Phase 1, First in Human Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Ad26.RSV.FA2
- Conditions
- Respiratory Syncytial Viruses
- Sponsor
- Crucell Holland BV
- Enrollment
- 34
- Primary Endpoint
- Number of Participants with Solicited Systemic Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety and tolerability of intramuscular prime-boost regimens of Ad26.RSV.FA2 given either once or twice followed by Ad35.RSV.FA2 (human adenovirus-vectored vaccine candidate) in healthy participants.
Detailed Description
This is a single-center, randomized (study vaccine assigned to participants by chance), placebo-controlled study (an inactive substance; a pretend treatment \[with no vaccine in it\] that is compared in a clinical trial with a vaccine to test if the vaccine has a real effect), double-blind (neither the researchers nor the participants know what treatment the participant is receiving) Phase 1 study in healthy participants. The study comprises a 4-week screening period; vaccination for each participant on Days 1, 85, and, 169; a 28-day follow-up period performed after each vaccination and a final visit at Day 337. Approximately 32 Participants will be randomized in parallel in a 3:3:2 ratio to 3 treatment groups (Group 1/2/3) to receive either Ad26.RSV.FA2 or Ad35.RSV.FA2 or placebo. The study duration will be approximately 52 weeks. Blood samples for immunogenicity will be collected. Participant's safety will be evaluated throughout the study.
Investigators
Eligibility 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 method 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
Arms & Interventions
Group 1
Two subsequent Intramuscular injections of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on Day 1 and Day 85, and one intramuscular injection of Ad35.RSV.FA2 (1x10\^11 virus particles \[vp\]) on Day 169.
Intervention: Ad26.RSV.FA2
Group 1
Two subsequent Intramuscular injections of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on Day 1 and Day 85, and one intramuscular injection of Ad35.RSV.FA2 (1x10\^11 virus particles \[vp\]) on Day 169.
Intervention: Ad35.RSV.FA2
Group 2
Intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on Day 1, an intramuscular injection of Ad35.RSV.FA2 (1x10\^11 vp) on Day 85 and and an intramuscular injection of placebo control consisting of the vaccine formulation buffer on Day 169.
Intervention: Ad26.RSV.FA2
Group 2
Intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on Day 1, an intramuscular injection of Ad35.RSV.FA2 (1x10\^11 vp) on Day 85 and and an intramuscular injection of placebo control consisting of the vaccine formulation buffer on Day 169.
Intervention: Ad35.RSV.FA2
Group 2
Intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on Day 1, an intramuscular injection of Ad35.RSV.FA2 (1x10\^11 vp) on Day 85 and and an intramuscular injection of placebo control consisting of the vaccine formulation buffer on Day 169.
Intervention: Placebo
Group 3
Three intramuscular injections of placebo control on Day 1, Day 85 and Day 169.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants with Solicited Systemic Adverse Events (AEs)
Time Frame: Up to 8 days after each vaccination
Number of Participants with Unsolicited AEs
Time Frame: From Signing of informed consent up to 28 days after each vaccination
Unsolicited AEs will be reported by the participant from when the informed consent form (ICF) is signed until 28 days after each vaccination, or early discontinuation.
Number of Participants with Solicited Local Adverse Events (AEs)
Time Frame: Up to 8 days after each vaccination
Solicited AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the participant diary.
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: From Signing of informed consent up to Day 337
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Secondary Outcomes
- Immune Responses to the Study Vaccine Regimens Measured by an Enzyme-linked Immunosorbent Assay (ELISA)(Day 1 (predose) up to day 337)
- Immune Responses to the Study Vaccine Regimens as Measured by a Virus Neutralization Assay(Day 1 (predose) up to day 337)
- Immune responses to the study vaccine regimens as measured by an Enzyme-linked Immunospot Assay (ELISpot)(Day 1 (predose) up to day 337)