Phase 2
Completed N=60
Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX
Source: ClinicalTrials.gov NCT03232567 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability] — 10; 10; 10; 15 Participants
Summary
This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects will be screened within 28 days of randomization (Day 1).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability] |
10; 10; 10; 15; 0; 0 | — |
| PRIMARY Number of Treatment-Emergent Reactogenicity Events in Participants [Safety and Tolerability] |
9; 9; 6; 6; 9; 11 | — |
| SECONDARY Geometric Mean Antibody Level Measured by Hemagglutination Inhibition (HAI) in Serum |
87.2; 136.1; 164.0; 31.3 | — |
| SECONDARY Geometric Mean Ratio of Postvaccination and Prevaccination Antibody Level Measured by Hemagglutination Inhibition (HAI) in Serum |
2.1; 2.2; 4.3; 0.9 | — |
| SECONDARY Seroprotection Rate |
80.0; 100; 100; 53.3 | 0.2451 |
| SECONDARY Seroconversion Rate |
13.3; 26.7; 33.3; 0.0 | 0.4828 |
| SECONDARY Antibody Level Measured by Microneutralization in Serum |
44.9; 113.1; 142.5; 17.8 | — |
| SECONDARY Antibody Responder Rate by Microneutralization |
40.0; 46.7; 73.3; 0.0; 13.3; 26.7 | 0.0169 sig |
Eligibility Criteria
Subjects who meet all of the following criteria may be included in the study:
- Men and women 18 to 49 years of age, inclusive
- Good general health status as determined by the Investigator
- Adequate venous access for repeated phlebotomies
- Screening laboratory results within institutional normal range or Grade 1 elevation 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 and predose on Day 1
- For women who have not been surgically sterilized or have laboratory confirmation of postmenopausal status, negative pregnancy test
- Willingness to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, or bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28 days after the NasoVAX/placebo dose
- Willingness to participate and comply with all aspects of the study through the entire study period, including nasopharyngeal swabs and blood and urine samples
- Provision of written informed consent
Subjects who meet any of the following criteria will be excluded from the study:
- Pregnant, possibly pregnant, or lactating women
- Household contacts of pregnant women, children 35.0 kg/m2
- Positive results for HIV, hepatitis B virus, or hepatitis C virus at Screening
- Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with the any of the following events in the past year:
- Daily symptoms
- Daily use of short acting beta 2 agonists
- Use of inhaled steroids or theophylline
- Use of pulse systemic steroids
- Emergency care or hospitalization related to asthma or other chronic lung disease
- Systemic steroids for asthma exacerbation
- History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
- History of coronary artery disease, arrhythmia, or congestive heart failure
- Clinically significant ECG abnormality as determined by the Investigator
- Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg) at Screening or predose on Day 1
- History of anaphylaxis or angioedema
- Known allergy to any of the ingredients in the vaccine formulation
- History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration
- Previous nasal surgery or nasal cauterization
- Any symptoms of upper respiratory infection or temperature > 38°C within 3 days before Day 1
- Any symptoms within 24 hours before Day 1 of upper respiratory illness of allergy flare-up that, in the opinion of the Investigator, presents as nasal congestion or rhinorrhea that could inhibit the proper administration of the IP
- Known or suspected malignancy, excluding non-melanoma skin cancers and other early stage surgically excised malignancies that the Investigator considers to be exceedingly unlikely to recur
- Immunocompromised individuals, including those who have used corticosteroids (including intranasal steroids), alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunomodulating therapies within 90 days before Day 1 or those who plan use during the study period
- Use of statin medication within 30 days before Day 1 (see list in Section 6.8.1
Data sourced from ClinicalTrials.gov (NCT03232567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.