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NCT03606512

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age

Completed Phase 1, PHASE2 Results posted Last updated 4 February 2025
What this trial tests

Phase 1, PHASE2 trial testing Ad26.RSV.preF in Respiratory Syncytial Virus in 38 participants. Completed in 2 November 2021.

Timeline
21 January 2019
Primary endpoint
2 November 2021
2 November 2021

Quick facts

Lead sponsorJanssen Vaccines & Prevention B.V.
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment38
Start date21 January 2019
Primary completion2 November 2021
Estimated completion2 November 2021
Sites25 locations across Finland, Sweden, United Kingdom, Poland, Canada, Australia, Spain, Brazil

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

Adults 12 Months to 24 Months, any sex, with Respiratory Syncytial Virus. 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 Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination Primary · Up to Day 8 (7 days after first vaccination on Day 1)

An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.

Solicited Local AEs
GroupValue95% CI
Placebo/Nimenrix2
Ad26.RSV.preF6
Solicited Systemic AEs
GroupValue95% CI
Placebo/Nimenrix11
Ad26.RSV.preF17
Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination Primary · Up to Day 36 (7 days after second vaccination on Day 29)

An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.

Solicited Local AEs
GroupValue95% CI
Placebo/Nimenrix1
Ad26.RSV.preF9
Solicited Systemic AEs
GroupValue95% CI
Placebo/Nimenrix9
Ad26.RSV.preF11
Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination Primary · Up to Day 64 (7 days after third vaccination on Day 57)

An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.

Solicited Local AEs
GroupValue95% CI
Placebo1
Nimenrix4
Ad26.RSV.preF7
Solicited Systemic AEs
GroupValue95% CI
Placebo3
Nimenrix4
Ad26.RSV.preF12
Number of Participants With Unsolicited AEs for 28 Days After First Vaccination Primary · Up to Day 29 (28 days after first vaccination on Day 1)

An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.

GroupValue95% CI
Placebo/Nimenrix5
Ad26.RSV.preF9
Number of Participants With Unsolicited AEs for 28 Days After Second Vaccination Primary · Up to Day 57 (28 days after second vaccination on Day 29)

An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.

GroupValue95% CI
Placebo/Nimenrix7
Ad26.RSV.preF9
Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination Primary · Up to Day 85 (28 days after third vaccination on Day 57)

An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.

GroupValue95% CI
Ad26.RSV.preF7
Placebo3
Nimenrix3
Number of Participants With Serious Adverse Events (SAEs) Primary · Up to 2 year 10 months

Number of participants with SAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a suspected transmission of any infectious agent via a medicinal product, is a congenital anomaly/birth defect and may

GroupValue95% CI
Ad26.RSV.preF1
Placebo0
Nimenrix0
Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain Secondary · Days 1, 8, 85, and 267 (End of first RSV season)

Neutralizing antibody titers assessed by virus neutralizing antibodies (VNA) against the RSV A2 strain were expressed as 50% inhibitory concentration (IC50) units.

Day 1
GroupValue95% CI
Placebo/NimenrixNANA – NA
Ad26.RSV.preFNANA – NA
Day 8
GroupValue95% CI
Placebo/NimenrixNANA – NA
Ad26.RSV.preFNANA – 52
Day 85
GroupValue95% CI
Placebo/NimenrixNANA – 45
Ad26.RSV.preF293240 – 358
Day 267 (End of first RSV season)
GroupValue95% CI
Placebo/NimenrixNANA – 46
Ad26.RSV.preF269115 – 632
Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) Secondary · Days 1, 8, 85, and 267 (End of first RSV season)

Pre-fusion A IgG serum antibody response was assessed by ELISA.

Day 1
GroupValue95% CI
Placebo/NimenrixNANA – NA
Ad26.RSV.preFNANA – NA
Day 8
GroupValue95% CI
Placebo/NimenrixNANA – NA
Ad26.RSV.preFNANA – NA
Day 85
GroupValue95% CI
Placebo/NimenrixNANA – NA
Ad26.RSV.preF236187 – 299
Day 267 (End of first RSV season)
GroupValue95% CI
Placebo/NimenrixNANA – 27
Ad26.RSV.preF21279 – 571
Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA Secondary · Days 1, 8, 85, and 267 (End of first RSV season)

Post-fusion A IgG serum antibody response as assessed by ELISA was reported.

