Dose, Safety, Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine, VRC-FLUNPF0103-00-VP, in Healthy Adults
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT04579250 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- VRC-FLUNPF0103-00-VP (H10ssF-6473) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H10ssF-6473 Product Administration |
3; 9; 5; 17; 0; 5 | — |
| PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H10ssF-6473 Product Administration |
2; 9; 8; 19; 1; 5 | — |
| PRIMARY Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H10ssF-6473 Product Administration |
1; 4; 0; 5; 1; 7 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) Following H10ssF-6473 Product Administration |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H10ssF-6473 Product Administration |
0; 1; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With New Chronic Medical Conditions Following H10ssF-6473 Product Administration |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Laboratory Measures of Safety Following H10ssF-6473 Product Administration |
0; 2; 0; 2; 1; 1 | — |
| SECONDARY Stem-Specific Antibody Response to H10ssF-6473 Following the Completion of Each Vaccination Regimen |
2726.67; 2421.80; 4122.82; 2938.72; 4796.47; 6899.17 | — |
Summary
Eligibility Criteria
INCLUSION CRITERIA
- Healthy adults between the ages of 18-70 years (excluding adults born between January 1, 1965 and December 31,1970)
- 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 2015 to the present
- Able and willing to complete the informed consent process
- Available for clinic visits for 40 weeks after enrollment
- 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 56 days before enrollment
Laboratory Criteria within 56 days before enrollment
- White blood cells (WBC) and differential 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/microL
- Platelets = 125,000 - 500,000 cells/microL
- Hemoglobin within institutional normal range or accompanied by the PI or designee approval
- Serum iron 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-Barre Syndrome
- Previous or current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) documented by polymerase chain reaction (PCR) test
- 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.
INCLUSION OF VULNERABLE PARTICIPANTS
Children
Children were not eligible to participate in this clinical trial because the investigational vaccine had not been previously evaluated in adults. If the product is assessed as safe and immunogenic, other protocols designed for children may be conducted in the future.
NIH Employees
NIH employees and members of their immediate families could have participated in this protocol. If eligible, the Guidelines for the Inclusion of Employees in NIH Research Studies were followed for employees and each employee was given a copy of the 'NIH Information Sheet on Employee Research Participation' and a copy of the 'Leave Policy for NIH Employees Participating in NIH Medical Research Studies.'
Neither participation nor refusal to participate had an effect, either beneficial or adverse, on the participant's employment or work situation. The NIH information sheet regarding NIH employee research participation was distributed to all potential participants who are NIH employees. The employee participant's privacy and confidentiality was preserved in accordance with NIH Clinical Center and NIAID policies. For NIH employee participants, consent was obtained by an individual who is independent of the participant's team. If the individual obtaining consent is a co
Data sourced from ClinicalTrials.gov (NCT04579250). 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.