Nasal Spray Vaccine for COVID-19

Overseen By Kawsar Talaat, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Steroids, Immunosuppressants, Intranasal medications

Disqualifiers: Pregnancy, Asthma, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

27 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop using systemic or nasal steroid preparations, immunosuppressive drugs, and intranasal medications like steroids, decongestants, or hormonal medications at least 30 days before vaccination. Topical steroid preparations are allowed.

What data supports the effectiveness of the nasal spray vaccine treatment B/HPIV3/S-6P for COVID-19?

Research shows that the B/HPIV3/S-6P nasal spray vaccine, when tested in hamsters, led to strong immune responses and protection against different COVID-19 variants, including Omicron. This suggests it could be effective in preventing COVID-19 in humans. ^{1 2 3 4 5}

Is the nasal spray vaccine B/HPIV3/S-6P safe for humans?

The nasal spray vaccine B/HPIV3/S-6P has been tested in hamsters and showed protection against COVID-19 without any reported safety issues in these animals. However, there is no specific safety data available for humans yet. ^{1 2 6 7 8}

How is the nasal spray vaccine B/HPIV3/S-6P different from other COVID-19 treatments?

The nasal spray vaccine B/HPIV3/S-6P is unique because it is administered intranasally (through the nose) and uses a live-attenuated virus vector to deliver a stabilized version of the SARS-CoV-2 spike protein, potentially offering protection against multiple variants of the virus. This approach aims to induce strong local immunity in the respiratory tract, which is the primary site of infection for COVID-19. ^{1 2 5 9 10}

What is the purpose of this trial?

This trial tests a new nasal spray vaccine on about 30 healthy volunteers. The vaccine uses a weakened virus to help the body recognize and fight COVID-19. Volunteers will be monitored for a long period after receiving the vaccine.

Eligibility Criteria

Adults aged 18-50 in good health, not pregnant or breastfeeding, who haven't had a live vaccine within 4 weeks or killed vaccine within 2 weeks before the study. They must avoid other vaccines for 90 days post-enrollment and use effective birth control. Excludes those with significant illnesses, drug abuse history, recent investigational product use, BMI <18.5 or >40, certain medication uses including steroids and immunosuppressives.

Inclusion Criteria

I agree not to donate blood during the study and for a year after my second vaccine dose.

Demonstrates comprehension of the protocol procedures and knowledge of the trial by passing a written comprehension examination (passing grade > 70%)

Persons of childbearing potential must have used effective birth control methods for at least one month prior to vaccination, and agree to continue with 'per label/fully effective use' for the chosen method for the duration of the study (30 days prior to first vaccination until 12 months after first vaccination), from amongst these: pharmacologic/hormonal contraceptives, condoms or diaphragm with spermicide, intrauterine device, absolute abstinence from heterosexual intercourse as a matter of normal preferred lifestyle, or must be surgically sterile or have documented menopause, having had no menses at all for at least one full year

Exclusion Criteria

I haven't used systemic or nasal steroids or immunosuppressants in the last 30 days.

I have used, or plan to use, nasal sprays or medications in the last 4 weeks.

I haven't had live vaccines in 4 weeks or killed vaccines in 2 weeks, except for the flu shot.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 doses of the B/HPIV3/S-6P vaccine intranasally, 56 days apart

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• B/HPIV3/S-6P

Trial Overview The trial is testing an intranasal COVID-19 vaccine called B/HPIV3/S-6P to see if it's safe and can stimulate the immune system effectively. It's given as a nasal spray using a modified virus to deliver parts of the SARS-CoV-2 spike protein into the body.

Participant Groups

Group I: Intranasal Vaccine Experimental Treatment 1 Intervention

B/HPIV3/S-6P vaccine intranasally given in 2 doses, 56 days apart.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Johns Hopkins Bloomberg School of Public Health

Collaborator

Trials

441

Recruited

2,157,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

In a study of 1842 patients who visited the emergency department within 10 days of receiving COVID-19 vaccines, the most common reasons for visits included trauma, hypertensive emergencies, and generalized pain, with a mortality rate of 2.2%.

The study found that serious adverse events (AEs) following vaccination were significantly lower than those associated with COVID-19 infections, indicating that while AEs can occur, they are less frequent and less severe compared to the risks of the virus itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and outcomes of adverse events after COVID-19 vaccination. Kewan, T., Flores, M., Mushtaq, K., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Live-attenuated pediatric parainfluenza vaccine expressing 6P-stabilized SARS-CoV-2 spike protein is protective against SARS-CoV-2 variants in hamsters. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Live-attenuated pediatric parainfluenza vaccine expressing 6P-stabilized SARS-CoV-2 spike protein is protective against SARS-CoV-2 variants in hamsters. [2023]

3. China pubmed.ncbi.nlm.nih.gov

A triple-RBD-based mucosal vaccine provides broad protection against SARS-CoV-2 variants of concern. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Nasal Spray of Neutralizing Monoclonal Antibody 35B5 Confers Potential Prophylaxis Against Severe Acute Respiratory Syndrome Coronavirus 2 Variants of Concern: A Small-Scale Clinical Trial. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A Pilot Study of 0.4% Povidone-Iodine Nasal Spray to Eradicate SARS-CoV-2 in the Nasopharynx. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Characteristics and outcomes of adverse events after COVID-19 vaccination. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Active Safety Surveillance of Four Types of COVID-19 Vaccines: A National Study from Jordan. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A single intranasal dose of a live-attenuated parainfluenza virus-vectored SARS-CoV-2 vaccine is protective in hamsters. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Respiratory mucosal delivery of next-generation COVID-19 vaccine provides robust protection against both ancestral and variant strains of SARS-CoV-2. [2022]