A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad35.RSV.FA2 Regimens Boosted With Ad26.RSV.FA2 in Healthy Adult Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Participants

In brief

The purpose of this study is to assess the safety and tolerability of intramuscular homologous and heterologous prime-boost regimens of Ad35.RSV.FA2 (human adenovirus-vectored vaccine candidate) and Ad26.RSV.FA2 in healthy participants.

Key facts

Study ID

NCT02440035

Run by

Crucell Holland BV

People needed

48

Starts

2015-04-21

Expected to finish

2016-06-09

Last updated by the study team

2017-08-22

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant must be in good health, without significant medical illness, on the basis of physical examination, medical history, vital signs measurement, and 12-lead electrocardiogram (ECG) performed at screening
• Participant must meet protocol defined laboratory criteria within 28 days before Day 1
• Before randomization, a woman must be either; Not of childbearing potential: postmenopausal or surgically sterilized; of childbearing potential and practicing an effective method of birth control before vaccination and through 3 months after the last vaccination. Women, who are not heterosexually active at screening, must agree to utilize highly-effective methods of birth control if they become heterosexually active until 3 months after receiving the last dose of study vaccine
• A woman must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at the screening visit, and a negative urine pregnancy test pre-vaccination on Day 1
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction until 3 months after receiving the last dose of study vaccine. A man must agree not to donate sperm until 3 months after receiving the last dose of study vaccine

You may not qualify if…

• Participant has a body mass index (BMI) less than or equal to (<=)19 and greater than or equal to (>=30) kilogram per square meter (kg/m2)
• Participant has any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation (e.g. history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections)
• Participant has had major surgery within the 4 weeks prior to randomization or has planned major surgery through the course of the study
• Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
• Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection

Where it is running

• Study site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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