A Phase 1/2a Study to Assess the Safety, Tolerability and Immunogenicity of Ad26.RSV.preF vaccine in Adults and Toddlers.
- Conditions
- Prophylactic respiratory syncytial virus (RSV) vaccine.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2017-001345-27-GB
- Lead Sponsor
- Janssen Vaccines and Prevention B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method