A Safety and Immunogenicity Study of Intranasal Sendai Virus Vectored Respiratory Syncytial Virus (SeVRSV) Vaccine in Healthy Adults

NCT03473002 | Completed Phase 1 FDA Drug

• 2 other identifiers: 16-0108HHSN272201300016I
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I randomized, double blind, placebo controlled trial in up to 25 males and non-pregnant females, 18-45 years old, inclusive, who are in good health and meet all eligibility criteria. This trial is designed to assess the safety, reactogenicity and immunogenicity of a single intranasal dose of Sendai virus vectored Respiratory Syncytial Virus (SeVRSV) vaccine. The subjects will be randomized in a 4:1 ratio to receive SeVRSV vaccine at a dose of 1 x 10\^7 EID50 or placebo (saline) intranasally. Study duration is approximately 11 months with subject participation duration approximately 6 months. The primary objectives are to: 1) assess the safety and reactogenicity of SeVRSV vaccine following receipt of one intranasal dose; 2) assess the ELISA antibody responses to SeV and to the RSV F protein at 28 days post receipt of one intranasal dose of SeVRSV vaccine; 3) assess the detection of vaccine virus from nasal washes at days 3, 5, 8 and 15 following receipt of one intranasal dose of SeVRSV vaccine.

Conditions

Antiviral Prophylaxis; Respiratory Syncytial Virus Infection

Keywords

Immunogenicity; Respiratory Syncytial Virus; Safety; Sendai Virus; Vaccine

Outcome Measures

Primary Outcomes (14)

• Occurrence of clinical safety laboratory abnormalities

  Up to 7 days

• Occurrence of Medically Significant Wheezing

  Up to 6 months

• Occurrence of New Onset Chronic Medical Conditions (NOCMCs)

  Up to 6 months

• Occurrence of SAEs not related to study product

  Up to 6 months

• Occurrence of solicited local reactogenicity

  Up to 14 days

• Occurrence of solicited systemic reactogenicity

  Up to 14 days

• Occurrence of unsolicited adverse events

  Up to day 28

• Occurrence of vaccine-related SAEs

  Up to 6 months

• Percentage of subjects achieving a 4 - fold rise in RSV F antibody titer measured by ELISA

  From day 1 through day 29

• Percentage of subjects achieving a 4 - fold rise in SeV antibody titer measured by ELISA

  From day 1 through day 29

• Percentage of subjects with vaccine virus detected by nasal wash assessed by Polymerase Chain Reaction (PCR)

  Day 15

• Percentage of subjects with vaccine virus detected by nasal wash assessed by Polymerase Chain Reaction (PCR)

  Day 3

• Percentage of subjects with vaccine virus detected by nasal wash assessed by Polymerase Chain Reaction (PCR)

  Day 5

• Percentage of subjects with vaccine virus detected by nasal wash assessed by Polymerase Chain Reaction (PCR)

  Day 8

Study Arms (2)

Placebo

PLACEBO COMPARATOR

One dose of placebo (0.9% Sodium Chloride) intranasally, n=4

Other: Placebo

SeVRSV

EXPERIMENTAL

1 x 10\^7 EID50 (one dose) of SeVRSV vaccine intranasally, n=16

Biological: SeVRSV Vaccine

Interventions

Placebo OTHER

0.9% Sodium Chloride

Placebo

SeVRSV Vaccine BIOLOGICAL

Recombinant Sendai virus vectored respiratory syncytial virus (SeVRSV) vaccine. SeVRSV is a replication-competent Sendai virus that carries the RSV F gene produced by reverse genetics technology.

SeVRSV

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Provide written informed consent before initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits/phone calls.
• \. Males or non-pregnant females 18-45, inclusive. 4. Are in good health.

You may not qualify if:

• \. Oral temperature is less than 100.0 degrees Fahrenheit. 6. Pulse is 47 to 105 beats per minute (bpm), inclusive. 7. Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive. 8. Diastolic blood pressure (BP) is 55 to 95 mmHg, inclusive. 9. Women of childbearing potential must use an acceptable method of contraception from 30 days prior to study vaccination until 60 days after study vaccination.
• Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or successful Essure (R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \< 1 year of the last menses if menopausal.
• \--- Includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, NuvaRing (R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
• \. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to study vaccination.
• \. Sexually active males with a woman of childbearing potential and has not had a vasectomy performed \> 1 year prior to screening must agree not to father a child for 60 days after vaccination.
• See criteria of women of childbearing potential above. ----- Must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner uses occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
• \. Erythrocyte sedimentation rate (ESR) is less than 30 mm per hour. 12. White blood cells (WBC) are greater than 4.4 x 10\^3/uL and less than 11.1 x 10\^3/uL.
• \. Hemoglobin (Hgb) is greater than 11.6 g/dL for females or is greater than 13.2 g/dL for males.
• \. Platelets are greater than 134 x 10\^3/uL and less than 466 x 10\^3/uL. 15. Absolute Neutrophil Count is greater than 1.7 x 10\^3/uL
• \. Alanine aminotransferase (ALT) is less than 1.25 ULN for females and males. 17. Aspartate aminotransferase (AST) is less than 1.25 ULN for females and males.
• \. Total bilirubin is less than 1.11 mg/dL. 19. Creatinine is less than 0.96 mg/dL for females or is less than 1.18 mg/dL for males.
• \. Sodium is greater than 135 mmol/L and less than 146 mmol/L. 21. Potassium is greater than 3.4 mmol/L and less than 5.2 mmol/L. 22. BUN is less than 19 mg/dL (BUN will be obtained only if creatinine is above normal range).
• \. HgbA1C is less than 6.3%. 24. Have normal screening laboratories for urine protein. Trace protein is acceptable.
• \. Drug screen for opiates is negative. 26. Have a normal ECG.
• Abnormal screening electrocardiogram (ECG) defined as pathologic Q waves and significant ST-T wave changes: criteria for left ventricular hypertrophy; and any non-sinus rhythm excluding isolated premature atrial contractions.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center - Infectious Diseases

Cincinnati, Ohio, 45206-1613, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 21, 2018
• Study Start: May 16, 2018
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: March 1, 2019

Record last verified: 2018-03-05

Locations

US (1)