Flu and COVID-19 Vaccines for Virus Protection

No longer recruiting at 21 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BioNTech SE

Must not be taking: Antivirals

Disqualifiers: Recent flu or COVID vaccine

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of flu and COVID-19 vaccines both separately and in combination. It aims to understand how different vaccine combinations can enhance protection against these viruses. Participants will receive one shot in each arm, which may include a flu vaccine, a COVID-19 vaccine, or a combination of both. Healthy adults who have not received a flu or COVID vaccine for the 2024-2025 season and have not recently used antiviral flu treatments are suitable candidates for this study. As a Phase 1/Phase 2 trial, the research focuses on understanding the vaccines' effects and measuring their effectiveness in an initial, smaller group, offering participants an opportunity to contribute to important vaccine development.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have been treated with antiviral therapies for influenza, you must not have taken them within 180 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies found the COVID-19 vaccine being tested to be well tolerated, triggering expected immune responses without major safety concerns. Some participants experienced reactions like sore arms or mild fever, but these were not serious.

The combined flu and COVID-19 vaccine also presented no serious safety issues. Mild side effects, such as pain at the injection site, were more common, with people generally experiencing mild discomfort that resolved on its own.

No serious adverse reactions have been linked to the investigational flu vaccine. Mild reactions, such as soreness or low-grade fever, can occur but are usually manageable and temporary.

Overall, research shows these vaccines are generally safe, with mostly mild and short-lived side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore innovative ways to protect against both influenza and COVID-19 with combined vaccines. Unlike the standard approach of separate vaccinations for flu and COVID-19, these combination vaccines aim to streamline protection by targeting both viruses in a single shot. This could simplify vaccination schedules and potentially increase vaccine uptake. Additionally, the investigational influenza vaccines are being tested to see if they offer broader or more robust protection compared to existing licensed flu vaccines. The potential for a combined vaccine and improved flu vaccines opens the door to more efficient and effective virus protection strategies.

What evidence suggests that this trial's treatments could be effective for virus protection?

Studies have shown that the COVID-19 vaccine, such as GEO-CM04S1, which participants in this trial may receive, offers strong protection against the virus by triggering a robust immune response. This vaccine targets different parts of the virus, potentially leading to broader protection.

For the combination vaccine for flu and COVID-19, another treatment option in this trial, research suggests that these combined shots may enhance the body's defenses against both viruses more effectively than separate shots. This approach could offer better overall protection, although past studies have shown mixed results regarding their effectiveness.

Regarding the investigational flu vaccine also studied in this trial, previous patients demonstrated increased levels of protective antibodies, which are proteins that help fight infections. However, these vaccines generally show moderate effectiveness, meaning they help but aren't completely foolproof against the flu. ^{4 6 7 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Healthy individuals aged 18 or older are eligible for this study, which examines responses to flu and COVID-19 vaccines. Participants will receive shots in both arms and must commit to at least three visits over six months.

Inclusion Criteria

Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Exclusion Criteria

I have taken antiviral medication for the flu in the last 6 months.

I have received a flu or COVID-19 vaccine for the 2024-2025 season.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one shot in each arm, either a flu or COVID vaccine, alone or mixed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

At least 3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• COVID-19 Vaccine
• Influenza and COVID Combination Vaccine
• Investigational Influenza Vaccine
• Licensed Influenza Vaccine 1
• Licensed Influenza Vaccine 2

Trial Overview The trial is testing how people respond to different combinations of flu and COVID-19 vaccines. This includes licensed influenza vaccines, an investigational influenza vaccine, a combination vaccine, a standalone COVID-19 vaccine, and placebos.

How Is the Trial Designed?

Group I: Arm N Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 7) and Placebo

Group II: Arm M Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 6) and Placebo

Group III: Arm L Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 5) and Placebo

Group IV: Arm K Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 4) and Placebo

Group V: Arm J Experimental Treatment 2 Interventions

Investigational Influenza Vaccine (Dose 3) and Placebo

Group VI: Arm I Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 3) and Placebo

Group VII: Arm H Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 2) and Placebo

Group VIII: Arm G Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 1) and Placebo

Group IX: Arm F Experimental Treatment 2 Interventions

Investigational Influenza Vaccine (Dose 2) and Placebo

Group X: Arm D Experimental Treatment 2 Interventions

Investigational Influenza Vaccine (Dose 1) and Placebo

Group XI: Arm B Experimental Treatment 2 Interventions

COVID-19 Vaccine (Dose 2) and Placebo

Group XII: Arm A Experimental Treatment 2 Interventions

COVID-19 Vaccine (Dose 1) and Placebo

Group XIII: Arm C Active Control 2 Interventions

COVID-19 Vaccine (Dose 3) and Placebo

Group XIV: Arm E Active Control 2 Interventions

Licensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3)

Group XV: Arm EE Active Control 2 Interventions

Licensed Influenza Vaccine 2 and COVID-19 Vaccine (Dose 3)

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Most adverse events reported from COVID-19 vaccines were mild or moderate, indicating a generally favorable safety profile during clinical trials.

However, some viral vector-based vaccines were associated with thrombotic events, highlighting the need for ongoing studies and post-marketing surveillance to fully understand potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[COVID-19 vaccine safety]. Chaparro Mérida, NA., Moreno Samper, D., Lacato, AOF.[2022]

A new combination vaccine platform has been developed that incorporates a part of the SARS-CoV-2 spike protein onto influenza A virus particles, which successfully elicited neutralizing antibodies and protected mice from both viruses.

This approach leverages existing influenza vaccine production infrastructure, potentially allowing for a cost-effective and scalable seasonal vaccine that can be easily reformulated to address emerging variants of both influenza and SARS-CoV-2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virion-Based Combination Vaccine Protects against Influenza and SARS-CoV-2 Disease in Mice. Chaparian, RR., Harding, AT., Hamele, CE., et al.[2023]

During the first 6 months of the US COVID-19 vaccination program, over 298 million doses of mRNA vaccines were administered, with the majority of reported adverse events being mild and short-lived, indicating a favorable safety profile.

Out of 340,522 reports to the Vaccine Adverse Event Reporting System (VAERS), 92.1% were classified as non-serious, and less than 1% of participants sought medical care after vaccination, suggesting that while reactogenicity was common, it was generally manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. Rosenblum, HG., Gee, J., Liu, R., et al.[2023]

Citations

1. geovax.com geovax.com/investors/press-releases/geovax-highlights-dual-protective-potential-of-geo-cm04s1-following-presentation-at-the-aai-annual-meeting-2026

GeoVax Highlights Dual Protective Potential of GEO-CM04S1 ... The vaccine expresses both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2, offering the potential for broader and more durable immune protection ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04639466

NCT04639466 | A Synthetic MVA-based SARS-CoV-2 ... This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously designated as COH04S1), a synthetic modified vaccinia Ankara ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10018591/

Synthetic multiantigen MVA vaccine COH04S1 and variant- ... COH04S1 afforded protection against SARS-CoV-2 ancestral virus and Beta and Delta variants in Syrian hamster and non-human primate models ...

4. cityofhope.org cityofhope.org/city-stories-blog/coh-covid-vaccine

Investigational COVID Vaccine Moves to Phase 2B Trial Diamond's team reported that people vaccinated with GEO-CM04S1 had a strong T cell immune response to both the spike and nucleocapsid antigens ...

5. cancer.gov cancer.gov/clinicaltrials/NCI-2023-04071

SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA ... GEO-CM04S1 works by inducing immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The immune system is stimulated to produce ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04639466

NCT04639466 | A Synthetic MVA-based SARS-CoV-2 ... This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously designated as COH04S1), a synthetic modified vaccinia Ankara ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8906816/

Safety and immunogenicity of a synthetic multiantigen ... COH04S1 was well tolerated and induced spike-specific and nucleocapsid-specific antibody and T-cell responses. Future evaluation of this COVID- ...

8. geovax.com geovax.com/investors/press-releases/geovax-reaffirms-commitment-to-evidence-based-vaccine-safety-and-development-of-geo-cm04s1-for-vulnerable-populations

Press Releases GEO-CM04S1 is a next-generation, multi-antigen COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary ...

9. cityofhope.org cityofhope.org/news/data-published-in-lancet-microbe-on-phase-1-clinical-trial

Data published in a Lancet journal on COH04S1, ... GeoVax's product pipeline includes two ongoing Phase 2 clinical trials of GEO-CM04S1 (formerly COH04S1) for COVID-19 as a universal booster ...