Day 1
GroupValue95% CI
Placebo/NimenrixNANA – NA
Ad26.RSV.preFNANA – NA
Day 8
GroupValue95% CI
Placebo/NimenrixNANA – NA
Ad26.RSV.preFNANA – NA
Day 85
GroupValue95% CI
Placebo/NimenrixNANA – NA
Ad26.RSV.preF4740 – 54
Day 267 (End of first RSV season)
GroupValue95% CI
Placebo/NimenrixNANA – 30
Ad26.RSV.preF5822 – 153
Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI) Secondary · Up to 2 year 10 months

Number of participants with severe RSV-LRTI were reported.

GroupValue95% CI
Placebo/Nimenrix0
Ad26.RSV.preF0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 year 10 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 0/6 (0%)
Deaths: 0/6
Nimenrix
Serious: 0/12 (0%)
Deaths: 0/12
Ad26.RSV.preF
Serious: 1/20 (5%)
Deaths: 0/20

Serious adverse events (1 terms)

ReactionSystemPlaceboNimenrixAd26.RSV.preF
Sleep Apnoea SyndromeRespiratory, thoracic and mediastinal disorders———
Other adverse events (41 terms — click to expand)

ReactionSystemPlaceboNimenrixAd26.RSV.preF
Respiratory Tract InfectionInfections and infestations———
TeethingGastrointestinal disorders———
Upper Respiratory Tract InfectionInfections and infestations———
Otitis MediaInfections and infestations———
Croup InfectiousInfections and infestations———
NasopharyngitisInfections and infestations———
Viral Upper Respiratory Tract InfectionInfections and infestations———
UrticariaSkin and subcutaneous tissue disorders———
Middle Ear EffusionEar and labyrinth disorders———
Abdominal PainGastrointestinal disorders———
DiarrhoeaGastrointestinal disorders———
StomatitisGastrointestinal disorders———
Injection Site BruisingGeneral disorders———
PyrexiaGeneral disorders———
TendernessGeneral disorders———
Allergy to Arthropod BiteImmune system disorders———
ConjunctivitisInfections and infestations———
Exanthema SubitumInfections and infestations———
Hand-Foot-And-Mouth DiseaseInfections and infestations———
Oral Viral InfectionInfections and infestations———
Otitis Media AcuteInfections and infestations———
PharyngitisInfections and infestations———
RhinitisInfections and infestations———
Rhinovirus InfectionInfections and infestations———
Viral InfectionInfections and infestations———
Arthropod BiteInjury, poisoning and procedural complications———
ContusionInjury, poisoning and procedural complications———
InjuryInjury, poisoning and procedural complications———
Skin AbrasionInjury, poisoning and procedural complications———
Skin LacerationInjury, poisoning and procedural complications———
Thermal BurnInjury, poisoning and procedural complications———
DroolingNervous system disorders———
IrritabilityPsychiatric disorders———
CoughRespiratory, thoracic and mediastinal disorders———
Nasal CongestionRespiratory, thoracic and mediastinal disorders———
RhinorrhoeaRespiratory, thoracic and mediastinal disorders———
Sleep Apnoea SyndromeRespiratory, thoracic and mediastinal disorders———
Dermatitis DiaperSkin and subcutaneous tissue disorders———
Dry SkinSkin and subcutaneous tissue disorders———
MiliariaSkin and subcutaneous tissue disorders———

Most-reported serious reactions: Sleep Apnoea Syndrome.

Data from ClinicalTrials.gov NCT03606512 adverse events section.

Sponsor's own description

The purpose of this study is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5\*10\^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months.

Publications & conference data

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

  1. 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
  2. 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
  3. Respiratory Syncytial Virus Vaccines: A Review of the Candidates and the Approved Vaccines.
    Topalidou X, Kalergis AM, Papazisis G. · · 2023 · cited 84× · PMID 37887775 · DOI 10.3390/pathogens12101259
  4. 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
  5. 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
  6. 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
  7. Adenoviral vector-based platforms for developing effective vaccines to combat respiratory viral infections.
    Elkashif A, Alhashimi M, Sayedahmed EE, Sambhara S, et al · · 2021 · cited 27× · PMID 34667600 · DOI 10.1002/cti2.1345
  8. Adenovectors encoding RSV-F protein induce durable and mucosal immunity in macaques after two intramuscular administrations.
    Salisch NC, Izquierdo Gil A, Czapska-Casey DN, Vorthoren L, et al · · 2019 · cited 27× · PMID 31885877 · DOI 10.1038/s41541-019-0150-4

Verify or expand the search:

Other trials of Ad26.RSV.preF

Trials testing the same drug.

Other recruiting trials for Respiratory Syncytial Virus

Currently open trials in the same condition.

Other Janssen Vaccines & Prevention B.V. trials

Trials by the same sponsor.

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Data sources for this page

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/NCT03606512.

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