Overview

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

Status:
Completed
Trial end date:
2016-06-09
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Crucell Holland BV
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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