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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04295070




Registration number
NCT04295070
Ethics application status
Date submitted
28/02/2020
Date registered
4/03/2020
Date last updated
1/12/2020

Titles & IDs
Public title
Safety and Immunogenicity of a Live-attenuated Vaccine Against Respiratory Syncytial Virus in Elderly Volunteers
Scientific title
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
Secondary ID [1] 0 0
CODA-RSV-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CodaVax-RSV
Other interventions - Normal saline

Placebo Comparator: Placebo - Saline (0.9%) delivered intranasally via dropper

Experimental: Low dose cohort - CodaVax-RSV delivered intranasally via dropper

Experimental: High dose cohort - CodaVax-RSV delivered intranasally via dropper


Other interventions: CodaVax-RSV
Codon deoptimized, live-attenuated vaccine against RSV delivered intranasally via dropper

Other interventions: Normal saline
Saline (0.9%) administered via dropper

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reactogenicity counts - Counts of participants with local and systemic events along with symptom severity and duration
Timepoint [1] 0 0
Days 1 through 7
Primary outcome [2] 0 0
Reactogenicity percentages - Percentages of participants with local and systemic events along with symptom severity and duration
Timepoint [2] 0 0
Days 1 through 7
Primary outcome [3] 0 0
Adverse events counts - Counts of participants with AEs not included as reactogenicity events
Timepoint [3] 0 0
Days 1 through 57
Primary outcome [4] 0 0
Adverse events percentages - Percentages of participants with AEs not included as reactogenicity events
Timepoint [4] 0 0
Days 1 through 57
Primary outcome [5] 0 0
Serious adverse events - Number of medically-attended AEs (MAEs), new onset chronic illnesses (NCIs), and serious AEs (SAEs) will be captured
Timepoint [5] 0 0
Days 1 through 209
Secondary outcome [1] 0 0
RSV-specific IgG - Titer of RSV-specific immunoglobulin G (IgG) antibodies measured by enzyme-linked immunosorbent assay (ELISA) in serum
Timepoint [1] 0 0
Days 1, 15, 29, 43, 57, 113, and 209
Secondary outcome [2] 0 0
Seroconversion rate IgG - Percent of participants with at least 4-fold increase in RSV-specific IgG as measured by ELISA over baseline
Timepoint [2] 0 0
Days 1, 15, 29, 43, 57, 113, and 209
Secondary outcome [3] 0 0
Neutralizing antibodies - Titer of neutralizing antibodies in serum measured via RSV micro neutralization assay
Timepoint [3] 0 0
Days 1, 15, 29, 43, 57, 113, and 209
Secondary outcome [4] 0 0
Percent of patients seroconverting via neutralizing antibodies - Percent of participants with at least 4- fold increase in neutralizing antibodies in serum over baseline
Timepoint [4] 0 0
Days 1, 15, 29, 43, 57, 113, and 209
Secondary outcome [5] 0 0
RSV-specific IgA - Geometric mean titer (GMT) of antibodies measured by ELISA in nasopharyngeal (NP) swab specimens
Timepoint [5] 0 0
Days 1, 15, 29, 43 and 57
Secondary outcome [6] 0 0
Percent of patients seroconverting via IgA - Percent of participants with at least 4 fold increases in RSV-specific IgA over baseline
Timepoint [6] 0 0
Days 1, 15, 29, 43 and 57

Eligibility
Key inclusion criteria
1. 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;

2. Body mass index (BMI) greater or equal to 18.0 kg/m2 and less than or equal to 35
kg/m2;

3. 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):

1. 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

2. Blood, tissue or organs must not be donated within 7 days after each vaccination

3. Severely immunosuppressed persons who require a protective environment are not to
be cared for by the participant within 7 days after each vaccination

4. Contact is not to be made with severely immunosuppressed persons who require a
protective environment within 7 days after each vaccination

5. 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

4. Adequate venous access for repeated phlebotomies;

5. 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;

6. Negative drug and alcohol screen at Screening (unless explained by prescribed
medication);

7. For participants in the main dosing groups, eligible RSV neutralizing antibody titer
as defined in the previous seroepidemiology study;

8. 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);

- Documented evidence of surgical sterilisation at least 6 months prior to
screening (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, or
bilateral oophorectomy for women or vasectomy for men [with appropriate post
vasectomy documentation of the absence of sperm in semen] provided the male
partner is a sole partner) Women not of childbearing potential must be
postmenopausal for greater or equal to 12 months. Postmenopausal status will be
confirmed through testing of follicle stimulating hormone (FSH) levels greater or
equal to 40 IU/mL at Screening for amenorrhoeic female participants.

Females who are abstinent from heterosexual intercourse will also be eligible.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods)
and withdrawal are not considered highly effective methods of birth control.

Female participants who are in same sex relationships are not required to use
contraception.

