Plant-Based Influenza Vaccine for Flu
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new plant-based flu vaccine to evaluate its safety and effectiveness in boosting the immune system. Researchers compare different doses of this recombinant influenza vaccine candidate in adults to determine the optimal dose for future use. Individuals in good health who haven't received a flu shot in the last four months and do not plan to get one soon may qualify for this study. As a Phase 1/Phase 2 trial, the study aims to understand the vaccine's effects and measure its effectiveness in an initial, smaller group, offering participants the chance to contribute to groundbreaking research.
Do I have to stop taking my current medications for the trial?
The trial requires that you do not take any medications or treatments that might alter the vaccine's immune response. Additionally, you should not use prophylactic medications like antihistamines or NSAIDs within 24 hours before the vaccination visit. It's best to discuss your current medications with the study team to see if they might affect your eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that recombinant influenza vaccines are generally safe and well-tolerated. One study found that these vaccines trigger immune responses in both children and adults with few side effects, most of which were mild, such as soreness or swelling at the injection site.
Another study found that serious adverse reactions occurred in only 1.1% of people who received a plant-based vaccine, a rate similar to those who received a placebo.
Overall, recipients of recombinant influenza vaccines mostly experienced mild or moderate side effects that resolved quickly. This suggests the vaccine is relatively safe for use.12345Why do researchers think this study treatment might be promising?
Researchers are excited about this plant-based recombinant influenza vaccine because it offers a novel way to combat the flu. Unlike traditional flu vaccines, which are typically developed using chicken eggs or cell-based methods, this vaccine is derived from plants. This plant-based approach could lead to faster production times and potentially lower costs, which is crucial during flu outbreaks. Additionally, the vaccine is designed to be effective at different dosages for varying age groups, which could optimize its effectiveness and broaden its protective reach. This innovative method could provide a more sustainable and adaptable solution to flu prevention.
What evidence suggests that this trial's treatments could be effective for flu?
Research has shown that plant-based flu vaccines might be more effective than traditional egg-based ones. One study found these vaccines prevented flu-related illnesses 70% of the time. Another study demonstrated complete protection in mice against a specific flu strain. Additionally, a different study found they reduced flu-related hospital visits by 36%. This trial will test various dosages of the plant-based recombinant influenza vaccine candidate across different age groups. Overall, early evidence suggests these new vaccines could offer strong protection against the flu.15678
Who Is on the Research Team?
Brian Ward, MD
Principal Investigator
McGill University
Are You a Good Fit for This Trial?
This trial is for adults aged 18 and older, including seniors, who are in good general health with a BMI of 39 or less. Participants must not live in institutionalized settings and should be able to follow study procedures.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study vaccine and are monitored for immediate adverse events
Short-term Follow-up
Participants are monitored for solicited local and systemic adverse events
Extended Follow-up
Participants are monitored for unsolicited adverse events and other safety measures
Long-term Follow-up
Participants are monitored for serious adverse events and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Recombinant Influenza vaccine candidate
Trial Overview
The study compares a new plant-based recombinant flu vaccine (trivalent VLP) to a standard commercial flu vaccine. It aims to test safety, immune response, and best dose in two age groups: adults under 65 and those 65 or older.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aramis Biotechnologies Inc.
Lead Sponsor
Citations
Projected impact of a plant-derived vaccine on the burden of ...
Plant-derived QVLP vaccines outperformed egg-derived vaccines in preventing influenza cases and influenza-related outcomes due to higher VE in both the 18–64 ...
Systematic review Efficacy of influenza vaccines and its ...
Pooled vaccine efficacy against laboratory-confirmed influenza was 48.48% (95% CI, 41.9–54.29), with significant heterogeneity (I2 = 70.1%; p < 0.0001).
3.
infectiousdiseaseadvisor.com
infectiousdiseaseadvisor.com/features/plant-based-vaccines-higher-cellular-response-for-influenza-potential-coronavirus/Plant-Based Vaccine Manufacturing for Influenza ...
The primary outcome was 70% absolute efficacy of the vaccine to prevent “laboratory-confirmed, respiratory illness caused by antigenically ...
Randomized Assessment of Influenza Vaccine Efficacy ...
The relative vaccine effectiveness (VE) of RIV compared with standard-dose IIV was 29% and was not statistically significant (95% Confidence ...
Plant-Produced Recombinant Influenza A Virus Candidate ...
Complete protection was observed in an experiment where immunized mice were challenged with 2xLD50 of A/Aichi/2/68 (H3N2) and 90% protection in the case of a ...
6.
vaccineadvisor.com
vaccineadvisor.com/news/recombinant-influenza-vaccine-immunogenic-in-pediatric-patients/Recombinant Influenza Vaccine Safe, Noninferior in ...
The quadrivalent recombinant influenza vaccine (RIV4) is well tolerated and demonstrates noninferior immune responses in pediatric and adult ...
Clinical Guidance for Seasonal Influenza Vaccine Safety
Some people experience no adverse events after receiving egg-based IIV3s. Some adverse events are relatively common (such as mild tenderness or ...
Safety of Recombinant Influenza Vaccine Compared to ... - PMC
This Phase 4 observational, postmarketing safety study included persons ≥18 years vaccinated with RIV3 or IIV3 in KPNC during the 2015–2016 influenza season.
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