Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04579250
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2020-10-07
Brief Title:
Dose Safety Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine VRC-FLUNPF0103-00-VP in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
VRC 323 A Phase I Open-Label Clinical Trial to Evaluate the Dose Safety Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine VRC-FLUNPF0103-00-VP in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 H10 flu a flu strain that infects humans
Objective
To test the safety and effectiveness of the H10 Stabilized Stem Ferritin vaccine VRC-FLUNPF0103-00-VP or H10ssF-6473
Eligibility
Healthy adults ages 18-70 but not born between 1965-1970
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 onwithvia a diary card for 7 days after each injection The injection site was checked for redness swelling itching or bruising
Participants had 8-10 follow-up visits over 10 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 collected 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
Objective
To test the safety and effectiveness of the H10 Stabilized Stem Ferritin vaccine VRC-FLUNPF0103-00-VP or H10ssF-6473
Eligibility
Healthy adults ages 18-70 but not born between 1965-1970
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 onwithvia a diary card for 7 days after each injection The injection site was checked for redness swelling itching or bruising
Participants had 8-10 follow-up visits over 10 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 collected 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
Detailed Description:
Design This was a Phase I open-label dose escalation study to evaluate the dose safety tolerability and immunogenicity of VRC-FLUNPF0103-00-VP in two regimens The hypotheses were that the vaccine is safe and tolerable and would 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-FLUNPF0103-00-VP H10ssF-6473 was developed by the Vaccine Research Center VRC National Institute of Allergy and Infectious Diseases NIAID and is composed of the haemagglutinin HA stem domain from AJiangxiIPB132013 H10N8 influenza genetically fused to the ferritin protein from Helicobacter pylori Purified H10ssF-6473 displays eight well-formed HA trimers that antigenically resemble the native H10 stem viral spikes The vaccine was supplied in single-use vials at a concentration of 180 mcgmL VRC-PBSPLA043-00-VP consisting of sterile phosphate buffered saline PBS was the diluent for H10ssF-6473 Prepared study product was administered intramuscularly IM in the deltoid muscle via needle and syringe
Participants
Healthy adults between the ages of 18-70 were enrolled adults born between 1965 and 1970 were excluded from the trial
Study Plan This study evaluated the safety tolerability and immunogenicity of 1 or 2 doses of H10ssF-6473 in a dose-escalation design
In Group 1 three participants received a single low dose 20 mcg of H10ssF-6473 on Day 0 For Group 1 the protocol required 1 vaccination visit 8 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 In Group 2A participants received a higher dose 60 mcg of H10ssF-6473 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 Groups 2A and 2B were stratified by age as shown in the vaccination schema below For Groups 2A and 2B the protocol required 2 vaccination visits 10 follow-up visits and a telephone contact after each vaccination
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 323 Vaccination Schema
Group 1 Age Cohort 18-50 Participants 3 Day 0 20 mcg IM
Group 2A Age Cohort 18-50 Participants 14 Day 0 60 mcg IM Week 16 60 mcg IM
Group 2B Age Cohort 55-70 Participants 8 Day 0 60 mcg IM Week 16 60 mcg IM
Total Participants 25
Study Duration
Participants were evaluated for 40 weeks following the first vaccine administration
Study Products The investigational vaccine VRC-FLUNPF0103-00-VP H10ssF-6473 was developed by the Vaccine Research Center VRC National Institute of Allergy and Infectious Diseases NIAID and is composed of the haemagglutinin HA stem domain from AJiangxiIPB132013 H10N8 influenza genetically fused to the ferritin protein from Helicobacter pylori Purified H10ssF-6473 displays eight well-formed HA trimers that antigenically resemble the native H10 stem viral spikes The vaccine was supplied in single-use vials at a concentration of 180 mcgmL VRC-PBSPLA043-00-VP consisting of sterile phosphate buffered saline PBS was the diluent for H10ssF-6473 Prepared study product was administered intramuscularly IM in the deltoid muscle via needle and syringe
Participants
Healthy adults between the ages of 18-70 were enrolled adults born between 1965 and 1970 were excluded from the trial
Study Plan This study evaluated the safety tolerability and immunogenicity of 1 or 2 doses of H10ssF-6473 in a dose-escalation design
In Group 1 three participants received a single low dose 20 mcg of H10ssF-6473 on Day 0 For Group 1 the protocol required 1 vaccination visit 8 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 In Group 2A participants received a higher dose 60 mcg of H10ssF-6473 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 Groups 2A and 2B were stratified by age as shown in the vaccination schema below For Groups 2A and 2B the protocol required 2 vaccination visits 10 follow-up visits and a telephone contact after each vaccination
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 323 Vaccination Schema
Group 1 Age Cohort 18-50 Participants 3 Day 0 20 mcg IM
Group 2A Age Cohort 18-50 Participants 14 Day 0 60 mcg IM Week 16 60 mcg IM
Group 2B Age Cohort 55-70 Participants 8 Day 0 60 mcg IM Week 16 60 mcg IM
Total Participants 25
Study Duration
Participants were evaluated for 40 weeks following the first vaccine administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-I-0145 | OTHER | NIH IRB | None |