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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new nasal spray vaccine to determine its safety and effectiveness in helping the body combat COVID-19. The vaccine, called B/HPIV3/S-6P, uses a modified virus to provide protection by targeting the coronavirus spike protein. It is administered in two doses, 56 days apart. Ideal participants are healthy adults who have not had asthma in the past five years and have neither been vaccinated nor infected with COVID-19 in the last 16 weeks. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this innovative vaccine.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the B/HPIV3/S-6P vaccine, administered as a nasal spray, is generally safe. In earlier studies, researchers tested this vaccine on rhesus macaques, monkeys similar to humans. These monkeys received the vaccine nasally and tolerated it well, with no major side effects reported.

The vaccine is now undergoing early human trials to further assess its safety. The main goal is to ensure people can use it without serious side effects. As this is an early trial, researchers are carefully monitoring for any reactions. Its progression to human testing suggests that the initial safety results are promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard COVID-19 vaccines, which are typically injected into the muscle, the B/HPIV3/S-6P vaccine is given as a nasal spray. This delivery method could potentially offer easier administration and greater acceptance among people who are needle-averse. Furthermore, by being administered intranasally, it might stimulate a strong immune response directly in the respiratory tract, which is the primary entry point for the virus. Researchers are excited about this approach because it could enhance the body's ability to block the virus right where it enters, potentially leading to better protection.

What evidence suggests that this nasal spray vaccine might be an effective treatment for COVID-19?

Research has shown that the B/HPIV3/S-6P nasal spray vaccine, which participants in this trial will receive, shows promise for COVID-19. In studies with animals like rhesus macaques, a single dose led to strong immune responses. This indicates that the vaccine effectively helped the body build defenses against the virus. It also produced stronger antibody responses compared to a similar vaccine. These early results suggest it might help protect against COVID-19 if humans respond similarly. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11189492

Paramyxoviruses as Vaccine Vectors Against Severe ... In a first study, the safety of B/HPIV3/S-6P following intranasal immunization was evaluated in adults (NCT06026514). The clinical evaluation has been completed ...

2. journals.plos.org journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1012585

Intranasal parainfluenza virus-vectored vaccine expressing ... B/HPIV3/S-6P was highly immunogenic and protective against the vaccine ... Based on these results, B/HPIV3/S-Delta-6P and B/HPIV3/S-Omicron-6P are also ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0092867422014180

Intranasal pediatric parainfluenza virus-vectored SARS- ... In this study, we evaluated the safety and efficacy of a single intranasal/intratracheal (IN/IT) dose of B/HPIV3/S-6P in rhesus macaques.

4. biorxiv.org biorxiv.org/content/biorxiv/early/2025/10/22/2025.10.22.683849.full.pdf

Co-administration of intranasal parainfluenza virus ... Based on these data, B/HPIV3/S-6P expressing the ancestral S is. 353 currently being evaluated in a phase I clinical trial (Clinicaltrials ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10325082/

Live-attenuated pediatric parainfluenza vaccine expressing ... B/HPIV3/S-6P induced significantly stronger anti-S serum IgA and IgG responses than B/HPIV3/S-2P. A single intranasal immunization with B/HPIV3/S-6P elicited ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9164439/

Intranasal pediatric parainfluenza virus-vectored SARS ... In the present study, we evaluated the safety and efficacy of a single intranasal/intratracheal (IN/IT) dose of B/HPIV3/S-6P in rhesus macaques (RM).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06026514?cond=cow%20lung&viewType=Table&checkSpell=&rank=10

Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal ... This Phase 1 clinical trial will evaluate the safety and immunogenicity of an intranasal vaccine candidate, a recombinant, live-attenuated, bovine/human ...