Safety and Immunogenicity of a Live-attenuated Vaccine Against Respiratory Syncytial Virus in Elderly Volunteers

NCT04295070 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CODA-RSV-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I trial will enroll 36 healthy adult volunteers. The study will enroll a sentinel group of 6 younger adults aged 18 to 49 years followed by approximately 30 healthy older adults aged 50 to 75 years. All participants will receive two doses, 28 days apart. The vaccine will be administered as nose drops to both the low and high dose cohorts.

Conditions

Respiratory Syncytial Virus Infections

Keywords

RSV; live-attenuated vaccine; codon deoptimized; respiratory infection

Outcome Measures

Primary Outcomes (5)

• Reactogenicity counts

  Counts of participants with local and systemic events along with symptom severity and duration

  Days 1 through 7

• Reactogenicity percentages

  Percentages of participants with local and systemic events along with symptom severity and duration

  Days 1 through 7

• Adverse events counts

  Counts of participants with AEs not included as reactogenicity events

  Days 1 through 57

• Adverse events percentages

  Percentages of participants with AEs not included as reactogenicity events

  Days 1 through 57

• Serious adverse events

  Number of medically-attended AEs (MAEs), new onset chronic illnesses (NCIs), and serious AEs (SAEs) will be captured

  Days 1 through 209

Secondary Outcomes (6)

• RSV-specific IgG

  Days 1, 15, 29, 43, 57, 113, and 209

• Seroconversion rate IgG

  Days 1, 15, 29, 43, 57, 113, and 209

• Neutralizing antibodies

  Days 1, 15, 29, 43, 57, 113, and 209

• Percent of patients seroconverting via neutralizing antibodies

  Days 1, 15, 29, 43, 57, 113, and 209

• RSV-specific IgA

  Days 1, 15, 29, 43 and 57

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Saline (0.9%) delivered intranasally via dropper

Biological: Normal saline

Low dose cohort

EXPERIMENTAL

CodaVax-RSV delivered intranasally via dropper

Biological: CodaVax-RSV

High dose cohort

EXPERIMENTAL

CodaVax-RSV delivered intranasally via dropper

Biological: CodaVax-RSV

Interventions

CodaVax-RSV BIOLOGICAL

Codon deoptimized, live-attenuated vaccine against RSV delivered intranasally via dropper

High dose cohort; Low dose cohort

Normal saline BIOLOGICAL

Saline (0.9%) administered via dropper

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women aged 50 to 75 years of age, inclusive (at the time of informed consent) for the main dosing group or healthy male and female volunteers aged 18 to 49 years of age, inclusive (at the time of informed consent) for the sentinel group;
• Body mass index (BMI) greater or equal to 18.0 kg/m2 and less than or equal to 35 kg/m2;
• Participants must be willing to comply with the following conditions to prevent the spread of genetically modified organisms (GMOs) according the Office of the Gene Technology Regulator (OGTR) Licence (DIR 144):
• Hygiene measures intended to prevent interpersonal transmission of study drug must be implemented, including but not limited to frequent handwashing with soap or hand disinfectant, respiratory hygiene and cough etiquette within 7 days after each vaccination
• Blood, tissue or organs must not be donated within 7 days after each vaccination
• Severely immunosuppressed persons who require a protective environment are not to be cared for by the participant within 7 days after each vaccination
• Contact is not to be made with severely immunosuppressed persons who require a protective environment within 7 days after each vaccination
• All tissues and materials used to collect respiratory secretions for 7 days after each vaccination are to be sealed in a primary container and placed within a secondary container so that it is not accessible to children or animals for 7 days until it is returned to the study site for disposal
• Adequate venous access for repeated phlebotomies;
• Screening laboratory results within the normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Creatine kinase or bilirubin may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant due to vigorous exercise or Gilbert's syndrome;
• Negative drug and alcohol screen at Screening (unless explained by prescribed medication);
• For participants in the main dosing groups, eligible RSV neutralizing antibody titer as defined in the previous seroepidemiology study;
• Women of childbearing potential (WOCBP) must be non-pregnant and non lactating, and must use an acceptable, highly effective double barrier contraception from Screening until 28 days after the final vaccination. Double contraception is defined as a condom AND one other form of the following:
• Established hormonal contraception (oral contraceptive pills \[OCPs\], long acting implantable hormones, injectable hormones);
• A vaginal ring or an intrauterine device (IUD);

You may not qualify if:

• Pregnant or lactating at Screening or planning to become pregnant (self or partner) prior to 28 days after the final vaccination;
• Household contacts or caregivers of infants \< 12 months of age or immunocompromised individuals (for the period up through 28 days post final vaccination). Immunocompromised individuals defined as but not limited to:
• Persons who are human immunodeficiency virus (HIV)-infected
• Persons who have received chemotherapy within 6 months
• Persons receiving immunosuppressive agents
• Person living with solid organ or bone marrow transplant;
• Positive result for HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) at Screening;
• Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with any of the following history related to asthma or lung disease:
• Daily symptoms for more than 1 week in the past 5 years;
• Use of short acting beta 2 agonists in the past 5 years (e.g., albuterol);
• Use of inhaled steroids, theophylline or pulse systemic steroids in the past 5 years; or
• Any history of intubation or hospitalization related to asthma or other chronic lung disease.
• History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently within the normal range);
• History of coronary artery disease, arrhythmia, or congestive heart failure;
• Clinically significant ECG abnormality as determined by the Investigator at Screening;

Sponsors & Collaborators

• Codagenix, Inc: lead

Study Sites (1)

Nucleus Network/Q-Pharm

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Respiratory Tract Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

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

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 4, 2020
• Study Start: July 10, 2020
• Primary Completion: March 6, 2021
• Study Completion: May 26, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)