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H1ssF Flu Vaccine Clinical Trial

This study is testing an experimental influenza (flu) vaccine called H1ssF vaccine against a licensed flu vaccine called Flucelvax seasonal vaccine. Researchers want to see how safe each vaccine is and how your body reacts to them. The H1ssF vaccine works using a nanoparticle mechanism. The study is looking for adults aged 18 to 70 years old who have received at least three seasonal flu vaccines in the past five years. To be considered successful, the study will track any side effects you might have for seven days after vaccination and any other adverse events for up to five weeks after a specific study visit. The current status of this study is unclear.

Study design
This is a Phase 1, open-label, randomized study with two groups, involving 112 participants. It compares the H1ssF vaccine to the Flucelvax seasonal vaccine.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for solicited side effects for 7 days after vaccination. Other adverse events will be tracked for up to 5 weeks after a study visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07340047

H1ssF Flu Vaccine Clinical Trial

Withdrawn
PHASE1Ages 18–70InterventionalPrevention
University of Minnesota
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:H1ssF vaccineFlucelvax seasonal vaccine

At a glance

Recruiting sites

Site status isn't published for this study.

What they're measuring
Occurrence of solicited local reactogenicity for 7 days after vaccine administration
Measured over Day 7
+3 more outcomes measured

Conditions

Influenza

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Influenza

Study leadership

  • Tim Schacker, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults aged 18-70 years inclusive.
Previous influenza immunization status:
The participant is able and willing to provide informed consent.
Medical chart review and medical history without clinically significant findings or concerns.
Physical examination without clinically significant findings or concerns.
Body mass index (BMI) ≤ 30 kg/m2. This inclusion criterion can be voided if the participant is otherwise eligible and the study team finds the participant suitable for the LN biopsy via LN palpation on the physical exam.
Screening laboratory results (blood) within institutional normal ranges (unless specified below otherwise). Screening lab tests include: CBCD, comprehensive metabolic panel (i.e., AST, ALT, ALP, BUN, creatinine, glucose, Na, K, Ca, total protein, albumin, total bilirubin), and HIV Ag/Ab test. Acceptance of screening lab results outside of the ranges below will need to be accompanied by a site investigator's approval.
Women of reproductive potential / premenopausal:
Sexual abstinence with male partners.
Surgical sterilization (tubal ligation).
Male condom with or without a spermicidal agent.
Female condom.
Diaphragm or cervical cap.
Intrauterine device (IUD) (published data shows that expected failure rate is \< 1% per year).
Hormone-based contraceptives including oral pills, injectables, implants, rings, and patches.
Partner has vasectomy.
The participant is agreeable to the following study requirements:

Exclusion

Breast-feeding or planning to become pregnant during the study.
Any of the following substances are exclusionary if currently used or planned to be used at any time during the 40-week study period:
History of any of the following clinically significant conditions:
History of ≥3 previous inguinal LN biopsies.
Not a suitable surgical candidate per investigators' assessment.

What this trial measures

  • Occurrence of solicited local reactogenicity for 7 days after vaccine administrationDay 7

    Number of participants with solicited local symptoms per protocol

  • Occurrence of solicited systemic reactogenicity for 7 days after vaccine administrationDay 7

    Number of participants with solicited systemic symptoms per protocol

  • Occurrence of adverse events of all severities from baseline through 1-week follow-up after the 2nd LN biopsy on week 4 study visitWeek 5

    Number of participants with any adverse event through week 5

  • Occurrence of serious adverse events at any time throughout the studyWeek 40

    Number of participants with any serious adverse event throughout the study