Nasal Vaccine for Respiratory Syncytial Virus

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Codagenix, Inc

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to CodaVax-RSV in healthy children. They will be vaccinated in spring to early autumn 2023 and followed through the 2023-24 RSV season. 18 children aged 2 to 5 years who are RSV-seropositive (have antibodies to RSV) and 33 children aged 6 months to \< 2 years who are RSV-seronegative (do not have antibodies to RSV) will be enrolled in escalating-dose cohorts. A safety committee will review the safety profile of each dosing group before the next dose-escalation. Children will receive 2 doses of the vaccine at one of several dose levels or placebo (saline solution with no active ingredient) as nose drops; doses will be 28 days apart. A parent/guardian will record temperature and other conditions in a diary daily for 7 days after each dose. The parent/guardian will be contacted by telephone on the day after Dose 1 for safety assessment and review of the diary data. Children will return to the clinic 3, 7, 14, and 28 days after each dose. The parent/guardian will then be contacted by telephone monthly until 1 year after the second dose. Study procedures include physical examinations, vital signs, and collections of blood and nose/throat swab samples to look at safety of the vaccine and to analyze body's immune response.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether participants must stop taking their current medications.

What data supports the idea that Nasal Vaccine for Respiratory Syncytial Virus is an effective treatment?

The available research does not provide any data on the effectiveness of the Nasal Vaccine for Respiratory Syncytial Virus. The studies listed focus on treatments for avian influenza and snakebites, not on the Nasal Vaccine for RSV. ^{1 2 3 4 5}

What safety data exists for the nasal RSV vaccine?

The nasal RSV vaccine, including candidates like PanAd3-RSV and MVA-RSV, has been evaluated in several clinical trials. These trials have shown that the vaccines are generally safe and well-tolerated in both adults and children. Common adverse events were mild, such as injection site reactions, and no serious vaccine-related adverse events were reported. The trials also demonstrated immunogenicity, with increased RSV-specific antibody and T cell responses. Further clinical evaluation is needed to assess efficacy. ^{6 7 8 9 10}

Is CodaVax-RSV a promising treatment for Respiratory Syncytial Virus?

The information provided does not mention CodaVax-RSV, so we cannot determine if it is a promising treatment for Respiratory Syncytial Virus based on the given research articles. ^{6 7 8 11 12}

Research Team

Eligibility Criteria

This trial is for healthy children who had a full-term birth. Kids aged 2-5 with RSV antibodies and those 6 months to under 2 years without these antibodies can join. They shouldn't be in close contact with certain vulnerable individuals or have conditions affecting their immune system.

Inclusion Criteria

Part A: 2 to 5 years, inclusive

Part B: RSV-seronegative

RSV Status at Screening:

Exclusion Criteria

Pregnant women

Household contact of another child enrolled into the study

I am currently taking medication that weakens my immune system.

Treatment Details

Interventions

• CodaVax-RSV (Virus Therapy)

Trial Overview The study tests CodaVax-RSV, a vaccine given as nose drops to prevent Respiratory Syncytial Virus (RSV). Children will get either the vaccine at different doses or a placebo, across two shots spaced by 28 days. Their health will be monitored over the RSV season.

Participant Groups

Group I: Experimental: CodaVax-RSV 10^6 PFU Experimental Treatment 1 Intervention

Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops

Group II: Experimental: CodaVax-RSV 10^5 PFU Experimental Treatment 1 Intervention

Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops

Group III: Experimental: CodaVax-RSV 10^4 PFU Experimental Treatment 1 Intervention

Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops

Group IV: Experimental: CodaVax-RSV 10^3 PFU Experimental Treatment 1 Intervention

Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops

Group V: Placebo comparator Placebo Group 1 Intervention

Administered as nose drops

Who Is Running the Clinical Trial?

Codagenix, Inc

Lead Sponsor

Trials

8

Recruited

380+

Findings from Research

The study developed a human monoclonal antibody (mAb 6-137) that specifically targets the H7 hemagglutinin (HA) of the H7N9 virus, showing high affinity and effective neutralization in vitro at very low concentrations (as low as 78 ng/mL).

In murine models, mAb 6-137 provided significant protection against lethal H7N9 virus challenges, indicating its potential as both a preventive and therapeutic treatment option for H7N9 infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A broadly neutralizing human monoclonal antibody against the hemagglutinin of avian influenza virus H7N9. Li, J., Zhang, L., Bao, L., et al.[2022]

In a study of 26 pediatric patients with rattlesnake envenomation treated with Crotalidae equine immune F(ab') 2 antivenom (F(ab') 2 AV), the treatment was found to be well tolerated, with only two patients experiencing mild infusion reactions that were easily managed.

No serious complications, recurrent symptoms, or readmissions were reported after discharge, indicating that F(ab') 2 AV is a safe and effective option for treating rattlesnake bites in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Rattlesnake Envenomations Treated With Crotalidae Equine Immune F(Ab') 2 Antivenom : A 3-Year Retrospective Observational Analysis. Seltzer, JA., Winkler, GA., Friedman, NA., et al.[2023]

The implementation of a nationally developed snakebite treatment protocol in India led to a 66% reduction in the amount of anti-snake venom (ASV) used, indicating more efficient use of resources in treating snakebite victims.

The protocol also correlated with a trend towards reduced mortality, showing an absolute reduction of 24%, suggesting that structured treatment guidelines can improve patient outcomes in snakebite cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A locally developed snakebite management protocol significantly reduces overall anti snake venom utilization in West Bengal, India. Ghosh, S., Maisnam, I., Murmu, BK., et al.[2008]

In a study of 176 snake bite patients, neurotoxic snake bites were identified as a significant risk factor for mortality, indicating that these types of bites pose a greater threat to patient survival.

The study found that early adverse reactions to anti-snake venom (ASV) occurred in only 4% of patients, and most received premedication with corticosteroids, suggesting that ASV is generally safe but may be less effective for neurotoxic bites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective study of use of polyvalent anti-snake venom and risk factors for mortality from snake bite in a tertiary care setting. Pore, SM., Ramanand, SJ., Patil, PT., et al.[2018]

In a study of 12 pediatric patients treated for rattlesnake bites, Crotalinae polyvalent immune Fab (ovine) antivenom was found to be safe, with no allergic reactions or permanent side effects reported.

The antivenom effectively controlled symptoms of envenomation, with severity scores stabilizing or improving within 24 hours after administration, using an average of 7.7 vials for initial symptom control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crotaline Fab antivenom for the treatment of children with rattlesnake envenomation. Offerman, SR., Bush, SP., Moynihan, JA., et al.[2019]

The ChAd155-RSV vaccine was well tolerated in a phase I/II trial with 82 RSV-seropositive children aged 12-23 months, showing no serious adverse events or RSV-related hospitalizations over a 2-year follow-up.

A dose-dependent immune response was observed, with increased RSV-A neutralizing antibody titers after the first dose, but no significant boost in antibody levels after the second dose, indicating the need for further studies in RSV-seronegative children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus (RSV) Vaccine in Healthy RSV-Seropositive Children 12-23 Months of Age. Díez-Domingo, J., Sáez-Llorens, X., Rodriguez-Weber, MA., et al.[2023]

The investigational ChAd155-RSV vaccine was found to have a safety profile similar to other childhood vaccines, with most adverse events occurring at rates comparable to or lower than those of active comparators.

The vaccine induced a strong immune response in infants, with higher RSV neutralizing titers and antibody concentrations compared to the comparator group, and there was no evidence of vaccine-associated enhanced respiratory disease (VAERD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a ChAd155-vectored respiratory syncytial virus vaccine in infants 6-7 months of age: a phase 1/2 randomized trial. Sáez-Llorens, X., Norero, X., Mussi-Pinhata, MM., et al.[2023]

The Ad26.RSV.preF vaccine candidate showed good safety and immunogenicity in a study involving 12 adults and 36 RSV-seropositive children, with no serious adverse events reported and only mild to moderate reactions observed.