WOCBP must have a negative pregnancy test at Screening and Day 1 and be willing to
have additional pregnancy tests as required throughout the study;

Males must be surgically sterile (>30 days since vasectomy with no viable sperm),
abstinent, or if engaged in sexual relations with a WOCBP, his partner must be
surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy,
bilateral oophorectomy) or using an acceptable, highly effective double barrier
contraceptive method from Screening until until 28 days after the final vaccination.
Acceptable methods of double barrier contraception include the use of condoms AND the
use of an effective contraceptive for the female partner that includes: OCPs,
long-acting implantable hormones, injectable hormones, a vaginal ring or an IUD.
Participants with same sex partners (abstinence from penile-vaginal intercourse) are
eligible when this is their preferred and usual lifestyle.

9. Males must not donate sperm for at least 90 days after the final vaccination;

10. Participants must have the ability and willingness to attend the necessary visits to
the clinical research unit (CRU);

11. Participants must be willing and able to provide written informed consent prior to the
commencement of any study procedures.
Minimum age
50 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant or lactating at Screening or planning to become pregnant (self or partner)
prior to 28 days after the final vaccination;

2. 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:

1. Persons who are human immunodeficiency virus (HIV)-infected

2. Persons who have received chemotherapy within 6 months

3. Persons receiving immunosuppressive agents

4. Person living with solid organ or bone marrow transplant;

3. Positive result for HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) at
Screening;

4. 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:

1. Daily symptoms for more than 1 week in the past 5 years;

2. Use of short acting beta 2 agonists in the past 5 years (e.g., albuterol);

3. Use of inhaled steroids, theophylline or pulse systemic steroids in the past 5
years; or

4. Any history of intubation or hospitalization related to asthma or other chronic
lung disease.

5. History of diabetes mellitus (gestational diabetes is allowed if treatment was not
required postpartum and serum glucose is currently within the normal range);

6. History of coronary artery disease, arrhythmia, or congestive heart failure;

7. Clinically significant ECG abnormality as determined by the Investigator at Screening;

8. Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood
pressure >95 mmHg) at Screening or predose on Day 1;

9. History of anaphylaxis or angioedema;

10. History of severe reaction to immunization;

11. Known allergy to any of the ingredients in the vaccine formulation;

12. History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other
nasal abnormality that might alter nasal mucosa and affect vaccine response;

13. Previous nasal surgery or nasal cauterization;

14. Epistaxis (nosebleed), symptoms of upper respiratory infection or subjective fever or
malaise within 3 days prior to dosing on Day 1 (temporary exclusion criterion);

15. Any symptoms or signs on Day 1 that could inhibit the proper administration of the
investigational product (IP) or interpretation of solicited AEs diary (e.g.,
temperature >38°C, nasal congestion or rhinorrhea) (temporary exclusion criteria);

16. Known or suspected malignancy, except for non-melanoma skin cancers and other early
stage surgically excised malignancies that the Investigator considers to be
exceedingly unlikely to recur;

17. Immunodeficiency including the use of corticosteroids (including IN steroids),
alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other
immunomodulating therapies within 90 days prior to dosing on Day 1, or for those
participants that plan to use any of these during the study follow-up period. Topical
steroid creams used on the skin are allowed;

18. History of bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet
disorder requiring special precautions);

19. History of autoimmune or demyelinating illness;

20. History of psychosis, hospitalization for psychiatric illness, or suicide attempt in
the past 10 years;

21. History of seizures (other than childhood febrile seizures), dementia or progressive
neurological disease;

22. Receipt of IN medications (including over the counter [OTC] medications but excluding
saline) within 30 days prior to Day 1;

23. Receipt of any other IP within 30 days or 5 half lives (whichever is longer) prior to
Day 1;

24. Receipt of any vaccine, tuberculosis (TB) skin test or allergy antigen inoculations
within 30 days prior to Day 1 or planned up to Day 57;

25. Receipt of IN vaccine within 90 days prior to Day 1;

26. Receipt of any licensed or investigational RSV vaccine;

27. Receipt of blood transfusion or blood products within 90 days prior to Day 1 or
planned up through Day 57;

28. Planned elective hospitalization or surgical procedure through Day 57;

29. Other chronic medical conditions not mentioned must be stable without necessitating
medication changes within 30 days prior to Day 1;

30. Past regular use or current use of IN illicit drugs;

31. Smokers of any type (e.g., cigarettes, electronic cigarettes, marijuana). Prior
smokers must have quit smoking at least 30 days prior to Day 1;

32. Employee of Codagenix, vendors, or research sites associated with the study;

33. Any medical, psychiatric or social condition, or occupational or other responsibility
that, in the judgment of the Investigator, would interfere with or serve as a
contraindication to protocol adherence, assessment of safety (including
reactogenicity), or a participant's ability to give informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network/Q-Pharm - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Codagenix, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04295070
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications