E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of Lower Respiratory Tract Disease Caused by The respiratory
syncytial virus (RSV) |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of Lower Respiratory Tract Disease Caused by RSV |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039247 |
E.1.2 | Term | RSV infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. To assess the safety and reactogenicity of Ad26.RSV.preF-based RSV vaccine in healthy adults aged 18 to 59 years
2. To assess the safety and reactogenicity of Ad26.RSV.preF-based RSV vaccine in adults aged 18 to 59 years at high-risk of severe RSV disease
3. If non-inferiority is demonstrated in adults: To demonstrate the noninferiority of the humoral response to the administration of Ad26.RSV.preF-based vaccine in high-risk adults aged 18 to 59 years versus in adults aged 65 years and older |
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E.2.2 | Secondary objectives of the trial |
1. Investigate the vaccine-induced immune responses post-vaccination
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Participants above the age of 18 years in stable health at the time of vaccination, according to the investigator's judgement.
- Female participants must be either
a. not of childbearing potential or
b. of childbearing potential and practicing an acceptable effective method of contraception and agrees to remain on such a method of contraception from signing the ICF until 3 months after study vaccination, and have a negative pregnancy test immediately prior to study vaccination
For Cohort 1 only:
-participant is aged 18 to 59 years (inclusive) on the day of signing the ICF
For Cohort 2 only (18-59 years):
-participant is aged 18 to 59 years (inclusive) on the day of signing the ICF
- has an existing chronic heart or lung condition, without hospitalizations or major medication class change (ie, new or stopped medications) within 30 days prior to screening, meeting the following criteria (based on Falsey et al. [2005]):
a. Cardiac disease: at least Class II symptoms per New York Heart Association classification
b. Pulmonary disease: activity-restricting symptoms or use of long-term medications.
- participant may have other underlying illnesses as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant’s healthcare provider.
For Cohort 3 only:
-participant is aged 65 years or older on the day of signing the ICF
- participant may have underlying illnesses such as hypertension, congestive heart failure, COPD, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant’s healthcare provider. |
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E.4 | Principal exclusion criteria |
1. history of malignancy within 5 years before screening which is not considered cured or with risk of recurrence, other than squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix
2. known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
3. abnormal function of the immune system resulting from some clinical conditions, use of corticosteroids, immunomodulating agents or antineoplastic agents
4. per medical history, participant has chronic active hepatitis B or hepatitis C infection.
5. per medical history, participant has HIV type 1 or type 2 infection.
6. history of acute polyneuropathy (eg, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy.
7. received hematopoietic stem cell transplant in medical history, treatment with immunoglobulins (including monoclonal antibodies for chronic underlying conditions) in the 2 months, immunoglobulins specific to RSV, human metapneumovirus, or parainfluenza viruses in the 12 months, apheresis therapies in the 4 months, or blood products in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study.
8. history of TTS or heparin-induced thrombocytopenia and thrombosis (HITT).
9. participant who is pregnant, breastfeeding or planning to become pregnant while enrolled in the study.
10. received or plans to receive:
a. Licensed live attenuated vaccines within 28 days before or after planned administration of the study vaccine.
b. Other licensed (not live) vaccines within 14 days before or after planned administration of the study vaccine.
11. received or plans to receive a SARS-COV-2 vaccine (licensed or used under EUA):
a. Live attenuated SARS-COV-2 vaccine within 28 days before or after planned administration of the study vaccine.
b. Non-live SARS-COV-2 vaccine within 14 days before or after planned administration of the study vaccine.
c. A viral-vectored SARS-COV-2 vaccine within 28 days prior to randomization or during the study period until 28 days after the study vaccination.
12. received an RSV vaccine in a previous RSV vaccine study.
13. received or plans to receive an Ad26-vectored vaccine at any time prior to randomization until 28 days after the last study vaccination, other than a SARS-COV-2 vaccine.
14. received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the study vaccine or is currently enrolled or plans to participate in another investigational study during this study.
15. has a serious chronic disorder, eg, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer’s disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
16. has had major surgery within 4 weeks before administration of the study vaccine or will not have recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.
17.has had major psychiatric illness and/or drug or alcohol abuse which in the investigator’s opinion would compromise the participant’s safety and/or compliance with the study procedures. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Solicited local (injection site) and systemic AEs for 7 days after vaccination
2. Unsolicited AEs for 28 days after vaccination
3. Serious adverse events (SAEs) and adverse events of special interest (AESIs) until 6 months after vaccination
4. Neutralizing antibody titers against RSV A2 strain at 14 days after vaccination
5. Seroresponse rate at 14 days after vaccination as determined by neutralization assay (VNA-A2). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- 7, 14, 28 days after vaccination
- SAEs and AESIs until 6 months after vaccination |
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E.5.2 | Secondary end point(s) |
1. Pre-F ELISA antibody titers at 14 days after vaccination |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
14 days after vaccination
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Reactogenicity and Immunogenicity |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 6 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
United States |
Belgium |
Germany |
Spain |
Sweden |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |