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| ID | Type | Description | Link |
|---|---|---|---|
| 17-I-0110 | Other Identifier | NIH NIAID IRB |
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Background:
Influenza, or "flu", is a very common infectious respiratory disease. Researchers want to develop a vaccine against flu. Vaccines teach the body to fight or prevent an infection. When the body learns to fight an infection, this is called an immune response. In this study, researchers want to test two new vaccines to help the body make an immune response to flu.
Subjects received the vaccine injections in the upper arm muscle. One vaccine, the influenza HA Ferritin vaccine (HA-F A/Sing), was given to all subjects with a needle injection. The other vaccine, influenza DNA vaccine (DNA A/Sing), was given to subjects in Group 3 by a needle-free device that uses high pressure to push the vaccine through the skin and into the muscle.
Objective:
To test the safety and side effects of two new vaccines for prevention of H2 influenza (flu).
Eligibility:
Part I: Healthy adults ages 18-47 born after 1969.
Part II: Healthy adults ages 18-70, but not born in 1966-1969.
Design:
Volunteers were tested for eligibility in a separate screening protocol.
In Part I, all subjects received injections of HA Ferritin vaccine. These subjects were not expected to have H2N2 exposure based on their age and when H2N2 last circulated in the population. Five subjects in Group 1 received one injection of 20 mcg dose vaccine at Day 0 to test if it is safe. Then, five additional subjects in Group 2 received a total of two injections of a 60 mcg dose on Day 0 and 16 weeks later.
In Part II, responses were evaluated from adults born before 1966 who may have prior potential exposure to H2N2 influenza as well as adults similar to those enrolled in Part I who are not expected to have H2N2 exposure. Also, Part II compared responses to 2 different vaccine regimens. Group 3 subjects received a DNA influenza vaccine prime at Day 0 and the HA Ferritin vaccine boost 16 weeks later. Group 4 subjects received the HA Ferritin vaccine 2 times, on Day 0 and 16 weeks later.
Study Design: This is a Phase I open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of VRC-FLUNPF081-00-VP (HA-F A/Sing) vaccine alone or in prime-boost regimens with VRC-FLUDNA082-00-VP (DNA A/Sing) vaccine. The hypotheses are that VRC-FLUNPF081-00-VP and VRC-FLUDNA082-00-VP vaccines are safe, well-tolerated, and induce an immune response to the H2 antigen. The primary objectives are to evaluate the safety and tolerability of two different doses of the HA-F A/Sing vaccine alone and in prime-boost regimens in healthy adults. Secondary objectives are related to the evaluation of the immunogenicity of the HA-F A/Sing and DNA A/Sing vaccines in prime-boost regimens.
Study Products: The investigational HA-F A/Sing vaccine, developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), is composed of Helicobacter pylori non-haem ferritin with an influenza virus H2 hemagglutinin (HA) insert to form a nanoparticle displaying eight HA trimers from A/Singapore/1/57 (H2N2) influenza.
The investigational DNA A/Sing vaccine, developed by the VRC, NIAID, is composed of a single closed-circular DNA plasmid that encodes the H2 protein of A/Singapore/1/57 influenza.
Subjects: Up to 80 healthy adults ages 18-70 were enrolled; adults born between 1966 and 1969 were excluded from the trial.
Study Plan: Vaccines were administered intramuscularly (IM) in the deltoid muscle. This study has two parts:
Part I evaluated the safety, tolerability, and immunogenicity of 1 or 2 doses of the HA-F A/Sing vaccine in a dose-escalation design. In Group 1, five subjects received a 20 mcg dose of the HA-F A/Sing vaccine via needle and syringe on Day 0. If this dose was assessed as safe and well tolerated, enrollment began for Group 2. In Group 2, five subjects received the higher 60 mcg dose of the HA-F A/Sing vaccine via needle and syringe on Day 0 and Week 16. If this higher dose was assessed as safe, enrollment began for Part II.
Part II evaluated the safety, tolerability, and immunogenicity of HA-F A/Sing vaccine in prime-boost regimens. Subjects were stratified by age and randomized equally into Groups 3 and Group 4. In Group 3, subjects received DNA A/Sing vaccine via a PharmaJet Needle-Free Injector on Day 0 and HA-F A/Sing vaccine via needle and syringe on Week 16. In Group 4, subjects received HA-F A/Sing vaccine via needle and syringe on Day 0 and Week 16.
For Group 1, the protocol required about 8 clinic visits and 1 telephone follow up contact after the injection.
For Group 2, Group 3 and Group 4, the protocol required about 10 clinic visits and 2 telephone follow-up contacts after each injection.
For all Groups, solicited reactogenicity were 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.
Study Duration: Subjects were evaluated for 40 weeks following the first vaccine administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: HA-F A/Sing (20 mcg), ages 18-47 Yrs | Experimental | HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2) |
|
| Group 2: HA-F A/Sing (60 mcg), ages 18-47 Yrs | Experimental | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) |
|
| Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), ages 18-47 Yrs | Experimental | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) |
|
| Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), ages 52-70 Yrs | Experimental | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRC-FLUNPF081-00-VP (HA-F A/Sing) | Biological | VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each HA-F A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects 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 (FDA Guidance - September 2007). | 7 days after each HA-F A/Sing product administration, at approximately Week 1 and/or at approximately Week 17 |
| Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the DNA A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects 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 (FDA Guidance - September 2007). | 7 days after DNA A/Sing product administration, at approximately Week 1 |
| Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each HA-F A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects 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 (FDA Guidance - September 2007). |
| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against A/Singapore/1/1957 (H2N2) Following the Completion of Each Vaccine Regimen | Hemagglutination inhibition assays (HAI) titers were determined against the homologous H2N2 A/Singapore/1/57 virus, and were summarized using geometric mean titers (GMTs). Negative samples were reported and GMTs were calculated using half the limit of detection. H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) subjects received either a single dose of 20 mcg HA-F A/Sing (H2-naïve), two doses of 60 mcg HA-F A/Sing 16 weeks apart (H2-naïve and H2-exposed), or a 4 mg DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks (H2-naïve and H2-exposed). |
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INCLUSION CRITERIA:
A subject must meet all of the following criteria:
Laboratory Criteria within 84 days before enrollment:
Criteria applicable to women of childbearing potential:
EXCLUSION CRITERIA:
A subject will be excluded if one or more of the following conditions apply:
- Breast-feeding or planning to become pregnant during the study.
Subject has received any of the following substances:
Subject has a history of any of the following clinically significant conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Grace L Chen, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23698367 | Background | 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. | |
| 20227466 | Background | Yamashita I, Iwahori K, Kumagai S. Ferritin in the field of nanodevices. Biochim Biophys Acta. 2010 Aug;1800(8):846-57. doi: 10.1016/j.bbagen.2010.03.005. Epub 2010 Mar 12. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs | HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 11, 2019 |
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| Group 4A: HA-F A/Sing (60 mcg), ages 18-47 Yrs |
| Experimental |
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) |
|
| Group 4B: HA-F A/Sing (60 mcg), ages 52-70 Yrs | Experimental | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity) |
|
| VRC-FLUDNA082-00-VP (DNA A/Sing) | Biological | VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
|
| 7 days after each HA-F A/Sing product administration, at approximately Week 1 and/or at approximately Week 17 |
| Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after DNA A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects 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 (FDA Guidance - September 2007). | 7 days after DNA A/Sing product administration, at approximately Week 1 |
| Number of Subjects With Abnormal Laboratory Measures of Safety | Any abnormal laboratory results recorded 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 screening (≤ 84 days before enrollment), Day 0 prior to study product administration (baseline), and at Days 14, 28, 112, 140 and 280. Creatinine results were collected at screening, Day 0 and Day 6. 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. | Day 0 through Day 280 |
| Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Each HA-F A/Sing 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 (reported as a separate outcome) and new chronic medical conditions that required ongoing medical management 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 subject with multiple experiences of the same event is counted once using the event of worst severity. | Day 0 through 4 weeks after each HA-F A/Sing product administration, up to Week 20 |
| Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) Following DNA A/Sing 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 (reported as a separate outcome) and new chronic medical conditions that required ongoing medical management 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 subject with multiple experiences of the same event is counted once using the event of worst severity. | Day 0 through 4 weeks after DNA A/Sing product administration, up to Week 4 |
| Number of Subjects With Influenza or Influenza-like Illness (ILIs) Following HA-F A/Sing 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. | Day 0 through Day 280 |
| Number of Subjects With Influenza or Influenza-like Illness (ILIs) Following DNA A/Sing 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. | Day 0 through Day 280 |
| Number of Subjects With Serious Adverse Events (SAEs) Following HA-F A/Sing Product Administration | SAEs were recorded from receipt of first study product administration through the last expected study visit at Day 280. 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 subject with multiple experiences of the same event is counted once using the event of worst severity. | Day 0 through Day 280 |
| Number of Subjects With Serious Adverse Events (SAEs) Following DNA A/Sing Product Administration | SAEs were recorded from receipt of first study product administration through the last expected study visit at Day 280. 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 subject with multiple experiences of the same event is counted once using the event of worst severity. | Day 0 through Day 280 |
| Four weeks after the first dose for groups that received a single vaccination, at Week 4 or two weeks after the second dose for groups that received two vaccinations, at Week 18 |
| Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against A/Singapore/1/1957 (H2N2) Following the Completion of Each Vaccine Regimen | Pseudoviral neutralization antibody titers were determined against the homologous H2N2 A/Singapore/1/57 virus, and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) subjects received either a single dose of 20 mcg HA-F A/Sing (H2-naïve), two doses of 60 mcg HA-F A/Sing 16 weeks apart (H2-naïve and H2-exposed), or a 4 mg DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks (H2-naïve and H2-exposed). | Four weeks after the first dose for groups that received a single vaccination, at Week 4 or two weeks after the second dose for groups that received two vaccinations, at Week 18 |
| Seroconversion Rate Following the Completion of Each Vaccine Regimen | Seroconversion rate: the proportion of subjects achieving seroconversion in hemagglutination inhibition assay (HAI) antibody titer. Seroconversion rates for HAI were summarized as the proportion of individuals in each group experiencing a positive response, defined per the FDA criteria of positivity as either a baseline titer of less than 1:10 and a post vaccination titer of 1:40 or more or a baseline titer of 1:10 or more and a minimum four-fold rise after vaccination. H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) subjects received either a single dose of 20 mcg HA-F A/Sing (H2-naïve), two doses of 60 mcg HA-F A/Sing 16 weeks apart (H2-naïve and H2-exposed), or a 4 mg DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks (H2-naïve and H2-exposed). | Four weeks after the first dose for groups that received a single vaccination, at Week 4 or two weeks after the second dose for groups that received two vaccinations, at Week 18 |
| 21390107 | Background | Nabel GJ, Wei CJ, Ledgerwood JE. Vaccinate for the next H2N2 pandemic now. Nature. 2011 Mar 10;471(7337):157-8. doi: 10.1038/471157a. No abstract available. |
| 35115707 | Derived | Andrews SF, Raab JE, Gorman J, Gillespie RA, Cheung CSF, Rawi R, Cominsky LY, Boyington JC, Creanga A, Shen CH, Harris DR, Olia AS, Nazzari AF, Zhou T, Houser KV, Chen GL, Mascola JR, Graham BS, Kanekiyo M, Ledgerwood JE, Kwong PD, McDermott AB. A single residue in influenza virus H2 hemagglutinin enhances the breadth of the B cell response elicited by H2 vaccination. Nat Med. 2022 Feb;28(2):373-382. doi: 10.1038/s41591-021-01636-8. Epub 2022 Feb 3. |
| 35115706 | Derived | Houser KV, Chen GL, Carter C, Crank MC, Nguyen TA, Burgos Florez MC, Berkowitz NM, Mendoza F, Hendel CS, Gordon IJ, Coates EE, Vazquez S, Stein J, Case CL, Lawlor H, Carlton K, Gaudinski MR, Strom L, Hofstetter AR, Liang CJ, Narpala S, Hatcher C, Gillespie RA, Creanga A, Kanekiyo M, Raab JE, Andrews SF, Zhang Y, Yang ES, Wang L, Leung K, Kong WP, Freyn AW, Nachbagauer R, Palese P, Bailer RT, McDermott AB, Koup RA, Gall JG, Arnold F, Mascola JR, Graham BS, Ledgerwood JE; VRC 316 Study Team. Safety and immunogenicity of a ferritin nanoparticle H2 influenza vaccine in healthy adults: a phase 1 trial. Nat Med. 2022 Feb;28(2):383-391. doi: 10.1038/s41591-021-01660-8. Epub 2022 Feb 3. |
| Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs |
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| FG002 | Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| FG003 | Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| FG004 | Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| FG005 | Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| Received First Product Administration |
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| Received All Product Administrations |
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| COMPLETED |
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| NOT COMPLETED |
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Population includes all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs | HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| BG001 | Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| BG002 | Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| BG003 | Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| BG004 | Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| BG005 | Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body Mass Index (BMI) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each HA-F A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects 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 (FDA Guidance - September 2007). | Population included all enrolled subjects who received at least one HA-F A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=47). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection. | Posted | Count of Participants | Participants | 7 days after each HA-F A/Sing product administration, at approximately Week 1 and/or at approximately Week 17 |
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| Primary | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the DNA A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects 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 (FDA Guidance - September 2007). | Population included all enrolled subjects who received the DNA A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=20). | Posted | Count of Participants | Participants | 7 days after DNA A/Sing product administration, at approximately Week 1 |
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| Primary | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each HA-F A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects 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 (FDA Guidance - September 2007). | Population included all enrolled subjects who received at least one HA-F A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=47). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection. | Posted | Count of Participants | Participants | 7 days after each HA-F A/Sing product administration, at approximately Week 1 and/or at approximately Week 17 |
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| Primary | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after DNA A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects 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 (FDA Guidance - September 2007). | Population included all enrolled subjects who received the DNA A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=20). | Posted | Count of Participants | Participants | 7 days after DNA A/Sing product administration, at approximately Week 1 |
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| Primary | Number of Subjects With Abnormal Laboratory Measures of Safety | Any abnormal laboratory results recorded 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 screening (≤ 84 days before enrollment), Day 0 prior to study product administration (baseline), and at Days 14, 28, 112, 140 and 280. Creatinine results were collected at screening, Day 0 and Day 6. 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. | Population included all enrolled subjects who had laboratory results available at any study visit post baseline. | Posted | Count of Participants | Participants | Day 0 through Day 280 |
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| Primary | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Each HA-F A/Sing 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 (reported as a separate outcome) and new chronic medical conditions that required ongoing medical management 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 subject with multiple experiences of the same event is counted once using the event of worst severity. | Population included all enrolled subjects who received at least one HA-F A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=47). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection. | Posted | Count of Participants | Participants | Day 0 through 4 weeks after each HA-F A/Sing product administration, up to Week 20 |
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| Primary | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) Following DNA A/Sing 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 (reported as a separate outcome) and new chronic medical conditions that required ongoing medical management 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 subject with multiple experiences of the same event is counted once using the event of worst severity. | Population included all enrolled subjects who received the DNA A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=20). | Posted | Count of Participants | Participants | Day 0 through 4 weeks after DNA A/Sing product administration, up to Week 4 |
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| Primary | Number of Subjects With Influenza or Influenza-like Illness (ILIs) Following HA-F A/Sing 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. | Population included all enrolled subjects who received at least one HA-F A/Sing study injection (N=47). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection. | Posted | Count of Participants | Participants | Day 0 through Day 280 |
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| Primary | Number of Subjects With Influenza or Influenza-like Illness (ILIs) Following DNA A/Sing 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. | Population included all enrolled subjects who received the DNA A/Sing study injection (N=20). | Posted | Count of Participants | Participants | Day 0 through Day 280 |
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| Primary | Number of Subjects With Serious Adverse Events (SAEs) Following HA-F A/Sing Product Administration | SAEs were recorded from receipt of first study product administration through the last expected study visit at Day 280. 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 subject with multiple experiences of the same event is counted once using the event of worst severity. | Population included all enrolled subjects who received at least one HA-F A/Sing study injection (N=47). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection. | Posted | Count of Participants | Participants | Day 0 through Day 280 |
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| Secondary | Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against A/Singapore/1/1957 (H2N2) Following the Completion of Each Vaccine Regimen | Hemagglutination inhibition assays (HAI) titers were determined against the homologous H2N2 A/Singapore/1/57 virus, and were summarized using geometric mean titers (GMTs). Negative samples were reported and GMTs were calculated using half the limit of detection. H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) subjects received either a single dose of 20 mcg HA-F A/Sing (H2-naïve), two doses of 60 mcg HA-F A/Sing 16 weeks apart (H2-naïve and H2-exposed), or a 4 mg DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks (H2-naïve and H2-exposed). | Overall number analyzed includes the H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity). The H2-naïve and H2-exposed number analyzed rows reflect the number of subjects analyzed in each group. | Posted | Geometric Mean | 95% Confidence Interval | titer | Four weeks after the first dose for groups that received a single vaccination, at Week 4 or two weeks after the second dose for groups that received two vaccinations, at Week 18 |
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| Secondary | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against A/Singapore/1/1957 (H2N2) Following the Completion of Each Vaccine Regimen | Pseudoviral neutralization antibody titers were determined against the homologous H2N2 A/Singapore/1/57 virus, and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) subjects received either a single dose of 20 mcg HA-F A/Sing (H2-naïve), two doses of 60 mcg HA-F A/Sing 16 weeks apart (H2-naïve and H2-exposed), or a 4 mg DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks (H2-naïve and H2-exposed). | Overall number analyzed includes the H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity). The H2-naïve and H2-exposed number analyzed rows reflect the number of subjects analyzed in each group. | Posted | Geometric Mean | 95% Confidence Interval | titer | Four weeks after the first dose for groups that received a single vaccination, at Week 4 or two weeks after the second dose for groups that received two vaccinations, at Week 18 |
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| Secondary | Seroconversion Rate Following the Completion of Each Vaccine Regimen | Seroconversion rate: the proportion of subjects achieving seroconversion in hemagglutination inhibition assay (HAI) antibody titer. Seroconversion rates for HAI were summarized as the proportion of individuals in each group experiencing a positive response, defined per the FDA criteria of positivity as either a baseline titer of less than 1:10 and a post vaccination titer of 1:40 or more or a baseline titer of 1:10 or more and a minimum four-fold rise after vaccination. H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) subjects received either a single dose of 20 mcg HA-F A/Sing (H2-naïve), two doses of 60 mcg HA-F A/Sing 16 weeks apart (H2-naïve and H2-exposed), or a 4 mg DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks (H2-naïve and H2-exposed). | Overall number analyzed includes the H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity). The H2-naïve and H2-exposed number analyzed rows reflect the number of subjects analyzed in each group. | Posted | Number | 95% Confidence Interval | percentage of participants | Four weeks after the first dose for groups that received a single vaccination, at Week 4 or two weeks after the second dose for groups that received two vaccinations, at Week 18 |
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| Primary | Number of Subjects With Serious Adverse Events (SAEs) Following DNA A/Sing Product Administration | SAEs were recorded from receipt of first study product administration through the last expected study visit at Day 280. 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 subject with multiple experiences of the same event is counted once using the event of worst severity. | Population included all enrolled subjects who received the DNA A/Sing study injection (N=20). | Posted | Count of Participants | Participants | Day 0 through Day 280 |
|
Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Incidence HA-F A/Sing (20 mcg) | HA-F A/Sing (20 mcg) dose group included H2-naïve (ages 18-47 years) adults who received a single 20 mcg dose of HA-F A/Sing. Population included all enrolled subjects who received a HA-F A/Sing (20 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=5). VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG001 | Overall Incidence HA-F A/Sing (60 mcg) | HA-F A/Sing (60 mcg) dose groups included H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) adults who received either two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks. Population included all enrolled subjects who received at least one HA-F A/Sing (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=42). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection. VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. | 0 | 42 | 1 | 42 | 21 | 42 |
| EG002 | Overall Incidence DNA A/Sing (4 mg) | DNA A/Sing prime dose groups included H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) adults who received a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks. Population included all enrolled subjects who received the DNA A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=20). VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. | 0 | 20 | 0 | 20 | 17 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Administration site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin Gaudinski, MD | Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health | 301-451-8715 | martin.gaudinski@nih.gov |
| Jul 8, 2020 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| 21-30 |
|
| 31-40 |
|
| 41-50 |
|
| 51-60 |
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| 61-70 |
|
| Male |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Hispanic or Latino |
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| Not Hispanic or Latino |
|
| 25.0-29.9 kg/m^2 |
|
| 30 kg/m^2 or over |
|
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
| OG005 | Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG006 | Overall Incidence HA-F A/Sing (20 mcg and 60 mcg) | HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks. |
| Mild |
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| Moderate |
|
| Severe |
|
| Swelling |
|
| Redness |
|
| Any Local Symptom |
|
| OG001 | Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG002 | Overall Incidence DNA A/Sing (4 mg) | DNA A/Sing prime dose groups included H2-naïve and H2-exposed adults who received a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks. |
|
|
| OG001 | Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG002 | Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG003 | Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG004 | Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG005 | Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG006 | Overall Incidence HA-F A/Sing (20 mcg and 60 mcg) | HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks. |
|
|
| OG001 | Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG002 | Overall Incidence DNA A/Sing (4 mg) | DNA A/Sing prime dose groups included H2-naïve and H2-exposed adults who received a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks. |
|
|
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG002 | Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG003 | Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG004 | Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG005 | Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
|
|
| OG001 | Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG002 | Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG003 | Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG004 | Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG005 | Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG006 | Overall Incidence HA-F A/Sing (20 mcg and 60 mcg) | HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks. |
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| OG001 | Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG002 | Overall Incidence DNA A/Sing (4 mg) | DNA A/Sing prime dose groups included H2-naïve and H2-exposed adults who received a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks. |
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DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG003 | Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG004 | Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG005 | Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
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| OG002 | Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG003 | Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine. |
| OG004 | Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG005 | Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
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| HA-F A/Sing (60 mcg), Ages 18-47 and 52-70 Yrs |
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG002 | DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 and 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity) |
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| HA-F A/Sing (60 mcg), Ages 18-47 and 52-70 Yrs |
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG002 | DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 and 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity) |
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| OG001 | HA-F A/Sing (60 mcg), Ages 18-47 and 52-70 Yrs | HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity) VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine. |
| OG002 | DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 and 52-70 Yrs | DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity) |
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| Mild |
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| Moderate |
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| Mild |
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| Mild |
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| Moderate |
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| Mild |
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| Moderate |
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| Mild |
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| Moderate |
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| Moderate |
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| Moderate |
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| Moderate |
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| Moderate |
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| Moderate |
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| Moderate |
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