Vaccine Immunogenicity
Conditions
Interventions
A target of 160 participants (80 participants are expected on Brazil) will be randomized in this study in a 2:1:1 ratio to 1 of 3 groups: Group 1: Ad26.COV2.S, Group 2: Ad26/protein preF RSV, Group 3:
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D20.215.894.899.205
Sponsors
Janssen Vaccines & Prevention B.V
Faculdade de Medicina da Universidade Federal de Minas Gerais
Eligibility
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Participant must have a body mass index less than 35.0 kilograms per meter square. In the investigator’s clinical judgment, participant may have a stable and well-controlled medical condition including comorbidities associated with an increased risk of progression to severe coronavirus disease-2019, 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. Participants will be included on the basis of relevant medical history, vital signs, and body mass index measurement at screening. - Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine. Before randomization, participants must be either: (a) Not of childbearing potential; (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 consent until 3 months after the last dose of study vaccine (including optional Ad26.COV2.S vaccination on Day 29 in Groups 2 and 3). Use of hormonal contraception should start at least 28 days before the first administration of study vaccine
Exclusion criteria
Exclusion criteria: Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence). Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including any of the excipients of the study vaccine, or trace residues [chicken and/or egg proteins, gentamicin]). Per medical history, participant has chronic active hepatitis B or hepatitis C infection. Per medical history, participant has human immunodeficiency virus type 1 or type 2 infection. Participant has a history of acute polyneuropathy (example, Guillain-Barré Syndrome) or chronic inflammatory demyelinating polyneuropathy. Participant has abnormal function of the immune system resulting from: (a) Clinical conditions (example, autoimmune disease or immunodeficiency) expected to have an impact on the immune response elicited by the study vaccine. Participants with autoimmune disease (example, autoimmune-mediated thyroid disease, autoimmune inflammatory rheumatic disease such as rheumatoid arthritis, and Type 1 diabetes) that is stable and inactive without the use of systemic immunomodulators, and glucocorticoids may be enrolled at the discretion of the investigator; (b) Use of systemic corticosteroids within 2 months before administration of the first study vaccine until 28 days after first study vaccination. A substantial immunosuppressive steroid dose is considered to be greater than (>) 2 weeks of daily receipt of 20 milligrams (mg) prednisone or equivalent. Note: Ocular, topical, or inhaled steroids are allowed; (c) Administration of antineoplastic and immunomodulating agents, example, cancer chemotherapeutic agents, or radiotherapy within 6 months before administration of study vaccine until 28 days after first study vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate innate, pro-inflammatory and other relevant pathway responses to Ad26-based vaccination up to 6 months after vaccination (up to day 183) based on the number of participants with cytokines, chemokines, and other protein mediators of the innate or adaptive immune response in cells or whole blood in response to vaccination as measured by enzyme-linked immunosorbent assay (ELISA) or multiplexed arrays | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the safety and reactogenicity of the Ad26.COV2.S vaccine, Ad26.RSV.preF-based RSV vaccine, and Ad26.ZEBOV vaccine in adults aged 18 to 59 years up to 7 days after vaccination (up to day 8) based on the reported number of participants with solicited locale adverse events for 7 days after first vaccination. An adverse event is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local adverse events (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary for 7 days after first vaccination;Assess the safety and reactogenicity of the Ad26.COV2.S vaccine, Ad26.RSV.preF-based RSV vaccine, and Ad26.ZEBOV vaccine in adults aged 18 to 59 Years up to 7 days after vaccination (up to day 8) based on the reported number of participants with solicited systemic adverse events for 7 days after first vaccination. Solicited systemic will be noted. Participants will also be instructed on how to note signs and symptoms in the participant diary on a daily basis for 7 days after first vaccination (day of vaccination and subsequent 7 days);Assess the safety and reactogenicity of the Ad26.COV2.S vaccine, Ad26.RSV.preF-based RSV vaccine, and Ad26.ZEBOV vaccine in adults aged 18 to 59 Years up to 28 days after vaccination (up to day 29) based on the reported number of participants with unsolicited adverse events for 28 days after first vaccination. Unsolicited are all adverse events for which the participant is not specifically questioned in the participant diary;Assess the safety and reactogenicity of the Ad26.COV2.S vaccine, Ad26.RSV.preF-based RSV vaccine, and Ad26.ZEBOV vaccine in adults aged 18 to 59 Years until 6 months post first vaccination (up to day 183) based on the reported number of participants with Serious Adverse Events for 6 months | — |
Countries
Brazil, United States
Contacts
Public ContactMilene Abrahão
Janssen Cilag Farmaceutica Ltda
Outcome results
None listed