Safety and Immunogenicity of a Nipah Virus Vaccine

NCT04199169 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CVIA 077; HeV-sG-01
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

A first-in-human, phase 1 trial is to be conducted in a healthy adult population in the US to assess the safety and immunogenicity of three ascending Nipah vaccine (HeV-sG-V; Hendra virus soluble glycoprotein vaccine) dosages. Different dosing regimens and number of doses will also be explored.

Conditions

Nipah Virus Infection

Keywords

Nipah, Vaccine, Henipah

Outcome Measures

Primary Outcomes (4)

• Rate of local and systemic solicited adverse events

  e.g., headache, fatigue, fever, etc.that are specifically asked about by the doctor

  for 1 week after each innoculation

• Incidence of clinically significant abnormalities in clinical safety laboratory test results reported as unsolicited AEs.

  e.g. hemoglobin, white blood cell count, neutrophil count, creatinine, etc.

  for 1 week after each innoculation

• Incidence of unsolicited adverse events

  Adverse events that are reported to the doctor beyond what is asked about by the doctor. An adverse event is any undesirable experience associated with the use of a medical product in a patient.

  for 1 month after the last vaccination

• Incidence of medically attended adverse events and serious adverse events

  A reaction to the vaccine that require medical attention. Serious adverse events can include death, hospitalization, disability, and death.

  through Day 197

Secondary Outcomes (2)

• Determine number of doses and timing of doses required

  through day 57

• Determine number of doses and timing of doses required

  through day 57

Study Arms (9)

Cohort 1, Group 1

EXPERIMENTAL

Ten subjects in the first cohort will receive a 10 mcg dose of HeV-sG-V on Visits 1 and 6.5 (Days 1 and 169\*). \*Second dose was administered at 6 months due to study pause from local COVID-19 shutdown.

Biological: HeV-sG-V

Cohort 1, Group 2

PLACEBO COMPARATOR

Two subjects in the first cohort will receive a dose of the placebo on Visits 1 and 6.5 (Days 1 and 169\*). \*Second dose was administered at 6 months due to study pause from local COVID-19 shutdown.

Biological: Normal Saline Placebo

Cohort 2, Group 3

EXPERIMENTAL

Thirty subjects in the second cohort will receive a 30 mcg dosage of HeV-sG-V on Visits 1 and 2 (Days 1 and 8) with placebo on Visit 3 (Day 29).

Biological: HeV-sG-V; Biological: Normal Saline Placebo

Cohort 2, Group 4

EXPERIMENTAL

Thirty subjects in the second cohort will receive a 30 mcg dosage of HeV-sG-V on Visits 1 and 3 (Days 1 and 29) with placebo on Visit 2 (Day 8)

Biological: HeV-sG-V; Biological: Normal Saline Placebo

Cohort 2, Group 5

PLACEBO COMPARATOR

Twelve subjects in the second cohort will receive a dose of the placebo on Visits 1, 2, and 3 (Days 1, 8 and 29).

Biological: Normal Saline Placebo

Cohort 3, Group 6

EXPERIMENTAL

Thirty subjects in the third cohort will receive a 100 mcg dosage of HeV-sG-V on Visit 1 (Day 1) and placebo on Visits 2 and 3 (Days 8 and 29).

Biological: HeV-sG-V; Biological: Normal Saline Placebo

Cohort 3, Group 7

EXPERIMENTAL

Thirty subjects in the third cohort will receive a 100 mcg dosage of HeV-sG-V on Visits 1 and 2 (Days 1 and 8) and placebo on Visit 3 (Day 29).

Biological: HeV-sG-V; Biological: Normal Saline Placebo

Cohort 3, Group 8

EXPERIMENTAL

Thirty subjects in the third cohort will receive a 100 mcg dosage of HeV-sG-V on Visits 1 and 3 (Days 1 and 29) and placebo on Visit 2 (Day 8).

Biological: HeV-sG-V; Biological: Normal Saline Placebo

Cohort 3, Group 9

PLACEBO COMPARATOR

Eighteen subjects in the third cohort will receive a dose of the placebo on Visits 1, 2, and 3 (Days 1, 8 and 29).

