A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Other: Placebo; Biological: RSV Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04453202

VAC18193RSV2005 (Other Identifier)

CR108835

Details and patient eligibility

About

The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).

Enrollment: 459 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)
• A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
• Agree to not donate blood from the time of vaccination until 3 months after vaccination
• Have a body mass index (BMI) less than (<) 40 kilogram per meter square (kg/m^2)
• Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study

Exclusion criteria

• Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)
• Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
• History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis
• Has hepatitis B or C infection, including history of treated hepatitis C infection
• Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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459 participants in 11 patient groups, including a placebo group

Cohort 1 Group 1: RSV Vaccine

Experimental group

Description:

Participants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1.

Treatment:

Biological: RSV Vaccine

Cohort 1 Group 2: RSV Vaccine

Experimental group

Description:

Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1.

Treatment:

Biological: RSV Vaccine

Cohort 1 Group 3: RSV Vaccine

Experimental group

Description:

Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1.

Treatment:

Biological: RSV Vaccine

Cohort 1 Group 4: RSV Vaccine

Experimental group

Description:

Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1.

Treatment:

Biological: RSV Vaccine

Cohort 1 Group 5: Placebo

Placebo Comparator group

Description:

Participants will receive IM injection of placebo on Day 1.

Treatment:

Other: Placebo

Cohort 2 Group 6: RSV Vaccine

Experimental group

Description:

Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Treatment:

Biological: RSV Vaccine

Cohort 2 Group 7: RSV Vaccine

Experimental group

Description:

Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1.

Treatment:

Biological: RSV Vaccine

Cohort 2 Group 8: Placebo

Placebo Comparator group

Description:

Participants will receive IM injection of placebo on Day 1.

Treatment:

Other: Placebo

Cohort 3 Group 9: RSV Vaccine

Experimental group

Description:

Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Treatment:

Biological: RSV Vaccine

Cohort 3 Group 10: RSV Vaccine

Experimental group

Description:

Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1.

Treatment:

Biological: RSV Vaccine

Cohort 3 Group 11: Placebo

Experimental group

Description:

Participants will receive IM injection of placebo on Day 1.

Treatment:

Other: Placebo