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

Healthy Participants Clinical Trial

Official title:

Phase 1, First in Human Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad35.RSV.FA2 Regimens Boosted With Ad26.RSV.FA2 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440035
• Other study ID #: CR107409
• Secondary ID: VAC18192RSV1001
• Status: Completed
• Phase: Phase 1
• First received: May 7, 2015
• Last updated: August 18, 2017
• Start date: April 21, 2015
• Est. completion date: June 9, 2016

Study information

• Verified date: August 2017
• Source: Crucell Holland BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a single-center, randomized (study medication assigned to participants by chance), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), double-blind (neither the researchers nor the participants know what treatment the participant is receiving) and 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 323 or 351. Participants will be randomly assigned to one of the 4 treatment groups (Group 1/2/3/4) to receive either Ad35.RSV.FA2 or Ad26.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 9, 2016
• Est. primary completion date: June 9, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Biological:
• Ad35.RSV.FA2
Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10^11) virus particles on Day 1 and 85 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10^11) virus particles on Day 1 and 169 in Group 2. Intramuscular injection of Ad35.RSV.FA2 (1x10^11) virus particles on Day 1 in Group 3.
• Ad26.RSV.FA2
Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on Day 169 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10^10) virus particles on Day 169 in Group 3. Intramuscular injection of Ad26.RSV.FA2 (5x10^10) virus particles on Day 169 in Group 4.

Drug:
• Placebo
Participants will receive intramuscular injection of placebo (sterile formulation buffer) on Day 85 in Group 2. One intramuscular injections of placebo on Day 85 in Group 3. Two intramuscular injections of placebo on Day 1, and Day 85 in Group 4.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Crucell Holland BV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Solicited Local and Systemic Adverse Events (AEs)	Solicited AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the participant diary.	Up to 8 days after each vaccination
Primary	Unsolicited AEs	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.	From Signing of informed consent up to 28 days after each vaccination
Primary	Serious Adverse Events (SAEs)	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	Up to Day 337
Secondary	Determination of Respiratory Syncytial Virus (RSV)-Specific Humoral Immune Response	Determine induction and persistence of humoral immune response against RSV F-protein.	Day 1 (predose) up to day 337
Secondary	To Assess RSV-specific Cellular Immune Response	Assess the quantity and quality of the elicited cellular immune response.	Day 1 (predose) up to day 337