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

Phase 1

• Conditions: Prophylactic respiratory syncytial virus (RSV) vaccine.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-003194-33-GB
• Lead Sponsor: Janssen Vaccines and Prevention B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-30
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

1.Subject is a man or woman, =18 to =50 years old on the day of ICF signature.
2. Subjects 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, and the results of clinical laboratory tests performed within 56 days of vaccination. If there are abnormalities, the subject 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 subject’s source documents and initialed by the investigator.
3. Subjects must have a non-clinically significant 12-lead ECG within 56 days of vaccination including:
a) normal sinus rhythm (heart rate between 50 and 100 beats per minute [bpm], extremes included)
b) QT interval corrected for heart rate according to Fridericia (QTcF) interval =450 ms
c) QT interval corrected for heart rate according to Bazett (QTcB) interval =450 ms
d) QRS interval <120 ms
e) PR interval =210 ms.
Note: Retesting of abnormal ECG values that may lead to exclusion will be allowed once without prior approval from the sponsor. Repeate ECG due to equipment failure will not count as a retest. Subjects with a normal value at retest may be included.
4. Subjects must be sero-suitable for RSV within 90 days of vaccination (low immunity to the RSV-A Memphis 37b virus using a virus neutralization assay).
5. Subject must be healthy on the basis of clinical laboratory tests performed within 56 days of vaccinaiton. If the results of the laboratory screening tests are outside the local laboratory normal reference ranges and additionally within the limits of toxicity Grade 1 according to the US Food and Drug Administration (FDA) toxicity tables (ie, for tests in the FDA table ), the subject 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 subject’s source documents and initialed by the investigator.
Note: If laboratory screening tests are out of local laboratory normal ranges and deemed clinically significant, repeat of screening tests is permitted once using an unscheduled visit during the screening period to assess eligibility.

Further criteria are defined in section 4.1 of the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the wellbeing) or that could prevent, limit, or confound the protocol-specified assessments.
2. Subject has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively or current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection.
3. Subject has previously participated in, or is currently participating in an RSV vaccine study, has previously received treatment with immunoglobulin or blood products in the 4 months before the planned administration of study vaccine or has any plans to receive such treatment during the study.
4. Subject has a history of chronic urticaria (recurrent hives), eczema and/or atopic dermatitis or has a history of acute polyneuropathy (eg, Guillain-Barré syndrome).
5. Subject has abnormal function of the immune system resulting from:
- clinical conditions (e.g. autoimmune disease or immunodeficiency)
- chronic (longer than 10 days) or recurrent use of systemic corticosteroids during the study and within 6 months before administration of study vaccine (Note: occular, topical or inhaled steroids are allowed)
- Administration of antineoplastic and immunomodulating agents or radiotherapy during the study and within 6 months before administration of study vaccine.

Further criteria are defined in section 4.2 of the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified