Phase 2
N=63
An Exploratory Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-old Adults
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03334695 ↗Enrolled (actual)
63
Serious AEs
0.9%
Results posted
Jul 2021
Primary outcome: Primary: Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) — 0; 236 log10 copies*hour per millilitre (h/mL) — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ad26.RSV.preF (Biological); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Vaccines & Prevention B.V.
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) |
0; 236 | 0.012 sig |
| SECONDARY Peak Viral Load of RSV-A Memphis 37b |
0.000; 5.365 | — |
| SECONDARY Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 |
0.821; 2.898; 1.261; 2.939; 1.761; 3.072 | — |
| SECONDARY VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 |
0.278; 1.587; 0.304; 1.737; 0.101; 1.226 | — |
| SECONDARY Percentage of Participants With Symptomatic RSV Infections |
22.2; 46.2; 33.3; 61.5 | — |
| SECONDARY Total Clinical Symptoms Score at Day 6 and 7 |
0.6; 2.6; 0.4; 2.8; 0.5; 2.5 | — |
| SECONDARY Weight of Mucus Secretions Over Time |
0.586; 0.175; 0.228; 0.086; 0.997; 0.428 | — |
| SECONDARY Number of Tissues Used Over Time |
1.8; 0.7; 1.7; 0.7; 2.9; 1.2 | — |
| SECONDARY Percentage of Participants With Unsolicited Adverse Events (AEs) |
35.5; 46.9; 74.1; 69.2 | — |
| SECONDARY Percentage of Participants With Serious Adverse Events (SAEs) |
0; 0; 3.2; 0 | — |
| SECONDARY Percentage of Participants With Solicited Local and Systemic AEs |
100.0; 18.8; 100.0; 50.0 | — |
| SECONDARY Percentage of Participants With Vital Signs Abnormalities |
64.5; 93.8; 22.6; 3.1; 6.5; 0 | — |
| SECONDARY Percentage of Participants With Electrocardiogram (ECG) Abnormalities |
0; 3.8; 0; 3.8; 0; 3.8 | — |
| SECONDARY Percentage of Participants With Clinical Laboratory Abnormalities (Graded) |
9.7; 0; 0; 3.1; 6.5; 0 | — |
Summary
The purpose of this study is to assess a trend for the prophylactic efficacy of a single dose of 1*10^11 virus particles (vp) of adenovirus serotype 26 respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) administered intramuscularly to adults aged 18-50 years in the respiratory syncytial virus (RSV) challenge model in terms of reduction of nasal wash viral load compared to placebo.
Eligibility Criteria
Inclusion Criteria
- Each participant must sign an Informed Consent Form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, is willing to be isolated and stay in the clinic for the quarantine phase, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
- Participants must be in good health, without significant medical illness, on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including height and weight), skin examination, medical history, vital signs (systolic and diastolic blood pressure and heart rate, respiratory rate, and body temperature), and the results of clinical laboratory tests performed within 56 days of vaccination. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Participants must have a non-clinically significant 12-lead electrocardiogram (ECG) within 56 days of vaccination including: normal sinus rhythm (heart rate between 50 and 100 beats per minute [bpm], extremes included); QT interval corrected for heart rate according to Fridericia (QTcF) interval less than or equal to ( =) 37.8 degree Centigrade within 24 hours prior to study vaccination
- Participant has history of malignancy (exceptions are basal cell carcinomas of the skin treated over 5 years prior to vaccination considered cured with minimal risk of recurrence)
- Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
Viral Challenge Exclusion Criteria:
- Participants having donated or lost more than 1 unit of blood (470 milliliter [mL]) within 60 days or more than one unit of plasma within 7 days
- Participants with active acute respiratory infection
Data sourced from ClinicalTrials.gov (NCT03334695). 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.