et al · · 2020 · cited 45× · PMID 33187337 · DOI 10.3390/vaccines8040672
Adenovector 26 encoded prefusion conformation stabilized RSV-F protein induces long-lasting Th1-biased immunity in neonatal mice.
van der Fits L, Bolder R, Heemskerk-van der Meer M, Drijver J, et al · · 2020 · cited 33× · PMID 32566260 · DOI 10.1038/s41541-020-0200-y
Current Insights in the Development of Efficacious Vaccines Against RSV.
Soto JA, Stephens LM, Waldstein KA, Canedo-Marroquín G, et al · · 2020 · cited 28× · PMID 32765520 · DOI 10.3389/fimmu.2020.01507

Verify or expand the search:

Other trials of RSV Vaccine

Trials testing the same drug.

NCT06521944 — RSV Vaccine Pregnancy Registry · recruiting
NCT04453202 — A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults · Phase 2 · completed
NCT04354480 — A Study to Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncy · Phase 1 · completed
NCT04071158 — A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARS · Phase 2 · completed

Other recruiting trials for Respiratory Syncytial Viruses

Currently open trials in the same condition.

NCT06813872 — Effectiveness of ABRYSVO® Maternal Respiratory Syncytial Virus (RSV) Vaccine Against RSV in Infants in Western Pennsylva · active not recruiting
NCT06077968 — A Study to Learn About ABRYSVO Vaccine in Older Adults to Prevent Severe Respiratory Syncytial Virus (RSV) Disease · active not recruiting

Other Janssen Vaccines & Prevention B.V. trials

Trials by the same sponsor.

NCT05901636 — A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults · Phase 1, PHASE2 · completed
NCT05327816 — A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Year · Phase 1, PHASE2 · terminated
NCT05091307 — A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults · Phase 3 · completed
NCT05101486 — A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years · Phase 3 · completed
NCT05083585 — A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Ag · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03982199 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Vaccines & Prevention B.V.
Last refreshed: 25 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03982199.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03982199: CYPRESS

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (248 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of RSV Vaccine

Other recruiting trials for Respiratory Syncytial Viruses

Other Janssen Vaccines & Prevention B.V. trials

Verify against primary sources