What side effects are associated with this type of intervention?

Intranasal vaccines for COVID-19, such as the recombinant live-attenuated bovine/human parainfluenza virus vector vaccine, commonly cause side effects like nasal congestion, runny nose, and mild irritation. Other widely used COVID-19 vaccines, including mRNA and adenovirus vector vaccines, typically report side effects such as injection site pain, fatigue, headache, muscle pain, chills, fever, and nausea. Serious side effects are rare but can include allergic reactions and, in very rare cases, blood clotting disorders.

What prior FDA approvals exist?

The FDA has granted emergency use approvals for several COVID-19 vaccines, including the BNT162 vaccine by Pfizer/BioNTech and the mRNA-1273 vaccine by Moderna Inc. These vaccines have shown around 95% clinical efficacy. Additionally, a Phase 1 clinical trial is evaluating the safety and immunogenicity of an intranasal vaccine candidate, which uses a recombinant, live-attenuated bovine/human parainfluenza virus vector expressing the SARS-CoV-2 spike protein. This approach is part of ongoing efforts to develop diverse and effective COVID-19 treatments.

What other types of research exist?

Promising alternatives to the intranasal vaccine candidate for COVID-19 include: 1) ChAd-SARS-CoV-2-S, a chimpanzee adenovirus-vectored vaccine encoding a prefusion stabilized spike protein, which induces robust systemic humoral and cell-mediated immune responses. 2) Ad26.COV2.S, a recombinant adenovirus serotype 26 vaccine expressing a prefusion stabilized SARS-CoV-2 spike antigen, which has shown immunogenicity and protective efficacy in preclinical models. 3) BNT162b2, an mRNA vaccine that has demonstrated immunogenicity and safety in both the general population and patients with autoimmune inflammatory rheumatic diseases.

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Virus Therapy

Nasal Spray Vaccine for COVID-19

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Nonpregnant adults between 18 years and 50 years of age, inclusive

Be between 18 and 65 years old

Must not have

Body mass index (BMI) < 18.5 or >40

A history of asthma within the past 5 years, or a current diagnosis of asthma or reactive airway disease associated with exercise, seasonal hay fever or allergic rhinitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on days 63, 70, 84, 180, 360

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed but may include typical reactions to vaccines such as nasal irritation from the spray delivery method, sneezing, headache, feverish feeling or mild respiratory symptoms due to its nature as an intranasal live attenuated vector vaccine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 50 years old and not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is either below 18.5 or above 40.

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I have had asthma or related symptoms due to allergies or exercise in the last 5 years.

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My lung function tests are below the normal range for my age, gender, and height.

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I have had Bell's palsy before.

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I have had my spleen removed.

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I have had significant issues or surgery related to my nose or upper throat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on days 63, 70, 84, 180, 360

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on days 63, 70, 84, 180, 360

This trial's timeline: 3 weeks for screening, Varies for treatment, and on days 63, 70, 84, 180, 360 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evidence of a >4-fold rise in HPIV3 antibody titers

To determine the frequency of vaccine-related lower respiratory illness

To determine the frequency of vaccine-related solicited adverse events (AEs)

+2 more

Secondary study objectives

Rise in serum neutralizing antibody titer to SARS-CoV-2 S protein

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intranasal VaccineExperimental Treatment1 Intervention

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for COVID-19 include antiviral therapies, immunomodulators, and vaccines. Antiviral therapies, such as remdesivir, work by inhibiting viral replication, thereby reducing the viral load and severity of the disease. Immunomodulators, like dexamethasone, help to modulate the immune response, reducing inflammation and preventing complications such as acute respiratory distress syndrome. Vaccines, including the intranasal vaccine candidate using a live-attenuated bovine/human parainfluenza virus vector, aim to stimulate the immune system to recognize and combat the virus effectively. This particular vaccine expresses the prefusion-stabilized SARS-CoV-2 spike protein, which is crucial for eliciting a strong and targeted immune response. These treatments are vital for COVID-19 patients as they can reduce disease severity, prevent complications, and enhance immunity, ultimately decreasing morbidity and mortality.

The increasing importance of the novel Coronavirus.