A Phase 1, First in Human, Randomized, Double-blind, Placebo Controlled Study of the Safety, Tolerability, and Immunogenicity of the CodaVax-RSV Vaccine in Healthy Adult Volunteers

Codagenix, Inc1 site in 1 country36 target enrollmentJuly 10, 2020

ConditionsRespiratory Syncytial Virus Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Respiratory Syncytial Virus Infections
Sponsor: Codagenix, Inc
Enrollment: 36
Locations: 1
Primary Endpoint: Adverse events counts
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 10, 2020

End Date

May 26, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Codagenix, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;

Exclusion Criteria

•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);

Outcomes

Primary Outcomes

Adverse events counts

Time Frame: Days 1 through 57

Counts of participants with AEs not included as reactogenicity events

Serious adverse events

Time Frame: Days 1 through 209

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

Reactogenicity counts

Time Frame: Days 1 through 7

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

Reactogenicity percentages

Time Frame: Days 1 through 7

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

Adverse events percentages

Time Frame: Days 1 through 57

Percentages of participants with AEs not included as reactogenicity events

Secondary Outcomes

RSV-specific IgG(Days 1, 15, 29, 43, 57, 113, and 209)
Percent of patients seroconverting via IgA(Days 1, 15, 29, 43 and 57)
Neutralizing antibodies(Days 1, 15, 29, 43, 57, 113, and 209)
Seroconversion rate IgG(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)