Clinical Studies

About

The National Institute of Allergy and Infectious Diseases (NIAID) Collaborative Influenza Vaccine Innovation Centers (CIVICs) program includes a network of cutting-edge research sites supporting NIAID’s initiative to develop a universal influenza vaccine. NIAID’s vision is to develop highly effective, long-lasting influenza vaccines that protect against multiple strains of the influenza virus and are suitable for all age groups. CIVICs is continually advancing vaccine candidates from the research laboratories to clinical trials.

Investigational vaccines undergo a four-stage process to test safety and efficacy as part of the Food and Drug Administration (FDA) clinical trial assessment process. The NIAID CIVICs program funds vaccine research and development through the first two stages of clinical trials, Phase 1 and Phase 2. In addition, the program funds the establishment of controlled human influenza infection models for evaluation of investigational vaccines. Such studies will be conducted as Phase 1 and Phase 2 clinical trials.

+6 Site Locations

Vaccine candidates are being tested in the U.S. and U.K.

+550 Participants

More volunteers are enrolling now!

5 Clinical Studies

Studies are under way to advance influenza vaccine science.

Phase 1

Phase 1 trials are small (typically up to 100 people) and primarily focus on evaluating vaccine safety. Phase I trials also evaluate vaccine immunogenicity and different doses, and are usually conducted in healthy volunteers.

Phase 2

Phase 2 trials are larger than Phase I (typically several hundred people) and focus on vaccine immunogenicity and further evaluation of vaccine safety.

Phase 3

Phase 3 trials are conducted to determine vaccine efficacy in support of FDA licensure and involve thousands of subjects.

Phase 4

Phase 4 trials are performed post-licensure to gather additional safety and efficacy data in the general population or in the population(s) for which the vaccine is indicated.

Scope

The CIVICs program supports clinical trials through two clinical cores located at Duke University in Durham, North Carolina and the University of Maryland School of Medicine in Baltimore, Maryland. These studies will shed light on the human immune responses to influenza vaccination and inform the development of vaccines that provide durable and broad protection against seasonal and pandemic influenza strains. If the vaccines show promise, they may advance into Phase 3 and Phase 4 studies supported outside the NIAID CIVICs program. Learn more about clinical trials supported by NIAID here.

Ongoing CIVICs Clinical Studies

CIVICs is conducting and supporting research to evaluate novel influenza vaccines. You can join the fight against influenza by volunteering to participate in a clinical trial. Learn more about ongoing studies below.

CIVICs Influenza, SARS-CoV-2, and Other Respiratory Pathogen Screening Protocol for Future Challenge and Vaccination Studies (20-0004)

Official Title: CIVICs Influenza, SARS-CoV-2, and Other Respiratory Pathogen Screening Protocol for Future Challenge and Vaccination Studies

Study ID Number: 20-0004 | ClinicalTrials.gov Identifier: Not Applicable

PHASE – Not Applicable

Description: The purpose of the screening protocol is to establish a volunteer registry of healthy adults who are pre-screened and readily available to enroll into CIVICs influenza virus challenge and vaccine studies, SARS-CoV-2 studies, and other respiratory pathogen studies, and to understand background population immunity to common influenza viruses, SARS-CoV-2, and other respiratory pathogens. Serum specimens will be collected from subjects twice a year. Evaluation of the frequency of antibody titers in the local community of the CIVICs sites will help inform screening and recruitment planning for future challenge and vaccine studies.

Site Locations: Duke University, Imperial College London, The State University of New York (SUNY), and University of Maryland School of Medicine

Learn More: Upstate University Hospital’s Informational Website

Influenza Challenge Study to Determine the Optimal Infectious Dose and Safety of a Recombinant H3N2 Influenza Strain (20-0005)

Official Title: A Multicenter, Blinded, Randomized, Placebo-Controlled, Dose-Ranging Influenza Challenge Study in Healthy Adult Volunteers to Determine the Optimal Infection Dose and Safety of a Recombinant H3N2 ((A/Texas/71/2017 (H3N2), Clade 3C3a) Influenza Challenge Virus

Study ID Numbers: 20-0005 | ClinicalTrials.gov Identifier: NCT04978454

PHASE 1

Description: This is a challenge study in healthy adult volunteers, designed to identify an optimal and safe H3N2 influenza virus dose for utilization in future intervention studies. The optimal dose is broadly defined as the minimum challenge virus dose that results in symptomatic influenza infection in the highest number of subjects without meeting safety-stopping criteria. Other outcome measures include evaluation of humoral, mucosal and cellular immune responses, physiological responses to infection, and changes in gene expression after infection. This study will last for up to 1 year depending upon the number of cohorts enrolled given the adaptive dose-escalation design.