Biological: Normal Saline Placebo

Interventions

HeV-sG-V BIOLOGICAL

A Hendra virus soluble glycoprotein vaccine formulated in phosphate buffer and adjuvanted with aluminum hydroxide. Placebo is normal saline.

Also known as: Nipah Vaccine, HenipaVaxTM

Cohort 1, Group 1; Cohort 2, Group 3; Cohort 2, Group 4; Cohort 3, Group 6; Cohort 3, Group 7; Cohort 3, Group 8

Normal Saline Placebo BIOLOGICAL

0.9% Saline

Also known as: Placebo

Cohort 1, Group 2; Cohort 2, Group 3; Cohort 2, Group 4; Cohort 2, Group 5; Cohort 3, Group 6; Cohort 3, Group 7; Cohort 3, Group 8; Cohort 3, Group 9

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or non-pregnant female 18 through 49 years of age at the time of consenting and IP administration.
• Provides written informed consent prior to performance of any study-specific procedure.
• Resides in study site area and is able and willing to adhere to all protocol visits and procedures, including plasmapheresis.
• Healthy, as defined by absence of any clinically significant medical conditions, either acute or chronic, as determined by medical history, physical examination, safety laboratory test results, and clinical assessment of the investigator.
• Female subjects of childbearing potential\* must have practiced adequate contraception\*\* for 28 days prior to administration of IP and agree to continue adequate contraception until completion of the plasmapheresis session or Visit 5 (Day 57) for subjects not selected for plasmapheresis.
• \* Females can be considered not of childbearing potential if they are with current bilateral tubal ligation or occlusion, or post-hysterectomy, or post-bilateral ovariectomy, or post-menopause.
• \*\* Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example:
• Abstinence from penile-vaginal intercourse
• Combined estrogen and progesterone oral contraceptives
• Injectable progestogen
• Implants of etonogestrel or levonorgestrel
• Contraceptive vaginal ring
• Percutaneous contraceptive patches
• Intrauterine device or intrauterine system
• Male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository), and/or progesterone alone oral contraceptive

You may not qualify if:

• Previous immunization with an investigational Nipah or Hendra virus vaccine.
• History of disease known to be caused by Nipah or Hendra virus.
• Travel to Kerala state, India within the previous three years or planned travel to Kerala sate or Bangladesh during the study period.
• Known hypersensitivity to any component of the IPs.
• Known hypersensitivity to citrate or ethylene oxide.
• History of hypersensitivity to any vaccine.
• Administration of any vaccine other than the IP within 28 days prior to IP administration or planned administration through completion of plasmapheresis or Visit 5 (Day 57) for subjects not selected for plasmapheresis.
• Administration of any investigational or non-registered drug within 90 days prior to IP administration or planned administration during the study period.
• Administration of immunoglobulin or any blood product within 90 days prior to IP administration or planned administration during the study period.
• Acute illness or fever (body temperature measured orally ≥ 38°C or 100.4°F) at the time of IP administration (once acute illness/fever is resolved, if appropriate, as per investigator assessment, subject may be screened again).
• History of or evidence for chronic clinically significant (as per investigator assessment) disorder or disease (including, but not limited to immunodeficiency, autoimmunity, bleeding or psychiatric disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease).
• Any condition that in the opinion of the investigator might compromise the safety or well-being of the subject or compromise adherence to protocol procedures or interfere with planned safety and immunogenicity assessments.
• History of chronic alcohol consumption or drug abuse that in the opinion of the investigator might compromise adherence to protocol procedures or interfere with planned safety and immunogenicity assessments.
• Blood donation or planned blood donation within 28 days prior to IP administration through 28 days after completion of the plasmapheresis session or Visit 5 (Day 57) for subjects not selected for plasmapheresis.
• Pregnant.

Sponsors & Collaborators

• Auro Vaccines LLC: lead
• PATH: collaborator
• Coalition for Epidemic Preparedness Innovations: collaborator
• Cincinnati Children's Hospital Medical Center (CCHMC): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center (CCHMC)

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Henipavirus Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert W. Frenck Jr., MD

  Cincinnati Children's Hospital Medical Center (CCHMC)

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Ascending dose study

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: February 18, 2020
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)