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Adenovirus serotype 26-based respiratory syncytial virus. preF · 1 trial · 2 indications
Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to protocol defined criteria were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated LRTD if the following criteria were met: new onset or worsening from baseline of 3 or more of the symptoms as captured on the respiratory infection intensity and impact questionnaire (RiiQ, version 2) at the same assessment time point: cough, short of breath, coughing up phlegm (sputum), and wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-item questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total LRTD symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm \[sputum\] and wheezing).
| Arm | Type | Description |
|---|---|---|
| Group 1: Respiratory Syncytial Virus (RSV) vaccine | EXPERIMENTAL | All participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1. |
| Group 2: Placebo | PLACEBO_COMPARATOR | All participants in the placebo group will receive a single IM injection of matching placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF | BIOLOGICAL | Participants will receive a single IM injection of an RSV vaccine. |
| Placebo | BIOLOGICAL | Participants will receive a single IM injection of matching placebo. |
Inclusion Criteria: * Must be able to work with smartphones/tablets/computers * From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood * Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator d...
The Ad26-based RSV preF vaccine is an investigational vaccine developed by Johnson & Johnson for the prevention of respiratory syncytial virus (RSV) and lower respiratory tract disease. It uses an adenovirus serotype 26 vector to deliver a pre-fusion conformation-stabilized F protein. It is also known as Ad26.RSV.preF.
It is being developed to prevent respiratory syncytial virus (RSV) and lower respiratory tract disease in adults aged 60 years and older. The vaccine targets RSV, an infectious disease that can cause serious lower respiratory tract illness in older adults.
Johnson & Johnson, which trades under the ticker JNJ, is developing the Ad26-based RSV preF vaccine. The company is the sponsor of the clinical program evaluating the vaccine for RSV prevention in older adults.
The Ad26-based RSV preF vaccine is in Phase 3 development. It is investigational and has not been approved. One Phase 3 trial has been completed, and no trials are currently active.
The vaccine was evaluated in the Phase 3 trial NCT04908683, titled a study of an adenovirus serotype 26 pre-fusion conformation-stabilized F protein based RSV vaccine in the prevention of lower respiratory tract disease in adults aged 60 years and older. It enrolled 25,236 participants and is completed.
Yes. Ad26.RSV.preF is another name for the adenovirus serotype 26-based respiratory syncytial virus preF vaccine. Both names refer to the same Johnson & Johnson investigational vaccine candidate for RSV prevention.