Phase 1
N=52
Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine in Healthy Adults
Influenza Infection
Bottom Line
View on ClinicalTrials.gov: NCT03814720 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration — 5; 8; 11; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- VRC-FLUNPF099-00-VP (H1ssF_3928) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration |
5; 8; 11; 9; 9; 42 | — |
| PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration |
5; 11; 11; 10; 9; 46 | — |
| PRIMARY Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration |
0; 1; 0; 1; 0; 2 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration |
0; 1; 0; 3; 0; 4 | — |
| PRIMARY Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration |
1; 1; 0; 0; 2; 4 | — |
| SECONDARY Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen |
618; 536; 212; 170; 283; 916 | — |
Summary
Background:
The flu is a common viral infection that can be deadly for certain people. Vaccines against flu have been developed to teach the body to prevent or fight the infection. A new vaccine may help the body to make an immune response to H1 flu, a flu strain that infects humans.
Objective:
To test the safety and effectiveness of the H1 Stabilized Stem Ferritin vaccine (VRC-FLUNPF099-00-VP).
Eligibility:
Healthy people ages 18-70 years old who got at least 1 licensed flu vaccine since January 1, 2014.
Design:
Participants received 1 or 2 vaccinations by injections (shots) in the upper arm muscle over 4 months. Participants received a thermometer and recorded their temperature and symptoms every day a diary card for 7 days after each injection. The injection site was checked for redness, swelling, or bruising.
Participants had 9-11 follow-up visits over 12-15 months. At follow-up visits, participants had blood drawn and were checked for health changes or problems. Participants who reported influenza-like illness had nose and throat swabs for evaluation of viral infection.
Some participants had apheresis. A needle was placed into a vein in both arms. Blood was removed through a needle in the vein of one arm. A machine removed the white blood cells and then the rest of the blood was returned to the participant through a needle in the other arm.
A separate consent was provided to participants for genetic testing on their samples.
Eligibility Criteria
INCLUSION CRITERIA
- Healthy adults between the ages of 18-70 years inclusive
- Based on history and examination, in good general health and without history of any of the conditions listed in the exclusion criteria
- Received at least one licensed influenza vaccine from 2014 to the present
- Able and willing to complete the informed consent process
- If enrolled in Group 1: Available for clinic visits for 52 weeks after enrollment and through an influenza season
- If enrolled in Group 2A, 2B, 2C, or 2D: Available for clinic visits for 68 weeks after enrollment and through an influenza season
- Willing to have blood samples collected, stored indefinitely, and used for research purposes
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 28 days before enrollment
Laboratory Criteria within 28 days before enrollment
- White blood cells (WBC) and differential either within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval
- Total lymphocyte count greater than or equal to 800 cells/mm^3
- Platelets = 125,000 - 500,000/mm3
- Hemoglobin within institutional normal range
- Serum iron either within institutional normal range or accompanied by the site PI or designee approval
- Serum ferritin within institutional normal range or accompanied by the site PI or designee approval
- Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) less than or equal to 1.25 x institutional ULN
- Alkaline phosphatase (ALP) 140 mmHg or diastolic > 90 mmHg)
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- Malignancy that is active or history of malignancy that is likely to recur during the period of the study.
- Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- Guillain-Barré Syndrome
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant's ability to give informed consent.
Data sourced from ClinicalTrials.gov (NCT03814720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.