Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults

Covid19 Clinical Trial

Official title:

Phase 1, Open-Label, Dose-Escalation Study to Evaluate Tolerability, Safety, and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus Vaccine Expressing Spike Protein of SARS-CoV-2 in Healthy Adults Ages 18 - 69 Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04798001
• Other study ID #: MV-101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 12, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: August 2022
• Source: Meissa Vaccines, Inc.
• Contact: Jay Lieberman, MD
• Phone: 3107538943
• Email: jay.lieberman[@]meissavaccines.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates an investigational vaccine that is designed to protect humans against infection with SARS-CoV-2, the novel coronavirus causing COVID-19 disease. The investigational vaccine, MV-014-212, is a live attenuated vaccine against respiratory syncytial virus (RSV) that is expressing the spike (S) protein of SARS-CoV-2. MV-014-212 is administered as drops or a spray in the nose. Specifically, this study analyzes the safety of, and the immune response to, the vaccine when administered to healthy adults between the ages of 18 and 69 years who are seronegative to SARS-CoV-2 and have not received a prior vaccine against COVID-19.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Healthy adults =18 and <56 years (Cohort A) and =56 years and <70 years (Cohort B) as determined at the day of signing informed consent
• SARS-CoV-2 RT-PCR (nasal swab) negative at Day 1 pre-dose
• Women of childbearing potential (WOCBP) or male subjects with partners who are WOCBP must agree to practice contraception during their study participation from the signing of informed consent for at least 3 months after the final MV-014-212 administration.
• Written informed consent

Exclusion Criteria:

• Diagnosis of chronic pulmonary disease (e.g. chronic obstructive pulmonary disease, asthma, pulmonary fibrosis, cystic fibrosis). Resolved childhood asthma is not exclusionary.
• Immunocompromised state due to comorbidities or other conditions as detailed in the study protocol
• Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
• Receipt of any other SARS-CoV-2, other experimental coronavirus, or experimental RSV vaccine at any time prior to the study
• Healthcare worker, long-term care or nursing home facility resident or employee, member of an emergency response team, or other occupation with high risk of exposure to SARS-CoV-2, and those working outside the home in customer facing occupations (e.g. waiter, cashier or store clerk, public transportation or taxi driver)
• Positive serum pregnancy test during Screening and/or positive urine pregnancy test on Day 1
• Breastfeeding during any period of study participation
• Occupational or household exposure to children <5 years of age or to immunocompromised persons
• Receipt of or scheduled to receive any other SARS-CoV-2 vaccine prior to Day 1. Once dosed with MV-014-212, subjects should not receive an authorized or approved COVID-19 vaccine until after the Day 57 visit (single-dose subjects) or the Day 92 visit (two-dose subjects)
• Any medical disease or condition that, in the opinion of the PI, precludes study participation. This includes acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 1, Single Dose, Intranasal Drops
Single intranasal dose on Day 1, by intranasal drops
• Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops
Single intranasal dose on Day 1, by intranasal drops
• Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops
Single intranasal dose on Day 1, by intranasal drops
• Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Two Doses, Intranasal Drops
Intranasal dose on Day 1 by intranasal drops. Followed by a second, identical dose on Day 36 by intranasal drops
• Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Spray
Single intranasal dose on Day 1, by intranasal spray

Locations

Country	Name	City	State
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Wake Research	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Meissa Vaccines, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stobart CC, Rostad CA, Ke Z, Dillard RS, Hampton CM, Strauss JD, Yi H, Hotard AL, Meng J, Pickles RJ, Sakamoto K, Lee S, Currier MG, Moin SM, Graham BS, Boukhvalova MS, Gilbert BE, Blanco JC, Piedra PA, Wright ER, Moore ML. A live RSV vaccine with engineered thermostability is immunogenic in cotton rats despite high attenuation. Nat Commun. 2016 Dec 21;7:13916. doi: 10.1038/ncomms13916. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Solicited adverse events (AEs)	Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that may occur after investigational vaccine administration.	Immediate post-vaccination period
Primary	Unsolicited AEs	Frequency of unsolicited AEs will be measured, categorized by severity. Unsolicited AEs are any untoward medical occurrences in a participant administered the investigational vaccine, regardless of causal relationship to the investigational vaccine. Unsolicited AEs can include unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of the investigational vaccine.	Immediate post-vaccination period
Primary	Serious adverse events (SAEs)	Frequency of SAEs will be measured, categorized by vaccine-relatedness. SAEs are AEs, whether considered causally related to the investigational vaccine or not, that threaten life or result in any of the following: death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect.	Full study duration, an average of 1 year
Primary	Medically attended adverse events (MAEs)	Frequency of MAEs will be measured, categorized by vaccine-relatedness. MAEs are AEs, whether considered causally related to the investigational vaccine or not, with unscheduled medically attended visits, such as urgent care visits, acute primary care visits, emergency department visits, or other previously unplanned visits to a medical provider. Scheduled medical visits such as routine physicals, wellness checks, 'check-ups', and vaccinations, are not considered MAEs.	Full study duration, an average of 1 year
Primary	Change in serum neutralizing antibody titers against vaccine-encoded SARS-CoV-2 S protein	Change in serum neutralizing antibody (nAb) titers against vaccine-encoded SARS-CoV-2 S protein will be measured per participant	Baseline through Day 29, an average of five (5) weeks
Secondary	Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein	Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein will be measured per participant	Baseline through Day 29, an average of five (5) weeks
Secondary	Potential vaccine virus shedding: frequency	Frequency of any post-vaccination shedding of vaccine virus (as detected by viral culture) will be measured per dosage group and overall	Baseline through Day 29, an average of four (4) weeks
Secondary	Potential vaccine virus shedding: magnitude	If post-vaccination shedding of vaccine virus is detected by culture, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall	Baseline through Day 29, an average of four (4) weeks
Secondary	Potential vaccine virus shedding: duration	If post-vaccination shedding of vaccine virus is detected by culture, duration of shedding (in days) will be measured per dosage group and overall	Baseline through Day 29, an average of four (4) weeks