A Phase I, first in human (FIH), randomised, double-blind, placebo-controlled, dose-escalation study to evaluate safety, reactogenicity and immunogenicity of the recombinant respiratory syncytial virus vaccines (BARS13) when administered intramuscularly (IM) to healthy adult volunteers.

Advanced Vaccine Laboratories Pty Ltd0 sites60 target enrollmentJune 5, 2018

ConditionsRespiratory Syncytial Virus Infection Infection - Other infectious diseases Respiratory - Other respiratory disorders / diseases

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Respiratory Syncytial Virus Infection
Sponsor: Advanced Vaccine Laboratories Pty Ltd
Enrollment: 60
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 5, 2018

End Date

August 2, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Advanced Vaccine Laboratories Pty Ltd

Eligibility Criteria

Inclusion Criteria

•1\.A male or female aged 18\-45 years (inclusive) at the time of the first vaccination.
•2\.Able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
•3\.Written informed consent signed prior to undertaking any protocol related procedures.
•4\.Haematology, clinical chemistry and urinalysis test results not deviating from the normal reference range by age and gender to a clinically relevant extent at screening.
•5\.Males must be surgically sterile (\>30 days since vasectomy with no viable sperm), abstinent or, if engaged in sexual relations with a person of child\-bearing potential, the participant and his partner must use an acceptable, highly effective, contraceptive method from screening and for a period of at least 3 months after the last dose of study drug. Acceptable methods of contraception are the use of condoms and an effective contraceptive for the female partner that could include: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception, or intrauterine contraception/device. The PI is to assess the adequacy of methods of contraception on a case\-by\-case basis.
•6\.Women of child\-bearing potential (WOCBP) must use highly effective contraceptive measures (failure rate of \< 1% per year when used consistently and correctly) throughout the study and intend to continue use of contraception for at least 3 months following the last vaccination. Highly effective contraceptive measures could include: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen\-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone releasing system, bilateral tubal occlusion, vasectomised partner, and sexual abstinence. The PI is to assess the adequacy of methods of contraception on a case\-by\-case basis.
•7\.Participant in otherwise general good health based on medical history and physical examination, as determined by the PI.

Exclusion Criteria

•1\.Presence of clinically significant medical history, unstable chronic or acute disease, or physical, or laboratory findings that, in the opinion of the PI may potentially increase the expected risk of exposure to the investigational vaccine, compromise the safety of the participant, or interfere with any aspect of study conduct or interpretation of results.
•2\.Body Mass Index (BMI) great than or equal to 40 at screening.
•3\.Significant infection or other acute illness, including fever over 37\.5°C/99\.5°F on the day of randomisation.
•4\.Birthmarks, tattoos, wound or other skin conditions over the deltoid region of both arms that, in the PI’s opinion, could reasonably obscure and interfere with evaluation of local injection site reactions.
•5\.Inadequate venous access to allow collection of blood samples.
•6\.Breastfeeding or pregnant as confirmed by a positive serum beta human chorionic gonadotropin (ß\-HCG) pregnancy test at screening or positive urine pregnancy test at subsequent clinic visits at time points as delineated in the study schedule.
•7\.Received any prophylactic or therapeutic vaccine, or investigational drug, within 3 months of first vaccination, or anticipated in the follow up period defined for this study.
•8\.History of severe allergy (requiring hospital care), severe reaction to any drug or prior vaccination, or any known or suspected allergies or sensitivities to any component of the investigational vaccine or placebo.
•9\.Immunosuppression caused by disease (such as human immunodeficiency virus \[HIV]) or medications, immunosuppressive therapy (such as long\-term systemic corticosteroids therapy).
•10\.History of hepatitis B or hepatitis C infection.