Phase 1 N=50 Randomized Prevention

Influenza HA Ferritin Vaccine, Alone or in Prime-Boost Regimens With an Influenza DNA Vaccine in Healthy Adults

Influenza

Bottom Line

View on ClinicalTrials.gov: NCT03186781 ↗

Enrolled (actual)

Serious AEs

1.5%

Results posted

Oct 2020

Primary outcome: Primary: Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration — 4; 3; 7; 9 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: VRC-FLUNPF081-00-VP (HA-F A/Sing) (Biological); VRC-FLUDNA082-00-VP (DNA A/Sing) (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration	4; 3; 7; 9; 8; 9	—
PRIMARY Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration	4; 4; 8; 6; 6; 12	—
PRIMARY Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration	4; 2; 7; 7; 9; 8	—
PRIMARY Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration	9; 8; 17; 1; 2; 3	—
PRIMARY Number of Subjects With Abnormal Laboratory Measures of Safety	0; 0; 0; 0; 0; 1	—
PRIMARY Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Each HA-F A/Sing Product Administration	1; 0; 0; 0; 1; 1	—
PRIMARY Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) Following DNA A/Sing Product Administration	1; 2; 3; 3; 4; 7	—
PRIMARY Number of Subjects With Influenza or Influenza-like Illness (ILIs) Following HA-F A/Sing Product Administration	0; 0; 1; 0; 1; 0	—
PRIMARY Number of Subjects With Influenza or Influenza-like Illness (ILIs) Following DNA A/Sing Product Administration	0; 0	—
PRIMARY Number of Subjects With Serious Adverse Events (SAEs) Following HA-F A/Sing Product Administration	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Subjects With Serious Adverse Events (SAEs) Following DNA A/Sing Product Administration	0; 0; 0; 0	—
SECONDARY Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against A/Singapore/1/1957 (H2N2) Following the Completion of Each Vaccine Regimen	NA; 24; 89; 64; 113	—
SECONDARY Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against A/Singapore/1/1957 (H2N2) Following the Completion of Each Vaccine Regimen	127; 844; 2723; 1279; 2718	—
SECONDARY Seroconversion Rate Following the Completion of Each Vaccine Regimen	0; 31; 78; 56; 89	—

Summary

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.

Eligibility Criteria

INCLUSION CRITERIA

A subject must meet all of the following criteria:

Healthy subjects aged 18-70 (excluding subjects born between 1966-1969)
Based on history and examination, must be in good general health and without history of any of the conditions listed in the exclusion criteria
Received at least one licensed current seasonal influenza vaccine from 2014 to the present
Able and willing to complete the informed consent process
Available for clinic visits for 40 weeks after enrollment
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 84 days before enrollment

Laboratory Criteria within 84 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/mm^3
Hemoglobin within institutional normal range
Serum iron either within institutional normal range or accompanied by the site PI or designee approval
Alanine aminotransferase (ALT) less than or equal to 1.25 times institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) less than or equal to 1.25 times institutional ULN
Alkaline phosphatase (ALP) less than or equal to 1.1 times institutional ULN
Total bilirubin within institutional ULN
Serum creatinine less than or equal to 1.1 times 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
Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study

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:

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 planning to receive investigational products while on the study
Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
Current anti-tuberculosis (TB) prophylaxis or therapy
Previous H2 influenza investigational vaccine
Receipt of a licensed influenza vaccine within 6 weeks before trial enrollment

Subject 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
Evidence of autoimmune disease or immunodeficiency
Hypertension that is not well controlled
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

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Data sourced from ClinicalTrials.gov (NCT03186781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.