Clinical trial NCT02561871: A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Viruses
Respiratory Tract Infections
Keywords: Ad26.RSV.FA2 (JNJ-61187165-AAA)
Ad35.RSV.FA2 (JNJ-61187191-AAA)
Healthy participants
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2015-09-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants with Solicited Local Adverse Events (AEs)
timeFrame: Up to 8 days after each vaccination
measure: Number of Participants with Solicited Systemic Adverse Events (AEs)
timeFrame: Up to 8 days after each vaccination
measure: Number of Participants with Unsolicited AEs
timeFrame: From Signing of informed consent up to 28 days after each vaccination
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: From Signing of informed consent up to Day 337
Secondary outcomes:
measure: Immune Responses to the Study Vaccine Regimens as Measured by a Virus Neutralization Assay
timeFrame: Day 1 (predose) up to day 337
measure: Immune Responses to the Study Vaccine Regimens Measured by an Enzyme-linked Immunosorbent Assay (ELISA)
timeFrame: Day 1 (predose) up to day 337
measure: Immune responses to the study vaccine regimens as measured by an Enzyme-linked Immunospot Assay (ELISpot)
timeFrame: Day 1 (predose) up to day 337
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Crucell Holland BV
name: Crucell Holland BV Clinical Trial
role: STUDY_DIRECTOR
References: