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Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine in Healthy Adults

Primary Purpose

Influenza Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VRC-FLUNPF099-00-VP (H1ssF_3928)

About this trial

This is an interventional prevention trial for Influenza Infection focused on measuring Flu, Seasonal Allergy, Respiratory Illness, Flu Virus, Viral Infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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) <1.1 x institutional ULN
Total bilirubin within institutional normal range
Serum creatinine less than or equal to 1.1 x institutional ULN
Negative for HIV infection by an FDA-approved method of detection
Criteria applicable to women of childbearing potential:
Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on the day of enrollment
Agreed to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study

EXCLUSION CRITERIA:

Breast-feeding or planning to become pregnant during the study.
Participant has received any of the following substances:
More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
Blood products within 16 weeks prior to enrollment
Live attenuated vaccines within 4 weeks prior to enrollment
Inactivated vaccines within 2 weeks prior to enrollment
Investigational research agents within 4 weeks prior to enrollment or planned to receive investigational products while on the study
Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
Current anti-TB (tuberculosis) prophylaxis or therapy
Previous investigational H1 influenza vaccine
Previous investigational ferritin-based vaccine
Receipt of a licensed influenza vaccine within 6 weeks before trial enrollment
Participant has a history of any of the following clinically significant conditions:
Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator
Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
Asthma that is not well controlled
Diabetes mellitus (type I or II), with the exception of gestational diabetes
Thyroid disease that is not well controlled
Idiopathic urticaria within the past year
Autoimmune disease or immunodeficiency
Hypertension that is not well controlled (baseline systolic > 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.

Sites / Locations

National Institutes of Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Group 1: H1ssF_3928 (20 mcg), ages 18-40 years

Group 2A: H1ssF_3928 (60 mcg), ages 18-40 years

Group 2B: H1ssF_3928 (60 mcg), ages 41-49 years

Group 2C: H1ssF_3928 (60 mcg), ages 50-59 years

Group 2D: H1ssF_3928 (60 mcg), ages 60-70 years

Arm Description

H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)

H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)

Outcomes

Primary Outcome Measures

Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration

Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration

Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.

Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration

Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 4 weeks after each study product administration. At other time periods between study product administrations and when greater than 4 weeks after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), influenza-like illness (ILI) or influenza and new chronic medical conditions that required ongoing medical management (reported as separate outcomes) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration

SAEs were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration

Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the first study product administration through the last study visit.

Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration

New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration

Any abnormal laboratory results recorded after product administration as unsolicited adverse events (AEs) are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil percents/counts) and chemistry (alanine aminotransferase (ALT), alanine aspartate (AST), alkaline phosphate (ALP), creatinine and total bilirubin). Complete blood count (CBC) with differential, total bilirubin, AST, ALT, and ALP results were collected at Days 14, 28, 280, 364 and 476. Iron and serum ferritin were collected at Day 28. Creatinine results were collected at Day 14. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.

Secondary Outcome Measures

Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen

Pseudoviral neutralization antibody titers were determined against the homologous H1N1 A/New Caledonia/20/99 virus, and were summarized using geometric mean 80% inhibitory concentration (IC80).

Full Information

NCT ID

NCT03814720

First Posted

January 23, 2019

Last Updated

April 4, 2022

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT03814720

Brief Title

Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine in Healthy Adults

Official Title

VRC 321: A Phase I Open-Label Clinical Trial to Evaluate Dose, Safety, Tolerability, and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine, VRCFLUNPF099-00-VP, in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

April 6, 2021 (Actual)

Study Completion Date

April 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

Study Design: This was a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of VRC-FLUNPF099-00-VP in two regimens. The hypotheses were that the vaccine is safe and tolerable and will elicit an immune response. The primary objective was to evaluate the safety and tolerability of the investigational vaccine in healthy adults. Secondary objectives were related to immunogenicity of the investigational vaccine and dosing regimen. Study Products: The investigational vaccine, VRC-FLUNPF099-00-VP (H1ssF_3928), was developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID) and is composed of Helicobacter pylori non-heme ferritin assembled with influenza virus H1 haemagglutinin (HA) insert to form a nanoparticle displaying eight HA stabilized stem trimers from A/New Caledonia/20/1999 (H1N1) influenza. The vaccine was supplied in single-use vials at a concentration of 180 mcg/mL. H1ssF_3928 was administered intramuscularly (IM) in the deltoid muscle via needle and syringe. Participants: Healthy adults between the ages of 18-70 years, inclusive. Study Plan: The study evaluated the safety, tolerability and immunogenicity of 1 or 2 doses of the H1ssF_3928 vaccine in a dose-escalation design. In Group 1, five participants received a single low dose (20 mcg) of H1ssF_3928 on Day 0. For Group 1, the protocol required 1 vaccination visit, about 9 follow-up visits, and a telephone contact after vaccination. Once the low dose was assessed as safe and well tolerated, enrollment began for Group 2A. Groups 2A, 2B, 2C, and 2D were stratified by age as shown in the vaccination schema below. In Group 2A, participants received a higher dose (60 mcg) of H1ssF_3928 on Day 0. Once this higher dose was assessed as safe and well tolerated, participants in Group 2A received a second vaccination at Week 16 and enrollment began for Groups 2B, 2C, and 2D. For Groups 2A, 2B, 2C, and 2D, the protocol required 2 vaccination visits, about 11 follow-up visits, and a telephone contact after each vaccination. Group 2A completed the product administration schedule per protocol. While most participants in Groups 2B-2D completed the second dose administration per protocol, one participant was not able to receive the second dose due to moving out of the area and 11 participants were not able to receive their second dose due to the COVID-19 pandemic. For all groups, solicited reactogenicity was evaluated using a 7-day diary card. Assessment of vaccine safety included clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study. VRC 321 Vaccination Schema: Group: 1; Age Cohort: 18-40; Participants: 5; Day 0: 20 mcg Group: 2A; Age Cohort: 18-40; Participants: 12; Day 0: 60 mcg; Week 16: 60 mcg Group: 2B; Age Cohort: 41-49; Participants: 12; Day 0: 60 mcg; Week 16: 60 mcg Group: 2C; Age Cohort: 50-59; Participants: 12; Day 0: 60 mcg; Week 16: 60 mcg Group: 2D; Age Cohort: 60-70; Participants: 11*; Day 0: 60 mcg; Week 16: 60 mcg Total: 52* *Recruitment for the final open group, Group 2D, was ongoing to meet the accrual target of 53 participants. However, due to the COVID-19 pandemic, enrollment was discontinued with a total of 52 participants enrolled. Study Duration: Group 1: Participants were evaluated for 52 weeks following the vaccine administration and through an influenza season. Groups 2A, 2B, 2C, 2D: Participants were evaluated for 52 weeks following the last vaccine administration and through an influenza season.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza Infection

Keywords

Flu, Seasonal Allergy, Respiratory Illness, Flu Virus, Viral Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: H1ssF_3928 (20 mcg), ages 18-40 years

Arm Type

Experimental

Arm Description

H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)

Arm Title

Group 2A: H1ssF_3928 (60 mcg), ages 18-40 years

Arm Type

Experimental

Arm Description

H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)

Arm Title

Group 2B: H1ssF_3928 (60 mcg), ages 41-49 years

Arm Type

Experimental

Arm Description

H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)

Arm Title

Group 2C: H1ssF_3928 (60 mcg), ages 50-59 years

Arm Type

Experimental

Arm Description

H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)

Arm Title

Group 2D: H1ssF_3928 (60 mcg), ages 60-70 years

Arm Type

Experimental

Arm Description

H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)

Intervention Type

Biological

Intervention Name(s)

VRC-FLUNPF099-00-VP (H1ssF_3928)

Intervention Description

The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.

Primary Outcome Measure Information:

Title

Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration

Description

Time Frame

7 days after each H1ssF_3928 product administration, at approximately Week 1 and at approximately Week 17

Title

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration

Description

Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.

Time Frame

7 days after each H1ssF_3928 product administration, at approximately Week 1 and at approximately Week 17

Title

Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration

Description

Time Frame

Day 0 through 4 weeks after each H1ssF_3928 product administration, up to Week 20

Title

Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration

Description

Time Frame

Day 0 through the study participation, up to Week 68

Title

Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration

Description

Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the first study product administration through the last study visit.

Time Frame

Day 0 through the study participation, up to Week 68

Title

Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration

Description

Time Frame

Day 0 through the study participation, up to Week 68

Title

Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration

Description

Time Frame

Day 0 through the study participation, up to Week 68

Secondary Outcome Measure Information:

Title

Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen

Description

Pseudoviral neutralization antibody titers were determined against the homologous H1N1 A/New Caledonia/20/99 virus, and were summarized using geometric mean 80% inhibitory concentration (IC80).

Time Frame

Baseline to 2 weeks after 1st dose for participants who received a single injection, at Week 2 or From Baseline to 2 weeks after 1st dose and from Week 16 to 2 weeks after 2nd dose for participants who received two injections, at Weeks 2 and 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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) <1.1 x institutional ULN Total bilirubin within institutional normal range Serum creatinine less than or equal to 1.1 x institutional ULN Negative for HIV infection by an FDA-approved method of detection Criteria applicable to women of childbearing potential: Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on the day of enrollment Agreed to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study EXCLUSION CRITERIA: Breast-feeding or planning to become pregnant during the study. Participant has received any of the following substances: More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment Blood products within 16 weeks prior to enrollment Live attenuated vaccines within 4 weeks prior to enrollment Inactivated vaccines within 2 weeks prior to enrollment Investigational research agents within 4 weeks prior to enrollment or planned to receive investigational products while on the study Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule Current anti-TB (tuberculosis) prophylaxis or therapy Previous investigational H1 influenza vaccine Previous investigational ferritin-based vaccine Receipt of a licensed influenza vaccine within 6 weeks before trial enrollment Participant has a history of any of the following clinically significant conditions: Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema Asthma that is not well controlled Diabetes mellitus (type I or II), with the exception of gestational diabetes Thyroid disease that is not well controlled Idiopathic urticaria within the past year Autoimmune disease or immunodeficiency Hypertension that is not well controlled (baseline systolic > 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alicia T Widge, M.D.

Organizational Affiliation

National Institute of Allergy and Infectious Diseases (NIAID)

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25007847

Citation

Krammer F, Palese P, Steel J. Advances in universal influenza virus vaccine design and antibody mediated therapies based on conserved regions of the hemagglutinin. Curr Top Microbiol Immunol. 2015;386:301-21. doi: 10.1007/82_2014_408.

Results Reference

background

PubMed Identifier

23698367

Citation

Kanekiyo M, Wei CJ, Yassine HM, McTamney PM, Boyington JC, Whittle JR, Rao SS, Kong WP, Wang L, Nabel GJ. Self-assembling influenza nanoparticle vaccines elicit broadly neutralizing H1N1 antibodies. Nature. 2013 Jul 4;499(7456):102-6. doi: 10.1038/nature12202. Epub 2013 May 22.

Results Reference

background

PubMed Identifier

26301691

Citation

Yassine HM, Boyington JC, McTamney PM, Wei CJ, Kanekiyo M, Kong WP, Gallagher JR, Wang L, Zhang Y, Joyce MG, Lingwood D, Moin SM, Andersen H, Okuno Y, Rao SS, Harris AK, Kwong PD, Mascola JR, Nabel GJ, Graham BS. Hemagglutinin-stem nanoparticles generate heterosubtypic influenza protection. Nat Med. 2015 Sep;21(9):1065-70. doi: 10.1038/nm.3927. Epub 2015 Aug 24.

Results Reference

background

Links:

URL

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2019-I-0032.html

Description

NIH Clinical Center Detailed Web Page

Learn more about this trial

Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine in Healthy Adults

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