Site Locations: Duke University and University of Maryland School of Medicine – Center for Vaccine Development and Global Health

Learn More: ClinicalTrials.gov

Recruitment Status: Completed

Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine in Children (20-0009)

Official Title: A Phase 1b, Double-Blind, Randomized, Dose-Escalating, Age De-Escalating, Placebo-Controlled Study to Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine Delivered Intranasally In a Healthy Pediatric Population 6 Months Through 17 Years of Age

Study ID Numbers: 20-0009 | ClinicalTrials.gov Identifier: NCT04960397

PHASE 1b

Description: This clinical trial will assess the safety and immunogenicity of one and two doses of the intranasal Sing2016 M2SR H3N2 influenza vaccine manufactured by FluGen in a pediatric population. The primary study objective is to assess the safety and tolerability of one and two doses of a novel live attenuated influenza vaccine administered intranasally at different escalating concentrations in healthy pediatric participants from 6 months to 17 years of age.

Site Locations: Duke University – Duke Vaccine and Trials Unit, University of Iowa – Infectious Disease Clinic, University of Maryland School of Medicine – Center for Vaccine Development and Global Health, and Vanderbilt University – Pediatric – Vanderbilt Vaccine Research Center

Learn More: ClinicalTrials.gov

Recruitment Status: Active, Not Recruiting

A Study to Evaluate the Safety and Immunogenicity of Two Doses of DCVC H1 HA mRNA-LNP in Healthy Adults (21-0009)

Official Title: A Phase 1, Comparator-Controlled, Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of Two Doses of DCVC H1 HA mRNA-LNP in Healthy Adults

Study ID Numbers: 21-0009 | ClinicalTrials.gov Identifier: NCT05945485

PHASE 1

Description: This clinical trial will assess the safety and immunogenicity of two doses of an mRNA-LNP vaccine, DCVC H1 HA mRNA Vaccine, developed by the Duke CIVICs Vaccine Center (DCVC) in up to 50 healthy adult volunteers from ages 18 to 49 years. The vaccine encodes the full-length hemagglutinin protein of influenza A/California/07/2009 (H1N1) and will be administered at varying doses intramuscularly to identify the optimal dose—the highest dose with no identified safety concerns. Serum antibody responses to the optimal dose of the DCVC H1 HA mRNA Vaccine will be assessed in comparison to participants receiving licensed quadrivalent influenza vaccine (IIV4).

Site Locations: University of Iowa Hospitals & Clinics – Department of Internal Medicine

Learn More: ClinicalTrials.gov

Recruitment Status: Recruiting

A Study to Evaluate the Safety and Immunogenicity of a Single Dose of H1ssF-3928 mRNA-LNP Vaccine in Healthy Adults (21-0010)

Official Title: A Phase 1, Open-Label, Comparator-Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of a Single Dose of VRC H1ssF-3928 mRNA-LNP in Healthy Adults

Study ID Numbers: 21-0010 | ClinicalTrials.gov Identifier: NCT05755620

PHASE 1

Description: This clinical trial is a First Time in Human study to assess the safety and immunogenicity of the H1ssF 3928 mRNA-LNP influenza investigational vaccine. The antigen encoded by this vaccine is an influenza A H1 hemagglutinin stem covalently fused to Helicobacter pylori ferritin, developed by the NIAID Vaccine Research Center (VRC). The primary objective of this study is to assess the safety and immunogenicity of a single dose of the VRC H1ssF 3928 mRNA-LNP vaccine administered intramuscularly in healthy adults, 18 to 49 years of age, at different escalating concentrations. A comparator group will receive licensed quadrivalent influenza vaccine (IIV4).

Site Locations: Duke University – Duke Vaccine and Trials Unit

Learn More: ClinicalTrials.gov

Recruitment Status: Recruiting