The vaccine significantly increased RSV neutralization titers in children and resulted in fewer RSV infections compared to the placebo group, indicating its potential effectiveness in preventing RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1/2a Safety and Immunogenicity of an Adenovirus 26 Vector Respiratory Syncytial Virus (RSV) Vaccine Encoding Prefusion F in Adults 18-50 Years and RSV-Seropositive Children 12-24 Months. Stuart, ASV., Virta, M., Williams, K., et al.[2023]

The PanAd3-RSV and MVA-RSV vaccines were found to be safe and well tolerated in a phase 1 clinical trial involving 42 healthy adults, with only mild injection site reactions reported and no serious adverse events.

Both vaccines effectively induced immune responses, including increased RSV neutralizing antibodies and T cell responses, suggesting they could be promising candidates for further evaluation in preventing RSV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimpanzee adenovirus- and MVA-vectored respiratory syncytial virus vaccine is safe and immunogenic in adults. Green, CA., Scarselli, E., Sande, CJ., et al.[2023]

In a phase 2a trial with 63 healthy participants aged 18 to 50, the MVA-BN-RSV vaccine significantly reduced viral load and symptoms of RSV infection compared to placebo, demonstrating an efficacy of 79.3% to 88.5%.

The vaccine also induced strong immune responses, with a fourfold increase in antibody levels and a significant rise in interferon-γ-producing cells, while only causing mild side effects like injection site pain and no serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced Respiratory Syncytial Virus Load, Symptoms, and Infections: A Human Challenge Trial of MVA-BN-RSV Vaccine. Jordan, E., Kabir, G., Schultz, S., et al.[2023]

The RSVNanoVax vaccine candidate, developed using polyanhydride nanoparticles and the RSV prefusion F protein, successfully induced long-lasting immunity in outbred Swiss Webster mice, with protective antibody responses sustained for at least 1 year post-vaccination.

Vaccinated mice showed rapid clearance of the RSV virus from their lungs after challenge, indicating that RSVNanoVax could provide effective protection against respiratory syncytial virus infections in a genetically diverse population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Lasting Protection Induced by a Polyanhydride Nanovaccine against Respiratory Syncytial Virus in an Outbred Mouse Model. Stephens, LM., Ross, KA., McLellan, JS., et al.[2023]

References

1. China pubmed.ncbi.nlm.nih.gov

A broadly neutralizing human monoclonal antibody against the hemagglutinin of avian influenza virus H7N9. [2022]

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

Pediatric Rattlesnake Envenomations Treated With Crotalidae Equine Immune F(Ab') 2 Antivenom : A 3-Year Retrospective Observational Analysis. [2023]

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

A locally developed snakebite management protocol significantly reduces overall anti snake venom utilization in West Bengal, India. [2008]

4. India pubmed.ncbi.nlm.nih.gov

A retrospective study of use of polyvalent anti-snake venom and risk factors for mortality from snake bite in a tertiary care setting. [2018]

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

Crotaline Fab antivenom for the treatment of children with rattlesnake envenomation. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of novel respiratory syncytial virus (RSV) vaccines based on the RSV viral proteins F, N and M2-1 encoded by simian adenovirus (PanAd3-RSV) and MVA (MVA-RSV); protocol for an open-label, dose-escalation, single-centre, phase 1 clinical trial in healthy adults. [2019]

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

Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus (RSV) Vaccine in Healthy RSV-Seropositive Children 12-23 Months of Age. [2023]

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

Safety and immunogenicity of a ChAd155-vectored respiratory syncytial virus vaccine in infants 6-7 months of age: a phase 1/2 randomized trial. [2023]

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

Phase 1/2a Safety and Immunogenicity of an Adenovirus 26 Vector Respiratory Syncytial Virus (RSV) Vaccine Encoding Prefusion F in Adults 18-50 Years and RSV-Seropositive Children 12-24 Months. [2023]

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

Chimpanzee adenovirus- and MVA-vectored respiratory syncytial virus vaccine is safe and immunogenic in adults. [2023]

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

Reduced Respiratory Syncytial Virus Load, Symptoms, and Infections: A Human Challenge Trial of MVA-BN-RSV Vaccine. [2023]

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

Long-Lasting Protection Induced by a Polyanhydride Nanovaccine against Respiratory Syncytial Virus in an Outbred Mouse Model. [2023]