Prophylactic respiratory syncytial virus (RSV) vaccine.
Conditions
Interventions
Product Name: Ad26.RSV.preF
Product Code: JNJ-64400141
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ad26.RSV.preF
Other descriptive name: JNJ-64400141
Concentration unit: billion o
Sponsors
Janssen Vaccines and Prevention B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult subjects: - Signed informed consent form (ICF) - Aged between =18 and =50 years old - In good health, without significant medical illness, on the basis of physical examination, medical history, and vital signs measurement - Healthy on the basis of clinical laboratory tests performed at screening -Contraceptive use by men or women consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies. - Women of childbearing potential must practise an effective method of contraception. - Women of childbearing potential must have a negative pregnancy test at screening and immediately prior to each study vaccine administration - Subject must agree not to donate blood from first vaccination until 3 months after the final dose. Paediatric subjects: - Informed consent form (ICF) signed by parent/ legal guardian - Aged between =12 months to =24 months and who is seropositive for RSV. Note: RSV-seropositive toddlers may be recruited if RSV seropositivity was assessed via RSV EIA or virus neutralization assay in a different study of the sponsor. - Born out of normal term pregnancy =37 weeks, with a minimum birth weight of 2.5 kg - In good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening - Received all routine immunizations appropriate for his or her age according to local guidelines - Parent/ local guardian must have access to a consistent means of contact either by telephone contact or email/computer Full details are available in section 4 of the protocol. Are the trial subjects under 18? yes Number of subjects for this age range: 36 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Adult subjects: - Acute illness or temperature =38.0 ºC/100.4 °F within 24 hours prior to the first dose of study vaccine - History of an underlying clinically significant acute or chronic medical condition or other unsuitable physical examination findings - History of malignancy within 5 years before screening (exceptions defined in the protocol) - Major surgery within 12 weeks before dosing, or will not have fully recovered from surgery, or has surgery planned during participation in the study or within 6 months after the last dose of study vaccine -Chronic active hepatitis B or hepatitis C infection - HIV-1 or HIV-2 infection - Psychiatric illness and/or drug or alcohol abuse - Received or planning to receive other vaccines during the study (vaccine types and time window defined in the protocol) - Participation in other interventional trial/ receipt of other investigational drug or medical device (as defined in the protocol) - Known allergy to vaccines or vaccine components, or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components - History of the following moderate to severe chronic conditions: urticaria, eczema or atopic dematitis - History of acute polyneuropathy - Abnormal function of the immune system - Contraindication to intramuscular injections and blood draws - Pregnancy (incl. planned pregnancy) or breast-feeding - Employee of the investigator or the study site directly involved in the study and family members of either the investigator, study-site employee, or employee of the sponsor - Subject who cannot communicate reliably with the investigator - Subject at risk of not adhering to the requirements of the study or dosing schedule Paediatric subjects: - Moderate or severe illness or temperature =38.0 ºC/100.4 °F within 24 hours prior to the first dose of study vaccine - Weight is below 10th percentile according to World Health Organization (WHO) pediatric growth and weight charts - Clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation (as detailed in the protocol) - Major congenital anomalies or known cytogenetic disorders - Major surgery within the 4 weeks prior to randomization or has planned major surgery through the course of the study - Received or planning to receive other vaccines during the study (vaccine types and time window defined in the protocol) - Known or suspected immunodeficiency, such as known HIV infection - Participation in other interventional trial/ receipt of other investigational drug or medical device (as defined in the protocol) - - Known allergy to vaccines or vaccine components, or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components - History of the following moderate to severe chronic conditions: urticaria, eczema or atopic dematitis - History of acute polyneuropathy - Chronic or recurrent use of immunomodulators/suppressors, oral or parenteral corticosteroids for at least 5 days within 42 days prior to randomization, or planned during the course of the study - History of receipt of blood products or immunoglobulin within 3 months of randomization or receipt of palivizumab/Synagis® at any time prior to randomization - Contraindication to intramuscular injections and blood draws - Parent/ legal guardian cannot communicate reliably with the investigator - Family member of either the investigator, study-site employee, or employee of the s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the safety and tolerability of an intramuscular regimen of two doses of 1x10e11 viral particles (vp) of Ad26.RSV.preF in adults aged 18 to 50 years. 2. To assess the safety and tolerability of an intramuscular regimen of two doses of 5x10e10 vp of Ad26.RSV.preF in RSV-seropositive toddlers aged 12 to 24 months. ;Secondary Objective: To assess the humoral and cellular immune responses as measured by virus neutralization assay, F-protein binding antibodies (pre-F and post-F) and intracellular cytokine staining (ICS; to assess T-helper (Th1/Th2) subtyping). ;Primary end point(s): 1. Solicited local and systemic adverse events (AEs) for 7 days after each vaccination. 2. Unsolicited AEs for 28 days after each vaccination (ie, from informed consent form [ICF] signature through the following 28 days post-first vaccination, and for subsequent vaccinations from time of vaccination through the following 28 days). 3. SAEs from ICF signature until the end of the study. ;Timepoint(s) of evaluation of this end point: 1. For 7 days after each vaccination 2. For 28 days after each vaccination 3. From ICF signature until the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immune Responses: The analysis of the immunogenicity of vaccine regimens will include the characterization of humoral as well as cellular responses. The focus of the immunogenicity analysis is on virus neutralizing antibodies (VNAs), F-protein antibodies (pre-F and/or post-F) and Th1/Th2 cytokine profile response. A) Humoral Immune Response - RSV neutralization A strain; Analysis of RSV A neutralizing antibodies. - RSV F-protein enzyme-linked immunosorbent assay (ELISA; pre- and/or post-fusion F antibodies); Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion form. B) Cell-mediated Immune Response - Intracellular cytokine staining or cytokine analysis; Analysis of CD4 and CD8 T-cell subsets and their cytokine expression patterns will be determined by flow cytometry after RSV F-protein peptide stimulation (including, but not limited to CD4/CD8, interleukin-2 [IL-2], IFN?, tumor necrosis factor alpha (TNFa) and Th1/Th2 subtyping). ;Timepoint(s) of evaluation of this end point: Pre-vaccination for 1st and 2nd doses and at 28 days post Dose 2 and 6 months post Dose 2. | — |
Countries
Finland, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen Research and Development
Outcome results
None listed